Zafirlukast, Oral

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KEY POINTS

• This medicine is taken by mouth to treat long-term asthma and to help prevent asthma attacks. Take it exactly as directed.
• This medicine will not stop an asthma attack that has already started. Your healthcare provider can prescribe a short-acting inhaled medicine to use when you have a sudden breathing problem.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: leukotriene receptor antagonist

Generic and brand names: zafirlukast, oral; Accolate

What is this medicine used for?

This medicine is taken by mouth to treat long-term asthma and to help prevent asthma attacks. It is not intended for use during asthma attacks.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Liver disease

Females of childbearing age: Tell your healthcare provider if you are pregnant or breast-feeding. Do not breast-feed while you are taking this medicine.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine 1 hour before or 2 hours after meals. Take it regularly as directed by your healthcare provider, even when you are not having symptoms of asthma. Do not reduce the dosage or stop taking your asthma medicines unless directed by your healthcare provider.

Check with your healthcare provider before using this medicine in children under age 5.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: rash, nausea.

What should I watch out for?

This medicine will not stop an asthma attack that has already started. Take this medicine as prescribed to help prevent attacks. Keep your quick-relief medicine with you to treat an asthma attack. Contact your healthcare provider if you need to use quick relief medicines more often than usual while you are taking this medicine.

This medicine may affect your liver. You may need to have blood tests regularly. Keep all appointments for blood tests.

Sleep problems and changes in your behavior can happen while you take this medicine. Tell your healthcare provider if you have any sleep problems or changes in behavior.

Also tell your provider if your symptoms do not improve or if your asthma gets worse while you are using this medicine.

Adults over the age of 65 may be at greater risk for side effects from this medicine. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): The need for medicine for asthma attacks more often than usual; chest pain; new or worsening trouble breathing; unexplained cough or fever; yellowing of your skin or eyes; dark urine; light-colored stools; muscle or joint pain; severe stomach pain; loss of appetite; unusual tiredness or weakness; severe nausea or vomiting; pain on your right side; severe skin rash; numbness or tingling in your arms or legs; pain and swelling in your sinuses; sudden mood, sleep, or behavior changes.

Other: Headache, runny nose, mild nausea or vomiting, diarrhea, dizziness, back pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as dapsone, erythromycin (E.E.S., Ery-Tab, Erythrocin), pyrimethamine (Daraprim), rifampin (Rifadin), rifapentine (Priftin), sulfadiazine, and sulfamethoxazole/trimethoprim (Bactrim, Septra)
• Antifungal medicines such as fluconazole (Diflucan), ketoconazole (Nizoral), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Aprepitant (Emend)
• Aspirin and other salicylates
• Bosentan (Tracleer)
• Cancer medicines such as abiraterone (Zytiga), capecitabine (Xeloda), ceritinib (Zykadia), dabrafenib (Tafinlar), enzalutamide (Xtandi), fluorouracil, and sorafenib (Nexavar)
• Cholesterol-lowering medicines such as fluvastatin (Lescol) and gemfibrozil (Lopid)
• Diabetes medicines such as chlorpropamide, glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), nateglinide (Starlix), repaglinide (Prandin), and tolbutamide
• Fluoxetine (Prozac)
• Heart medicines such as amiodarone (Cordarone, Pacerone), carvedilol (Coreg), irbesartan (Avapro), losartan (Cozaar), and nicardipine
• HIV medicines such as delavirdine (Rescriptor), efavirenz (Sustiva), and etravirine (Intelence)
• Leflunomide (Arava)
• Lumacaftor/ivacaftor (Orkambi)
• Mifepristone (Korlym, Mifeprex)
• Omeprazole (Prilosec)
• Pimozide (Orap)
• Quinine
• Tamoxifen
• Theophylline
• Ticagrelor (Brilinta)
• Tizanidine (Zanaflex)
• Torsemide (Demadex)
• Warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.