Generic Name: beclomethasone inhalation (be kloe METH a sone)
Brand Names: Qvar

What is Qvar (beclomethasone inhalation)?

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

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

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

What is the most important information I should know about Qvar (beclomethasone inhalation)?

Do not use beclomethasone 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.

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

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. Your dosage needs may also change if you have surgery, are ill, are under stress, or have recently had an asthma attack. If you were switched from an oral (taken by mouth) steroid to beclomethasone 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 Qvar (beclomethasone inhalation)?

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

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

Beclomethasone 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 5 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. Talk with your doctor about your risk of osteoporosis.

How should I use Qvar (beclomethasone 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. Beclomethasone comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Do not use beclomethasone 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.

To reduce the chance of developing a yeast infection in your mouth, rinse with water after using beclomethasone 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 is important to use beclomethasone inhalation regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

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

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. Your dosage needs may also change if you have surgery, are ill, are under stress, or have recently had an asthma attack. If you were switched from an oral (taken by mouth) steroid to beclomethasone 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 beclomethasone inhalation at room temperature away from moisture and heat. Keep the medicine canister away from high heat, such as open flame or in a car on a hot day. The canister may explode if it gets too hot.

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

What should I avoid while using Qvar (beclomethasone inhalation)?

Beclomethasone 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. Contact your doctor if you have been exposed to someone with measles or chicken pox.

Qvar (beclomethasone 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:

• weakness, tired feeling, nausea, loss of appetite, weight loss;

• 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);

• worsening asthma symptoms.

Less serious side effects may include:

• headache;

• dryness in your mouth, nose, or throat;

• white patches or sores inside your mouth or on your lips;

• stuffy nose, sinus pain, sore throat, cough; 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 Qvar (beclomethasone inhalation)?

If you are also using a bronchodilator (a drug that opens the airways to improve breathing), use it first before using the beclomethasone inhaler. This will allow more beclomethasone to reach your lungs. Bronchodilators include albuterol (Proventil, Ventolin), pirbuterol (Maxair), bitolterol (Tornalate), and others.

There may be other drugs that can interact with beclomethasone 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 beclomethasone 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.

Copyright 1996-2006 Cerner Multum, Inc. Version: 7.02. Revision Date: 11/19/2009 8:54:01 AM.

Generic Name: Beclomethasone (be-kloe-METH-a-sone)
Brand Name: Qvar

Qvar Aerosol Solution is used for:

Treating asthma. Qvar Aerosol Solution is also used to prevent asthma attacks. It will not stop an asthma attack once one has started. It may also be used to treat other conditions as determined by your doctor.

Qvar Aerosol Solution is a corticosteroid. It works by decreasing inflammation in the airways, which helps to prevent asthma symptoms.

Do NOT use Qvar Aerosol Solution if:

• you are allergic to any ingredient in Qvar Aerosol Solution
• you are having an asthma attack

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

Before using Qvar Aerosol Solution:

Some medical conditions may interact with Qvar Aerosol Solution. 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 an infection or illness, diarrhea, a herpes infection near the eye, cataracts, or glaucoma
• if you have tuberculosis (TB), measles, chickenpox, or had a positive TB skin test
• if you have recently received or are scheduled to receive a vaccine
• if you have had recent surgery or injury

Some MEDICINES MAY INTERACT with Qvar Aerosol Solution. However, no specific interactions are known at this time.

Ask your health care provider if Qvar Aerosol Solution 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 Qvar Aerosol Solution:

Use Qvar Aerosol Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Before using Qvar Aerosol Solution, be sure that the canister is properly placed in the inhaler unit.
• Each time a new inhaler is used, turn the canister away from the face and press down into the mouthpiece to release test sprays into the air. This process is called priming and will allow you to be sure the inhaler is working properly and will provide a full dose of medicine.
• 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 Qvar Aerosol Solution. 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.
• Rinse your mouth or gargle with water after using Qvar Aerosol Solution to prevent mouth sores or bad taste.
• Keep track of the number of sprays you use and subtract this number from the number of doses in the container. This will help you know when the container is becoming empty.
• If you miss a dose of Qvar Aerosol Solution, 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 Qvar Aerosol Solution.

Important safety information:

• Qvar Aerosol Solution will not stop an asthma attack once one has started. If you are also using a bronchodilator inhaler, be sure to always carry the bronchodilator inhaler with you to use during asthma attacks.
• It may take several weeks for Qvar Aerosol Solution to give full benefit. Continue to use it as directed during this time. If your symptoms do not get better after regular use or if your asthma gets worse, check with your doctor.
• Avoid spraying Qvar Aerosol Solution in the eyes.
• Use caution if you switch from an oral steroid (eg, prednisone) to Qvar Aerosol Solution. 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.
• Tell your doctor or dentist that you take Qvar Aerosol Solution before you receive any medical or dental care, emergency care, or surgery.
• If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does.
• Some patients may have trouble using Qvar Aerosol Solution 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.
• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Qvar Aerosol Solution.
• Qvar Aerosol Solution should not be used in CHILDREN younger than 5 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 Qvar Aerosol Solution while you are pregnant. It is not known if Qvar Aerosol Solution is found in breast milk. If you are or will be breast-feeding while you use Qvar Aerosol Solution, check with your doctor. Discuss any possible risks to your baby.

If you stop taking Qvar Aerosol Solution suddenly, you may have WITHDRAWAL symptoms. These may include joint or muscle pain, exhaustion, or depression may occur when you stop taking Qvar Aerosol Solution. Carefully follow your doctor’s instructions for stopping the use of Qvar Aerosol Solution.

Possible side effects of Qvar Aerosol Solution:

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:

Back pain; headache; dry mouth; hoarseness; nausea; runny nose; throat irritation; upper respiratory tract infection.

