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Budesonide Powder

30/06/10

Generic Name: Budesonide (byoo-DESS-oh-nide)
Brand Name: Pulmicort Turbuhaler

Use caution if you switch from an oral steroid (eg, prednisone) to Budesonide Powder. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again.

Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur.

Budesonide Powder is used for:

Preventing asthma in adults and children 6 years of age or older. It may also be used in patients who require oral corticosteroid medicine. It is not used to relieve an asthma attack. It may also be used for other conditions as determined by your doctor.

Budesonide Powder is an inhaled corticosteroid. It works by decreasing the irritation and swelling of the breathing tubes (bronchioles) of the lung to control or prevent asthma symptoms.

Do NOT use Budesonide Powder if:

you are allergic to any ingredient in Budesonide Powder
you are having an acute asthma attack
you are taking mifepristone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Budesonide Powder:

Some medical conditions may interact with Budesonide Powder. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have glaucoma; cataracts; a herpes eye infection; a bacterial, fungal, parasitic, or viral infection; diarrhea; measles; tuberculosis; chicken pox; or shingles
if you have had a positive TB skin test or have recently been vaccinated

Some MEDICINES MAY INTERACT with Budesonide Powder. Tell your health care provider if you are taking any other medicines, especially any of the following:

Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), or rifampin because they may decrease Budesonide Powder’s effectiveness
Clarithromycin, steroidal contraceptives (eg, birth control pills), or imidazole antifungals (eg, ketoconazole, itraconazole) because they may increase the risk of Budesonide Powder’s side effects
Ritodrine or live vaccines because the risk of their side effects may be increased by Budesonide Powder
Hydantoins (eg, phenytoin) because their effectiveness may be decreased by Budesonide Powder
Mifepristone because risk of side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Budesonide Powder may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Budesonide Powder:

Use Budesonide Powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Budesonide Powder. Talk to your pharmacist if you have questions about this information.
Budesonide Powder must be inhaled through the mouth. Do not breathe out through the inhaler.
Before using, prime the inhaler by holding the unit in an upright position and turning the grip fully to the right, then fully to the left until it clicks.
Do not shake the inhaler.
While inhaling, hold the inhaler in an upright position (mouthpiece on top) during loading in order to provide the correct dose. Place the mouthpiece between your lips and inhale forcefully and deeply.
Rinse the mouth with water (without swallowing) after each use to help prevent mouth or throat infections.
Do not bite or chew the mouthpiece.
Even though you do not sense or taste the powder, you should still be getting the right dose.
Improvement in asthma control can occur within 24 hours of beginning treatment; the maximum effect of Budesonide Powder may take as long as 1 to 2 weeks, or longer. If symptoms do not improve within that period of time, contact your health care provider.
Do not use Budesonide Powder with a spacer.
Keep the inhaler clean and dry at all times.
If you miss a dose of Budesonide Powder, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Budesonide Powder.

Important safety information:

It may take several days for Budesonide Powder to work. Do not stop using Budesonide Powder without checking with your doctor.
Budesonide Powder will not stop an asthma attack. Always carry appropriate medicine (eg, bronchodilator inhaler) in case you have an asthma attack. Contact your doctor immediately if your bronchodilator does not help you to breathe normally.
Tell your doctor or dentist that you take Budesonide Powder before you receive any medical or dental care, emergency care, or surgery.
Carry an ID card at all times that says you take Budesonide Powder.
Use caution if you switch from an oral steroid (eg, prednisone) to Budesonide Powder. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again. Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur.
Budesonide Powder may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does.
Do not receive a live vaccine (eg, measles, mumps) while you are taking Budesonide Powder. Talk with your doctor before you receive any vaccine.
Lab tests, including adrenal function assessment, may be performed while you use Budesonide Powder. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Budesonide Powder.
Budesonide Powder should not be used in CHILDREN younger than 6 years old. Budesonide Powder should be used with extreme caution in CHILDREN 6 to 17 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Budesonide Powder while you are pregnant. It is unknown if Budesonide Powder is found in breast milk. If you are or will be breast-feeding while you use Budesonide Powder, check with your doctor. Discuss any possible risks to your baby.

If symptoms of WITHDRAWAL occur when switching from an oral medicine to an inhaled one (muscle and joint pain, exhaustion; depression), contact your health care provider at once.

Possible side effects of Budesonide Powder:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bad taste in mouth; back pain; cough; fever; headache; hoarseness; indigestion; nausea; pain; throat irritation.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); ear infection; fainting; increased wheezing; infection (fever, chills, sore throat); mental/mood changes; severe dizziness; shortness of breath after using Budesonide Powder; sinus infection; sudden weight loss; tightness in the lungs; vomiting; white patches in mouth or on throat.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/DNN/), or emergency room immediately.

Proper storage of Budesonide Powder:

Store Budesonide Powder at room temperature, between 68 and 77 degrees F (20 to 25 degrees C). Store away from heat, moisture, and direct sunlight. Replace the cover after each use. Do not puncture, break, or burn the canister even if it appears to be empty. Do not store in the bathroom. Keep Budesonide Powder out of the reach of children and away from pets.

General information:

If you have any questions about Budesonide Powder, please talk with your doctor, pharmacist, or other health care provider.
Budesonide Powder is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Budesonide Powder. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

B,Med-facts

Comments (0)

Budesonide Suspension

30/06/10

Generic Name: Budesonide (bue-DES-oh-nide)
Brand Name: Pulmicort Respules

Use caution if you switch from an oral steroid (eg, prednisone) to Budesonide Suspension. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again.

Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur.

Budesonide Suspension is used for:

Long-term treatment of asthma and prevention of asthma in children 1 to 8 years of age. It may also be used for other conditions as determined by your doctor.

Budesonide Suspension is an inhaled corticosteroid. It works by decreasing the irritation and swelling of the breathing tubes (bronchioles) of the lung to control or prevent asthma symptoms.

Do NOT use Budesonide Suspension if:

you are allergic to any ingredient in Budesonide Suspension
you are having an asthma attack
you are taking mifepristone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Budesonide Suspension:

Some medical conditions may interact with Budesonide Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have glaucoma; cataracts; weak bones (eg, osteoporosis); a herpes eye infection; a bacterial, fungal, parasitic, or viral infection; diarrhea; measles; tuberculosis; chickenpox; or shingles
if you have had a positive TB skin test or have recently been vaccinated
if you will be having surgery

Some MEDICINES MAY INTERACT with Budesonide Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

Cimetidine, clarithromycin, imidazole antifungals (eg, ketoconazole, itraconazole), or steroidal contraceptives (eg, birth control pills) because they may increase the risk of Budesonide Suspension’s side effects
Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), or rifampin because they may decrease Budesonide Suspension’s effectiveness
Anticoagulants (eg, warfarin), live vaccines, quinolones (eg, ciprofloxacin), or ritodrine because the risk of their side effects may be increased by Budesonide Suspension
Anticoagulants (eg, warfarin), hydantoins (eg, phenytoin), or interleukin-2 because their effectiveness may be decreased by Budesonide Suspension
Mifepristone because risk of side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Budesonide Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Budesonide Suspension:

Use Budesonide Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Budesonide Suspension. Talk to your pharmacist if you have questions about this information.
Do not mix Budesonide Suspension with other medicines in the nebulizer.
Budesonide Suspension is to be used in a jet nebulizer. Do not use Budesonide Suspension in an ultrasonic nebulizer.
Open the aluminum foil envelope and remove 1 ampule. Record the date on which you open the foil on the back of the envelope. Once the foil is open, the unused ampules should be used within 2 weeks.
Gently shake the ampule, and then squeeze the contents into the nebulizer. Connect the nebulizer to the air pump and begin treatment as directed. Breathe calmly and evenly. When there is no more mist in the nebulizer chamber, the treatment is complete.
Rinse your mouth with water (without swallowing) after each treatment to help prevent mouth infections. Make sure to wash your face after using a face mask. Rinse well and dry.
Once an ampule is opened, use the medicine immediately or discard.
Improvement may be seen within 2 to 8 days after beginning treatment, although the full benefit may not been seen for 4 to 6 weeks after starting treatment. If the asthma symptoms do not get better in 4 to 6 weeks or if they get worse, contact your health care provider.
After use, wash the reservoir of the nebulizer, mouthpiece, and mask according to the manufacturer’s directions.
Continue to use Budesonide Suspension even if you feel well. Do not miss any doses.
If you miss a dose of Budesonide Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Budesonide Suspension.

Important safety information:

It may take several days for Budesonide Suspension to work. Do not stop using Budesonide Suspension without checking with your doctor.
Budesonide Suspension will not stop an asthma attack. Be sure to carry a short-acting bronchodilator inhaler with you at all times to treat any breathing problems that may occur between doses of Budesonide Suspension (eg, severe or sudden onset of wheezing or shortness of breath). If you have any questions about which medicines stop asthma attacks, check with your doctor or pharmacist.
Tell your doctor or dentist that you take Budesonide Suspension before you receive any medical or dental care, emergency care, or surgery.
Carry an ID card at all times that says you take Budesonide Suspension.
Use caution if you switch from an oral steroid (eg, prednisone) to Budesonide Suspension. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again. Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur.
Budesonide Suspension may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. Tell your doctor right away if you are exposed to anyone who has these infections.
Do not receive a live vaccine (eg, measles, mumps) while you are taking Budesonide Suspension. Talk with your doctor before you receive any vaccine.
Tell your doctor at once if you notice that your short-acting bronchodilator inhaler does not work as well, if you need to use it often (eg, 4 or more times a day for more than 2 days in a row, more than 1 canister in 8 weeks), or if you have a decrease in your peak flow meter results.
Contact your doctor or seek medical care right away if you have breathing problems that worsen quickly, or if you use your short-acting bronchodilator and do not get relief.
Talk with your doctor or pharmacist about all of your asthma medicines and how to use them. Do not start, stop, or change the dose of any asthma medicine unless your doctor tells you to.
The medicine may sometimes cause breathing problems right after you use a dose. If this happens, use your short-acting bronchodilator. Contact your doctor or seek other medical care at once.
Lab tests, including adrenal function assessment or eye exams, may be performed while you use Budesonide Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Budesonide Suspension.
Budesonide Suspension should not be used in CHILDREN younger than 12 months old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Budesonide Suspension while you are pregnant. It is unknown if Budesonide Suspension is found in breast milk. If you are or will be breast-feeding while you use Budesonide Suspension, check with your doctor. Discuss any possible risks to your baby.

If symptoms of WITHDRAWAL occur when switching from an oral medicine to an inhaled one (muscle and joint pain, exhaustion, depression), contact your health care provider at once.

Possible side effects of Budesonide Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; diarrhea; nosebleed; runny or stuffy nose; throat irritation.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bone or joint pain; depression; ear pain or discharge; fainting; increased wheezing; infection (fever, chills, persistent cough or sore throat); mental or mood changes (eg, aggressiveness, anxiety, irritability); red, swollen, itchy, or watery eyes; severe dizziness; sudden weight loss; tightness in the lungs; unusual weakness; vision changes; white patches in the mouth or throat.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Budesonide Suspension:

Store Budesonide Suspension at controlled room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in the foil envelope. Store away from heat, moisture, and direct sunlight. Do not refrigerate or freeze. Do not store in the bathroom. Once the foil envelope has been opened, discard any unused ampules after 2 weeks. Keep Budesonide Suspension out of the reach of children and away from pets.

General information:

If you have any questions about Budesonide Suspension, please talk with your doctor, pharmacist, or other health care provider.
Budesonide Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Budesonide Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

B,Med-facts

Comments (0)

Budesonide Spray

30/06/10

Generic Name: Budesonide (bue-DES-oh-nide)
Brand Name: Rhinocort Aqua

Budesonide Spray is used for:

Treating nasal allergy symptoms, including runny nose, nasal congestion, and sneezing. It may also be used for other conditions as determined by your doctor.

Budesonide Spray is a corticosteroid. It works by shrinking swollen and inflamed nasal tissue, and by blocking the action of certain cells and chemicals of the immune system.

Do NOT use Budesonide Spray if:

you are allergic to any ingredient in Budesonide Spray
you are taking mifepristone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Budesonide Spray:

Some medical conditions may interact with Budesonide Spray. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a bacterial, viral, fungal, or parasitic infection; chickenpox; tuberculosis (TB); a positive TB skin test; measles; diarrhea; nasal ulcer, surgery, or trauma; or herpes infection in the eye; or if you have had a recent vaccine

Some MEDICINES MAY INTERACT with Budesonide Spray. Tell your health care provider if you are taking any other medicines, especially any of the following:

Clarithromycin, imidazoles (eg, ketoconazole), hormonal contraceptives (eg, birth control pills), or mifepristone because side effects, such as adrenal suppression effects, may occur
Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), or rifampin because they may decrease Budesonide Spray’s effectiveness
Live vaccines, mifepristone, or ritodrine because the risk of their side effects may be increased by Budesonide Spray
Hydantoins (eg, phenytoin) because their effectiveness may be decreased by Budesonide Spray

This may not be a complete list of all interactions that may occur. Ask your health care provider if Budesonide Spray may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Budesonide Spray:

Use Budesonide Spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Budesonide Spray is for use in the nose.
Shake well before each use.
Before using Budesonide Spray for the first time, gently shake the container and prime the pump 8 times.
Clear your nose before using Budesonide Spray. You may sniff gently to distribute the medicine into your nose, but do not breathe deeply.
If Budesonide Spray is used daily, the pump does not need to be reprimed. If it is not used for 2 consecutive days, reprime it with 1 spray or until a fine mist appears.
If Budesonide Spray is not used for more than 14 days, rinse the applicator and reprime it with 2 sprays or until a fine mist appears.
Use Budesonide Spray on a regular schedule to get the most benefit from it.
Continue to use Budesonide Spray even if you feel well. Do not miss any doses.
Throw the bottle away after 120 sprays following the priming of the bottle. You may not get the correct amount of medication in each spray after a certain number of uses. Do not transfer any remaining suspension to another bottle.
If you miss a dose of Budesonide Spray, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Budesonide Spray.

Important safety information:

Use caution if you switch from an oral steroid (eg, prednisone) to Budesonide Spray. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again. Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur.
Avoid spraying in the eyes.
Always have a spare inhaler available in case the unit malfunctions or is empty.
Symptoms can start to improve as soon as 10 hours after you start using Budesonide Spray, and should improve within a few days. If symptoms do not improve within 2 weeks, or if the condition worsens, contact your health care provider.
If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does.
Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Budesonide Spray.
Budesonide Spray should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Budesonide Spray while you are pregnant. Budesonide Spray is found in breast milk. If you are or will be breast-feeding while you use Budesonide Spray, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Budesonide Spray:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bad taste; coughing; headache; hoarseness; nasal irritation or dryness; nausea; sore throat; tightness in the lungs.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); continuing nose discomfort; increased pressure in the eye; infection (eg, fever, chills, sore throat); nosebleeds or soreness; pounding in the chest.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include body discomfort; depression; difficulty breathing; dizziness; exhaustion; fainting; joint pain; loss of appetite; muscle aches; nausea.

