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To reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID and other antibacterial drugs, DIFICID should be used only to treat infections that are proven or strongly suspected to be caused by Clostridium difficile.
Clostridium difficile-Associated Diarrhea
DIFICID is a macrolide antibacterial drug indicated in adults ( ≥ 18 years of age) for treatment of Clostridium difficile-associated diarrhea (CDAD).
DOSAGE AND ADMINISTRATION
The recommended dose is one 200 mg DIFICID tablet orally twice daily for 10 days with or without food.
Dosage Forms And Strengths
200 mg white to off-white film-coated, oblong tablets; each tablet is debossed with “FDX” on one side and “200” on the other side.
Storage And Handling
DIFICID tablets are white to off-white film-coated, oblong tablets containing 200 mg of fidaxomicin; each tablet is debossed with “FDX” on one side and “200” on the other side.
DIFICID tablets are supplied as:
Bottles of 20 tablets, (NDC 52015-080-01)
Bottles of 60 tablets, (NDC 52015-080-02)
10 tablet aluminum blister cards, with 10 cards per carton, (NDC 52015-080-12)
Store at 20°C-25°C (68°F-77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
See USP Controlled Room Temperature.
Manufactured for Optimer Pharmaceuticals, Inc., San Diego CA 92121 by Patheon, Inc., Optimer Pharmaceuticals, Inc. 10110 Sorrento Valley Road, Suite C San Diego, CA 92121. Revised: 2011This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/18/2013
Additional Dificid Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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