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Asmanex Twist

29/06/10

Generic Name: mometasone (Inhalation route)

moe-MET-a-sone

Commonly used brand name(s):

In the U.S.

Asmanex Twist

Available Dosage Forms:

Powder

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Adrenal Glucocorticoid

Uses For Asmanex Twist

Mometasone belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It is used to help prevent the symptoms of asthma. When used regularly every day, inhaled mometasone decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Inhaled mometasone works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms.

This medicine is available only with your doctor’s prescription.

Before Using Asmanex Twist

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

This medicine has only been tested in children 12 years of age or older. Mometasone powder for inhalation may adversely effect the adrenal gland and stunt growth in pediatric patients. Before this medicine is given to a child, you and your child’s doctor should talk about the good this medicine will do as well as the risks of using it.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of mometasone inhalation powder in the elderly with use in other age groups.

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 this medicine 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.

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 Asmanex Twist

Dosing

The dose of this medicine 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 this medicine. 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 asthma (treatment)
- If you have had previous asthma therapy with bronchodilators alone:
  - Adults—220 mcg once daily in the evening
  - Children—Use and dose must be determined by your doctor.
- If you have had previous asthma therapy with inhaled corticosteroids alone:
  - Adults—220 mcg once daily in the evening
  - Children—Use and dose must be determined by your doctor.
- If you have had previous asthma therapy with oral corticosteroids:
  - Adults—440 mcg twice daily
  - Children—Use and dose must be determined by your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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.

Precautions While Using Asmanex Twist

Check with your doctor if:

You go through a period of unusual stress to your body, such as surgery, injury, or infection.
You have an asthma attack that does not improve after you take a bronchodilator medicine.
Your asthma symptoms do not improve or your condition worsens.
You are exposed to the chickenpox or measles.

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

Asmanex Twist 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
cold or flu-like symptoms
congestion
cough
dryness or soreness of throat

Less common

Abdominal or stomach pain
diarrhea
fever or chills
loss of appetite
lower back or side pain
nausea

Rare

White patches inside nose or mouth

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

Difficulty in moving
discouragement
fatigue
feeling sad or empty
increased abdominal pain and cramping during menstrual periods
irritability
lack of appetite
loss of interest or pleasure
muscle pain or stiffness
musculoskeletal pain
nasal burning and irritation
pain in joints
stomach discomfort following meals
stuffy or runny nose or headache
tiredness
trouble concentrating
trouble sleeping
unexplained runny nose or sneezing
upset stomach

Less common

Accidental injury
bladder pain
bloody or cloudy urine
bloody mucus or unexplained nosebleeds
chest congestion
chills
cough
diarrhea
difficult, burning, or painful urination
flatulence
frequent urge to urinate
general feeling of discomfort or illness
lower back or side pain
menstrual changes
nausea
post-procedure pain
shivering
sore throat
sweating
unusual tiredness or weakness
vomiting

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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Asmanex Twisthaler Powder

29/06/10

Generic Name: Mometasone (moe-MET-a-sone)
Brand Name: Asmanex Twisthaler

Asmanex Twisthaler Powder is used for:

Preventing or reducing the frequency and seriousness of bronchial asthma attacks. It is also used in certain asthma patients when adding an inhaled corticosteroid may decrease the amount of other types of corticosteroids needed. Asmanex Twisthaler Powder does not help during an acute asthma attack.

Asmanex Twisthaler Powder is a corticosteroid. It works by reducing inflammation in the airways.

Do NOT use Asmanex Twisthaler Powder if:

you are allergic to any ingredient in Asmanex Twisthaler Powder
you are having a severe asthma attack requiring quick relief

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

Before using Asmanex Twisthaler Powder:

Some medical conditions may interact with Asmanex Twisthaler 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 active or inactive tuberculosis or a positive skin test for tuberculosis
if you have an infection of the respiratory tract, any untreated infection (fungal, bacterial, parasitic, viral), measles, chickenpox, herpes simplex in or around the eye, or eczema, or if you have recently received a vaccination
if you have increased pressure in the eye, glaucoma, cataracts, diarrhea, osteoporosis (weak bones), or a family history of osteoporosis
if you will be confined to a bed or chair for a prolonged period of time

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

Anticonvulsants (eg, phenytoin) or corticosteroids (eg, prednisone) because the risk of serious side effects such as weakened bones may be increased
Ketoconazole because it may increase the risk of Asmanex Twisthaler Powder’s side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Asmanex Twisthaler 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 Asmanex Twisthaler Powder:

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

An extra patient leaflet is available with Asmanex Twisthaler Powder. Talk to your pharmacist if you have questions about this information.
Hold the inhaler upright and remove the cap by twisting in a counter-clockwise direction. Exhale fully. Place the mouthpiece in your mouth and firmly close your lips around the mouthpiece. Take a fast, deep breath. You may not be able to feel or taste the medicine after you inhale it. Remove the inhaler from your mouth, and hold your breath for about 10 seconds. Breathe out slowly. Do not breathe out through the inhaler.
Gently wipe the mouthpiece dry. Replace the cap by gently pressing down and rotating the cap in a clockwise direction until a click is heard. If you do not replace the cap, your next dose will not be properly loaded.
Rinse your mouth with water after each dose. Spit out the rinse water. This will help to decrease the risk of developing a fungal infection of the mouth from Asmanex Twisthaler Powder.
Throw away the inhaler 45 days after opening the foil pouch or when the dose counter reads zero, whichever comes first.
Use Asmanex Twisthaler Powder on a regular schedule to get the most benefit from it.
Continue to use Asmanex Twisthaler Powder even if you feel well. Do not miss any doses.
If you miss a dose of Asmanex Twisthaler Powder, use 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 use 2 doses at once.