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); fainting; severe dizziness; sudden weight loss; unusual weakness; vomiting; white curd-like patches 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 Qvar Aerosol Solution:

Store Qvar Aerosol Solution 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. Do not puncture, break, or burn the canister even if it appears to be empty. Do not use or store near heat or open flames. Never throw the container into a fire. Contents are under pressure. Do not expose to temperatures above 120 degrees F (40 degrees C). Keep Qvar Aerosol Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Qvar Aerosol Solution, please talk with your doctor, pharmacist, or other health care provider.
• Qvar Aerosol Solution 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 Qvar Aerosol Solution. 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.

Brand names: Vancenase Nasal Inhaler and PocketHaler Nasal Inhaler, Vanceril Inhalation Aerosol and Double Strength Inhalation Aerosol, Vanceril Inhaler, Beconase AQ Nasal Spray, Beconase Inhalation Aerosol, Qvar Inhalation Aerosol, Vancenase AQ Nasal Spray and Double Strength Nasal Spray, Beclomethasone, Beclovent

Why is Qvar Inhalation Aerosol prescribed?

Beclomethasone is a type of steroid used for respiratory problems. Beclovent and Vanceril are prescribed for the prevention of recurring symptoms of bronchial asthma.

Beconase and Vancenase are used to relieve the symptoms of hay fever and to prevent regrowth of nasal polyps following surgical removal.

Most important fact about Qvar Inhalation Aerosol

Beclomethasone is not a bronchodilator medication (it does not quickly open the airways); and it should not be used for relief of asthma when bronchodilators and other nonsteroid drugs prove effective. Do not expect immediate relief from beclomethasone, and do not take higher doses in an attempt to make it work. It is not intended for rapid relief, but it will help control symptoms when taken routinely.

How should you take Qvar Inhalation Aerosol?

Beclomethasone is prescribed in an oral inhalant or a nasal spray form. Use Qvar Inhalation Aerosol only as preventive therapy, and take only the dose prescribed.

Although some people begin to notice improvement within a day or two, it may take 1 or 2 weeks for the full benefits to appear. If there’s no improvement after 3 weeks, let your doctor know.

If you are already taking a steroid in tablet form for asthma, you’ll need to make a gradual transition to the oral inhalant. During the first week, you’ll probably take the usual number of tablets. After that, you’ll be instructed to slowly reduce the number of tablets, replacing them with the inhalant.

Be sure to take the drug regularly, even if you have no symptoms. Many people will require additional drugs to control asthma symptoms fully, but Qvar Inhalation Aerosol may allow other drugs to be used in smaller doses.

If you are also using a bronchodilator inhalant, take it before inhaling beclomethasone. This will improve the effect of the second drug. Take the two inhalations several minutes apart.

Spray the inhalation aerosol into the air twice before you use it for the first time and when you have not used it for more than 7 days. Use it within 6 months.

Before you use Vancenase AQ 84 microgram nasal spray, press the pump 6 times or until you see a fine spray. If you don’t use it for more than 4 days, reprime the pump by spraying once or until a fine spray appears.

To use the inhaler:

1. Remove the cap and hold inhaler upright.
2. Shake the inhaler thoroughly.
3. Take a drink of water to moisten the throat.
4. Breathe out as fully as you comfortably can. Hold the inhaler upright and close your lips around the mouthpiece, keeping your tongue below it.
5. While pressing down on the can, inhale deeply. Hold your breath as long as you can.
6. Take your finger off the can, remove the inhaler, and breathe out gently.
7. Allow at least 1 minute between inhalations.

Gargling and rinsing your mouth with water after each dose may help prevent hoarseness and throat irritation. Do not swallow the water after you rinse.

Be careful to avoid spraying the medication into your eyes. This medication comes with directions. Read them carefully before using it.

• If you miss a dose…
  Take it as soon as you remember and take the remaining doses for that day at evenly spaced intervals. If it is time for your next dose, skip the one you missed. Never take 2 doses at the same time.

• Storage instructions…
  Store at room temperature in a dry place, away from heat and cold. Do not puncture the container, store it near open flame, or dispose of it in a fire or incinerator.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Qvar Inhalation Aerosol.

• Side effects may include:
  Acne, agitation, allergic reactions, breathing problems, bruising, cataracts, chest pain, cold sores, cough, depression, dizziness, dry mouth, ear infections, fever, fluid retention, flu-like symptoms, headache, hives, hoarseness, increased pressure within the eye (glaucoma), itching, joint pain, light-headedness, mental disturbances, moon face, mouth or throat infection, muscle pain, nasal and throat dryness and irritation, nasal burning, nausea, nose infection, nosebleed, pain, pinkeye, “pins and needles” sensation, ringing in the ears, runny nose, skin rash, skin wasting, sneezing, sore mouth or throat, stuffy nose, stunted growth, tearing eyes, unpleasant—or loss of—taste and smell, upset stomach, vomiting, weight gain, wheezing

Why should Qvar Inhalation Aerosol not be prescribed?

Your doctor will prescribe beclomethasone only if your asthma cannot be controlled with bronchodilators and other nonsteroid medications.

Beclomethasone is not used for the treatment of non-asthmatic bronchitis, or for intermittent asthma therapy.

Do not use beclomethasone nasal products if you’ve recently had nasal ulcers, nose surgery, or an injury to the nose. It could interfere with the healing process.

If you are sensitive to or have ever had an allergic reaction to beclomethasone or other steroid drugs, you should not take Qvar Inhalation Aerosol. Rare cases of immediate and delayed allergic reactions, such as hives, a rash, or wheezing, have occured. Make sure that your doctor is aware of any drug reactions that you have experienced.

Although unlikely, immediate allergic reactions to beclomethasone have been known to occur.

Special warnings about Qvar Inhalation Aerosol

When steroid drugs are taken by mouth they substitute for and decrease the body’s normal ability to make its own steroids as well as its ability to respond to stress.