Proper storage of Budesonide Spray:

Store Budesonide Spray at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in an upright position. Store away from heat, moisture, and light. Do not store in the bathroom. Do not freeze. Keep Budesonide Spray out of the reach of children and away from pets.

General information:

If you have any questions about Budesonide Spray, please talk with your doctor, pharmacist, or other health care provider.
Budesonide Spray is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Budesonide Spray. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

B,Med-facts

Comments (0)

budesonide and formoterol (Inhalation route)

30/06/10

bue-DES-oh-nide, for-MOE-ter-ol FUE-ma-rate

Inhalation, oralAerosol Liquid

Long-acting beta(2)-adrenergic agonists may increase the risk of asthma-related death. Therefore, when treating patients with asthma, budesonide/formoterol fumarate should only be used for patients not adequately controlled on other asthma-controller medications (e.g., low-to-medium dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. Data from a large placebo-controlled US study that compared the safety of another long-acting beta(2)-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a long-acting beta(2)-adrenergic agonist), one of the active ingredients in budesonide/formoterol fumarate .

Long-acting beta(2)-adrenergic agonists may increase the risk of asthma-related deaths. Therefore, when treating patients with asthma, budesonide/formoterol fumarate should only be used for patients not adequately controlled on other asthma-controller medications or whose disease severity clearly warrants initiation of treatment with two maintenance therapies .

Commonly used brand name(s):

In the U.S.

Symbicort

In Canada

Symbicort 100 Turbuhaler
Symbicort 200 Turbuhaler

Available Dosage Forms:

Aerosol Liquid
Powder

Therapeutic Class: Antiasthma, Anti-Inflammatory/Bronchodilator Combination

Pharmacologic Class: Adrenal Glucocorticoid

Uses For budesonide and formoterol

Budesonide and formoterol is a combination of two medicines that are used to help control the symptoms of asthma and improve lung function. It is used when a patient’s asthma has not been controlled sufficiently on other asthma medicines, or when a patient’s condition is so severe that more than one medicine is needed every day. budesonide and formoterol will not relieve an asthma attack that has already started.

budesonide and formoterol is also used to treat air flow blockage and reduce the worsening of chronic obstructive pulmonary disease (COPD). This includes chronic bronchitis and emphysema.

Inhaled budesonide belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It works by preventing inflammation (swelling) in the lungs that causes an asthma attack.

Inhaled formoterol belongs to the family of medicines known as bronchodilators. It works by helping the muscles around the airways in your lungs stay relaxed to prevent asthma symptoms, such as wheezing and shortness of breath.

budesonide and formoterol is available only with your doctor’s prescription.

Before Using budesonide and formoterol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For budesonide and formoterol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to budesonide and formoterol or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of budesonide and formoterol combination in children. However, safety and efficacy have not been established in children below 12 years of age. .

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of budesonide and formoterol combination in the elderly. However, elderly patients with heart problems may require special caution when receiving budesonide and formoterol combination.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using budesonide and formoterol with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol
Alprenolol
Arotinolol
Atenolol
Befunolol
Betaxolol
Bevantolol
Bisoprolol
Bopindolol
Brofaromine
Bucindolol
Bupranolol
Bupropion
Carteolol
Carvedilol
Celiprolol
Clorgyline
Dilevalol
Esmolol
Furazolidone
Iproniazid
Isocarboxazid
Labetalol
Landiolol
Lazabemide
Levobetaxolol
Levobunolol
Linezolid
Mepindolol
Metipranolol
Metoprolol
Moclobemide
Nadolol
Nebivolol
Nialamide
Nipradilol
Oxprenolol
Pargyline
Penbutolol
Phenelzine
Pindolol
Procarbazine
Propranolol
Rasagiline
Selegiline
Sotalol
Talinolol
Tertatolol
Timolol
Toloxatone
Tranylcypromine

Using budesonide and formoterol with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Erythromycin
Itraconazole
Ketoconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of budesonide and formoterol

budesonide and formoterol is used with a special inhaler and usually comes with patient directions or a Medication Guide. Read the directions carefully before using budesonide and formoterol. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor or pharmacist to show you what to do.

Use budesonide and formoterol only as directed. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking budesonide and formoterol without telling your doctor. To do so may increase the chance of side effects.

When you use the inhaler for the first time, or if you have not used it for 7 days or longer, or if the inhaler has been dropped, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it by spraying the medicine two times into the air away from the face, and shaking it well for 5 seconds before each spray.

How to use budesonide and formoterol:

Take the inhaler out of the moisture-protective foil pouch before you use it for the first time.
Do not use the inhaler for budesonide and formoterol with any other medicine.
Prime the inhaler before use by shaking the inhaler well for 5 seconds and then releasing a test spray. Once again, shake the inhaler and release a second test spray.
Breathe out to the end of a normal breath (exhale). Do not breathe into the inhaler.
Holding the inhaler level, put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue.
While pressing down firmly and fully on the grey top of the inhaler, breathe in through your mouth as deeply as you can until you have taken a full deep breath.
Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 10 seconds before breathing out slowly. This gives the medicine time to settle in your airways and lungs.
Release your finger from the grey top and then turn your head away from the inhaler. Breathe out slowly to the end of a normal breath. Do not breathe into the inhaler.
Shake the inhaler again for 5 seconds and take the second puff following exactly the same steps you used for the first puff.
Replace the mouthpiece cover after using the medicine.
Gargle and rinse your mouth with water after each dose; this will help prevent hoarseness, throat irritation, and infection in the mouth. Do not swallow the water after rinsing.

Each inhaler comes with a dose tracker card to track the number of puffs you have used. Mark off or punch through each of your morning and evening doses. You must discard the inhaler after you have used the number of inhalations on the product label and box, or within 3 months of opening the foil pouch.

Clean the inhaler every 7 days by wiping the mouthpiece with dry cloth. However, you must use a new inhaler with each refill of your medicine.

Dosing

The dose of budesonide and formoterol will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of budesonide and formoterol. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For inhalation dosage form (aerosol):
- For preventing an asthma attack:
  - Adults and children 12 years of age and older—Two puffs in the morning and another 2 puffs in the evening. Each puff contains 80 or 160 micrograms (mcg) of budesonide and 4.5 mcg of formoterol.
  - Children younger than 12 years of age—Use and dose must be determined by your child’s doctor.
- For treatment of COPD:
  - Adults—Two puffs in the morning and another 2 puffs in the evening. Each puff contains 160 micrograms (mcg) of budesonide and 4.5 mcg of formoterol.
  - Children 12 years of age and older—Not used for COPD in this age group.
  - Children younger than 12 years of age—Not used for COPD in this age group.

Missed Dose

If you miss a dose of budesonide and formoterol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep budesonide and formoterol inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

When you store the inhaler, make sure to always place the mouthpiece down.

Precautions While Using budesonide and formoterol

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and check you for any problems or unwanted effects that may be caused by budesonide and formoterol.

Although budesonide and formoterol decreases the number of asthma episodes, it may increase the chances of a severe asthma episode when they do occur. Talk to your doctor or pharmacist about any questions or concerns that you have.

You should not use budesonide and formoterol if your asthma attack has already started or if you already have a severe asthma attack. Your doctor may prescribe another medicine (e.g., a short-acting inhaler) for you to use in case of an acute asthma attack. Call your doctor immediately for instructions.

Do not use any other asthma medicine or medicine for breathing problems without talking to your doctor. budesonide and formoterol should not be used with salmeterol (Serevent®), formoterol (Perforomist™), or arformoterol (Brovana®) inhalers.

Talk to your doctor or get medical care right away if:

Your symptoms do not improve after using budesonide and formoterol for 1 week or if they become worse.
Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often (e.g.; you use 1 whole canister of your short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of your short-acting inhaler for 2 or more days in a row).
You have a significant decrease in your peak flow when measured as directed by your doctor.

Do not change your doses or stop using your medicines without asking your doctor.

Your doctor may want you to carry a medical identification card stating that you are using budesonide and formoterol and that you may need additional medicine during times of emergency, a severe asthma attack or other illness, or unusual stress.

You may get infections more easily while using budesonide and formoterol. Tell your doctor right away if you have been exposed to someone with chickenpox or measles.

Patients with COPD may be more likely to have pneumonia. Check with your doctor if you start having increased sputum (spit) production, change in sputum color, fever, chills, increased cough, or an increase in breathing problems.

Using too much of budesonide and formoterol or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you have more than one of these symptoms while you are using budesonide and formoterol: darkening of the skin; diarrhea; dizziness; fainting; loss of appetite; mental depression; nausea; skin rash; unusual tiredness or weakness; or vomiting.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

budesonide and formoterol may cause paradoxical bronchospasm, which may be life-threatening. Check with your doctor right away if you are having a cough, difficulty with breathing, shortness of breath, or wheezing.

If you develop a skin rash, hives, or any allergic reaction to budesonide and formoterol, stop taking the medicine and check with your doctor as soon as possible.

budesonide and formoterol may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.

budesonide and formoterol may cause children to grow more slowly than usual. Talk to your child’s doctor if you have any concerns.

budesonide and formoterol may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

budesonide and formoterol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Body aches or pain
chills
cough, fever, sneezing, or sore throat
difficulty with breathing
ear congestion
fever
headache
loss of voice
muscle aches
pain or tenderness around the eyes and cheekbones
shortness of breath or troubled breathing
stuffy or runny nose
tightness of the chest or wheezing
unusual tiredness or weakness

Less common

Abdominal or stomach pain
bladder pain
bloody or cloudy urine
congestion
cough producing mucus
diarrhea
difficult, burning, or painful urination
dryness of the throat
fast, irregular, pounding, or racing heartbeat or pulse
frequent urge to urinate
general feeling of discomfort or illness
hoarseness
joint pain
loss of appetite
lower back or side pain
nausea
noisy breathing
shakiness in the legs, arms, hands, or feet
shivering
sore mouth or tongue
sweating
tender, swollen glands in the neck
trembling or shaking of the hands or feet
trouble with swallowing
trouble with sleeping
voice changes
vomiting
white patches in the mouth or on the tongue

Rare

Blurred vision
confusion
decreased urine
dizziness or lightheadedness when getting up from a lying or sitting position suddenly
dry mouth
enlarged pupils
fainting
flushed, dry skin
fruit-like breath odor
increased hunger
increased sensitivity of the eyes to light
increased sweating, possibly with fever or cold, clammy skin
increased thirst
increased urination
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
mood changes
muscle cramps
nervousness
numbness or tingling in the hands, feet, or lips
pounding in the ears
seizures
severe chest pain
severe headache
slow, fast, pounding, or irregular heartbeat or pulse
stiff or sore neck
unexplained weight loss

Incidence not known

Blindness
decreased vision
eye pain
puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
tearing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Arm, back, or jaw pain
chest pain or discomfort
darkening of the skin
drowsiness
mental depression
rapid, deep breathing
restlessness
skin rash
sleeplessness
stomach cramps
unable to sleep

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Stomach discomfort

Less common

Acid or sour stomach
belching
difficulty with moving
heartburn
indigestion
muscle spasms or stiffness
pain in the arms or legs
stomach upset
swollen joints

Rare

Bad, unusual, or unpleasant (after) taste
change in taste
deep or fast breathing with dizziness, numbness to feet, hands, and around the mouth
fear
hives or welts
irritability
itching skin
large, flat, blue or purplish patches in the skin
redness of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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budesonide and formoterol inhalation

30/06/10

Generic Name: budesonide and formoterol inhalation (bue DES oh nide and for MOE te rol)
Brand names: Symbicort, Symbicort Turbuhaler, Symbicort 400/12 Turbohaler

What is budesonide and formoterol inhalation?

Budesonide is a steroid that reduces inflammation in the body.

Formoterol is a bronchodilator that relaxes muscles in the airways to improve breathing.

The combination of budesonide and formoterol is used to prevent bronchospasm in people with asthma or chronic obstructive pulmonary disease (COPD).

Budesonide and formoterol inhalation may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about budesonide and formoterol inhalation?

Do not use budesonide and formoterol inhalation to treat an asthma attack that has already begun. Budesonide and formoterol inhalation may increase the risk of asthma-related death. Use only the prescribed dose of budesonide and formoterol, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits in using this medication.

Use all of your medications as directed by your doctor. Talk with your doctor if your medications do not seem to work as well in treating or preventing attacks. Do not change your doses or medication schedule without advice from your doctor.

Before using budesonide and formoterol, tell your doctor if you have heart disease, high blood pressure, a seizure disorder, an infection (including herpes infection of the eyes), diabetes, tuberculosis, a thyroid disorder, or an electrolyte imbalance (such as low potassium levels in your blood).

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. If you use a peak flow meter at home, call your doctor if your numbers are lower than normal.

What should I discuss with my healthcare provider before using budesonide and formoterol inhalation?

You should not use this medication if you are allergic to budesonide (Entocort, Pulmicort, Rhinocort) or formoterol (Foradil, Perforomist).

If you have any of these other conditions, you may need a dose adjustment or special tests:

heart disease or high blood pressure;
epilepsy or other seizure disorder;
diabetes;
herpes infection of the eyes;
tuberculosis;
any active infection;
an electrolyte imbalance (such as low potassium levels in your blood); or
a thyroid disorder.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before using budesonide and formoterol, tell your doctor if you are pregnant or plan to become pregnant during treatment. Budesonide can pass into breast milk and could harm a nursing baby. Do not use budesonide and formoterol inhalation without telling your doctor if you are breast-feeding a baby. Budesonide can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication. Do not give this medication to a child younger than 12 years old.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis.

How should I use budesonide and formoterol inhalation?

Budesonide and formoterol inhalation may increase the risk of asthma-related death. Use only the prescribed dose of budesonide and formoterol, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits in using this medication. Do not use budesonide and formoterol to treat an asthma attack that has already begun. It will not work fast enough. Use only a fast-acting inhalation medication.

Budesonide and formoterol comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. Always rinse your mouth after using the inhaler device.

Prime the inhaler device before the first use by pumping 2 test sprays into the air, away from your face. Shake the inhaler for at least 5 seconds before each spray. Prime the inhaler if it has not been used for longer than 7 days, or if the inhaler has been dropped.

Do not try to clean or take apart the inhaler device. Throw it away when the medicine runs out. Do not float the medicine canister in water. The dose indicator on the inhaler will turn red when there are 10 doses left in the device. Get your prescription refilled before you run out of medicine completely. Always use the new device provided with the medication when you get your prescription filled.