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

Important safety information:

Asmanex Twisthaler Powder is for oral inhalation only. Do not get it in your eyes. If you get it in your eyes, rinse right away with cool water.
Do NOT take more than the recommended dose. If your symptoms do not get better within 2 weeks or if they get worse, check with your doctor.
Asmanex Twisthaler Powder is used to prevent asthma attacks. It is not to be used for a severe asthma attack that requires quick relief.
If you are also using a bronchodilator inhaler, be sure to always carry the bronchodilator inhaler with you to use during asthma attacks.
Use caution if you switch from an oral steroid (eg, prednisone) to Asmanex Twisthaler 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.
If your symptoms do not get better or if they get worse, check with your doctor. Do not increase the dosage.
Contact your health care provider at once if you have an asthma attack and do not get relief from your bronchodilator inhaler.
Asmanex Twisthaler 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. If exposed, contact your doctor at once.
Tell your doctor or dentist that you take Asmanex Twisthaler Powder before you receive any medical or dental care, emergency care, or surgery.
Check with your doctor before having any vaccinations while you are using Asmanex Twisthaler Powder.
Lab tests, including lung function, may be performed while you use Asmanex Twisthaler 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 Asmanex Twisthaler Powder.
Asmanex Twisthaler Powder should be used with extreme caution in CHILDREN younger than 4 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 Asmanex Twisthaler Powder while you are pregnant. It is not known if Asmanex Twisthaler Powder is found in breast milk. If you are or will be breast-feeding while you use Asmanex Twisthaler Powder, check with your doctor. Discuss any possible risks to your baby.

Contact your health care provider if WITHDRAWAL symptoms (joint or muscle pain, lack of energy, depression) occur after you stop using Asmanex Twisthaler Powder. Do not suddenly stop using Asmanex Twisthaler Powder without first checking with your doctor.

Possible side effects of Asmanex Twisthaler 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:

Decreased appetite; flu-like symptoms; headache; indigestion; nausea; runny nose; sinus swelling; sore throat; stomach pain or upset; stuffy nose.

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); chest pain; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; lack of energy; menstrual changes or painful menstruation; mental or mood changes; muscle or bone pain; new or worsening breathing problems; shakiness; shortness of breath; swelling; tiredness; vision changes; vomiting; weakness; wheezing; white curd-like patches or rash in the mouth.

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 Asmanex Twisthaler Powder:

Store Asmanex Twisthaler Powder at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Asmanex Twisthaler Powder out of the reach of children and away from pets.

General information:

If you have any questions about Asmanex Twisthaler Powder, please talk with your doctor, pharmacist, or other health care provider.
Asmanex Twisthaler 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 Asmanex Twisthaler 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

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Asmanex Twisthaler 120 Dose

29/06/10

Generic Name: mometasone inhalation (moe MET a sone)
Brand Names: Asmanex Twisthaler 120 Dose, Asmanex Twisthaler 14 Dose, Asmanex Twisthaler 30 Dose, Asmanex Twisthaler 60 Dose, Asmanex Twisthaler 7 Dose

What is Asmanex Twisthaler 120 Dose (mometasone inhalation)?

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

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

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

What is the most important information I should know about Asmanex Twisthaler 120 Dose (mometasone inhalation)?

Do not use mometasone inhalation to treat an asthma attack that has already begun. It will not work fast enough to reverse your symptoms. Use another, faster-acting inhalation medication to treat an asthma attack. 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. 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 2 weeks of treatment.

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 were switched from an oral (taken by mouth) steroid to mometasone inhalation, you may need to go back to taking the oral medicine if you are under stress or have an asthma attack or other medical emergency. Carry an identification card or wear a medical alert ID to let others know that you may need an oral steroid in an emergency.

What should I discuss with my healthcare provider before using Asmanex Twisthaler 120 Dose (mometasone inhalation)?

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

FDA pregnancy category C. It is not known whether mometasone is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether mometasone passes into breast milk or if it could harm a nursing baby. Do not use mometasone inhalation without telling your doctor if you are breast-feeding a baby.

Mometasone 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 4 years old without the advice of a doctor.

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. Talk with your doctor about your risk of osteoporosis.

How should I use Asmanex Twisthaler 120 Dose (mometasone 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. 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.

Mometasone is a powder that comes with a special inhaler device preloaded with the medicine. The device will deliver a measured dose of mometasone as a fine spray of powder each time you use the inhaler.

You may or may not be able to feel or taste this powder in your mouth while using the inhaler. Do not use extra doses if you do not feel or taste the powder. Tell your doctor or pharmacist if you think your inhaler is not working properly.

To reduce the chance of developing a yeast infection in your mouth, rinse with water after using mometasone inhalation. Do not swallow.