There is a risk of causing a serious condition called “adrenal insufficiency” when people change from steroid tablets taken by mouth to aerosol beclomethasone. Although the aerosol may provide adequate control of asthma during the changeover period, it does not provide the normal amount of steroid the body needs during acute stress situations, such as injury, surgery, and infection—particularly stomach flu. If you are being transferred from steroid tablets to beclomethasone and you experience a period of stress or a severe asthma attack, contact your doctor immediately. He may prescribe additional treatment with steroid tablets. You should also carry a warning card indicating that you may need steroid tablets during such incidents. As you continue taking beclomethasone, your doctor may conduct periodic tests to measure your adrenal function.

Transfer from steroid tablet therapy to beclomethasone aerosol may reactivate allergic conditions that were previously suppressed by the steroid tablet therapy, such as runny nose, inflamed eyelids, and eczema. Some people also experience withdrawal side effects when they switch from tablets to aerosol. Potential symptoms include joint or muscle pain, weakness, and depression. Inform your doctor if you experience any of these symptoms.

High doses of steroids can suppress your immune system. When beclomethasone is used nasally, your chances of developing nose and throat infections increase. Also take extra care to avoid exposure to measles or chickenpox if you have never had them or never had shots. These infections can be serious or even fatal if your immune system is below par. If you are exposed, seek medical advice immediately.

Symptoms such as mental disturbances, increased bruising, weight gain, facial swelling (moon face), acne, menstrual irregularities, increased pressure in the eyes, and cataracts may occur with steroids. If you experience any of these symptoms, notify your doctor immediately. If you’ve ever had cataracts or increased eye pressure, your doctor will monitor you closely if you have any problems with your vision.

Long-term use of steroids can slow down growth in children. If your child seems to be growing more slowly than normal, call your doctor.

If bronchodilator medications seem less effective after you start taking beclomethasone, be sure to tell your doctor. Do not abruptly stop using beclomethasone on your own.

If you have tuberculosis, a herpes infection of the eye, or any untreated fungal, bacterial, viral, or parasitic infections, your doctor may not want you to use an inhaled steroid.

Special information if you are pregnant or breastfeeding

The effects of beclomethasone in pregnancy have not been adequately studied. If you are pregnant or are planning a pregnancy, let your doctor know. Steroids do appear in breast milk and could harm your baby. Your doctor may want you to avoid breastfeeding while you are using beclomethasone.

Recommended dosage for Qvar Inhalation Aerosol

ADULTS

Beclomethasone Oral Inhalant

The usual recommended dose for adults and children 12 years of age and over is 2 inhalations taken 3 to 4 times a day. Four inhalations taken twice daily have been shown to be effective in some people. If you have severe asthma, your doctor may advise you to start with 12 to 16 inhalations a day. Daily intake should not exceed 20 inhalations.

For the double-strength inhalation aerosol, the usual dose is 2 inhalations twice a day. If your asthma is severe, your doctor may have you start with 6 to 8 inhalations a day. The maximum daily dosage is 10 inhalations.

For Qvar, a CFC-free form of the drug, the recommended starting dose is 40 to 80 micrograms twice daily if you’ve been using bronchodilators alone, and 40 to 160 micrograms if you’ve been using other inhaled steroid products. Take no more than 320 micrograms twice a day.

Beclomethasone Nasal Inhalation

For adults and children 12 years of age and over, the dosage of Vancenase PocketHaler is 1 inhalation in each nostril 2 to 4 times a day. A 3-times-daily schedule is often sufficient.

Beclomethasone Nasal Spray

For adults and children 12 years of age and older, the usual dosage is 1 or 2 inhalations in each nostril 2 to 4 times a day, depending on the brand. For the double strength nasal spray, the dosage is 1 or 2 inhalations in each nostril once a day.

The usual dosage of Vancenase AQ 84 micrograms for adults and children 6 years and over is 1 or 2 inhalations in each nostril once a day.

CHILDREN

Beclomethasone Oral Inhalant

Children 6 to 12 years of age: The usual recommended dose is 1 or 2 inhalations 3 or 4 times a day. Four inhalations twice daily have been effective for some children. Daily intake should not exceed 10 inhalations.

For the double-strength inhalation aerosol, the usual dose is 2 inhalations twice daily, with a maximum of 5 inhalations a day.

For the Qvar brand, the recommended starting dose for children 5 to 11 is 40 micrograms twice daily. The highest recommended dose is 80 micrograms twice daily.

Beclomethasone Nasal Inhalation

Children 6 to 12 years of age: The usual dose of Vancenase PocketHaler is 1 inhalation 3 times a day.

Beclomethasone Nasal Spray

Children 6 to 12 years of age: The usual dosage is 1 inhalation in each nostril 2 times a day. Some children may need 2 inhalations. However, once adequate control is achieved, the dose should be decreased to 1 inhalation in each nostril twice daily. The maximum daily dose should not exceed 2 inhalations in each nostril twice daily. The dosage for the double strength nasal spray is 1 or 2 inhalations in each nostril once a day.

Beclomethasone should not be given to children under the age of 6 unless advised by your doctor.

Overdosage

Any medication taken in excess can have serious consequences. The main risk in an overdose of beclomethasone is adrenal insufficiency. If you suspect an overdose, seek medical attention immediately.

Generic Name: quinine (Oral route)

KWYE-nine

Commonly used brand name(s):

In the U.S.

• Qualaquin
• Quinamm
• Quiphile

Available Dosage Forms:

• Tablet, Extended Release
• Tablet
• Capsule

Therapeutic Class: Musculoskeletal Agent

Chemical Class: Cinchona Alkaloid

Uses For Quiphile

Quinine is used to treat malaria. This medicine usually is given with one or more other medicines for malaria.