It may take up to 2 weeks before your symptoms improve. Keep using the medication as directed. Call your doctor if your symptoms do not improve after the first week of treatment, or if your symptoms get worse.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Your dosage needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your doses or medication schedule without advice from your doctor.

If you also use a steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about using less and less of the steroid before stopping completely.

Carry an identification card or wear a medical alert ID to let others know that you may need an oral steroid in an emergency. Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack. If you use a peak flow meter at home, call your doctor if your numbers are lower than normal.

Store at room temperature, away from moisture, light, and heat. Always keep the cover on the inhaler device when not in use. Keep the medicine canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause redness around your nose, runny nose, trouble breathing, nervousness, muscle cramps, dry mouth, nausea, vomiting, sleep problems (insomnia), tremors, chest pain, fast or pounding heartbeats, fainting, and seizure (convulsions).

What should I avoid while using budesonide and formoterol inhalation?

Do not use a second form of formoterol (such as Foradil, Performist) or use a similar inhaled bronchodilator such as salmeterol (Serevent, Advair) or arformoterol (Brovana) unless your doctor has told you to.

Using a steroid can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medicines.

Budesonide and formoterol inhalation side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

worsening asthma symptoms;
chest pain, fast or pounding heartbeats, tremors, nervousness;
wheezing, throat irritation, choking, or other breathing problems after using this medication;
signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding, unusual weakness;
blurred vision, eye pain, or seeing halos around lights;
white patches or sores in your mouth or throat; or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

headache;
nausea, vomiting, diarrhea, upset stomach;
back pain;
stuffy nose;
muscle or joint pain; or
changes in your voice.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Budesonide and formoterol inhalation Dosing Information

Usual Adult Dose for Asthma — Maintenance:

For patients not currently on an inhaled corticosteroid, including patients on non-corticosteroid maintenance therapy, the recommended dosage is 2 inhalations of 80 mcg-4.5 mcg twice a day. Depending upon asthma severity, the dosage may be increased to 2 inhalations of 160 mcg-4.5 mcg twice a day.

For patients currently receiving medium to high doses of inhaled corticosteroid therapy, the recommended starting dose is 2 inhalations of 160 mcg-4.5 mcg twice a day.

For patients currently receiving low to medium to high doses of inhaled corticosteroid therapy, the recommended starting dose is 2 inhalations of 80 mcg-4.5 mcg twice a day.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease — Maintenance:

For maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema:
2 inhalations of budesonide-formoterol 160 mcg-4.5 mcg/inh by inhalation twice daily. Note: budesonide-formoterol 160 mcg-4.5 mcg/inh is the only approved dosage for the treatment of COPD.

Usual Pediatric Dose for Asthma — Maintenance:

12 years or older:

For patients currently receiving medium to high doses of inhaled corticosteroid therapy, the recommended starting dose is 2 inhalations of 160 mcg-4.5 mcg twice a day.

For patients currently receiving low to medium to high doses of inhaled corticosteroid therapy, the recommended starting dose is 2 inhalations of 80 mcg-4.5 mcg twice a day.

What other drugs will affect budesonide and formoterol?

Before using budesonide and formoterol inhalation tell your doctor if you are taking any of the following medicines:

antibiotics such as azithromycin (Zithromax), clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), or telithromycin (Ketek);
antifungal medication such as ketoconazole (Nizoral), or itraconazole (Sporanox);
a diuretic (water pill);
an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);
an antidepressant such as amitriptyline (Elavil, Etrafon), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil); or
a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

This list is not complete and other drugs may interact with budesonide and formoterol inhalation. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about budesonide and formoterol inhalation.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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budesonide inhalation

30/06/10

Generic Name: budesonide inhalation (byoo DES oh nide)
Brand Names: Pulmicort Flexhaler, Pulmicort Respules

What is budesonide inhalation?

Budesonide is a steroid. It prevents the release of substances in the body that cause inflammation.

Budesonide inhalation is used to prevent asthma attacks. It will not treat an asthma attack that has already begun.

Budesonide may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about budesonide inhalation?

Do not use budesonide inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use only a fast-acting inhalation medicine to treat an asthma attack.

Contact your doctor if your asthma symptoms do not improve after using budesonide inhalation for 2 weeks.

Call your doctor right away if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack.

Your dosage needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.

If you also use an oral steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about taking less and less of the steroid before stopping completely.

What should I discuss with my healthcare provider before using budesonide inhalation?

You should not take this medication if you are allergic to budesonide, or if you are having an acute asthma attack.

Before using budesonide inhalation, tell your doctor if you are allergic to any drugs, or if you have:

liver disease;
osteoporosis;
herpes simplex infection of your eyes;
any type of bacterial, fungal, or viral infection; or
a history of tuberculosis.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Budesonide can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Budesonide can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

Do not give this medicine to a child younger than 6 years old without the advice of a doctor.

How should I use budesonide inhalation?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.

Read all patient instructions that come with your inhaler device. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

To reduce the chance of developing a yeast infection in your mouth, rinse your mouth with water after using budesonide inhalation. If you are using a nebulizer with a face mask, wash the mask area of your face after each use.

If you also use a steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about taking less and less of the steroid before stopping completely.

Contact your doctor if your asthma symptoms do not improve after using budesonide inhalation for 2 weeks.

Asthma is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor.

Call your doctor right away if you feel that this medicine makes your condition worse. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor.

To be sure budesonide inhalation is not causing harmful effects, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Using a steroid can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill.

Store this medication at room temperature away from moisture and heat. Keep the cover on your inhaler device while not in use.

Keep the strip of Pulmicort Respules in the foil envelope, protected from light until you are ready to use the medication. After tearing off one ampule, return the strip to the envelope to protect the remaining ampules from light. Store the foil envelope upright. Once you have opened an envelope, you must use the ampules within 2 weeks.

The Pulmicort Flexhaler device has indicator marks to show you how many doses are left inside. These dose-counter marks show increments of 20 doses. The indicator may not appear to move until about 5 doses have been used.

Do not use an extra dose just because the Flexhaler indicator has not visibly moved to a lower number after one use. Ask your pharmacist if you have questions about using your inhaler device.

Get your budesonide prescription refilled before you run out of medicine completely. Throw the old inhaler device away. It is a disposable container and cannot be refilled with budesonide.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

An overdose of budesonide inhalation is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while taking budesonide inhalation?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Budesonide inhalation side effects

weakness, tired feeling, nausea, vomiting, feeling like you might pass out;
wheezing or breathing problems after using this medication;
worsening respiratory symptoms;
ear pain with fever;
vision problems; or
changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

Less serious side effects may include:

white patches or sores inside your mouth or on your lips;
runny or stuffy nose, sneezing;
sore throat, cough;
nausea, vomiting, diarrhea, stomach pain;
nosebleed; or
headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Budesonide inhalation Dosing Information

Usual Adult Dose for Crohn’s Disease — Acute:

Mild to moderate active Crohn’s Disease involving the ileum and or ascending colon:
9 mg orally once daily in the morning for up to 8 weeks. Treatment can be tapered to 6 mg daily for 2 weeks prior to complete cessation. For recurring episodes of active Crohn’s Disease, repeated eight-week courses can be given. Following 8 week course(s) of treatment for active disease and once the patient’s symptoms are controlled, 6 mg once daily is recommended for maintenance of clinical remission up to 3 months.

Usual Adult Dose for Asthma — Maintenance:

Pulmicort Turbuhaler (200 mcg/inh):

Previously treated with bronchodilators alone:
I to 2 inhalations (200 mcg to 400 mcg) twice daily. Maximum dose: 2 inhalations (400 mcg) twice daily.

Previously treated with inhaled corticosteroids:
I to 2 inhalations (200 mcg to 400 mcg) twice daily. Maximum dose: 4 inhalations (800 mcg) twice daily.

Previously treated with oral corticosteroids:
I to 4 inhalations (400 mcg to 800 mcg) twice daily. Maximum dose: 4 inhalations (800 mcg) twice daily.

Pulmicort Flexhaler (90 and 180 mcg/inh):
2 inhalations (360 mcg) twice daily. In some patients, a starting dose of 180 mcg twice daily may be appropriate. The maximum dosage should not exceed 360 mcg twice daily.

Usual Pediatric Dose for Asthma — Maintenance:

inhalation powder:
6 years or older:

Pulmicort Turbuhaler (200 mcg/inh):
Previously treated with bronchodilators alone or with inhaled corticosteroids:
I inhalation (200 mcg) twice daily. Maximum dose: 2 inhalations (400 mcg) twice daily.
Previously treated with oral corticosteroids:
2 inhalations (400 mcg) twice daily. Maximum dose: 2 inhalations (400 mcg) twice daily.

Pulmicort Flexhaler (90 and 180 mcg/inh):
1 inhalation (180 mcg) twice daily. In some patients, a starting dose of 360 mcg twice daily may be appropriate. The maximum dosage should not exceed 360 mcg twice daily.

inhalation suspension:
1 to 8 years:
Previously treated with bronchodilators alone:
0.5 mg total daily dose given once or twice daily in divided doses. Maximum dose: 0.5 mg /day.
Previously treated with inhaled corticosteroids:
0.5 mg total daily dose given once or twice daily in divided doses. Maximum dose: 1 mg /day.
Previously treated with oral corticosteroids:
1 mg total daily dose given once or twice daily in divided doses. Maximum dose: 1 mg /day.

Symptomatic children not responding to nonsteroidal asthma medications: Initial: 0.25 mg once daily may be considered

Usual Pediatric Dose for Crohn’s Disease — Acute:

Limited data available; optimal dose and duration of treatment not established.
Children 6 years or older:
Active Crohn’s disease (treatment): 9 mg/day given once daily for 7 to 8 weeks.
Maintenance of remission: 6 mg/day given once daily for 3 to 4 weeks.
Note: One study in children 10 to 19 years of age showed a trend for higher remission rates using an induction dose of 12 mg/day given once daily for 4 weeks, followed by 9 mg/day for 3 weeks, followed by 6 mg/day for 3 weeks.
Further studies are needed to establish optimal dosing regimen.

What other drugs will affect budesonide inhalation?

The following drugs can interact with budesonide. Tell your doctor if you are using any of these:

HIV /AIDS medicine such as nelfinavir (Viracept) or ritonavir (Norvir);
an antibiotic such as clarithromycin (Biaxin) or erythromycin (E.E.S., E-Mycin, Ery-Tab, Erythrocin);
an antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);
an “SSRI” antidepressant such as fluoxetine (Prozac), fluvoxamine (Luvox), or paroxetine (Paxil); or
a tricyclic antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

This list is not complete and there may be other drugs that can interact with budesonide inhalation. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about budesonide inhalation.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

B,Concise

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Budesonide Inhalation Suspension

30/06/10

Dosage Form: inhalation suspension

Budesonide Inhalation Suspension

Rx only

For inhalation use via compressed air driven jet nebulizers only (not for use with ultrasonic devices). Not for injection.

Read patient instructions before using.

Budesonide Inhalation Suspension Description

Budesonide Inhalation Suspension is a corticosteroid designated chemically as (RS)-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with butyraldehyde. Budesonide Inhalation Suspension is provided as a mixture of two epimers (22R and 22S) and it has the following structural formula:

Budesonide Inhalation Suspension is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 × 103.

Budesonide Inhalation Suspension is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient Budesonide Inhalation Suspension (micronized), and the inactive ingredients: citric acid monohydrate, disodium edetate, polysorbate 80, sodium chloride, tri-sodium citrate dihydrate and water for injection.

Two dose strengths are available in single-dose vials: 0.25 mg and 0.5 mg per 2 mL vial. For Budesonide Inhalation Suspension, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under in vitro conditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of 5.5 L/min. The mean nebulization time was 5 minutes or less. Budesonide Inhalation Suspension should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION).

Budesonide Inhalation Suspension – Clinical Pharmacology

Mechanism of Action

Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity. In standard in vitro and animal models, budesonide has approximately a 200-fold higher affinity for the glucocorticoid receptor and a 1000-fold higher topical anti-inflammatory potency than cortisol (rat croton oil ear edema assay). As a measure of systemic activity, budesonide is 40 times more potent than cortisol when administered subcutaneously and 25 times more potent when administered orally in the rat thymus involution assay.

The activity of Budesonide Inhalation Suspension is due to the parent drug, budesonide. In glucocorticoid receptor affinity studies, the 22R form was two times as active as the 22S epimer. In vitro studies indicated that the two forms of budesonide do not interconvert.

The precise mechanism of corticosteroid actions on inflammation in asthma is not well known. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of inhibitory activities against multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic- and non-allergic-mediated inflammation. The anti-inflammatory actions of corticosteroids may contribute to their efficacy in asthma.

Studies in asthmatic patients have shown a favorable ratio between topical anti-inflammatory activities and systemic corticosteroid effects over a wide dose range of inhaled budesonide in a variety of formulations and delivery systems including budesonide dry powder inhaler (an inhalation-driven, multi-dose dry powder inhaler) and the inhalation suspension for nebulization. This is explained by a combination of a relatively high local anti-inflammatory effect, extensive first pass hepatic degradation of orally absorbed drug (85 to 95%) and the low potency of metabolites (see below).

Pharmacokinetics

Absorption

In asthmatic children 4 to 6 years of age, the total absolute bioavailability (i.e., lung + oral) following administration of Budesonide Inhalation Suspension via jet nebulizer was approximately 6% of the labeled dose.

In children, a peak plasma concentration of 2.6 nmol/L was obtained approximately 20 minutes after nebulization of a 1 mg dose. Systemic exposure, as measured by AUC and Cmax, is similar for young children and adults after inhalation of the same dose of Budesonide Inhalation Suspension.

Distribution

In asthmatic children 4 to 6 years of age, the volume of distribution at steady-state of budesonide was 3 L/kg, approximately the same as in healthy adults. Budesonide is 85 to 90% bound to plasma proteins, the degree of binding being constant over the concentration range (1 to 100 nmol/L) achieved with, and exceeding, recommended doses. Budesonide showed little or no binding to corticosteroid-binding globulin. Budesonide rapidly equilibrated with red blood cells in a concentration independent manner with a blood/plasma ratio of about 0.8.

Metabolism

In vitro studies with human liver homogenates have shown that budesonide is rapidly and extensively metabolized. Two major metabolites formed via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4) catalyzed biotransformation have been isolated and identified as 16 α -hydroxyprednisolone and 6β -hydroxybudesonide. The corticosteroid activity of each of these two metabolites is less than 1% of that of the parent compound. No qualitative difference between the in vitro and in vivo metabolic patterns has been detected. Negligible metabolic inactivation was observed in human lung and serum preparations.