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.

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 2 weeks of treatment.

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 were switched from an oral (taken by mouth) steroid to mometasone inhalation, you may need to go back to taking the oral medicine if you are under stress or have an asthma attack or other medical emergency. Carry an identification card or wear a medical alert ID to let others know that you may need an oral steroid in an emergency. Store mometasone inhalation at room temperature away from moisture and heat. When you first open the foil pouch and remove the inhaler device, write the date on the device. Throw away the inhaler after 45 days, or when the dose counter shows “00.”

Do not wash your inhaler device or allow it to get wet. Wipe the mouthpiece with a clean dry tissue or cloth after each use.

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 mometasone inhalation is not expected to produce life-threatening symptoms.

What should I avoid while using Asmanex Twisthaler 120 Dose (mometasone inhalation)?

Mometasone inhalation 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. 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 mometasone inhalation.

Asmanex Twisthaler 120 Dose (mometasone 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:

wheezing or breathing problems after using this medication;
skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist); or
worsening asthma symptoms.

Less serious side effects may include:

headache;
runny nose, increased sinus allergy symptoms;
stuffy nose, sinus pain, sore throat, nosebleed;
muscle or joint pain, back pain;
nausea, upset stomach, loss of appetite;
changes in menstrual periods;
tired feeling; or
hoarseness or deepened 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.

What other drugs will affect Asmanex Twisthaler 120 Dose (mometasone inhalation)?

Before using mometasone inhalation, tell your doctor if you are using ketoconazole (Nizoral).

There may be other drugs that can interact with mometasone inhalation. 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 mometasone 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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Asmanex Twisthaler 14 Dose

29/06/10

What is Asmanex Twisthaler 14 Dose (mometasone inhalation)?

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

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

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

What is the most important information I should know about Asmanex Twisthaler 14 Dose (mometasone inhalation)?

What should I discuss with my healthcare provider before using Asmanex Twisthaler 14 Dose (mometasone inhalation)?

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

Mometasone 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 4 years old without the advice of a doctor.

How should I use Asmanex Twisthaler 14 Dose (mometasone inhalation)?

To reduce the chance of developing a yeast infection in your mouth, rinse with water after using mometasone inhalation. Do not swallow.

Your dosage needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack.

Do not wash your inhaler device or allow it to get wet. Wipe the mouthpiece with a clean dry tissue or cloth after each use.

What happens if I miss a dose?

What happens if I overdose?

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

An overdose of mometasone inhalation is not expected to produce life-threatening symptoms.

What should I avoid while using Asmanex Twisthaler 14 Dose (mometasone inhalation)?

Asmanex Twisthaler 14 Dose (mometasone inhalation) side effects

wheezing or breathing problems after using this medication;
skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist); or
worsening asthma symptoms.

Less serious side effects may include:

headache;
runny nose, increased sinus allergy symptoms;
stuffy nose, sinus pain, sore throat, nosebleed;
muscle or joint pain, back pain;
nausea, upset stomach, loss of appetite;
changes in menstrual periods;
tired feeling; or
hoarseness or deepened 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.

What other drugs will affect Asmanex Twisthaler 14 Dose (mometasone inhalation)?

Before using mometasone inhalation, tell your doctor if you are using ketoconazole (Nizoral).

Where can I get more information?

Your pharmacist can provide more information about mometasone 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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Asacol Delayed-Release Tablets

29/06/10

Generic Name: Mesalamine (me-SAL-a-meen)
Brand Name: Examples include Asacol and Lialda

Asacol Delayed-Release Tablets are used for:

Treating and causing remission of various forms of mild to moderate ulcerative colitis (inflammation of the colon). Asacol Delayed-Release Tablets may also be used for other conditions as determined by your doctor.

Asacol Delayed-Release Tablets are a 5-aminosalicylic acid (5-ASA). It works by preventing the production of substances that cause inflammation of the colon.

Do NOT use Asacol Delayed-Release Tablets if:

you are allergic to any ingredient in Asacol Delayed-Release Tablets, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen), or salicylates (eg, aspirin)
you are younger than 18 years of age and you have the flu or chickenpox, or you have received a live vaccine (eg, varicella, influenza) within the past 6 weeks
you are taking probenecid or sulfinpyrazone

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

Before using Asacol Delayed-Release Tablets:

Some medical conditions may interact with Asacol Delayed-Release Tablets. 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 (including sulfasalazine), foods, or other substances
if you have had a stroke, bleeding in the brain, or an aneurysm
if you have a history of liver or kidney problems, certain stomach problems (pyloric stenosis), pancreas problems (eg, pancreatitis), Kawasaki syndrome, or a rheumatic (inflammatory) disease (eg, rheumatoid arthritis)
if you have a history of heart problems (eg, inflammation of the sac around your heart)
if you have the flu or chickenpox or have recently received a live vaccine (eg, varicella, influenza)

