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|Tracleer

Tracleer

Tracleer is used for:

Treating high blood pressure in the lungs (pulmonary arterial hypertension).

Tracleer is an endothelin receptor antagonist. It works by blocking a certain substance in the lungs, which relaxes blood vessels and decreases blood pressure.

Do NOT use Tracleer if:

• you are allergic to any ingredient in Tracleer
• you are pregnant
• you are taking cyclosporine or sulfonylureas (eg, glyburide)

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

Before using Tracleer :

Some medical conditions may interact with Tracleer . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are 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 or kidney problems or blood tests that show possible liver problems
• if you have heart problems (eg, congestive heart failure) or blood disorders (eg, anemia, high blood transaminases)

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

• Amiodarone, cyclosporine, fluconazole, imidazole antifungals (eg, ketoconazole), ritonavir, or tacrolimus because side effects may be increased
• Sulfonylureas (eg, glyburide) because risk of liver problems may be increased
• Blood thinners (eg, warfarin), contraceptives (eg, oral, injected, patch, or implanted birth control), or HMG-CoA reductase inhibitors (eg, simvastatin) because effectiveness may be decreased by Tracleer

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

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

• Tracleer comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Tracleer refilled.
• Tracleer may be taken with or without food.
• Take Tracleer regularly to receive the most benefit from it. Taking Tracleer at the same times each day will help you to remember to take it.
• If you miss a dose of Tracleer , 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 Tracleer .

Important safety information:

• Tracleer may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Tracleer . If dizziness occurs, sit or stand up slowly.
• Do not stop taking Tracleer without checking with your doctor. Some conditions may become worse when the medicine is suddenly stopped.
• Patients being treated for high blood pressure should avoid using nonprescription medicines that contain stimulants, such as products used for dieting (appetite suppressants) or for cold symptoms (eg, pseudoephedrine).
• Women of childbearing age or potential must have a pregnancy test before starting Tracleer and monthly while they are taking Tracleer . If you are able to become pregnant, you must use effective birth control while taking Tracleer . Tracleer may decrease the effectiveness of birth control pills, injections, patches, or implants. Use at least 2 reliable forms of birth control while you are taking Tracleer . Talk with your doctor or pharmacist for more information.
• LAB TESTS, including liver function tests or complete blood cell counts, will be performed to check for side effects. Be sure to keep all doctor and lab appointments.
• Tracleer is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Tracleer if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. It is unknown if Tracleer is excreted in breast milk. Do not breast-feed while taking Tracleer .

Possible side effects of Tracleer :

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:

Flushing; headache; nose or throat irritation; stomach upset.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); coughing up blood; dark urine; dizziness; fainting; fever; irregular heartbeat; lightheadedness; nausea; pale stools; pounding in the chest; shortness of breath; stomach pain; sudden weight gain; swelling of the ankles or legs; unusual tiredness or weakness; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or 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/findyour.htm), or emergency room immediately. Symptoms may include fast heartbeat; nausea; severe headache; vomiting.

Store Tracleer at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store in the bathroom. Keep Tracleer out of the reach of children and away from pets.

General information:

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