Accolate

Accolate is used for:

Prevention and long-term treatment of asthma in patients 5 years of age and older. It should not be used to treat acute asthma attacks. The medicine may be used for other conditions as determined by your doctor.

Accolate is a leukotriene receptor antagonist. It works by blocking the action of certain chemicals that are responsible for some forms of asthma.

Do NOT use Accolate if:

• you are allergic to any ingredient in Accolate

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

Before using Accolate :

Some medical conditions may interact with Accolate . 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 liver problems

Some MEDICINES MAY INTERACT with Accolate . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Oral blood thinners (eg, warfarin) because the risk of their side effects, including increased risk of bleeding, may be increased by Accolate . If you are taking an oral anticoagulant with Accolate , your doctor should monitor your prothrombin time and adjust your dose accordingly
• Terfenadine because the risk of its actions and side effects may be increased when taken with Accolate
• Theophyllines (eg, aminophylline) because their effectiveness may be decreased or the risk of their side effects could be increased by Accolate

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

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

• Take Accolate by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
• Taking Accolate at the same time each day will help you remember to take it.
• Continue to take Accolate even if you feel well. Do not miss any doses.
• If you miss a dose of Accolate , take 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 take 2 doses at once.

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

Important safety information:

• Accolate 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.
• If your symptoms do not get better or if they get worse, check with your doctor.
• If your doctor tells you that you have had liver damage due to use of Accolate , never take Accolate again.
• Lab tests, including liver function tests, may be performed while you use Accolate . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Accolate should not be used in CHILDREN younger than 5 years old; safety and effectiveness in these children have not been confirmed. Accolate should be used with extreme caution in CHILDREN between 5 and 6 years old.
• PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Accolate while you are pregnant. Accolate is found in breast milk. Do not breast-feed while taking Accolate .

Possible side effects of Accolate :

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:

Diarrhea; headache; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; fever; flu-like symptoms; itching; joint or muscle aches and pains; loss of appetite; persistent nausea or stomach pain; tiredness; yellowing of the eyes or skin.

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.

Store Accolate at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Accolate out of the reach of children and away from pets.

General information:

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

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