Some MEDICINES MAY INTERACT with Asacol Delayed-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Gingko biloba extract because side effects, such as increased bleeding, may occur
Corticosteroids (eg, prednisone) because they may decrease Asacol Delayed-Release Tablets’s effectiveness
Carbonic anhydrase inhibitors (eg, acetazolamide), insulin, meglitinide antidiabetics (eg, repaglinide), sulfonylureas (eg, glipizide), or valproic acid because the risk of their side effects may be increased by Asacol Delayed-Release Tablets
Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), probenecid, spironolactone, or sulfinpyrazone because their effectiveness may be decreased by Asacol Delayed-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Asacol Delayed-Release Tablets 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 Asacol Delayed-Release Tablets:

Use Asacol Delayed-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Asacol Delayed-Release Tablets by mouth with or without food. If stomach upset occurs, take with food or milk to reduce stomach irritation.
Swallow Asacol Delayed-Release Tablets whole. Do not break, crush, or chew before swallowing.
Continue to take Asacol Delayed-Release Tablets even if you feel well. Do not miss any doses.
If you miss a dose of Asacol Delayed-Release Tablets, 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 Asacol Delayed-Release Tablets.

Important safety information:

Asacol Delayed-Release Tablets may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Asacol Delayed-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Asacol Delayed-Release Tablets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Asacol Delayed-Release Tablets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
You may notice undissolved parts of Asacol Delayed-Release Tablets in your stool with some brands of Asacol Delayed-Release Tablets. If this occurs repeatedly, contact your doctor.
Some patients may experience an intolerance reaction to Asacol Delayed-Release Tablets. Signs of intolerance are very similar to symptoms of inflammatory bowel disease. They may include severe or persistent stomach pain or cramping, bloody diarrhea, fever, headache, or rash. If you experience any of these symptoms, contact your doctor right away.
Salicylates have been linked to a serious illness called Reye syndrome. Do not give Asacol Delayed-Release Tablets to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.
Lab tests, including kidney function, liver function, and complete blood cell counts, may be performed while you use Asacol Delayed-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Asacol Delayed-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially blood problems.
Asacol Delayed-Release Tablets should be used with extreme caution in CHILDREN; safety and effectiveness in 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 Asacol Delayed-Release Tablets while you are pregnant. Asacol Delayed-Release Tablets are found in breast milk. If you are or will be breast-feeding while you use Asacol Delayed-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Asacol Delayed-Release Tablets:

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:

Diarrhea; gas; headache; mild stomach discomfort or pain; nausea; runny or stuffy nose.

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); blood in the urine; bloody diarrhea; bloody or coffee ground-like vomit; change in the amount of urine; chest pain; dark urine; fever, chills, or persistent sore throat; severe or persistent headache; severe or sudden stomach pain or cramping; shortness of breath; unusual bruising or bleeding; yellowing of the skin or eyes.

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 confusion; diarrhea; dizziness; drowsiness; fast or difficult breathing; fever; headache; hearing loss; ringing in the ears; seizures; sweating; vomiting of blood; weakness.

Proper storage of Asacol Delayed-Release Tablets:

Store Asacol Delayed-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Asacol Delayed-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Asacol Delayed-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
Asacol Delayed-Release Tablets are 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 Asacol Delayed-Release Tablets. 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

A,Med-facts

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Asacol 800

29/06/10

Generic Name: mesalamine (Oral route)

me-SAL-a-meen

Commonly used brand name(s):

In the U.S.

Apriso
Asacol
Asacol HD
Lialda
Pentasa

In Canada

Asacol 800

Available Dosage Forms:

Tablet, Delayed Release
Tablet, Enteric Coated
Capsule, Extended Release
Tablet

Therapeutic Class: Anti-Inflammatory

Chemical Class: Salicylate, Non-Aspirin

Uses For Asacol 800

Mesalamine is used to treat an inflammatory bowel disease called ulcerative colitis. It works inside the intestines (bowel) to reduce the inflammation and other symptoms of the disease.

This medicine is available only with your doctor’s prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, mesalamine is used in certain patients with the following medical conditions:

Mild or moderate Crohn’s disease—for treatment and to prevent it from occurring again.

Before Using Asacol 800

Allergies

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of mesalamine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mesalamine in the elderly. However, elderly patients are more likely to have blood problems (e.g., neutropenia, pancytopenia) and age-related kidney disease, which may require caution in patients receiving mesalamine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Interactions with Medicines

Using this medicine 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.

Varicella Virus Vaccine

Ardeparin
Certoparin
Dalteparin
Danaparoid
Enoxaparin
Nadroparin
Parnaparin
Reviparin
Tamarind
Tinzaparin
Warfarin

Interactions with Food/Tobacco/Alcohol

Proper Use of mesalamine

This section provides information on the proper use of a number of products that contain mesalamine. It may not be specific to Asacol 800. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without first checking with your doctor.

Keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.

You should take the delayed-release tablets with food. All other brands of capsules and tablets can be taken with or without food.

Swallow the capsule or tablet whole. Do not open, break, crush, or chew it before swallowing.

Do not change to another brand without checking with your doctor. The number of capsules or tablets that you take depends on the brand and strength of the medicine. If you refill your medicine and it looks different, check with your pharmacist. One tablet of Asacol® HD 800 milligrams (mg) tablet may not work the same way as two Asacol® 400 mg tablets.