Quinine may also be used for other problems as determined by your doctor. Do not confuse quinine with quinidine, a different medicine that is used for heart problems.

Quinine 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 these uses are not included in product labeling, quinine is used in certain patients with the following medical conditions:

• Babesiosis (infection caused by parasites)

Before Using Quiphile

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 been used to treat malaria in children and, in effective doses, has not been shown to cause different side effects or problems in children than it does in adults.

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 quinine 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 is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Astemizole
• Aurothioglucose
• Dronedarone

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.

• Asenapine
• Digoxin
• Droperidol
• Iloperidone
• Lapatinib
• Lumefantrine
• Mefloquine
• Methadone
• Pancuronium
• Ranolazine
• Sunitinib

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.

• Cyclosporine
• Rifapentine

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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blackwater fever, history of, or
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency or
• Purpura, or history of (purplish or brownish-red discoloration of skin)—Patients with a history of blackwater fever, G6PD deficiency, or purpura may have an increased risk of side effects affecting the blood

• Heart disease—Quinine can cause side effects affecting the heart, usually at higher doses

• Hypoglycemia—Quinine may cause low blood sugar

• Myasthenia gravis—Quinine may increase muscle weakness in patients with myasthenia gravis

Proper Use of quinine

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

Take this medicine only as directed. Do not take more of it, do not take it more often, and do not take it for a longer time than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

Take this medicine with or after meals to lessen possible stomach upset, unless otherwise directed by your doctor. If you are to take this medicine at bedtime, take it with a snack or with a glass of water, milk, or other beverage.

For patients taking quinine for malaria:

• To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return. Do not miss any doses.

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 treatment of malaria:
  • Adults and teenagers: 600 to 650 mg every eight hours for at least three days. This medicine must be taken with other medicine to treat malaria.
  • Children: Dose must be determined by the 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

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.

Precautions While Using Quiphile

Quinine may cause blurred vision or a change in color vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not able to see well. If these reactions are especially bothersome, check with your doctor.

Quiphile 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

• Abdominal or stomach cramps or pain
• diarrhea
• nausea
• vomiting

Less common

• Anxiety
• behavior change, similar to drunkenness
• black, tarry stools
• blood in urine or stools
• blurred vision
• cold sweats
• confusion
• convulsions (seizures) or coma
• cool pale skin
• cough or hoarseness
• difficulty in concentrating
• drowsiness
• excessive hunger
• fast heartbeat
• fever or chills
• headache
• lower back or side pain
• nervousness
• nightmares
• painful or difficult urination
• pinpoint red spots on skin
• restless sleep
• shakiness
• slurred speech
• sore throat
• unusual bleeding or bruising
• unusual tiredness or weakness

Rare

• Difficulty in breathing and/or swallowing
• disturbed color perception
• double vision
• hives
• increased sweating
• muscle aches
• night blindness
• reddening of the skin, especially around ears
• ringing or buzzing in ears
• swelling of eyes, face, or inside of nose

Signs and symptoms of overdose

• Blindness
• chest pain
• dizziness
• double vision
• fainting
• lightheadedness
• rapid or irregular heartbeat
• sleepiness

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Blurred vision or change in vision

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.

Generic Name: levofloxacin ophthalmic (leev oh FLOX a sin off THAL mik)
Brand Names: Quixin

What is Quixin (levofloxacin ophthalmic)?

Levofloxacin is in a group of antibiotics called fluoroquinolones (flor-o-KWIN-o-lones). Levofloxacin fights bacteria in the body.

Levofloxacin ophthalmic is used to treat bacterial infections of the eyes.

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

What is the most important information I should know about Quixin (levofloxacin ophthalmic)?

You should not use this medication if you are allergic to levofloxacin or a similar antibiotic such as ciprofloxacin (Cipro), ofloxacin (Floxin), norfloxacin (Noroxin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), and others.

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

Serious side effects of levofloxacin ophthalmic may include eye drainage or crusting, severe eye irritation, feeling like there is something in your eye, vision problems, increased light sensitivity, eye redness or swelling, or any signs of new infection.

Keep using this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using levofloxacin ophthalmic before putting your contact lenses in.

You should not wear contact lenses while you still have active symptoms of the eye infection you are treating.

What should I discuss with my healthcare provider before using Quixin (levofloxacin ophthalmic)?

You should not use this medication if you are allergic to levofloxacin or a similar antibiotic such as ciprofloxacin (Cipro), ofloxacin (Floxin), norfloxacin (Noroxin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), and others. FDA pregnancy category C. This medication may 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 levofloxacin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Quixin (levofloxacin ophthalmic)?

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

Wash your hands before using the eye drops.

To apply the eye drops:

• Tilt your head back slightly and pull down your lower eyelid. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

• Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.

• Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Store levofloxacin ophthalmic at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

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?

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

An overdose of levofloxacin ophthalmic is not likely to cause life-threatening symptoms.

What should I avoid while using Quixin (levofloxacin ophthalmic)?

Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using levofloxacin ophthalmic before putting your contact lenses in.

You should not wear contact lenses while you still have active symptoms of the eye infection you are treating.

Quixin (levofloxacin ophthalmic) 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 a serious side effect such as:

• drainage or crusting of your eye;

• severe eye irritation after using the eye drops;

• feeling like there is something in your eye;

• vision problems, increased light sensitivity;

• eye redness or swelling; or

• fever, or any signs of a new infection.

Less serious side effects may include:

• dry or itchy eyes;

• headache;

• sore throat; or

• mild eye pain, burning, or discomfort.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Quixin (levofloxacin ophthalmic)?

It is not likely that other drugs you take orally or inject will have an effect on levofloxacin ophthalmic. But many drugs can interact with each other.

Oral levofloxacin taken by mouth can interact with caffeine, theophylline (Theo-Dur, Elixophyllin, Respbid, Uniphyl, and others) or blood thinners such as warfarin (Coumadin). Tell your doctor if you take any of these medications.

