ZAFIRLUKAST (Systemic)?

Some commonly used brand names are:

In the U.S.?

• Accolate

? Not commercially available in Canada.

Category

• Antiasthmatic, leukotriene receptor antagonist

Description

Zafirlukast (za-FIR-loo-kast)is used by patients with mild-to-moderate asthma to decrease the symptomsof asthma and the number of acute asthma attacks. However, this medicine shouldnot be used to relieve an asthma attack that has already started.

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

Oral
• Tablets (U.S.)

Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to zafirlukast.

Pregnancy?Zafirlukast has not been studied in pregnant women.Studies in animals have shown that this medicine causes problems only whengiven in doses many times higher than the usual human dose.

Breast-feeding?Zafirlukast passes into breast milk and may causeunwanted effects in nursing babies. Breast-feeding is not recommended whileyou are taking zafirlukast.

Children?Studies on this medicine have been done only in adultpatients and there is no specific information comparing use of zafirlukastin children up to 7 years of age with use in other age groups.

Older adults?In studies, mild to moderate respiratory tract infectionswere more likely to occur in patients 55 years of age or older taking zafirlukast.It is not known whether these infections were caused by taking zafirlukastor by other factors.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingzafirlukast, it is especially important that your health care professionalknow if you are taking any of the following:

• Warfarin (e.g., Coumadin)?Zafirlukast may increase the effectsof this medicine

Proper Use of This Medicine

Zafirlukast is used to prevent asthma attacks. It is not used to relieve anattack that has already started. For relief of an asthma attack thathas already started, you should use another medicine. If you do not have anothermedicine to use for an attack or if you have any questions about this, checkwith your health care professional.

Food may change the amount of zafirlukast that is absorbed.For this reason, it should be taken on an empty stomach, 1 hour before or2 hours after a meal.

Dosing?The dose of this medicine will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of zafirlukast. If your dose is different,do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For asthma:
    • Adults and children 12 years of age and older?20 milligrams(mg) two times a day, on an empty stomach, at least 1 hour before or 2 hoursafter meals.
    • Children between 7 and 11 years of age?10 milligrams two timesa day, on an empty stomach, at least 1 hour before or 2 hours after meals.
    • Children up to 7 years of age?Use and dose must be determinedby your doctor.

Missed dose?If you miss a dose of this medicine, take it assoon as possible. However, if it is almost time for your next dose, skip themissed dose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

To work properly, zafirlukast must be taken every day at regularlyspaced times, even if your asthma seems better.

You may be taking other medicines for asthma alongwith zafirlukast. Do not stop taking or reduce the dose of the other medicines,even if your asthma seems better, unless you are told to do so by your doctor.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects.The following side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome:

Less common