Who should not take Ranexa

Do not take Ranexa if you are taking certain medications including Nizoral® (ketoconazole),Sporanox® (itraconazole), Biaxin® (clarithromycin), Serzone® (nefazodone), Viracept® (nelfinavir), Norvir® (ritonavir), Crixivan® (indinavir), Fortovase® (saquinavir), Rifadin® (rifampin), Mycobutin® (rifabutin), Priftin® (rifapentin), phenobarbital, Tegretol® (carbamazepine), Phenytek® (phenytoin), or the herbal supplement St. John’s wort.

Do not take Ranexa if you have liver cirrhosis.

What are the possible serious side effects of Ranexa?

Ranexa may lead to a change in your heartbeat called QTc interval prolongation. This change is measured by an electrocardiogram. Tell your doctor if you or a family member have had heart-rhythm or heartbeat problems, or if you are taking medicines that prolong the QT interval, such as quinidine, Tikosyn® (dofetilide), Betapace® (sotalol), Cordarone® (amiodarone), erythromycin, Mellaril® (thioridazine), or Geodon® (ziprasidone).

What are the most common side effects of Ranexa?

The most common side effects of Ranexa include dizziness, headache, constipation, and nausea. Ranexa may cause dizziness and lightheadedness; therefore, patients should know how they react to this drug before they operate an automobile, or machinery, or engage in activities requiring mental alertness or coordination.

Tell your doctor if you faint or have a side effect that bothers you or does not go away. If you have any questions about your condition or your treatment, including Ranexa, talk with your doctor.

What information should I know about taking other medicines with Ranexa?

Tell your doctor and pharmacist about all of the prescription medications, over-the-counter (OTC) medications, and herbal supplements you take. The dose of Ranexa may need to be adjusted when taken with certain medications such as Cardizem® (diltiazem), Calan SR® (verapamil), erythromycin, fluconazole, and cyclosporine.

If you take Ranexa, you should limit the amount of grapefruit juice or grapefruit products you consume. The doses of other medications, such as, Prograf® (tacrolimus), Rapamune® (sirolimus), lovastatin, cyclosporine, tricyclic antidepressants, antipsychotics, or digoxin, may need to be adjusted when taken with Ranexa. Tell your doctor if you take any medicines containing simvastatin, such as Zocor®, Vytorin®, or Simcor®. You should not take more than 20 mg of simvastatin a day if you take Ranexa.

How should I take Ranexa?

Take Ranexa exactly as your doctor tells you. You can take Ranexa with or without meals. Ranexa should be swallowed whole and not crushed, broken, or chewed. Doses of Ranexa higher than 1000 mg twice daily should not be used. If a dose of Ranexa is missed, the usual dose should be taken at the next scheduled time. The next dose should not be doubled.

Biaxin, Norvir, and Simcor are registered trademarks of Abbott Laboratories. Prograf is a registered trademark of Astellas Pharma US, Inc. Betapace is a registered trademark of Bayer Healthcare Pharmaceuticals. Serzone is a registered trademark of Bristol-Myers Squibb. Sporanox is a registered trademark of Janssen Pharmaceuticals. Cardizem is a registered trademark of Biovail. Nizoral is a registered trademark of McNeil Consumer & Specialty Pharmaceuticals. Crixivan, Vytorin, and Zocor are registered trademarks of Merck. Phenytek is a registered trademark of Mylan Laboratories. Mellaril and Tegretol are registered trademarks of Novartis Pharmaceuticals Corporation. Calan SR, Geodon, Mycobutin, Rapamune, Tikosyn, and Viracept are registered trademarks of Pfizer Inc. Fortovase is a registered trademark of Roche. Priftin and Rifadin are registered trademarks of Sanofi-Aventis U.S. LLC. Cordarone is a registered trademark of Wyeth Pharmaceuticals.

This Web site contains a summary of important information about Ranexa. It does not take the place of talking with your doctor. Check with your doctor for more information.

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www.FDA.gov/medwatchFull Prescribing Information for RANEXA

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