Excretion/Elimination

Budesonide is primarily cleared by the liver. Budesonide is excreted in urine and feces in the form of metabolites. In adults, approximately 60% of an intravenous radiolabeled dose was recovered in the urine. No unchanged budesonide was detected in the urine.

In asthmatic children 4 to 6 years of age, the terminal half-life of budesonide after nebulization is 2.3 hours, and the systemic clearance is 0.5 L/min, which is approximately 50% greater than in healthy adults after adjustment for differences in weight.

Special Populations

No differences in pharmacokinetics due to race, gender, or age have been identified.

Hepatic Insufficiency

Reduced liver function may affect the elimination of corticosteroids. The pharmacokinetics of budesonide were affected by compromised liver function as evidenced by a doubled systemic availability after oral ingestion. The intravenous pharmacokinetics of budesonide were, however, similar in cirrhotic patients and in healthy adults.

Nursing Mothers

The disposition of budesonide when delivered by inhalation from a dry powder inhaler at doses of 200 or 400 mcg twice daily for at least 3 months was studied in eight lactating women with asthma from 1 to 6 months postpartum. Systemic exposure to budesonide in these women appears to be comparable to that in non-lactating women with asthma from other studies. Breast milk obtained over eight hours post-dose revealed that the maximum concentration of budesonide for the 400 and 800 mcg doses was 0.39 and 0.78 nmol/L, respectively, and occurred within 45 minutes after dosing. The estimated oral daily dose of budesonide from breast milk to the infant is approximately 0.007 and 0.014 mcg/kg/day for the two-dose regimens used in this study, which represents approximately 0.3% to 1% of the dose inhaled by the mother. Budesonide levels in plasma samples obtained from five infants at about 90 minutes after breast-feeding (and about 140 minutes after drug administration to the mother) were below quantifiable levels (< 0.02 nmol/L in four infants and < 0.04 nmol/L in one infant) (see PRECAUTIONS, Nursing Mothers).

Pharmacodynamics

The therapeutic effects of conventional doses of orally inhaled budesonide are largely explained by its direct local action on the respiratory tract. To confirm that systemic absorption is not a significant factor in the clinical efficacy of inhaled budesonide, a clinical study in adult patients with asthma was performed comparing 400 mcg budesonide administered via a pressurized metered dose inhaler with a tube spacer to 1400 mcg of oral budesonide and placebo. The study demonstrated the efficacy of inhaled budesonide but not orally ingested budesonide despite comparable systemic levels.

Improvement in the control of asthma symptoms following inhalation of Budesonide Inhalation Suspension can occur within 2 to 8 days of beginning treatment, although maximum benefit may not be achieved for 4 to 6 weeks.

Budesonide administered via a dry powder inhaler has been shown in various challenge models (including histamine, methacholine, sodium metabisulfite, and adenosine monophosphate) to decrease bronchial hyper-responsiveness in asthmatic patients. The clinical relevance of these models is not certain.

Pre-treatment with budesonide administered as 1600 mcg daily (800 mcg twice daily) via a dry powder inhaler for 2 weeks reduced the acute (early-phase reaction) and delayed (late-phase reaction) decrease in FEV1 following inhaled allergen challenge.

The effects of Budesonide Inhalation Suspension on the hypothalamic-pituitary-adrenal (HPA) axis were studied in three, 12-week, double-blind, placebo-controlled studies in 293 pediatric patients, 6 months to 8 years of age, with persistent asthma. For most patients, the ability to increase cortisol production in response to stress, as assessed by the short cosyntropin (ACTH) stimulation test, remained intact with Budesonide Inhalation Suspension treatment. In a subgroup of children age 6 months to 2 years (n = 21) treated with a total daily dose of Budesonide Inhalation Suspension up to 1 mg or placebo, the mean change from baseline in ACTH-stimulated cortisol levels showed a decline in peak stimulated cortisol at 12 weeks compared to an increase in the placebo group. These mean differences were not statistically significant compared to placebo. Another 12-week study was conducted in 141 pediatric patients 6 to 12 months of age with mild to moderate asthma or recurrent/persistent wheezing. All patients were treated with a total daily dose of either 0.5 mg or 1 mg of Budesonide Inhalation Suspension or placebo. A total of 28, 17, and 31 patients in the Budesonide Inhalation Suspension 0.5 mg, 1 mg, and placebo arms respectively had an evaluation of serum cortisol levels post-ACTH stimulation both at baseline and at the end of the study. The mean change from baseline to Week 12 ACTH-stimulated minus basal plasma cortisol levels did not indicate adrenal suppression in patients treated with Budesonide Inhalation Suspension versus placebo. However, 7 patients in this study (4 of whom received Budesonide Inhalation Suspension 0.5 mg, 2 of whom received Budesonide Inhalation Suspension 1 mg and 1 of whom received placebo) showed a shift from normal baseline stimulated cortisol level (≥ 500 nmol/L) to a subnormal level (< 500 nmol/L) at Week 12. In 4 of these patients receiving Budesonide Inhalation Suspension, the cortisol values were near the cutoff value of 500 nmol/L.

The effects of Budesonide Inhalation Suspension at doses of 0.5 mg twice daily, and 1 mg and 2 mg twice daily (2 times and 4 times the highest recommended total daily dose, respectively) on 24-hour urinary cortisol excretion were studied in 18 patients between 6 to 15 years of age with persistent asthma in a cross-over study design (4 weeks of treatment per dose level). There was a dose-related decrease in urinary cortisol excretion at 2 and 4 times the recommended daily dose. The two higher doses of Budesonide Inhalation Suspension (1 and 2 mg twice daily) showed statistically significantly reduced (43 to 52%) urinary cortisol excretion compared to the run-in period. The highest recommended dose of Budesonide Inhalation Suspension, 1 mg total daily dose, did not show statistically significantly reduced urinary cortisol excretion compared to the run-in period.

Budesonide Inhalation Suspension, like other inhaled corticosteroid products, may impact the HPA axis, especially in susceptible individuals, in younger children, and in patients given high doses for prolonged periods.

Clinical Trials

Three double-blind, placebo-controlled, parallel group, randomized U.S. clinical trials of 12-weeks duration each were conducted in 1018 pediatric patients, 6 months to 8 years of age, with persistent asthma of varying disease duration (2 to 107 months) and severity. Doses of 0.25 mg and 0.5 mg administered twice daily were compared to placebo to provide information about appropriate dosing to cover a range of asthma severity. A Pari-LC-Jet Plus Nebulizer (with a face mask or mouthpiece) connected to a Pari Master compressor was used to deliver Budesonide Inhalation Suspension to patients in the 3 U.S. controlled clinical trials. The co-primary endpoints were nighttime and daytime asthma symptom scores (0 to 3 scale). Each of the doses discussed below were studied in one or two, but not all three of the U.S. studies.

Results of the 3 controlled clinical trials for recommended dosages of Budesonide Inhalation Suspension (0.25 mg to 0.5 mg twice daily, up to a total daily dose of 1 mg) in patients, 12 months to 8 years of age, are presented below. Compared to placebo, Budesonide Inhalation Suspension significantly decreased both nighttime and daytime symptom scores of asthma at doses of 0.25 mg twice daily, and 0.5 mg twice daily. Symptom reduction in response to Budesonide Inhalation Suspension occurred across gender and age. Budesonide Inhalation Suspension significantly reduced the need for bronchodilator therapy at all the doses studied.

Improvements in lung function were associated with Budesonide Inhalation Suspension treatment in the subgroup of patients capable of performing lung function testing. Significant improvements were seen in FEV1 [Budesonide Inhalation Suspension 0.5 mg twice daily] and morning PEF [Budesonide Inhalation Suspension 0.25 mg twice daily and 0.5 mg twice daily] compared to placebo.

A numerical reduction in nighttime and daytime symptom scores (0 to 3 scale) of asthma was observed within 2 to 8 days, although maximum benefit was not achieved for 4 to 6 weeks after starting treatment. The reduction in nighttime and daytime asthma symptom scores was maintained throughout the 12 weeks of the double-blind trials.

Patients Previously Maintained on Inhaled Corticosteroid Therapy

The efficacy of Budesonide Inhalation Suspension at doses of 0.25 mg and 0.5 mg twice daily was evaluated in 133 pediatric asthma patients, 4 to 8 years of age, previously maintained on inhaled corticosteroids (mean FEV1 79.5% predicted; mean baseline nighttime asthma symptom scores of the treatment groups ranged from 1.04 to 1.18; mean baseline dose of beclomethasone dipropionate of 265 mcg/day, ranging between 42 to 1008 mcg/day; mean baseline dose of triamcinolone acetonide of 572 mcg/day, ranging between 200 to 1200 mcg/day). The changes from baseline to Weeks 0 to 12 in nighttime asthma symptom scores are shown in Figure 1. Nighttime asthma symptom scores were significantly improved in patients treated with Budesonide Inhalation Suspension compared to placebo. Similar improvements were also observed for daytime asthma symptom scores.

Budesonide Inhalation Suspension at a dose of 0.5 mg twice daily significantly improved FEV1, and both doses (0.25 mg and 0.5 mg twice daily) significantly increased morning PEF, compared to placebo.

Figure 1. A 12-Week Trial in Pediatric Patients Previously Maintained on Inhaled Corticosteroid Therapy Prior to Study Entry

Patients Either Maintained on Bronchodilators Alone or Inhaled Corticosteroid Therapy

The efficacy of Budesonide Inhalation Suspension at doses of 0.25 mg twice daily and 0.5 mg twice daily, was evaluated in pediatric patients 12 months to 8 years of age (mean baseline nighttime asthma symptom scores of the treatment groups ranged from 1.13 to 1.31).

Approximately 70% were not previously receiving inhaled corticosteroids. The changes from baseline to Weeks 0 to 12 in nighttime asthma symptom scores are shown in Figure 2. Budesonide Inhalation Suspension at doses of 0.25 mg and 0.5 mg twice daily, significantly improved nighttime asthma symptom scores compared to placebo. Similar improvements were also observed for daytime asthma symptom scores.

Budesonide Inhalation Suspension at a dose of 0.5 mg twice daily significantly improved FEV1, and at doses of 0.25 mg and 0.5 mg twice daily significantly improved morning PEF, compared to placebo.

Figure 2. A 12-Week Trial in Pediatric Patients Either Maintained on Bronchodilators Alone or Inhaled Corticosteroid Therapy Prior to Study Entry

Indications and Usage for Budesonide Inhalation Suspension

Budesonide Inhalation Suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age.

Budesonide Inhalation Suspension is NOT indicated for the relief of acute bronchospasm.

Contraindications

Budesonide Inhalation Suspension is contraindicated as the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

Hypersensitivity to Budesonide Inhalation Suspension or any of the ingredients of this preparation contraindicates the use of Budesonide Inhalation Suspension.

Warnings

Particular care is needed for patients who are transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA)-axis function.

Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn.

During this period of HPA-axis suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss. Although Budesonide Inhalation Suspension may provide control of asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of corticosteroid systemically and does NOT provide the mineralocorticoid activity that is necessary for coping with these emergencies.

During periods of stress or a severe asthma attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and to contact their physicians for further instructions. These patients should also be instructed to carry a warning card indicating that they may need supplementary systemic corticosteroids during periods of stress or a severe asthma attack.

Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to Budesonide Inhalation Suspension. Lung function (FEV1 or AM PEF), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids. In addition to monitoring asthma signs and symptoms, patients should be observed for signs and symptoms of adrenal insufficiency such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension.

Transfer of patients from systemic corticosteroid therapy to Budesonide Inhalation Suspension may unmask allergic or other immunologic conditions previously suppressed by the systemic corticosteroid therapy, e.g., rhinitis, conjunctivitis, eosinophilic conditions, eczema, and arthritis (see DOSAGE AND ADMINISTRATION).

Patients who are on drugs which suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible pediatric patients or adults on immunosuppressant doses of corticosteroids. In pediatric or adult patients who have not had these diseases, or who have not been properly vaccinated, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known.

The clinical course of chicken pox or measles infection in patients on inhaled corticosteroids has not been studied. However, a clinical study has examined the immune responsiveness of asthma patients 12 months to 8 years of age who were treated with Budesonide Inhalation Suspension (see PRECAUTIONS, Pediatric Use).

If a patient on immunosuppressant doses of corticosteroids is exposed to chicken pox, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated (see the respective package inserts for complete VZIG and IG prescribing information). If chicken pox develops, treatment with antiviral agents may be considered.

Budesonide inhalation suspension is not a bronchodilator and is not indicated for the rapid relief of acute bronchospasm or other acute episodes of asthma.

As with other inhaled asthma medications, bronchospasm, with an immediate increase in wheezing, may occur after dosing. If acute bronchospasm occurs following dosing with Budesonide Inhalation Suspension, it should be treated immediately with a fast-acting inhaled bronchodilator. Treatment with Budesonide Inhalation Suspension should be discontinued and alternate therapy instituted.

Patients should be instructed to contact their physician immediately when episodes of asthma not responsive to their usual doses of bronchodilators occur during treatment with Budesonide Inhalation Suspension.

Hypersensitivity Reactions Including Anaphylaxis

Hypersensitivity reactions including anaphylaxis, rash, contact dermatitis, urticaria, angioedema, and bronchospasm have been reported with use of Budesonide Inhalation Suspension . Discontinue Budesonide Inhalation Suspension if such reactions occur (see CONTRAINDICATIONS and ADVERSE REACTIONS).

Precautions

General

During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function (see DOSAGE AND ADMINISTRATION).

Because budesonide is absorbed into the circulation and may be systemically active, particularly at higher doses, suppression of HPA function may be associated when Budesonide Inhalation Suspension is administered at doses exceeding those recommended (see DOSAGE AND ADMINISTRATION), or when the dose is not titrated to the lowest effective dose. Since individual sensitivity to effects on cortisol production exists, physicians should consider this information when prescribing Budesonide Inhalation Suspension.

Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with Budesonide Inhalation Suspension should be observed carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients post-operatively or during periods of stress for evidence of inadequate adrenal response.

It is possible that systemic corticosteroid effects such as hypercorticism, reduced bone mineral density, and adrenal suppression may appear in a small number of patients, particularly at higher doses. If such changes occur, Budesonide Inhalation Suspension should be reduced slowly, consistent with accepted procedures for management of asthma symptoms and for tapering of systemic corticosteroids.

Orally inhaled corticosteroids, including budesonide, may cause a reduction in growth velocity when administered to pediatric patients. A reduction in growth velocity may occur as a result of inadequate control of asthma or from use of corticosteroids for treatment. The potential effects of prolonged treatment on growth velocity should be weighed against the clinical benefits obtained and the risks associated with alternative therapies. To minimize the systemic effects of orally inhaled corticosteroids, including Budesonide Inhalation Suspension, each patient should be titrated to his/her lowest effective dose (see PRECAUTIONS, Pediatric Use).