Your doctor should know 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 doctor or pharmacist can provide more information about levofloxacin ophthalmic.

• 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.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.05. Revision Date: 4/12/2009 4:44:26 PM.

Generic Name: Levofloxacin (lee-voe-FLOX-ah-sin)
Brand Name: Quixin

Quixin Eye Drops are used for:

Treating eye infections caused by bacteria sensitive to Quixin Eye Drops. It may also be used for other conditions as determined by your doctor.

Quixin Eye Drops are a fluoroquinolone eye drop. It works by blocking bacteria from reproducing in the eye.

Do NOT use Quixin Eye Drops if:

• you are allergic to any ingredient in Quixin Eye Drops or any other fluoroquinolone antibiotic (eg, ciprofloxacin, gatifloxacin)

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

Before using Quixin Eye Drops:

Some medical conditions may interact with Quixin Eye Drops. Tell your health care provider 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

Some MEDICINES MAY INTERACT with Quixin Eye Drops. Because little, if any, of Quixin Eye Drops are absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Quixin Eye Drops 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 Quixin Eye Drops:

Use Quixin Eye Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Quixin Eye Drops are only for the eye. Do not get it in your nose or mouth.
• To use Quixin Eye Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
• Do not wear contact lenses while you are using Quixin Eye Drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
• Quixin Eye Drops works best if it is used at the same time each day.
• To clear up your infection completely, use Quixin Eye Drops for the full course of treatment. Keep using it even if you feel better in a few days.
• Do not miss any doses of Quixin Eye Drops. If you miss a dose of Quixin Eye Drops, use it as soon as you remember. 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 Quixin Eye Drops.

Important safety information:

• Quixin Eye Drops may cause dizziness or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Quixin Eye Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Be sure to use Quixin Eye Drops for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Long-term or repeated use of Quixin Eye Drops may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• If you notice vision changes, vaginal irritation or itching, or white patches in your mouth, contact your doctor at once.
• Diabetes patients – Quixin Eye Drops may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Quixin Eye Drops 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 Quixin Eye Drops while you are pregnant. Quixin Eye Drops are found in breast milk. Do not breast-feed while taking Quixin Eye Drops.

Possible side effects of Quixin Eye Drops:

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:

Eye dryness; eye pain, burning, or discomfort; feeling of something in the eye; fever; headache; sensitivity to light; sore throat; strange taste; temporary decreased vision.

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); eyelid itching; eye or eyelid swelling.

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 Quixin Eye Drops:

Store Quixin Eye Drops at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Quixin Eye Drops out of the reach of children and away from pets.

General information:

• If you have any questions about Quixin Eye Drops, please talk with your doctor, pharmacist, or other health care provider.
• Quixin Eye Drops 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 Quixin Eye Drops. 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.

Generic Name: Capsaicin (kap-SAY-sin)
Brand Name: Qutenza

Qutenza Patch is used for:

Treating a certain type of nerve pain caused by the shingles (postherpetic neuralgia). It may also be used for other conditions as determined by your doctor.

Qutenza Patch is a TRVP1 channel agonist. It works by decreasing certain pain receptors on some nerve endings.

Do NOT use Qutenza Patch if:

• you are allergic to any ingredient in Qutenza Patch

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

Before using Qutenza Patch:

Some medical conditions may interact with Qutenza Patch. 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 broken or damaged skin at the application site
• if you have a history of high blood pressure, other heart problems, or recent heart attack or stroke

Some MEDICINES MAY INTERACT with Qutenza Patch. However, no specific interactions with Qutenza Patch are known at this time.

Ask your health care provider if Qutenza Patch 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 Qutenza Patch:

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

• Qutenza Patch is usually applied at your doctor’s office, hospital, or clinic. If you will be using Qutenza Patch at home, a health care provider will teach you how to use it. Be sure you understand how to use Qutenza Patch. Follow the procedures you are taught when you use it. Contact your health care provider if you have any questions.
• Do not remove the patch from the sealed pouch until right before use.
• You may receive other medicine to treat pain that occurs during and after your treatment with Qutenza Patch. Discuss any questions or concerns with your doctor.
• Do not touch the patch while it is on your skin. Burning or stinging may occur.
• If you miss a dose of Qutenza Patch, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Qutenza Patch.

Important safety information:

• Do not use Qutenza Patch on the face or scalp. Do not get it in the eyes, nose, mouth, or genital area. If you get Qutenza Patch in any of these areas, rinse right away with cool water.
• Do not inhale any of Qutenza Patch. It may cause shortness of breath, coughing, or sneezing. Tell your health care provider if any of these symptoms occur.
• Do not get Qutenza Patch on skin that is not being treated. Tell your health care provider if Qutenza Patch comes into contact with skin that is not being treated.
• The treated area may be sensitive to heat (eg, hot showers or baths, direct sunlight, strong exercise) for a few days after Qutenza Patch is applied.
• Lab tests, including blood pressure, may be performed while you use Qutenza Patch. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Qutenza Patch should be used with extreme caution in CHILDREN younger than 18 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 Qutenza Patch while you are pregnant. It is not known if Qutenza Patch is found in breast milk. Do not breast-feed on the day of treatment after you have received your treatment with Qutenza Patch.

Possible side effects of Qutenza Patch:

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:

Mild pain, redness, burning, or itching at the application site; mild sore throat; nausea.

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); blisters or swelling at the application site; severe or persistent dizziness or headache; severe or persistent pain, redness, burning, or itching at the application site; shortness of breath, coughing, or sneezing.

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 Qutenza Patch:

Store Qutenza Patch between 68 and 77 degrees F (20 and 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 Qutenza Patch out of the reach of children and away from pets.