Dosing

For ulcerative colitis:
- For long-acting oral dosage form (delayed-release tablets):
  - Adults:
    - For Asacol®: 800 milligrams (mg) (two 400 mg tablets) three times a day. For maintenance (long-term) treatment, 1600 mg per day in divided doses.
    - For Asacol® HD: 1600 milligrams (mg) (two 800 mg tablets) three times a day for 6 weeks.
    - For Lialda™: 2.4 to 4.8 grams (two to four tablets) once a day as a single dose with food.
  - Children—Use and dose must be determined by your doctor.
- For long-acting oral dosage form (extended-release capsules):
  - Adults:
    - For Apriso™: 1.5 grams (four capsules) once a day as a single dose in the morning.
    - For Pentasa®: 1 gram (2 or 4 capsules) four times a day.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, 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

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.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the delayed-release tablets in a tightly-closed container to protect them from moisture. Putting desiccant pouches in the container may also help to keep the tablets from getting moist.

Precautions While Using Asacol 800

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Urine or blood tests may be needed to check for unwanted effects.

Check with your doctor right away if you have abdominal or stomach pain, bloody diarrhea, cramps, fever, headache, or a rash while you are using this medicine. These may be symptoms of a condition called mesalamine-induced acute intolerance syndrome.

Do not take antacids (e.g., Amphojel®, Maalox®, Mylanta®, Tums®) while you are taking the Apriso™ extended-release capsules. Using these medicines together may change the amount of medicine that is released in the body.

If you are taking the extended-release capsule or the delayed-release tablet, part of the capsule or tablet may pass into your stool after your body has absorbed the medicine. This is normal and nothing to worry about.

Asacol 800 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:

Less common

Abdominal or stomach cramps or pain (severe)
bloody diarrhea
fever
headache (severe)
skin rash and itching

Rare

Anxiety
back or stomach pain (severe)
blue or pale skin
chest pain, possibly moving to the left arm, neck, or shoulder
chills
fast heartbeat
nausea or vomiting
shortness of breath
swelling of the stomach
unusual tiredness or weakness
yellow eyes or skin

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

Symptoms of overdose

Confusion
diarrhea (severe or continuing)
dizziness or lightheadedness
drowsiness (severe)
fast or deep breathing
headache (severe or continuing)
hearing loss or ringing or buzzing in the ears (continuing)
nausea or vomiting (continuing)

More common

Abdominal or stomach cramps or pain (mild)
diarrhea (mild)
dizziness
headache (mild)
runny or stuffy nose or sneezing

Less common

Acne
back or joint pain
gas or flatulence
indigestion
loss of appetite
loss of hair

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.

A,Advanced

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Asacol HD

29/06/10

Generic Name: mesalamine (oral) (me SAL a meen)
Brand Names: Apriso, Asacol, Asacol HD, Lialda, Pentasa

What is Asacol HD (mesalamine (oral))?

Mesalamine affects a substance in the body that causes inflammation, tissue damage, and diarrhea.

Mesalamine is used to treat ulcerative colitis, proctitis, and proctosigmoiditis. Mesalamine is also used to prevent the symptoms of ulcerative colitis from recurring.

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

What is the most important information I should know about Asacol HD (mesalamine (oral))?

You should not use this medication if you are allergic to mesalamine or to aspirin or other salicylates (such as Disalcid, Doan’s Pills, Dolobid, Salflex, Tricosal, and others). Before you take mesalamine, tell your doctor if you have kidney or liver disease, a stomach condition called pyloric stenosis, a heart condition such as congestive heart failure, or a history of allergy to sulfasalazine (Azulfidine). Do not crush, break, or chew a mesalamine tablet or capsule. Swallow the pill whole. It is specially formulated to release the medicine after it has passed through your stomach into your intestines.

Call your doctor if you find undissolved tablets in your stool.

Stop using mesalamine and call your doctor at once if you have severe stomach pain, cramping, fever, headache, and bloody diarrhea.

What should I discuss with my healthcare provider before taking Asacol HD (mesalamine (oral))?

You should not use this medication if you are allergic to mesalamine or to aspirin or other salicylates (such as Disalcid, Doan’s Pills, Dolobid, Salflex, Tricosal, and others).

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

a stomach condition called pyloric stenosis;
a history of allergy to sulfasalazine (Azulfidine);
a heart condition such as congestive heart failure;
kidney disease; or
liver disease.

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. Mesalamine 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.

How should I take Asacol HD (mesalamine (oral))?

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

Take mesalamine with a full glass of water.

Mesalamine can usually be taken with or without food. Follow your doctor’s instructions.

Mesalamine extended-release capsules(Lialda) should be taken with a meal. Do not crush, break, or chew a mesalamine tablet or capsule. Swallow the pill whole.

The extended-release capsule is specially formulated to release the medicine after it has passed through your stomach into your intestines. Breaking the pill may cause the drug to be released too early in the digestive tract.

The enteric-coated tablet has a special coating to protect your stomach. Breaking the pill could damage this coating.

Call your doctor if you find undissolved tablets in your stool.

Store mesalamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take 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.

Overdose symptoms may include ringing in your ears, dizziness, headache, confusion, drowsiness, sweating, shortness of breath, vomiting, and diarrhea.

What should I avoid while taking Asacol HD (mesalamine (oral))?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using mesalamine.

