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What is the most important information I should know about zafirlukast?

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

It may take up to several 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 several weeks of treatment.

Call your doctor right away if you feel that this medicine is not working as well as usual, or if it makes your condition worse. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor.

Warning

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.

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What is zafirlukast?

Zafirlukast is a leukotriene (loo-koe-TRY-een) inhibitor. Leukotrienes are chemicals your body releases when you breathe in an allergen (such as pollen). These chemicals cause swelling in your lungs and tightening of the muscles around your airways, which can result in asthma symptoms.

Zafirlukast is used to treat and prevent asthma attacks in adults and children as young as 5 years old.

Do not give this medication to a child without a doctor’s advice.

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

Precautions

Do not use this medication if you are allergic to zafirlukast.

Before using zafirlukast, tell your doctor if you are allergic to any drugs (especially aspirin), or if you have liver disease. You may not be able to use zafirlukast, or you may need dosage adjustments or special tests during treatment.

The chewable tablet form of this medication may contain up to 0.842 milligrams of phenylalanine. Talk to your doctor before using this form of zafirlukast if you have phenylketonuria (PKU).

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.

Zafirlukast 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.

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

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Instructions

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

Overdose symptoms may include skin rash and upset stomach.

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 your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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Side Effects

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

Call your doctor at once if you have any of these serious side effects:

  • worsening asthma symptoms;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness; or
  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • headache;
  • nausea, vomiting, diarrhea, stomach pain;
  • weakness;
  • dizziness;
  • muscle pain; or
  • fever, sore throat, cold symptoms.

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.

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Interactions

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

  • aspirin;
  • a blood thinner such as warfarin (Coumadin);
  • tolbutamide (Orinase);
  • erythromycin (E.E.S., E-Mycin, Ery-Tab, Erythrocin);
  • theophylline (Elixophyllin, Respbid, Slo-Bid, TheoDur, and others);
  • carbamazepine (Carbatrol, Tegretol); or
  • phenytoin (Dilantin).

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

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Disclaimer

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 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04