General information:

• If you have any questions about Qutenza Patch, please talk with your doctor, pharmacist, or other health care provider.
• Qutenza Patch 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 Qutenza Patch. 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.

Pronunciation: (KWIE-nine SUL-fate)
Class: Cinchona alkaloid

Trade Names:
Qualaquin
- Capsules 324 mg

Trade Names:
Quinine sulfate
- Capsules 200 mg
- Capsules 260 mg
- Capsules 325 mg
- Tablets 260 mg

Apo-Quinine (Canada)
Quinine-Odan (Canada)

Pharmacology

Causes pH elevation in intracellular organelles of parasites; also has skeletal muscle relaxant effects and CV effects similar to those of quinidine.

Pharmacokinetics

Absorption

Exposure is higher in patients with malaria than in healthy subjects. T _max in healthy subjects or patient with malaria is 2.8 h and 5.9 h, respectively. C _max in healthy subjects or patients with malaria is 3.2 and 8.4 mcg/mL, respectively.

Distribution

In healthy subjects, the Vd ranged from 2.5 to 7.1 L/kg. In patients with malaria, the Vd decreases in proportion to the severity of the infection. Protein binding ranges from 69% to 92% in healthy subjects and 78% to 95% in patients with malaria. Penetration into the CSF is relatively poor in patients with cerebral malaria, reaching approximately 2% to 7% of plasma concentrations. Concentrations in placental cord blood and breast milk are approximately 32% and 31%, respectively, of concentrations in maternal plasma. Less than 2 to 3 mg/day of quinine is secreted into breast milk.

Metabolism

Metabolism is almost exclusively via CYP pathways, primarily CYP3A4; other isozymes, including CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP2E1, are less influential in quinine metabolism.

Elimination

Elimination is primarily by hepatic biotransformation. Approximately 20% is excreted unchanged in the urine. Half-life is 4 to 5 h. Elimination is twice as rapid in an acid urine compared with an alkaline urine. In healthy subjects, the mean plasma Cl ranges from 0.08 to 0.47 L/h/kg, with a mean plasma elimination half-life of 9.7 to 12.5 h.

Special Populations

Renal Function Impairment

The effects of mild and moderate renal impairment on pharmacokinetics and efficacy of quinine are not known. Because the plasma half-life is prolonged from 26 h in patients with severe chronic renal impairment compared with 9.7 h in healthy controls, dosage adjustments are needed in patients with severe chronic renal failure. Negligible amounts are removed by hemodialysis or hemofiltration.

Hepatic Function Impairment

In patients with mild to moderate hepatic impairment, dosage adjustment is not needed; however, monitor patient for adverse reactions.

Elderly

Mean AUC is approximately 38% higher in healthy subjects 65 to 78 yr of age compared with subjects 20 to 35 yr of age. Mean T _max and C _max are similar in elderly and younger subjects. Mean oral Cl is decreased and mean elimination half-life is increased in elderly compared with younger subjects. The proportion of quinine excreted unchanged in the urine is larger in elderly compared with younger patients. Despite these pharmacokinetic differences, no alteration in dosage is needed.

Children

Pharmacokinetics are similar in children 1.5 to 12 yr of age compared with adults with uncomplicated malaria. Mean total Cl and Vd are reduced in children with malaria compared with healthy pediatric controls.

Indications and Usage

Treatment of uncomplicated Plasmodium falciparum malaria.

Unlabeled Uses

Prevention and treatment of nocturnal recumbency leg cramps.

Contraindications

Blackwater fever; pregnancy (except Qualaquin ); hypersensitivity to any component of the product; G-6-PD deficiency; history of thrombocytopenia; optic neuritis; tinnitus.

Qualaquin

Prolonged QT interval; myasthenia gravis.

Dosage and Administration

Falciparum Malaria
Adults and Children 16 yr of age and older

PO 260 to 975 mg 3 times daily for 6 to 12 days.

Qualaquin

648 mg every 8 h for 7 days. In patients with acute uncomplicated malaria and severe chronic renal failure, administer a 648 mg loading dose followed 12 h later by maintenance dosages of 324 mg every 12 h.

General Advice

• Administer with food to minimize GI upset.

Storage/Stability

Store at 59° to 86°F. Protect from moisture. Protect from light.

Qualaquin capsules

Store at 77° to 86°F.

Drug Interactions

Aluminum/Magnesium-containing antacids

Causes delayed or decreased quinine absorption.

Anticoagulants, oral (eg, warfarin)

May cause depression of hepatic enzyme system that synthesizes vitamin K–dependent clotting factors and may enhance action of oral anticoagulants.

Carbamazepine, phenobarbital

Plasma concentrations of these drugs may be elevated, increasing the pharmacologic effects and risk of adverse reactions.

Cimetidine, ranitidine

May reduce quinine’s Cl and prolong its half-life.

CYP1A2 substrates (aminophylline, theophylline)

Plasma concentrations of these agents may be reduced, decreasing the efficacy.

CYP2D6 (eg, debrisoquine, desipramine, dextromethorphan, flecainide, metoprolol, mexiletine, tolterodine) and CYP3A4 (eg, atorvastatin, zolpidem) substrates

Quinine may inhibit the metabolism of these substrates, increasing the pharmacologic effects and risk of adverse reactions.

Digoxin

May cause increased digoxin serum concentration.

Erythromycin, ketoconazole

Quinine metabolism may be inhibited, increasing the risk of adverse reactions.

Mefloquine

May cause ECG abnormalities or cardiac arrest and may increase risk of convulsions. Do not use concurrently. Delay administration 12 h after last dose of quinine.

Neuromuscular blocking agents

May potentiate neuromuscular blockade and may result in respiratory difficulties.

Phenobarbital, phenytoin, rifampin

Quinine metabolism may be increased, reducing plasma concentrations and decreasing the efficacy.