Asacol HD (mesalamine (oral)) 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. Stop using mesalamine and call your doctor at once if you have any of these serious side effects:

severe stomach pain, cramping, fever, headache, and bloody diarrhea.

Less serious side effects may include:

mild nausea, vomiting, stomach cramps, diarrhea, gas;
fever, sore throat, or other flu symptoms;
constipation;
headache or dizziness;
tired feeling; or
skin rash.

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.

What other drugs will affect Asacol HD (mesalamine (oral))?

Before taking mesalamine, tell your doctor if you are using any of the following drugs:

azathioprine (Imuran) or mercaptopurine (Purinethol);
pentamidine (Nebupent, Pentam);
tacrolimus (Prograf);
amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet);
antibiotics such as capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled);
antiviral medicines such as acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir);
cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid); or
aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel).

This list is not complete and there may be other drugs that can interact with mesalamine. 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 mesalamine.

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.

A,Concise

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Asacol HD Delayed-Release Tablets

29/06/10

Generic Name: Mesalamine (me-SAL-a-meen)
Brand Name: Asacol HD

Asacol HD Delayed-Release Tablets are used for:

Treating moderately active ulcerative colitis (inflammation of the colon). Asacol HD Delayed-Release Tablets may also be used for other conditions as determined by your doctor.

Asacol HD Delayed-Release Tablets are a 5-aminosalicylic acid (5-ASA). It works by preventing the production of substances that cause inflammation of the colon.

Do NOT use Asacol HD Delayed-Release Tablets if:

you are allergic to any ingredient in Asacol HD Delayed-Release Tablets, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen), or salicylates (eg, aspirin)
you are younger than 18 years of age and you have the flu or chickenpox, or you have received a live vaccine (eg, varicella, influenza) within the past 6 weeks
you are taking probenecid or sulfinpyrazone

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

Before using Asacol HD Delayed-Release Tablets:

Some medical conditions may interact with Asacol HD Delayed-Release Tablets. 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 (including sulfasalazine), foods, or other substances
if you have had a stroke, bleeding in the brain, or an aneurysm
if you have a history of liver or kidney problems, certain stomach problems (pyloric stenosis), pancreas problems (eg, pancreatitis), Kawasaki syndrome, or a rheumatic (inflammatory) disease (eg, rheumatoid arthritis)
if you have a history of heart problems (eg, inflammation of the sac around your heart)
if you have the flu or chickenpox or have recently received a live vaccine (eg, varicella, influenza)

Some MEDICINES MAY INTERACT with Asacol HD Delayed-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Gingko biloba extract because side effects, such as increased bleeding, may occur
Corticosteroids (eg, prednisone) because they may decrease Asacol HD Delayed-Release Tablets’s effectiveness
Carbonic anhydrase inhibitors (eg, acetazolamide), insulin, meglitinide antidiabetics (eg, repaglinide), sulfonylureas (eg, glipizide), or valproic acid because the risk of their side effects may be increased by Asacol HD Delayed-Release Tablets
Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), probenecid, spironolactone, or sulfinpyrazone because their effectiveness may be decreased by Asacol HD Delayed-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Asacol HD Delayed-Release Tablets 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 Asacol HD Delayed-Release Tablets:

Use Asacol HD Delayed-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Asacol HD Delayed-Release Tablets by mouth with or without food. If stomach upset occurs, take with food or milk to reduce stomach irritation.
Swallow Asacol HD Delayed-Release Tablets whole. Do not break, crush, or chew before swallowing.
Continue to take Asacol HD Delayed-Release Tablets even if you feel well. Do not miss any doses.
If you miss a dose of Asacol HD Delayed-Release Tablets, 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 Asacol HD Delayed-Release Tablets.

Important safety information:

Asacol HD Delayed-Release Tablets may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Asacol HD Delayed-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Asacol HD Delayed-Release Tablets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Asacol HD Delayed-Release Tablets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
You may notice undissolved parts of Asacol HD Delayed-Release Tablets in your stool with some brands of Asacol HD Delayed-Release Tablets. If this occurs repeatedly, contact your doctor.
Some patients may experience an intolerance reaction to Asacol HD Delayed-Release Tablets. Signs of intolerance are very similar to symptoms of inflammatory bowel disease. They may include severe or persistent stomach pain or cramping, bloody diarrhea, fever, headache, or rash. If you experience any of these symptoms, contact your doctor right away.
Salicylates have been linked to a serious illness called Reye syndrome. Do not give Asacol HD Delayed-Release Tablets to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.
Lab tests, including kidney function, liver function, and complete blood cell counts, may be performed while you use Asacol HD Delayed-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Asacol HD Delayed-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially blood problems.
Asacol HD Delayed-Release Tablets should be used with extreme caution in CHILDREN; safety and effectiveness in 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 Asacol HD Delayed-Release Tablets while you are pregnant. Asacol HD Delayed-Release Tablets are found in breast milk. If you are or will be breast-feeding while you use Asacol HD Delayed-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Asacol HD Delayed-Release Tablets:

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:

Diarrhea; gas; headache; mild stomach discomfort or pain; nausea; runny or stuffy nose.

