Dificid (Fidaxomicin) - Indications and Dosage

INDICATIONS AND USAGE

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.

HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

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).

Storage

Storage: 20 °-25°C (68 °-77°F); excursions permitted to 15° - 30°C (59° - 86°F).

See USP controlled room temperature.