QT-prolonging drugs (eg, amiodarone, cisapride, disopyramide, dofetilide, halofantrine, levofloxacin, macrolide antibiotics [eg, clarithromycin, erythromycin], mefloquine, paroxetine, pimozide, procainamide, propafenone, quinidine, sotalol)

Risk of life-threatening arrhythmias, including torsades de pointes, may be increased; coadministration of quinine is not recommended.

Tetracycline

Quinine plasma concentrations may be elevated, increasing the risk of adverse reactions.

Urinary alkalinizers

May increase quinine serum concentrations and potentiate toxicity.

Laboratory Test Interactions

Urinary 17-ketogenic steroids may have elevated values with Zimmerman method.

Adverse Reactions

Cardiovascular

Angina, atrioventricular block, bradycardia, cardiac arrest, chest pain, disturbances in cardiac rhythm or conduction, hypotension, irregular rhythm, nodal escape beats, palpitations, postural hypotension, QT prolongation, syncope, tachycardia, torsades de pointes, unifocal premature ventricular contractions, U waves, vasodilation, ventricular tachycardia.

CNS

Acute dystonic reaction, aphasia, apprehension, ataxia, altered mental status, asthenia, coma, confusion, disorientation, dizziness, headache, restlessness, seizures, suicide, tremor, vertigo.

Dermatologic

Acrinal necrosis, allergic contact dermatitis, bullous dermatitis, cutaneous rash (including popular, scarlatinal, or urticarial rashes), cutaneous vasculitis, erythema multiforme, exfoliative dermatitis, facial edema, fixed drug eruption, photosensitivity reactions, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), urticaria.

EENT

Blindness, burred vision, deafness, diminished visual fields, diplopia, disturbances in color perception, fixed papillary dilatation, hearing impairment, night blindness, optic neuritis, photophobia, sudden loss of vision, tinnitus, visual impairment (including blurred vision with scotomata).

GI

Abdominal pain, diarrhea, epigastric pain, esophagitis, gastric irritation, nausea, vomiting.

Genitourinary

Acute interstitial nephritis, hemoglobinuria, renal failure, renal impairment.

Hematologic-Lymphatic

Acute hemolysis, agranulocytosis, aplastic anemia, blackwater fever, coagulopathy, DIS, ecchymosis, hemolytic anemia, hemolytic uremic syndrome, hemorrhage, hypoprothrombinemia, idiopathic thrombocytopenic purpura, leukopenia, lupus anticoagulant, neutropenia, pancytopenia, petechiae, thrombocytopenia, thrombotic thrombocytopenic purpura.

Hepatic

Abnormal LFTs, granulomatous hepatitis, hepatitis, jaundice.

Hypersensitivity

Hypersensitivity reactions.

Metabolic-Nutritional

Anorexia; hypoglycemia.

Musculoskeletal

Myalgia, muscle weakness.

Respiratory

Asthma, dyspnea, pulmonary edema.

Miscellaneous

Chills, fever, flushing, lupus-like syndrome, sweating.

Precautions

Monitor Monitor patients with hepatic impairment for adverse reactions.

Pregnancy

Category X .

Qualaquin

Category C .

Lactation

Excreted in breast milk.

Children

Safety and efficacy not established in children younger than 16 yr of age.

Elderly

Studies did not include sufficient numbers of subjects older than 65 yr of age to determine if they respond differently from younger subjects.

Hypersensitivity

Serious hypersensitivity reactions, including anaphylactic and anaphylactoid reactions, angioedema, Stevens-Johnson syndrome, and TEN, have been reported.

Renal Function

Adjust dose in patients with severe chronic renal failure. Effects of mild and moderate renal impairment are not known.

Hepatic Function

Use with caution.

Atrial fibrillation

Use with caution.

Cardiac disease

Patients with cardiac arrhythmias may have exacerbation of symptoms with quinine, which acts similarly to quinidine. May cause cardiotoxicity. In patients with atrial fibrillation, quinine requires the same precautions as for quinidine.

Hemolysis

Has been associated with G-6-PD deficiency. Discontinue immediately if hemolysis appears.

Hypoglycemia

Release of insulin from the pancreas may be stimulated, increasing the risk of hypoglycemia, especially in pregnant women.

Interrupted therapy

May predispose patients to serious complications of blackwater fever, including anemia, RBC destruction, and renal failure.

Myasthenia gravis

Muscle weakness may be exacerbated.

QT prolongation

Unpredictable, serious, and life-threatening hypersensitivity reactions may occur. Potentially fatal cardiac arrhythmias, including torsades de pointes and ventricular fibrillation. Avoid use in patients with known QT interval prolongation or conditions know to prolong the QT interval (eg, bradycardia, certain cardiac conditions, uncorrected hypokalemia).

Overdosage

Symptoms

Adult respiratory distress syndrome, cardiogenic shock, cardiotoxicity (including bundle branch block, increased QT interval, PR prolongation, sinus tachycardia, T-wave inversion, widening of the QRS complex), cinchonism (symptoms may include abdominal pain, blindness, blurred vision, cardiac arrhythmias, circulatory collapse, deafness, diarrhea, flushing, headache, hearing impairment, hypoglycemia, nausea, sweating, tinnitus, vertigo, vomiting), CNS toxicity (eg, ataxia, coma, convulsions, disturbed consciousness, drowsiness, respiratory depression), death, exacerbation of myocardial depression caused by decreased coronary perfusion, hypoglycemia, hypotension, pulmonary edema, ventricular arrhythmias (including AV block, bradycardia, idioventricular rhythm, torsades de pointes, ventricular fibrillation, ventricular tachycardia,), visual impairment (including blurred vision, effective color perception, visual field constriction and permanent blindness).