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); blood in the urine; bloody diarrhea; bloody or coffee ground-like vomit; change in the amount of urine; chest pain; dark urine; fever, chills, or persistent sore throat; severe or persistent headache; severe or sudden stomach pain or cramping; shortness of breath; unusual bruising or bleeding; yellowing of the skin or eyes.

If OVERDOSE is suspected:

Proper storage of Asacol HD Delayed-Release Tablets:

Store Asacol HD Delayed-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Asacol HD Delayed-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Asacol HD Delayed-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
Asacol HD Delayed-Release Tablets are 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 Asacol HD Delayed-Release Tablets. 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

A,Med-facts

Comments (0)

Ascarel

29/06/10

Generic Name: pyrantel (pie RAN tell)
Brand Names: Antiminth, Ascarel, Pin-X, Pinworm Caplets, Pinworm Medicine

What is Ascarel (pyrantel)?

Pyrantel is an “antihelmintic,” or anti-worm, medication. It prevents worms from growing or multiplying in your body.

Pyrantel is used to treat infections caused by worms such as pinworm and roundworm.

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

What is the most important information I should know about Ascarel (pyrantel)?

Take the whole dose of pyrantel. It can be taken with food or on an empty stomach at any time during the day.

Follow your doctor’s instructions or the instructions that accompany the package about treatment; about washing of clothes, linens, and towels; and about household disinfecting. Pinworm infections are easily spread from one person to another.

Who should not take Ascarel (pyrantel)?

Before taking pyrantel, talk to your doctor about any other medical conditions that you have. Pyrantel should not be used if you have liver disease or if you have had an allergic reaction to this medicine in the past.

Do not take pyrantel without first talking to your doctor if you are pregnant. Do not take pyrantel without first talking to your doctor if you are breast-feeding a baby. Children younger than 2 years of age should not use pyrantel unless otherwise directed by your doctor.

How should I take Ascarel (pyrantel)?

Take pyrantel exactly as directed by your doctor or as directed in the package labeling. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Pyrantel may be taken with or without food at any time of the day.

Shake the suspension well before measuring a dose.

Use a dose-measuring spoon, cup, or dropper (not a regular tablespoon) to ensure that you measure the correct dose of medication. Ask your pharmacist where you can get a dose-measuring device if you do not have one.

Fasting, laxatives, and purging will not help cure this infection.

Treatment of family members and other close contacts may be necessary. Pinworm is spread very easily to others in close contact with the infected person.

Toilets must be disinfected daily and clothing, linens, towels, and pajamas must be changed and washed daily.

Store pyrantel at room temperature away from moisture and heat.

What happens if I miss a dose?

Since pyrantel is usually taken in one dose, you are not likely to miss a dose.

What happens if I overdose?

Seek emergency medical attention.

What should I avoid while taking Ascarel (pyrantel)?

Treatment of family members and other close contacts may be necessary. Pinworm is spread very easily to others in close contact with the infected person.

To prevent reinfection, toilets must be disinfected daily, and clothing, linens, towels, and pajamas must be changed and washed daily.

Use caution when driving, operating machinery, or performing other hazardous activities. Pyrantel may cause dizziness. If you experience dizziness, avoid these activities.

Ascarel (pyrantel) side effects

Seek emergency medical attention if you experience an allergic reaction (swelling of your lips, tongue, or face; shortness of breath; closing of your throat; or hives).

Other, less serious side effects may be more likely to occur. Continue to take pyrantel and talk to your doctor if you experience

nausea, vomiting, abdominal cramps, diarrhea, or a decreased appetite;
headache;
drowsiness or dizziness;
insomnia; or
a rash.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ascarel (pyrantel)?

Do not take other anti-worm medicines at the same time as pyrantel unless otherwise directed by your doctor. Other drugs used to treat infections caused by worms may decrease the effectiveness of pyrantel.

Theophylline (Theo-Dur, Theolair, Theochron, Theo-Bid, Elixophylline, others) may have dangerous side effects when taken during therapy with pyrantel. Your doctor may want to monitor your theophylline blood levels.

Drugs other than those listed here may also interact with pyrantel. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

Your pharmacist has more information about pyrantel written for health professionals that you may read.

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.

A,Concise

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Ascocid

29/06/10

Generic Name: ascorbic acid (Oral route)

as-KORE-bik AS-id

Commonly used brand name(s):

In the U.S.

Ascocid
C-500
Cecon
Cemill 1000
Cemill 500
Cevi-Bid
C-Time w/Rose Hips
Mega-C
One-Gram C
Protexin
Sunkist Vitamin C

In Canada

Ce-Vi-Sol
Revitalose-C-1000
Revitonus C-1000 Yellow Ampule
Vitamin C Powder

Available Dosage Forms:

Tablet
Powder
Powder for Solution
Capsule, Liquid Filled
Tablet, Chewable
Granule
Capsule
Syrup
Powder for Suspension
Liquid
Solution
Tablet, Extended Release
Lozenge/Troche
Capsule, Extended Release

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin C

Uses For Ascocid

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Ascorbic acid, also known as vitamin C, is necessary for wound healing. It is needed for many functions in the body, including helping the body use carbohydrates, fats, and protein. Vitamin C also strengthens blood vessel walls.