Although patients in clinical trials have received Budesonide Inhalation Suspension on a continuous basis for periods of up to 1 year, the long-term local and systemic effects of Budesonide Inhalation Suspension in human subjects are not completely known. In particular, the effects resulting from chronic use of Budesonide Inhalation Suspension on developmental or immunological processes in the mouth, pharynx, trachea, and lung are unknown.

In clinical trials with Budesonide Inhalation Suspension, localized infections with Candida albicans occurred in the mouth and pharynx in some patients. The incidences of localized infections of Candida albicans were similar between the placebo and Budesonide Inhalation Suspension treatment groups. If these infections develop, they may require treatment with appropriate antifungal therapy and/or discontinuance of treatment with Budesonide Inhalation Suspension.

Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract, untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

Rare instances of glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids.

Information for Patients

Patients being treated with Budesonide Inhalation Suspension should receive the following information and instructions. This information is intended to aid the patient in the safe and effective use of the medication. It is not a disclosure of all possible adverse or intended effects. For instructions on the proper use of Budesonide Inhalation Suspension and to attain the maximum improvement in asthma symptoms, the patient or the parent/guardian of the patient should receive, read, and follow the accompanying patient information and instructions carefully.

Patients should take Budesonide Inhalation Suspension at regular intervals twice a day as directed, since its effectiveness depends on regular use. The patient should not alter the prescribed dosage unless advised to do so by the physician.
The effects of mixing Budesonide Inhalation Suspension with other nebulizable medications have not been adequately assessed. Budesonide Inhalation Suspension should be administered separately in the nebulizer.
Budesonide Inhalation Suspension is not a bronchodilator, and its use is not intended to treat acute life-threatening episodes of asthma.
Budesonide Inhalation Suspension should be administered with a jet nebulizer connected to a compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask. The face mask should be properly adjusted to optimize delivery and to avoid exposing the eyes to the nebulized medication (see DOSAGE AND ADMINISTRATION).
Ultrasonic nebulizers are not suitable for the adequate administration of Budesonide Inhalation Suspension and, therefore, are not recommended (see DOSAGE AND ADMINISTRATION).
Rinsing the mouth with water after each treatment may decrease the risk of development of local candidiasis. Corticosteroid effects on the skin can be avoided if the face is washed after the use of a face mask.
Improvement in asthma control following treatment with Budesonide Inhalation Suspension can occur within 2 to 8 days of beginning treatment, although maximum benefit may not be achieved for 4 to 6 weeks after starting treatment. If the asthma symptoms do not improve in that time frame, or if the condition worsens, the patient or the patient’s parent/guardian should be instructed not to increase the dosage, but to contact the physician.
Patients should not stop the use of Budesonide Inhalation Suspension abruptly without consulting with their prescribing physician.
Patients whose chronic systemic corticosteroids have been reduced or withdrawn should be instructed to carry a warning card indicating that they may need supplemental systemic corticosteroids during periods of stress or an asthma attack that does not respond to bronchodilators.
As always, care should be taken to avoid exposure to persons with chicken pox and measles. If exposure to such a person occurs, and the child has not had chicken pox or been properly vaccinated, a physician should be consulted without delay (see WARNINGS and PRECAUTIONS, Pediatric Use).
Long-term use of inhaled corticosteroids, including budesonide, may increase the risk of some eye problems (cataracts or glaucoma). Regular eye examinations should be considered.
Patients or their parents/guardians considering use of Budesonide Inhalation Suspension should consult with their physician if they are allergic to budesonide or any other orally inhaled corticosteroid.
Physicians should be informed of other medications patients are taking as Budesonide Inhalation Suspension may not be suitable in some circumstances and the physician may wish to use a different medicine.
Budesonide Inhalation Suspension should be stored upright at controlled room temperature 20° to 25°C (68° to 77°F) and protected from light. Budesonide Inhalation Suspension should not be refrigerated or frozen.
When an aluminum foil envelope has been opened, the shelf life of the unused vials is two weeks when protected from light. The date the envelope was opened should be recorded on the front of the envelope in the space provided.
After opening the aluminum foil envelope, the unused vials should be returned to the envelope to protect them from light. Any individually opened vials must be used promptly.
For proper usage of Budesonide Inhalation Suspension and to attain maximum improvement, the accompanying Patient’s Instructions for Use should be read and followed.

Drug Interactions

In clinical studies, concurrent administration of budesonide and other drugs commonly used in the treatment of asthma has not resulted in an increased frequency of adverse events. The main route of metabolism of budesonide, as well as other corticosteroids, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a potent inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. Concomitant administration of other known inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, erythromycin, etc.) may inhibit the metabolism of, and increase the systemic exposure to, budesonide. Care should be exercised when budesonide is coadministered with long-term ketoconazole and other known CYP3A4 inhibitors. Omeprazole did not have effects on the pharmacokinetics of oral budesonide, while cimetidine, primarily an inhibitor of CYP1A2, caused a slight decrease in budesonide clearance and a corresponding increase in its oral bioavailability.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies were conducted in rats and mice using oral administration to evaluate the carcinogenic potential of budesonide.

In a two-year study in Sprague-Dawley rats, budesonide caused a statistically significant increase in the incidence of gliomas in male rats at an oral dose of 50 mcg/kg (less than the maximum recommended daily inhalation dose in adults and children on a mcg/m2 basis). No tumorigenicity was seen in male and female rats at respective oral doses up to 25 and 50 mcg/kg (less than the maximum recommended daily inhalation dose in adults and children on a mcg/m2 basis). In two additional two-year studies in male Fischer and Sprague-Dawley rats, budesonide caused no gliomas at an oral dose of 50 mcg/kg (less than the maximum recommended daily inhalation dose in adults and children on a mcg/m2 basis). However, in the male Sprague-Dawley rats, budesonide caused a statistically significant increase in the incidence of hepatocellular tumors at an oral dose of 50 mcg/kg (less than the maximum recommended daily inhalation dose in adults and children on a mcg/m2 basis). The concurrent reference corticosteroids (prednisolone and triamcinolone acetonide) in these two studies showed similar findings.

In a 91-week study in mice, budesonide caused no treatment-related carcinogenicity at oral doses up to 200 mcg/kg (less than the maximum recommended daily inhalation dose in adults and children on a mcg/m2 basis).

Budesonide was not mutagenic or clastogenic in six different test systems: Ames Salmonella/microsome plate test, mouse micronucleus test, mouse lymphoma test, chromosome aberration test in human lymphocytes, sex-linked recessive lethal test in Drosophila melanogaster, and DNA repair analysis in rat hepatocyte culture.

In rats, budesonide had no effect on fertility at subcutaneous doses up to 80 mcg/kg (less than the maximum recommended daily inhalation dose in adults on a mcg/m2 basis). However, it caused a decrease in prenatal viability and viability in the pups at birth and during lactation, along with a decrease in maternal body-weight gain, at subcutaneous doses of 20 mcg/kg and above (less than the maximum recommended daily inhalation dose in adults on a mcg/m2 basis). No such effects were noted at 5 mcg/kg (less than the maximum recommended daily inhalation dose in adults on a mcg/m2 basis).

Pregnancy

Teratogenic Effects

Pregnancy category B

As with other corticosteroids, budesonide was teratogenic and embryocidal in rabbits and rats. Budesonide produced fetal loss, decreased pup weights, and skeletal abnormalities at subcutaneous doses of 25 mcg/kg in rabbits (less than the maximum recommended daily inhalation dose in adults on a mcg/m2 basis) and 500 mcg/kg in rats (approximately 4 times the maximum recommended daily inhalation dose in adults on a mcg/m2 basis). In another study in rats, no teratogenic or embryocidal effects were seen at inhalation doses up to 250 mcg/kg (approximately 2 times the maximum recommended daily inhalation dose in adults on a mcg/m2 basis).

Experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans.

Studies of pregnant women, however, have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnancy. The results from a large population-based prospective cohort epidemiological study reviewing data from three Swedish registries covering approximately 99% of the pregnancies from 1995 to 1997 (i.e., Swedish Medical Birth Registry; Registry of Congenital Malformations; Child Cardiology Registry) indicate no increased risk for congenital malformations from the use of inhaled budesonide during early pregnancy. Congenital malformations were studied in 2014 infants born to mothers reporting the use of inhaled budesonide for asthma in early pregnancy (usually 10 to 12 weeks after the last menstrual period), the period when most major organ malformations occur. The rate of recorded congenital malformations was similar compared to the general population rate (3.8% vs. 3.5%, respectively). In addition, after exposure to inhaled budesonide, the number of infants born with or ofacial clefts was similar to the expected number in the normal population (4 children vs. 3.3, respectively).

These same data were utilized in a second study bringing the total to 2534 infants whose mothers were exposed to inhaled budesonide. In this study, the rate of congenital malformations among infants whose mothers were exposed to inhaled budesonide during early pregnancy was not different from the rate for all newborn babies during the same period (3.6%).

Despite the animal findings, it would appear that the possibility of fetal harm is remote if the drug is used during pregnancy. Nevertheless, because the studies in humans cannot rule out the possibility of harm, Budesonide Inhalation Suspension should be used during pregnancy only if clearly needed.

Non-teratogenic Effects

Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully observed.

Nursing Mothers

Budesonide, like other corticosteroids, is secreted in human milk. Data with budesonide delivered via dry powder inhaler indicates that the total daily oral dose of budesonide in breast milk to the infant is approximately 0.3% to 1% of the dose inhaled by the mother (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations, Nursing Mothers). No studies have been conducted in breastfeeding women with Budesonide Inhalation Suspension; however, the dose of budesonide available to the infant in breast milk, as a percentage of the maternal dose, would be expected to be similar. Budesonide should be used in nursing women only if clinically appropriate. Prescribers should weigh the known benefits of breastfeeding for the mother and the infant against the potential risks of minimal budesonide exposure in the infant.

Pediatric Use

Safety in pediatric patients six months to 12 months of age has been evaluated. Safety and effectiveness in pediatric patients 12 months to 8 years of age have been established (see CLINICAL PHARMACOLOGY, Pharmacodynamics, CLINICAL TRIALS and ADVERSE REACTIONS).

It has been reported a study in pediatric patients 6 to 12 months of age with mild to moderate asthma or recurrent/persistent wheezing. All patients were randomized to receive either Budesonide Inhalation Suspension or placebo. Adrenal axis function was assessed with an ACTH stimulation test at the beginning and end of the study, and mean changes from baseline in this variable did not indicate adrenal suppression in patients who received Budesonide Inhalation Suspension versus placebo. However, on an individual basis, 7 patients in this study (6 in the Budesonide Inhalation Suspension treatment arms and 1 in the placebo arm) experienced a shift from having a normal baseline stimulated cortisol level to having a subnormal level at Week 12 (see CLINICAL PHARMACOLOGY, Pharmacodynamics). Pneumonia was observed more frequently in patients treated with Budesonide Inhalation Suspension than in patients treated with placebo, (N = 2, 1, and 0) in the Budesonide Inhalation Suspension 0.5 mg, 1 mg, and placebo groups, respectively.

A dose dependent effect on growth was also noted in this 12-week trial. Infants in the placebo arm experienced an average growth of 3.7 cm over 12 weeks compared with 3.5 cm and 3.1 cm in the Budesonide Inhalation Suspension 0.5 mg and 1 mg arms respectively. This corresponds to estimated mean (95% CI) reductions in 12-week growth velocity between placebo and Budesonide Inhalation Suspension 0.5 mg of 0.2 cm (-0.6 to 1) and between placebo and Budesonide Inhalation Suspension 1 mg of 0.6 cm (-0.2 to 1.4). These findings support that the use of Budesonide Inhalation Suspension in infants 6 to 12 months of age may result in systemic effects and are consistent with findings of growth suppression in other studies with inhaled corticosteroids.

Controlled clinical studies have shown that inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients. In these studies, the mean reduction in growth velocity was approximately one centimeter per year (range 0.3 to 1.8 cm per year) and appears to be related to dose and duration of exposure. This effect has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA)-axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA-axis function. The long-term effects of this reduction in growth velocity associated with inhaled corticosteroids, including the impact on final adult height, are unknown.

The potential for “catch up” growth following discontinuation of treatment with inhaled corticosteroids has not been adequately studied.

In a study of asthmatic children 5 to 12 years of age, those treated with budesonide administered via a dry powder inhaler 200 mcg twice daily (n = 311) had a 1.1-centimeter reduction in growth compared with those receiving placebo (n = 418) at the end of one year; the difference between these two treatment groups did not increase further over three years of additional treatment. By the end of four years, children treated with the budesonide dry powder inhaler and children treated with placebo had similar growth velocities. Conclusions drawn from this study may be confounded by the unequal use of corticosteroids in the treatment groups and inclusion of data from patients attaining puberty during the course of the study.

The growth of pediatric patients receiving inhaled corticosteroids, including Budesonide Inhalation Suspension, should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the risks and benefits associated with alternative therapies. To minimize the systemic effects of inhaled corticosteroids, including Budesonide Inhalation Suspension, each patient should be titrated to his/her lowest effective dose.

An open-label non-randomized clinical study examined the immune responsiveness of varicella vaccine in 243 asthma patients 12 months to 8 years of age who were treated with a total daily dose of Budesonide Inhalation Suspension up to 1 mg (n = 151) or non-corticosteroid asthma therapy (n = 92) (i.e., beta2-agonists, leukotriene receptor antagonists, cromones). The percentage of patients developing a seroprotective antibody titer of ≥ 5 (gpELISA value) in response to the vaccination was similar in patients treated with Budesonide Inhalation Suspension (85%) compared to patients treated with non-corticosteroid asthma therapy (90%). No patient treated with Budesonide Inhalation Suspension developed chicken pox as a result of vaccination.

Geriatric Use

Of the 215 patients in 3 clinical trials of Budesonide Inhalation Suspension in adult patients, 65 (30%) were 65 years of age or older, while 22 (10%) were 75 years of age or older. No overall differences in safety were observed between these patients and younger patients, and other reported clinical or medical surveillance experience has not identified differences in responses between the elderly and younger patients.

Adverse Reactions

The following adverse reactions were reported in pediatric patients treated with Budesonide Inhalation Suspension.

The incidence of common adverse reactions is based on three double-blind, placebo-controlled, US clinical trials in which 945 patients, 12 months to 8 years of age, (98 patients ≥ 12 months and < 2 years of age; 225 patients ≥ 2 and < 4 years of age; and 622 patients ≥ 4 and ≤ 8 years of age) were treated with Budesonide Inhalation Suspension or vehicle placebo. The incidence and nature of adverse events reported for Budesonide Inhalation Suspension was comparable to that reported for placebo. The following table shows the incidence of adverse events in US controlled clinical trials, regardless of relationship to treatment, in patients previously receiving bronchodilators and/or inhaled corticosteroids. This population included a total of 605 male and 340 female patients.

