DIFICID™ (fidaxomicin) tablet
| Initial U.S. approval: 2011
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.
DIFICID tablets (200 mg) are film-coated and contain the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, hydroxypropyl cellulose, butylated hydroxytoluene, sodium starch glycolate, magnesium stearate, polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol, and lecithin (soy).
| CLINICAL PHARMACOLOGY
Mechanism of Action
Mechanism of Decreased Susceptibility to Fidaxomicin
Indications and usage
|DIFICID is a macrolide antibacterial drug indicated in adults (≥18 years of age) for treatment of Clostridium difficile-associated diarrhea|
| WARNINGS AND PRECAUTIONS
DIFICID should not be used for systemic infections.
Development of Drug Resistant Bacteria: Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile.
USE IN SPECIFIC POPULATIONS
| The most common adverse reactions are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%), and neutropenia (2%).
To report SUSPECTED ADVERSE REACTIONS, contact Optimer Pharmaceuticals at 1-855-DIFICID (1-855-343-4243) or FDA at (1-800-FDA-1088) or www.fda.gov/medwatch.
Dosage and administration
| DOSAGE AND ADMINISTRATION
One 200 mg tablet orally twice daily for 10 days with or without food .
| Package Insert data:
Manufactured for Optimer Pharmaceuticals, Inc., San Diego CA 92121 by Patheon, Inc.
DIFICID™ is a trademark of Optimer Pharmaceuticals, Inc.
Optimer Pharmaceuticals, Inc.
Copyright ® Optimer Pharmaceuticals, Inc.
PRINCIPAL DISPLAY PANEL - 200 mg Tablets
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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