Lack of vitamin C can lead to a condition called scurvy, which causes muscle weakness, swollen and bleeding gums, loss of teeth, and bleeding under the skin, as well as tiredness and depression. Wounds also do not heal easily. Your health care professional may treat scurvy by prescribing vitamin C for you.

Some conditions may increase your need for vitamin C. These include:

AIDS (acquired immune deficiency syndrome)
Alcoholism
Burns
Cancer
Diarrhea (prolonged)
Fever (prolonged)
Infection (prolonged)
Intestinal diseases
Overactive thyroid (hyperthyroidism)
Stomach ulcer
Stress (continuing)
Surgical removal of stomach
Tuberculosis

Also, the following groups of people may have a deficiency of vitamin C:

Infants receiving unfortified formulas
Smokers
Patients using an artificial kidney (on hemodialysis)
Patients who undergo surgery
Individuals who are exposed to long periods of cold temperatures

Increased need for vitamin C should be determined by your health care professional.

Vitamin C may be used for other conditions as determined by your health care professional.

Claims that vitamin C is effective for preventing senility and the common cold, and for treating asthma, some mental problems, cancer, hardening of the arteries, allergies, eye ulcers, blood clots, gum disease, and pressure sores have not been proven. Although vitamin C is being used to reduce the risk of cardiovascular disease and certain types of cancer, there is not enough information to show that these uses are effective.

Injectable vitamin C is given by or under the supervision of a health care professional. Other forms of vitamin C are available without a prescription.

Once a medicine or dietary supplement has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, vitamin C is used in certain patients with the following medical conditions:

Overdose of iron (to help another drug in decreasing iron levels in the body)
Methemoglobinemia (a blood disease)

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Vitamin C is found in various foods, including citrus fruits (oranges, lemons, grapefruit), green vegetables (peppers, broccoli, cabbage), tomatoes, and potatoes. It is best to eat fresh fruits and vegetables whenever possible since they contain the most vitamins. Food processing may destroy some of the vitamins. For example, exposure to air, drying, salting, or cooking (especially in copper pots), mincing of fresh vegetables, or mashing potatoes may reduce the amount of vitamin C in foods. Freezing does not usually cause loss of vitamin C unless foods are stored for a very long time.

Vitamins alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods.

The daily amount of vitamin C needed is defined in several different ways.

For U.S.—
Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person’s age, sex, and physical condition (e.g., pregnancy).
Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

For Canada—
Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes for vitamin C are generally defined as follows:

Persons	U.S. (mg)	Canada (mg)
Infants and children Birth to 3 years of age	30–40	20
4 to 6 years of age	45	25
7 to 10 years of age	45	25
Adolescent and adult males	50–60	25–40
Adolescent and adult females	50–60	25–30
Pregnant females	70	30–40
Breast-feeding females	90–95	55
Smokers	100	45–60

Before Using Ascocid

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, the following should be considered:

Allergies

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

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

Interactions with Medicines

Using this dietary supplement 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.

Amygdalin

Using this dietary supplement 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.

Indinavir

Interactions with Food/Tobacco/Alcohol

Proper Use of ascorbic acid

This section provides information on the proper use of a number of products that contain ascorbic acid. It may not be specific to Ascocid. Please read with care.

Dosing

For oral dosage form (capsules, tablets, oral solution, syrup):
- To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes:
  - For the U.S.
  - Adult and teenage males—50 to 60 milligrams (mg) per day.
  - Adult and teenage females—50 to 60 mg per day.
  - Pregnant females—70 mg per day.
  - Breast-feeding females—90 to 95 mg per day.
  - Smokers—100 mg per day.
  - Children 4 to 10 years of age—45 mg per day.
  - Children birth to 3 years of age—30 to 40 mg per day.
  - For Canada
  - Adult and teenage males—25 to 40 mg per day.
  - Adult and teenage females—25 to 30 mg per day.
  - Pregnant females—30 to 40 mg per day.
  - Breast-feeding females—55 mg per day.
  - Smokers—45 to 60 mg per day.
  - Children 4 to 10 years of age—25 mg per day.
  - Children birth to 3 years of age—20 mg per day.
- To treat deficiency:
  - Adults and teenagers—Treatment dose is determined by prescriber for each individual based on the severity of deficiency. The following dose has been determined for scurvy: 500 mg a day for at least 2 weeks.
  - Children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency. The following dose has been determined for scurvy: 100 to 300 mg a day for at least 2 weeks.

For those individuals taking the oral liquid form of vitamin C:

This preparation is to be taken by mouth even though it comes in a dropper bottle.
This dietary supplement may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food.

Missed Dose

If you miss taking a vitamin for one or more days there is no cause for concern, since it takes some time for your body to become seriously low in vitamins.

Storage

Store the dietary supplement in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Ascocid

Vitamin C is not stored in the body. If you take more than you need, the extra vitamin C will pass into your urine. Very large doses may also interfere with tests for sugar in diabetics and with tests for blood in the stool.

Ascocid 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 as soon as possible if any of the following side effects occur:

Less common or rare – with high doses

Side or lower back pain

Less common or rare – with high doses

Diarrhea
dizziness or faintness (with the injection only)
flushing or redness of skin
headache
increase in urination (mild)
nausea or vomiting
stomach cramps

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.

A,Advanced

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