Accolate

Accolate is a prescription medication used for prevention and chronic treatment of asthma in adults and children 5 years and older.

This medication belongs to a group of drugs called leukotriene receptor antagonists. Accolate works by blocking the actions of leukotriene, a natural substance that causes swelling and tightening of the airways.

Accolate comes in tablet form and is usually taken twice daily on an empty stomach, 1 hour before, or 2 hours after a meal.

Common side effects include headache, nausea, and diarrhea.

Accolate is a prescription medication used for prevention and chronic treatment of asthma in adults and children 5 years of age and older.

Asthma is a chronic lung disease that causes airway inflammation and difficulty breathing.

Take Accolate exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose of Accolate prescribed for you or your child's asthma is based on age:

• The recommended dose of Accolate in adults and children 12 years and older is 20 mg twice daily.
• The recommended dose of Accolate in children 5 through 11 years of age is 10 mg twice daily.

Serious side effects have been reported with Accolate including the following:

• Liver dysfuntion. Tell your healthcare provider right away if you have some or all of the following symptoms: abdominal pain, nausea, fatigue, lethargy, pruritus, jaundice, flu-like symptoms, or loss of appetite.
• Behavior and mood-related changes. Tell your doctor right away if you have mood-related changes.
• Increase in certain white blood cells (eosinophils) and possible inflamed blood vessels throughout the body (systemic vasculitis). Rarely, this can happen in people with asthma who take Accolate. This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. 

If you have asthma and aspirin makes your asthma symptoms worse, continue to avoid taking aspirin or other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) while taking Accolate.

Avoid taking Accolate if you have liver disease including cirrhosis.

Do not taking Accolate if you are allergic to Accolate or to any of its ingredients.

Serious side effects have been reported with Accolate. See the "Accolate Precautions" section.

Common side effects of Accolate include:

• headache
• infection
• nausea
• diarrhea
• stomach pain
• dizziness
• fever
• back pain
• vomiting
• acid indigestion

This is not a complete list of Accolate side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or do not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• warfarin (Coumadin, Jantoven)
• theophylline (Theo-24)
• erythromycin (Ery-Tab, Erythrocin)
• fluconazole (Diflucan)
• aspirin

This is not a complete list of Accolate drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Accolate falls into category B. There are no well-done studies that have been done in humans with Accolate. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication. Accolate should be used during pregnancy only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Accolate has been detected in human breast milk. Because of the potential for serious harm in nursing infants from Accolate, a decision should be made whether to discontinue nursing or to discontinue Accolate, taking into account the importance of the medication to the mother.