Patient Information

• Caution patient that this medication must not be taken during pregnancy or when pregnancy is possible. Advise patient to use reliable form of birth control while taking this drug.
• If medication is being used to treat malaria, advise patient to take medication around clock and to take full course of treatment even if feeling better.
• Emphasize importance of medical follow-up when this course of therapy has been completed to ensure that therapy has been successful.
• Instruct patient to consult health care provider before combining any new medications with this drug.
• Advise patient to take medication with or after meals or snack to minimize GI distress.
• Instruct patient to report the following symptoms to the health care provider: flushing, itching, rash, fever, difficulty breathing, vision problems, ringing in ears, diarrhea, nausea/vomiting, vertigo.
• Advise patient that drug may cause dizziness and vision problems, and to use caution while driving or performing other tasks requiring mental alertness.
• Instruct patient not to take OTC medications (especially cold preparations) without consulting health care provider.
• Instruct patient that if a dose is missed, not to double the next dose. If it has been more than 4 h since the missed dose, advise the patient to wait and take the regular dose at the next scheduled time. Instruct patient to call health care provider if not sure what to do.

Copyright © 2009 Wolters Kluwer Health.

Generic Name: guaifenesin/phenylephrine/phenylpropanolamine (gwye FEN e sin/fen ill EFF rin/fen ill proe pa NOLE a meen)
Brand Names: Ami-Tex, Banex, Dura-Gest, Duratex, Enomine, Entex, Fentex, Guaifenex, Phenylfenesin, Quintex

What is Quintex (guaifenesin/phenylephrine/phenylpropanolamine)?

Guaifenesin is an expectorant. It is used to break up congestion and mucous to ease breathing. Guaifenesin thins mucous, increases lubrication of the respiratory tract (lungs, nose, and throat), and increases the removal of mucous.

Phenylpropanolamine and phenylephrine are decongestants. They constrict (shrink) blood vessels (veins and arteries), which reduces the swelling of mucous membranes in areas such as the nose and sinuses.

Guaifenesin/phenylephrine/phenylpropanolamine is used to treat the symptoms of the common cold and of infections of your sinuses, your lungs, and your throat.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Guaifenesin/phenylephrine/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Quintex (guaifenesin/phenylephrine/phenylpropanolamine)?

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Drink plenty of extra fluids while taking this medication. Do not crush or chew the tablets. Swallow them whole or break them in half where they are scored to make them easier to swallow if needed.

Who should not take Quintex (guaifenesin/phenylephrine/phenylpropanolamine)?

Do not take guaifenesin/phenylephrine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• high blood pressure or any other type of heart disease,

• diabetes,

• a peripheral vascular disorder (poor circulation),

• glaucoma or increased pressure in the eyes,

• an overactive thyroid, or

• difficulty urinating or an enlarged prostate.

You may not be able to take guaifenesin/phenylephrine/phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Guaifenesin/phenylephrine/phenylpropanolamine is in the FDA pregnancy category C. This means that it is not known whether guaifenesin/phenylephrine/phenylpropanolamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Guaifenesin/phenylephrine/phenylpropanolamine passes into breast milk and may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from guaifenesin/phenylephrine/phenylpropanolamine. You may require a lower dose of this medication. Guaifenesin/phenylephrine/phenylpropanolamine has not been approved for use by children younger than 6 years of age.

How should I take Quintex (guaifenesin/phenylephrine/phenylpropanolamine)?

Take guaifenesin/phenylephrine/phenylpropanolamine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take guaifenesin/phenylephrine/phenylpropanolamine with food if stomach upset occurs. Do not crush or chew the tablets. Swallow them whole or break them in half where they are scored to make them easier to swallow if needed.

To ensure that you get a correct dose, measure the liquid form of guaifenesin/phenylephrine/phenylpropanolamine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Store guaifenesin/phenylephrine/phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a guaifenesin/phenylephrine/phenylpropanolamine overdose include vomiting, high blood pressure (headache, red face, blurred vision), an irregular heartbeat, and numbness of the fingers or toes.

What should I avoid while taking Quintex (guaifenesin/phenylephrine/phenylpropanolamine)?

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

Quintex (guaifenesin/phenylephrine/phenylpropanolamine) side effects

No serious side effects from guaifenesin/phenylephrine/phenylpropanolamine are expected. Stop taking guaifenesin/phenylephrine/phenylpropanolamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

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

• dizziness or headache;

• nervousness, restlessness, or insomnia;

• nausea or stomach upset; or

• difficulty urinating.

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.

What other drugs will affect Quintex (guaifenesin/phenylephrine/phenylpropanolamine)?

Do not take guaifenesin/phenylephrine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Heart medications such as methyldopa (Aldomet), reserpine (Serpalan, Serpasil), and guanethidine (Ismelin) may have decreased effects. Talk to your doctor before taking guaifenesin/phenylephrine/phenylpropanolamine.

Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking guaifenesin/phenylephrine/phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain guaifenesin, phenylephrine, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.

Drugs other than those listed here may also interact with guaifenesin/phenylephrine/phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Where can I get more information?

• Your pharmacist has additional information about guaifenesin/phenylephrine/phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

Guaifenesin/phenylephrine/phenylpropanolamine is available with a prescription under the brand names Entex and Dura-Gest. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Entex, 200 mg of guaifenesin, 5 mg of phenylephrine, and 45 mg of phenylpropanolamine–orange/white capsules

• Entex Liquid, 100 mg of guaifenesin, 5 mg of phenylephrine, and 20 mg of phenylpropanolamine with 5% alcohol per 5 mL (1 teaspoon)– orange-colored liquid

• Dura-Gest, 200 mg of guaifenesin, 5 mg of phenylephrine, and 45 mg of phenylpropanolamine–gray/white capsules

• 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.

Copyright 1996-2006 Cerner Multum, Inc. Version: 5.04. Revision Date: 2/13/04 4:04:30 PM.