Adverse Events With ≥ 3% Incidence Reported By Patients On Budesonide
		Budesonide
	Vehicle	Total Daily Dose
	Placebo	0.5 mg	1 mg
Adverse Events	(n = 227)	(n = 223)	(n = 317)
	%	%	%
Respiratory System Disorder
Respiratory Infection	36	35	38
Rhinitis	9	11	12
Coughing	5	9	8
Resistance Mechanism Disorders
Otitis Media	11	11	9
Viral Infection	3	5	3
Moniliasis	2	3	4
Gastrointestinal System Disorders
Gastroenteritis	4	5	5
Vomiting	3	4	4
Diarrhea	2	4	2
Abdominal Pain	2	2	3
Hearing and Vestibular Disorders
Ear Infection	4	4	5
Platelet, Bleeding, and Clotting Disorders
Epistaxis	1	4	3
Vision Disorders
Conjunctivitis	2	4	2
Skin and Appendages Disorders
Rash	3	4	2

The above table shows all adverse events with an incidence of 3% or more in at least one active treatment group where the incidence was higher with Budesonide Inhalation Suspension than with placebo.

The following adverse events occurred with an incidence of 3% or more in at least one Budesonide Inhalation Suspension group where the incidence was equal to or less than that of the placebo group: fever, sinusitis, pain, pharyngitis, bronchospasm, bronchitis, and headache.

Incidence 1% to ≤ 3% (by Body System)

The information below includes all adverse events with an incidence of 1 to ≤ 3%, in at least one Budesonide Inhalation Suspension treatment group where the incidence was higher with Budesonide Inhalation Suspension than with placebo, regardless of relationship to treatment.

Body as a Whole
Allergic reaction, chest pain, fatigue, flu-like disorder

Respiratory System
Stridor

Resistance Mechanisms
Herpes simplex, external ear infection, infection

Central & Peripheral Nervous System
Dysphonia, hyperkinesia

Skin & Appendages
Eczema, pustular rash, pruritus

Hearing & Vestibular
Earache

Vision
Eye infection

Psychiatric
Anorexia, emotional lability

Musculoskeletal System
Fracture, myalgia

Application Site
Contact dermatitis

Platelet, Bleeding & Clotting
Purpura

White Cell and Resistance
Cervical lymphadenopathy

The incidence of reported adverse events was similar between the 447 Budesonide Inhalation Suspension-treated (mean total daily dose 0.5 to 1 mg) and 223 conventional therapy-treated pediatric asthma patients followed for one year in three open-label studies.

Cases of growth suppression have been reported for inhaled corticosteroids including post-marketing reports for Budesonide Inhalation Suspension (see PRECAUTIONS, Pediatric Use).

Less frequent adverse events (<1%) reported in the published literature, long-term, open-label clinical trials, or from worldwide marketing experience with any formulation of inhaled budesonide include: immediate and delayed hypersensitivity reactions including anaphylaxis, rash, contact dermatitis, urticaria, angioedema, and bronchospasm (see WARNINGS, Hypersensitivity Reactions Including Anaphylaxis ); symptoms of hypocorticism and hypercorticism; glaucoma, cataracts; psychiatric symptoms including depression, aggressive reactions, irritability, anxiety, and psychosis; and bone disorders including avascular necrosis of the femoral head and osteoporosis.

Overdosage

The potential for acute toxic effects following overdose of Budesonide Inhalation Suspension is low. If inhaled corticosteroids are used at excessive doses for prolonged periods, systemic corticosteroid effects such as hypercorticism or growth suppression may occur (see PRECAUTIONS).

In mice the minimal lethal inhalation dose was 100 mg/kg (approximately 410 or 120 times, respectively, the maximum recommended daily inhalation dose in adults or children on a mg/m2 basis). In rats there were no deaths at an inhalation dose of 68 mg/kg (approximately 550 or 160 times, respectively, the maximum recommended daily inhalation dose in adults or children on a mg/m2 basis). In mice the minimal oral lethal dose was 200 mg/kg (approximately 810 or 240 times, respectively, the maximum recommended daily inhalation dose in adults or children on a mg/m2 basis). In rats, the minimal oral lethal dose was less than 100 mg/kg (approximately 810 or 240 times, respectively, the maximum recommended daily inhalation dose in adults or children on a mg/m2 basis).

Budesonide Inhalation Suspension Dosage and Administration

Budesonide Inhalation Suspension is indicated for use in asthmatic patients 12 months to 8 years of age. Budesonide Inhalation Suspension should be administered by the inhaled route via jet nebulizer connected to an air compressor. Individual patients will experience a variable onset and degree of symptom relief. Improvement in asthma control following inhaled administration of Budesonide Inhalation Suspension can occur within 2 to 8 days of initiation of treatment, although maximum benefit may not be achieved for 4 to 6 weeks. The safety and efficacy of Budesonide Inhalation Suspension when administered in excess of recommended doses have not been established. In all patients, it is desirable to downward-titrate to the lowest effective dose once asthma stability is achieved. The recommended starting dose and highest recommended dose of Budesonide Inhalation Suspension, based on prior asthma therapy, are listed in the following table.

Previous	Recommended	Highest
Therapy	Starting Dose	Recommended Dose
Bronchodilators Alone	0.5 mg total daily dose administered twice daily in divided doses	0.5 mg total daily dose
Inhaled Corticosteroids	0.5 mg total daily dose administered twice daily in divided doses	1 mg total daily dose
Oral Corticosteroids	1 mg total daily dose administered as 0.5 mg twice daily	1 mg total daily dose

Patients Not Receiving Systemic (Oral) Corticosteroids

Patients who require maintenance therapy of their asthma may benefit from treatment with Budesonide Inhalation Suspension at the doses recommended above. Once the desired clinical effect is achieved, consideration should be given to tapering to the lowest effective dose.

Patients Maintained on Chronic Oral Corticosteroids

Initially, Budesonide Inhalation Suspension should be used concurrently with the patient’s usual maintenance dose of systemic corticosteroid. After approximately one week, gradual withdrawal of the systemic corticosteroid may be initiated by reducing the daily or alternate daily dose. Further incremental reductions may be made after an interval of one or two weeks, depending on the response of the patient. Generally, these decrements should not exceed 25% of the prednisone dose or its equivalent. A slow rate of withdrawal is strongly recommended. During reduction of oral corticosteroids, patients should be carefully monitored for asthma instability, including objective measures of airway function, and for adrenal insufficiency (see WARNINGS).

During withdrawal, some patients may experience symptoms of systemic corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement in pulmonary function. Such patients should be encouraged to continue with Budesonide Inhalation Suspension but should be monitored for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic corticosteroid doses should be increased temporarily and thereafter withdrawal should continue more slowly. During periods of stress or a severe asthma attack, transfer patients may require supplementary treatment with systemic corticosteroids.

A Pari-LC-Jet Plus Nebulizer (with face mask or mouthpiece) connected to a Pari Master compressor was used to deliver Budesonide Inhalation Suspension to each patient in 3 U.S. controlled clinical studies. The safety and efficacy of Budesonide Inhalation Suspension delivered by other nebulizers and compressors have not been established.

Budesonide Inhalation Suspension should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask. Ultrasonic nebulizers are not suitable for the adequate administration of Budesonide Inhalation Suspension and, therefore, are NOT recommended.

The effects of mixing Budesonide Inhalation Suspension with other nebulizable medications have not been adequately assessed. Budesonide Inhalation Suspension should be administered separately in the nebulizer (see PRECAUTIONS, Information for Patients).

Directions for Use

Illustrated Patient’s Instructions for Use accompany each package of Budesonide Inhalation Suspension.

How is Budesonide Inhalation Suspension Supplied

Budesonide Inhalation Suspension, 0.25 mg/2 mL is supplied in a sealed aluminum foil envelope containing one plastic strip of five single-dose vials. Each single-dose vial contains 2 mL of sterile liquid suspension, supplied in unit-dose cartons of 30 vials (6 pouches × 5 vials).

Budesonide Inhalation Suspension, 0.5 mg/2 mL is supplied in a sealed aluminum foil envelope containing one plastic strip of five single-dose vials. Each single-dose vial contains 2 mL of sterile liquid suspension, supplied in unit-dose cartons of 30 vials (6 pouches × 5 vials).

Storage

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store upright and protect from light.

When an envelope has been opened, the shelf life of the unused vials is 2 weeks when protected. After opening the aluminum foil envelope, the unused vials should be returned to the aluminum foil envelope to protect them from light. Any opened vial must be used promptly. Gently shake the vial using a circular motion before use. Keep out of reach of children. Do not freeze.

Manufactured In England By:
IVAX PHARMACEUTICALS UK
Runcorn, Cheshire WA7 3FA England

Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. D 10/2009
PE2189

PATIENT’S INSTRUCTIONS FOR USE

Budesonide (byü-des-o-n l d) Inhalation Suspension
2 mL vials containing 0.25 mg or 0.5 mg

Rx only

FOR INHALATION ONLY

Please read this leaflet carefully before taking Budesonide Inhalation Suspension.

It provides a summary of information about this medication. Following these instructions helps to ensure that you are using the medication correctly.

The medication named Budesonide Inhalation Suspension is intended for inhalation use only with compressed air driven nebulizer systems, also known as jet nebulizers.

Do not use with an ultrasonic nebulizer.

For further information, ask your doctor or pharmacist.

IMPORTANT POINTS TO REMEMBER ABOUT Budesonide Inhalation Suspension

Your doctor has prescribed Budesonide Inhalation Suspension which is a synthetic corticosteroid. It is important that your child take Budesonide Inhalation Suspension using a compressed air driven jet nebulizer as instructed.
Use this nebulizer therapy as directed at the same time each day, even during symptom-free periods. DO NOT STOP TREATMENT OR REDUCE THE DOSE EVEN IF YOUR CHILD FEELS BETTER, unless told to do so by your doctor.
DO NOT let your child inhale more doses or use this medication more often than instructed.
This medication is intended to help prevent and control asthma symptoms. It is NOT intended to provide rapid relief of breathing difficulties during an asthma attack.
Your doctor may prescribe additional medication (such as bronchodilators) for emergency relief if an acute asthma attack occurs. Please contact your doctor if:

-

an asthma attack does not respond to the additional medication,

-

your child requires more of the additional medication than usual.
If your child uses another medication by inhalation, consult your healthcare provider for instructions on when to use it in relation to using Budesonide Inhalation Suspension.
Budesonide Inhalation Suspension has not been studied when mixed with other nebulizable medications. Budesonide Inhalation Suspension should be given separately in the nebulizer.

BEFORE USING Budesonide Inhalation Suspension

Tell your doctor before starting to take this medication if your child:

Is allergic to budesonide or any other inhaled corticosteroid,
Is taking any other medications,
Has any infections,
Has or had tuberculosis,
Has osteoporosis,
Has recently been around anyone with chicken pox or measles,
Is planning to have surgery,
Has been taking an oral corticosteroid medicine like prednisone. You may have to follow specific instructions to avoid health risks associated with stopping the use of these types of medicines.

In some circumstances, this medicine may not be suitable and your doctor may wish to prescribe a different medicine. Make sure that your doctor knows what other medicines your child is taking, including prescription and non-prescription medicines, as well as any vitamins or dietary and herbal supplements.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF Budesonide Inhalation Suspension?

As with all inhaled corticosteroids, you should be aware of the following side effects:

Increased wheezing right after taking Budesonide Inhalation Suspension. Always have a short-acting bronchodilator medicine with you to treat sudden wheezing. Short-acting bronchodilator medicines help to relax the muscles around the airways in your lungs. Wheezing happens when the muscles around the airways tighten. This makes it hard to breathe. In severe cases, wheezing can stop your breathing and cause death if not treated right away.
Immune system effects and a higher chance of infections.
Hypersensitivity reactions including anaphylaxis. Tell your doctor if you have a sudden skin rash, severe itching, breathing problems, skin redness or swelling.
Eye problems including glaucoma and cataracts. Eye examinations should be considered while using Budesonide Inhalation Suspension.
Your child’s growth should be checked regularly while taking Budesonide Inhalation Suspension because of the potential for slowed growth.

Based on clinical trials, the most common side effects reported by patients using Budesonide Inhalation Suspension are:

Respiratory infections
Ear infections
Runny nose

These are not all of the possible side effects of Budesonide Inhalation Suspension. For more information, ask your doctor or pharmacist.

USING Budesonide Inhalation Suspension

Budesonide Inhalation Suspension should be used with a compressed air driven jet nebulizer following the manufacturer’s instructions. The mist produced is then inhaled through either a mouthpiece or face mask. The treatment generally takes five to ten minutes. Treatment is complete when mist no longer comes out of the mouthpiece or face mask. The face mask should be properly adjusted to optimize delivery and to avoid exposing the eyes to the nebulized medication.

DOSAGE

Patients should take Budesonide Inhalation Suspension at regular intervals twice a day, as directed, since its effectiveness depends on regular use.

Improvement in the control of asthma symptoms with Budesonide Inhalation Suspension can occur within 2 to 8 days. It may take up to 4 to 6 weeks before maximum improvement is seen.

If your child misses a dose by more than several hours, just take the next regularly scheduled dose when it is due.

DO NOT DOUBLE the dose.

HOW TO USE Budesonide Inhalation Suspension

Assemble the nebulizer according to the instructions supplied by the manufacturer.
Open the sealed aluminum foil envelope and remove one (1) single-dose vial from the strip (Figure 1). Record the date that you open the foil on the front of the envelope in the space provided.

Place the unused vials remaining on the strip back into the aluminum foil envelope before storing. This will protect the medication from light. Budesonide Inhalation Suspension should be stored upright at room temperature, 20° to 25°C (68° to 77°F). Do not refrigerate or freeze.
Gently shake the vial using a circular motion as shown in Figure 2.
Hold the vial upright without squeezing and open by twisting off the top (Figure 3).
Place the open end of the vial into the nebulizer cup and slowly squeeze out all of the contents as shown in Figure 4.
If using a face mask, make sure that the mask fits tightly so that the mist does not get into the child’s eyes. Turn on the compressor to begin nebulizing the medication.Use the nebulizer as directed. Continue the treatment with Budesonide Inhalation Suspension until mist is no longer coming out of the mouthpiece/face mask (usually about 5 to 10 minutes).
Throw away the empty vial. See the CLEANING OF EQUIPMENT and STORING YOUR Budesonide Inhalation Suspension sections for additional information.

NOTE:

As with other inhaled corticosteroids, rinse your child’s mouth with water after each dose to reduce the risk of developing thrush.
Wash your child’s face after treatment to avoid possible skin irritation.

CLEANING OF EQUIPMENT

The nebulizer cup and the mouthpiece or the face mask should be cleaned according to the instructions supplied by the manufacturer.

STORING YOUR Budesonide Inhalation Suspension

Budesonide Inhalation Suspension should be stored in an upright position at temperatures between 20° to 25°C (68° to 77°F) in the aluminum foil envelope to protect from light. Do not freeze.

When the foil envelope is opened, the unused vials should be used within 2 weeks. After opening the aluminum foil package, the unused vials should be returned to the foil envelope to protect them from light. Any individually opened vial must be used promptly.

Remember to record the date you open the foil on the front of the envelope in the space provided.

Store Budesonide Inhalation Suspension, like all medications, in a secure place out of the reach of children.

FURTHER INFORMATION ABOUT Budesonide Inhalation Suspension

This leaflet does not contain the complete information about this medication. If you have any questions, you should ask your doctor or pharmacist.

You may want to read this leaflet again. Please DO NOT THROW IT AWAY until you have finished the medication.

REMEMBER: This medication has been prescribed for your child by your doctor. DO NOT give this medication to anyone else.

USE THIS PRODUCT AS DIRECTED, UNLESS INSTRUCTED TO DO OTHERWISE BY YOUR DOCTOR.

If your child is exposed to chicken pox or measles, consult your doctor.

Manufactured In England By:
IVAX PHARMACEUTICALS UK
Runcorn, Cheshire WA7 3FA England

Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960

Budesonide Inhalation Suspension

Rev. D 10/2009

PE2189

6815

6816

PRINCIPAL DISPLAY PANEL – 0.25 mg/2 mL Label

NDC 0093-6815-45

Budesonide Inhalation Suspension
0.25 mg/2 mL
Rx Only

FOR ORAL INHALATION ONLY
Shake gently using a circular motion prior to use. Once a vial is opened, use the contents
immediately. For use only in a jet nebulizer. Do NOT use in an ultrasonic nebulizer.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not freeze.
Store unopened vials in the foil envelope placed upright in the carton. Protect from light.
Use as directed by a physician. Follow the Patient Instructions for proper use of budesonide
inhalation suspension.
See package insert for full prescribing information.
Once the foil envelope is opened, use the vials within 2 weeks.
Date Opened:_______
Each unit-dose vial delivers 2 mL of a sterile suspension containing 0.25 mg of micronized
budesonide
Inactive Ingredients: citric acid monohydrate, disodium edetate, polysorbate 80, sodium chloride,
tri-sodium citrate dihydrate and water for injection
Keep out of reach of children.
DO NOT DISCARD THE FOIL ENVELOPE UNTIL THE LAST VIAL IS USED.
1 pouch x five 2 mL vials each
Manufactured In England By: IVAX Pharmaceuticals UK, Runcorn, Cheshire WA7 3FA England
Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960

Rev. B 12/2007

LOT:

EXP:

PRINCIPAL DISPLAY PANEL – 0.5 mg/2 mL Label

NDC 0093-6816-45

Budesonide Inhalation Suspension
0.5 mg/2 mL
Rx Only

FOR ORAL INHALATION ONLY
Shake gently using a circular motion prior to use. Once a vial is opened, use the contents
immediately. For use only in a jet nebulizer. Do NOT use in an ultrasonic nebulizer.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not freeze.
Store unopened vials in the foil envelope placed upright in the carton. Protect from light.
Use as directed by a physician. Follow the Patient Instructions for proper use of budesonide
inhalation suspension.
See package insert for full prescribing information.
Once the foil envelope is opened, use the vials within 2 weeks.
Date Opened:_______
Each unit-dose vial delivers 2 mL of a sterile suspension containing 0.5 mg of micronized
budesonide
Inactive Ingredients: citric acid monohydrate, disodium edetate, polysorbate 80, sodium chloride,
tri-sodium citrate dihydrate and water for injection
Keep out of reach of children.
DO NOT DISCARD THE FOIL ENVELOPE UNTIL THE LAST VIAL IS USED.
1 pouch x five 2 mL vials each
Manufactured In England By: IVAX Pharmaceuticals UK, Runcorn, Cheshire WA7 3FA England
Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960

Rev. B 12/2007

LOT:

EXP:

BUDESONIDE
budesonide suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0093-6815
Route of Administration	RESPIRATORY (INHALATION)	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Budesonide (Budesonide)	Budesonide	0.25 mg in 2 mL

Inactive Ingredients
Ingredient Name	Strength
citric acid monohydrate
edetate disodium
polysorbate 80
sodium chloride
trisodium citrate dihydrate
water

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0093-6815-73	6 POUCH In 1 CARTON	contains a POUCH
1		5 VIAL In 1 POUCH	This package is contained within the CARTON (0093-6815-73) and contains a VIAL
1		2 mL In 1 VIAL	This package is contained within a POUCH and a CARTON (0093-6815-73)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077519	12/15/2009

BUDESONIDE
budesonide suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0093-6816
Route of Administration	RESPIRATORY (INHALATION)	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Budesonide (Budesonide)	Budesonide	0.5 mg in 2 mL

Inactive Ingredients
Ingredient Name	Strength
citric acid monohydrate
edetate disodium
polysorbate 80
sodium chloride
trisodium citrate dihydrate
water

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0093-6816-73	6 POUCH In 1 CARTON	contains a POUCH
1		5 VIAL In 1 POUCH	This package is contained within the CARTON (0093-6816-73) and contains a VIAL
1		2 mL In 1 VIAL	This package is contained within a POUCH and a CARTON (0093-6816-73)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077519	12/15/2009

Labeler - TEVA Pharmaceuticals USA (118234421)

Establishment
Name	Address	ID/FEI	Operations
IVAX Pharmaceuticals		217481352	MANUFACTURE

Revised: 03/2010TEVA Pharmaceuticals USA

B,Professional

Comments (0)

budesonide nasal

30/06/10

Generic Name: budesonide nasal (byoo DEH so nide)
Brand names: Rhinocort Aqua, Rhinocort

What is budesonide nasal?

Budesonide is a steroid. It prevents the release of substances in the body that cause inflammation.

Budesonide nasal is used to treat nasal symptoms such as congestion, sneezing, and runny nose caused by seasonal or year-round allergies. Budesonide is also used to keep nasal polyps from coming back after surgery to remove them.

Budesonide may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about budesonide nasal?

Before using budesonide, tell your doctor if you have been sick or had an infection of any kind. Also tell your doctor if you have liver disease, glaucoma or cataracts, herpes simplex infection of your eyes, tuberculosis, sores or ulcers in your nose, or if you have recently had injury of or surgery on your nose.

It may take up to 2 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after a week of treatment.

To be sure this medication is not causing harmful effects on your nose or sinuses, your doctor may want to check your progress on a regular basis. Do not miss any scheduled visits to your doctor.

Budesonide nasal can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using budesonide nasal.

Avoid getting this medication in your eyes. If this does happen, rinse with water and call your doctor.

Steroid medicines can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using budesonide nasal.

What should I discuss with my healthcare provider before using budesonide nasal?

You should not use this medication if you are allergic to budesonide.

Before using budesonide, tell your doctor if you have been sick or had an infection of any kind. You may not be able to use budesonide nasal until you are well.

Also tell your doctor if you are allergic to any drugs, or if you have:

liver disease;
glaucoma or cataracts;
herpes simplex virus of your eyes;
tuberculosis or any other infection or illness;
sores or ulcers inside your nose; or
if you have recently had injury of or surgery on your nose.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether budesonide passes into breast milk or if it could harm a nursing baby. Do not use budesonide nasal without telling your doctor if you are breast-feeding a baby.

Steroid medicines can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using budesonide nasal.

How should I use budesonide nasal?

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

The usual dose of budesonide nasal is 1 to 4 sprays into each nostril once per day. Follow your doctor’s instructions.

Before using the spray for the first time, you must prime the spray pump. Shake the medicine well and spray 8 test sprays into the air and away from your face. Spray until a fine mist appears. Prime the spray pump any time you have not used your nasal spray for longer than 2 days. If longer than 2 weeks has passed, rinse the applicator and prime with 2 test sprays.

Shake the medicine bottle well just before each use. It may take up to 2 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after a week of treatment.

To be sure this medication is not causing harmful effects on your nose or sinuses, your doctor may want to check your progress on a regular basis. Do not miss any scheduled visits to your doctor.

Store this medication in an upright position at room temperature, away from moisture and heat.

Throw the medication away after you have used 120 sprays, even if there is still medicine left in the bottle.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of budesonide nasal is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using budesonide nasal?

Avoid getting this medication in your eyes. If this does happen, rinse with water and call your doctor.

Budesonide nasal side effects

severe or ongoing nose bleed;
sores in the nose that won’t heal;
wheezing, trouble breathing;
vision problems; or
fever, chills, body aches, flu symptoms.

Less serious side effects may include:

dry or sore throat, cough;
irritation in your nose;
pain, swelling, burning, itching, or irritation in your throat;
sores or white patches inside or around your nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Budesonide nasal Dosing Information

Usual Adult Dose for Allergic Rhinitis:

Nasal aerosol:
2 sprays (32 mcg/spray) in each nostril in the morning and evening or 4 sprays in each nostril in the morning. Maximum recommended dose is 8 sprays (256 mcg)/day.

Nasal Spray:
1 spray (32 mcg) in each nostril once daily. Maximum dose: 4 sprays (128 mcg) in each nostril once daily.

Usual Pediatric Dose for Allergic Rhinitis:

6 years or older:
Nasal aerosol: 2 sprays (32 mcg/spray) in each nostril in the morning and evening or
4 sprays in each nostril in the morning. Maximum recommended dose is 8 sprays (256 mcg)/day.

Nasal spray: 1 spray (32 mcg) in each nostril once daily. Maximum dose: less than 12 years: 2 sprays (64 mcg) in each nostril once daily; 12 years or older: 4 sprays (128 mcg) in each nostril once daily.

What other drugs will affect budesonide nasal?

Before using budesonide nasal, tell your doctor if you are using any of the following drugs:

HIV /AIDS medicine such as nelfinavir (Viracept) or ritonavir (Norvir);
an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., E-Mycin, Ery-Tab, Erythrocin), troleandomycin (Tao);
an antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);
an “SSRI” antidepressant such as fluoxetine (Prozac), fluvoxamine (Luvox), or paroxetine (Paxil); or
a tricyclic antidepressant such as amitriptyline (Elavil, Etrafon), amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).

This list is not complete and here may be other drugs that can interact with budesonide nasal. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about budesonide nasal.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

B,Concise

Comments (0)

30/06/10

Budesonide/

Formoterol Aerosol

Generic Name: Budesonide/Formoterol (bue-DES-oh-nide/for-MOE-ter-ol)
Brand Name: Symbicort

Long-acting beta-agonists such as Budesonide/Formoterol Aerosol have been rarely associated with an increased risk of asthma-related death. It should only be used by certain patients with severe asthma or by patients who cannot get adequate control of asthma symptoms by using other asthma controller medicines (eg, inhaled corticosteroids).

Budesonide/Formoterol Aerosol is used for:

Long-term treatment of asthma and chronic obstructive pulmonary disease (COPD) in certain patients. It may also be used for other conditions as determined by your doctor.

Budesonide/Formoterol Aerosol is a combination of a synthetic corticosteroid and a long-acting beta-agonist bronchodilator. It works by decreasing irritation and inflammation in the lungs; it widens the airways in the lungs, which helps you breathe more easily.

Do NOT use Budesonide/Formoterol Aerosol if:

you are allergic to any ingredient in Budesonide/Formoterol Aerosol
you are using another medicine that has a long-acting beta-agonist (eg, salmeterol) in it
you are having an asthma attack (eg, sudden, severe onset or worsening of asthma or COPD symptoms such as wheezing, cough, chest tightness, shortness of breath)
you are taking mifepristone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Budesonide/Formoterol Aerosol:

Some medical conditions may interact with Budesonide/Formoterol Aerosol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a history of diabetes, heart problems (eg, fast or irregular heartbeat, heart blood vessel problems), high blood pressure, low blood potassium levels, seizures, tuberculosis, a weakened immune system, liver problems, or thyroid problems
if you have weakened bones (eg, osteoporosis), a family history of weakened bones, or have other risk factors for weak bones (eg, smoking, poor nutrition)
if you have a history of eye problems (eg, glaucoma, cataracts, increased eye pressure)
if you have a fungal, bacterial, or parasitic infection; a viral infection (eg, chickenpox, measles); herpes infection of the eye; or a lung infection (eg, pneumonia)
if you have recently been to an emergency room for asthma, have a history of frequent hospitalizations for asthma, or have ever had a life-threatening asthma attack
if you have had an unusual reaction to a sympathomimetic medicine (eg, albuterol, pseudoephedrine), such as fast or irregular heartbeat, overexcitement, or severe trouble sleeping
if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or a tricyclic antidepressant (eg, amitriptyline), or if you have taken either of these medicines within the last 14 days

Some MEDICINES MAY INTERACT with Budesonide/Formoterol Aerosol. Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta agonists (eg, albuterol), corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), or xanthines (eg, theophylline) because the risk of low blood potassium or irregular heartbeat may be increased
Ritodrine because the risk of maternal lung edema may be increased
Catechol-o-methyltransferase (COMT) inhibitors (eg, entacapone), clarithromycin, HIV protease inhibitors (eg, atazanavir, ritonavir), itraconazole, ketoconazole, long-acting beta-agonists (eg, salmeterol), MAOIs (eg, phenelzine), nefazodone, telithromycin, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Budesonide/Formoterol Aerosol’s side effects
Barbiturates (eg, phenobarbital), beta-blockers (eg, propranolol), carbamazepine, hydantoins (eg, phenytoin), oral contraceptives, or rifampin because they may decrease Budesonide/Formoterol Aerosol’s effectiveness or worsen your condition
Mifepristone because the risk of its side effects may be increased by Budesonide/Formoterol Aerosol

This may not be a complete list of all interactions that may occur. Ask your health care provider if Budesonide/Formoterol Aerosol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Budesonide/Formoterol Aerosol:

Use Budesonide/Formoterol Aerosol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Budesonide/Formoterol Aerosol comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Budesonide/Formoterol Aerosol refilled.
Store Budesonide/Formoterol Aerosol in the foil package until right before use.
You will need to prime the inhaler before using it for the first time. To prime the inhaler, shake it for 5 seconds, then release a test spray into the air away from your face. Shake well again for 5 seconds and release a second test spray into the air.
To use Budesonide/Formoterol Aerosol, remove the inhaler from the foil pouch. Write the date that you open the foil pouch on the dose tracker card that comes with Budesonide/Formoterol Aerosol.
Be sure that the canister is properly placed in the inhaler unit. Shake well. Remove the mouthpiece cover. Check the mouthpiece for foreign objects. Breathe out slowly and completely. Place the mouthpiece between your lips and try to rest your tongue flat, unless your doctor has told you otherwise. Your doctor may have told you to hold the inhaler 1 or 2 inches (2 or 3 centimeters) away from the open mouth or to use a special spacing device. As you start to take a slow, deep breath, press the canister and mouthpiece together at exactly the same time. This will release a dose of Budesonide/Formoterol Aerosol. Continue breathing in slowly and deeply and hold for as long as comfortable, then breathe out slowly through pursed lips or your nose. If more than 1 inhalation is to be used, wait a few minutes and repeat the above steps. Keep the spray away from your eyes. Close the mouthpiece cover after each use.
If the inhaler is not used for more than 7 days or if it is dropped, it will need to be reprimed again before you use it.
Wipe the mouthpiece clean with a dry cloth at least once a week.
Rinse your mouth with water after you finish using the medicine (do not swallow). This will help remove excess medicine and decrease your risk of developing an oral fungal infection.
Use the enclosed dose tracker card to keep track of the number of puffs you have used. Throw the inhaler away after you have used the labeled number of puffs or after it has been removed from the foil pouch for longer than 3 months, even if the container does not feel empty.
Use the new inhaler that comes with each refill. Do not reuse an old inhaler. Do not use Budesonide/Formoterol Aerosol with a different kind of inhaler.
Never wash the mouthpiece or any other part of the inhaler with water. Keep it dry and always store in a dry place. Do NOT try to take the inhaler apart.
Continue to use Budesonide/Formoterol Aerosol even if you feel well. Do not miss any doses.
If you miss a dose of Budesonide/Formoterol Aerosol, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Budesonide/Formoterol Aerosol.

Important safety information:

Budesonide/Formoterol Aerosol may cause dizziness. This effect may be worse if you use it with alcohol or certain medicines. Use Budesonide/Formoterol Aerosol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Some patients may have trouble using Budesonide/Formoterol Aerosol correctly. Some may also get mouth sores or a bad taste in the mouth after using it. If you have any of these problems, ask your health care provider if a spacing device may help.
The risk of serious heart problems (eg, irregular heartbeat) may be greater if you use Budesonide/Formoterol Aerosol in high doses. Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
Use caution if you switch from an oral steroid (eg, prednisone) to Budesonide/Formoterol Aerosol. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again. Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur.
Budesonide/Formoterol Aerosol may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. Tell your doctor right away if you are exposed to anyone who has these infections.
Do not receive a live vaccine (eg, measles, mumps) while you are taking Budesonide/Formoterol Aerosol. Talk with your doctor before you receive any vaccine.
Budesonide/Formoterol Aerosol will not stop an asthma attack once it has already started. Be sure to carry a short-acting bronchodilator inhaler with you at all times to treat any breathing problems that may occur between doses of Budesonide/Formoterol Aerosol (eg, severe or sudden onset of wheezing or shortness of breath). If you have any questions about which medicines stop asthma attacks, check with your doctor or pharmacist.
If you have been regularly using a short-acting bronchodilator inhaler (eg, albuterol), talk with your doctor about how to use it with Budesonide/Formoterol Aerosol. Short-acting bronchodilators are normally only used with Budesonide/Formoterol Aerosol to treat breathing problems that may occur between doses.
If your symptoms do not get better within 1 to 2 weeks of starting Budesonide/Formoterol Aerosol or if they get worse, contact your doctor right away.
Tell your doctor at once if you notice that your short-acting bronchodilator inhaler does not work as well, if you need to use it often (eg, 4 or more times a day for more than 2 days in a row, more than 1 canister in 8 weeks), or if you have a decrease in your peak flow meter results.
Contact your doctor or seek medical care right away if you have breathing problems that worsen quickly, or if you use your short-acting bronchodilator and do not get relief.
Talk with your doctor or pharmacist about all of your asthma medicines and how to use them. Do not start, stop, or change the dose of any asthma medicine unless your doctor tells you to.
The medicine may sometimes cause breathing problems right after you use a dose. If this happens, use your short-acting bronchodilator. Contact your doctor or seek other medical care at once.
Lab tests, including lung function tests, blood pressure, and eye exams, may be performed while you use Budesonide/Formoterol Aerosol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Budesonide/Formoterol Aerosol with caution in the ELDERLY; they may be more sensitive to its effects, especially weakened bones.
Corticosteroids may affect the growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Budesonide/Formoterol Aerosol.
Budesonide/Formoterol Aerosol should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Budesonide/Formoterol Aerosol while you are pregnant. Budesonide/Formoterol Aerosol is found in breast milk. Do not breast-feed while taking Budesonide/Formoterol Aerosol.

Possible side effects of Budesonide/Formoterol Aerosol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; dry mouth; headache; nausea; nervousness; stomach pain or upset; stuffy nose; throat irritation; tiredness; tremor; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness); back pain; bone pain; chest pain; fast or irregular heartbeat; fever, chills, or persistent sore throat; increased mucus production or change in color of mucus; new or worsening asthma or COPD symptoms (eg, coughing, increased chest tightness, shortness of breath, wheezing); seizures; severe or persistent dizziness, headache, nervousness, or tremor; severe or persistent muscle pain or cramps; trouble speaking; vision changes; white patches in your mouth or throat.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include chest pain; fast or irregular heartbeat; fatigue; headache; increased thirst or urination; muscle pain or cramps; nausea; nervousness; seizures; severe or persistent dizziness; tremors; trouble sleeping; vomiting.

Proper storage of Budesonide/Formoterol Aerosol:

Store Budesonide/Formoterol Aerosol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and direct sunlight. Do not store in the bathroom. Do not puncture, break, or burn the canister even if it appears to be empty. Store Budesonide/Formoterol Aerosol with the mouthpiece down. Keep Budesonide/Formoterol Aerosol out of the reach of children and away from pets.

General information:

If you have any questions about Budesonide/Formoterol Aerosol, please talk with your doctor, pharmacist, or other health care provider.
Budesonide/Formoterol Aerosol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Budesonide/Formoterol Aerosol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

B,Med-facts

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Budesonide / Formoterol Fumarate Dihydrate

30/06/10

Pronunciation: (bue-DES-oh-nide/for-MOE-ter-ol FUE-ma-rate DYE-hye-drate)
Class: Respiratory inhalant combination

Trade Names:
Symbicort 80/4.5
- Inhalation aerosol budesonide 80 mcg and formoterol 4.5 mcg/actuation

Trade Names:
Symbicort 160/4.5
- Inhalation aerosol budesonide 160 mcg and formoterol 4.5 mcg/actuation

Pharmacology

Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity.

Formoterol fumarate is a long-acting selective beta-2 adrenergic agonist (beta-2 agonist) with a rapid onset of action. Inhaled formoterol fumarate acts locally in the lung as a bronchodilator.

Indications and Usage

Long-term maintenance treatment of asthma; maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema.

Contraindications

Primary treatment of status asthmaticus or other acute episodes of asthma in which intensive measures are required; hypersensitivity to any component of the product.

Dosage and Administration

Asthma
Adults and Children 12 yr of age and older

Oral Inhalation Recommended starting dose is 2 inhalations of budesonide/formoterol (80/4.5 or 160/4.5) twice daily approximately 12 h apart, depending upon asthma severity.

COPD
Adults

Oral Inhalation Recommended dose is 2 inhalations of budesonide 160 mcg/formoterol 4.5 mcg twice daily. If shortness of breath occurs between doses, an inhaled short-acting beta-2 agonist should be taken for immediate relief.

General Advice

Max daily recommended dosage is budesonide/formoterol (640/18 mcg) given as 2 inhalations of 160/4.5 mcg twice daily approximately 12 h apart.
Do not use more than twice daily or for more than 2 inhalations.
Rinse mouth with water without swallowing after inhalation.
Titrate to the lowest effective strength after adequate asthma stability has been achieved.
If symptoms arise in the period between doses, take an inhaled short-acting beta-2 agonist for immediate relief.
Shake well for 5 min before using.
Before using for the first time, prime the inhaler by releasing 2 test sprays into the air away from the face, shaking well for 5 sec before each spray. Prime the inhaler again by shaking well before each spray and releasing 2 test sprays if inhaler is not used for more than 7 days or if it is dropped.

Storage/Stability

Store at 68° to 77°F. Store with the mouthpiece down.

Drug Interactions

Beta-blockers (eg, propranolol)

If possible, avoid coadministration because beta-blockers may block the pulmonary effect of formoterol, in addition to producing severe bronchospasm in asthmatic patients.

Inhibitors of CYP3A4 (eg, ketoconazole)

Use with caution because budesonide plasma levels may be increased.

Loop diuretics (eg, furosemide), thiazide diuretics (eg, hydrochlorothiazide)

ECG changes and/or hypokalemia resulting from non–potassium-sparing diuretics can be worsened by formoterol.

MAOIs (eg, phenelzine), tricyclic antidepressants (eg, amitriptyline)

Use with caution in patients treated with MAOIs or tricyclic antidepressants, or within 2 wk of discontinuing these agents, because action of formoterol on the vascular system may be potentiated.

Salmeterol

Do not use in combination.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Angina pectoris, atrial fibrillation, atrial and ventricular tachyarrhythmias, extrasystoles, hypertension, hypotension, palpitations, tachycardia (postmarketing).

CNS

Headache (11%); agitation, behavior disturbances, depression, dizziness, nervousness, restlessness, sleep disturbances, tremor (postmarketing).

Dermatologic

Bruising (postmarketing).

EENT

Nasopharyngitis (11%); pharyngolaryngeal pain (9%); nasal congestion (3%); cataract, glaucoma, IOP (postmarketing).

GI

Stomach discomfort (7%); oral candidiasis (6%); vomiting (3%); nausea, oropharyngeal candidiasis (postmarketing).

Endocrine

Growth velocity reduction in children, hypercorticism (postmarketing).

Hypersensitivity

Delayed and immediate hypersensitivity reactions, including anaphylactic reaction, angioedema, bronchospasm, dermatitis, exanthema, pruritus, and urticaria (postmarketing).

Metabolic-Nutritional

Hyperglycemia, hypokalemia (postmarketing).

Musculoskeletal

Back pain (3%); muscle cramps (postmarketing).

Respiratory

Upper respiratory tract infection (11%); sinusitis (6%); bronchitis (5%); cough, dysphonia, throat irritation (postmarketing).

Miscellaneous

Influenza (3%).

Precautions

Warnings

Long-acting beta-2 adrenergic agonists, such as formoterol, may increase the risk of asthma-related death. Therefore, only use for patients not adequately managed on other asthma-controller medications or whose disease severity warrants treatment with 2 maintenance agents.

Monitor

Monitor for increasing use of inhaled short-acting beta-2 agonist, which may indicate deterioration of asthma.

Observe patients for evidence of systemic corticosteroid effects. Closely monitor patients with a change in vision or with a history of increased IOP, glaucoma, and/or cataracts. Closely monitor use in patients with hepatic disease.

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established in asthmatic children younger than 12 yr of age. May cause reduction in growth velocity when administered to children.

Elderly

Use with caution in elderly patients who have concomitant CV disease that could be adversely affected by beta-2 agonists.

Hypersensitivity

Immediate hypersensitivity reactions, such as urticaria, angioedema, rash, and bronchospasm, may occur.

Hepatic Function

Use with caution and closely monitor patients.

Special Risk Patients

Use with caution in patients with CV disorders, especially coronary insufficiency, cardiac arrhythmias, hypertension, convulsive disorders, untreated hypokalemia, thyrotoxicosis, active or quiescent tuberculosis of the respiratory tract, untreated systemic fungal, bacterial, viral, or parasitic infection, or ocular herpes simplex, and in patients taking daily or alternate-day steroid therapy because of increased likelihood of hypothalmic-pituitary axis suppression.

Acute bronchospasm

Not indicated for the relief of acute bronchospasm.

Adrenal suppression

Adrenal suppression (including adrenal crisis) and hypercorticism may appear in a small number of patients.

Deteriorations of disease

Do not initiate treatment in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD. Do not use as rescue treatment of acute episodes of bronchospasm.

Eosinophilic conditions

In rare cases, systemic eosinophilic conditions may occur in patients receiving inhaled corticosteroids.

Excessive use

CV effects and fatalities have been reported with excessive use of inhaled sympathomimetic agents.

Hyperglycemia and hypokalemia

Changes in blood glucose and/or serum potassium may occur.

Immunosuppression

Patients receiving immunosuppressive agents are more susceptible to infections than healthy individuals. If patient is exposed to measles or chickenpox, appropriate prophylaxis and treatment may be warranted.

Infections

Lower respiratory tract infections, including pneumonia, have been reported following inhaled administration of corticosteroids. Localized Candida albicans infections occurred in the mouth and pharynx.

Metabolic effects

Long-term use of orally inhaled corticosteroids may affect normal bone metabolism, resulting in loss of bone mineral density.

Ocular effects

Glaucoma, increased IOP, and cataracts have been reported with following the long-term use of corticosteroids, including budesonide.

Paradoxical bronchospasm

Life-threatening paradoxical bronchospasm may occur.

Systemic corticosteroids

Transferring patients from systemic corticosteroid therapy to inhaled corticosteroids may unmask conditions previously suppressed by systemic corticosteroid therapy (eg, arthritis, eczema). Budesonide/formoterol should not be used for transferring patients from systemic corticosteroids.

Overdosage

Symptoms

Budesonide

Adrenal suppression, hypercorticism.

Formoterol

Angina, arrhythmias, cardiac arrest, death, dizziness, dry mouth, fatigue, headache, hyperglycemia, hypertension, hypokalemia, hypotension, insomnia, malaise, metabolic acidosis, muscle cramps, nausea, nervousness, palpitation, prolonged QTc interval, seizures, tachycardia, tremor, vomiting.

Patient Information

Advise patient to read the patient information leaflet material before using product the first time and with each refill.
Explain name, dose, action, how to use the inhaler, possible drug interactions, and potential adverse reactions of drug.
Instruct patient to notify health care provider immediately if they experience decreasing effectiveness, need for more inhalations than usual, a decrease in lung function as outlined by the health care provider, or a marked change in symptoms.
Instruct patient to use exactly as prescribed and not to change the dose or discontinue therapy unless advised by health care provider.
Warn patient to avoid exposure to chickenpox or measles and to notify health care provider immediately if exposed.
Instruct patient regarding how to store, administer, and dispose of outdated medication.

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Figure 1. A 12-Week Trial in Pediatric Patients Previously Maintained on Inhaled Corticosteroid Therapy Prior to Study Entry

Budesonide/

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