tablet , film-coated , white , oblong oblong
White to off-whiteDebossed
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.
1.1 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).
2 DOSAGE AND ADMINISTRATION
The recommended dose is one 200 mg DIFICID tablet orally twice daily for
10 days with or without food.
3 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.
5 WARNINGS AND PRECAUTIONS
5.1 Not for Systemic Infections
Since there is minimal systemic absorption of fidaxomicin, DIFICID is not
effective for treatment of systemic infections.
5.2 Development of Drug Resistant Bacteria
Prescribing DIFICID in the absence of a proven or strongly suspected
C. difficile infection is unlikely to provide benefit to the patient and increases
the risk of the development of drug resistant bacteria.
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse
event rates observed in the clinical trials of a drug cannot be directly compared
to rates in the clinical trials of any other drug and may not reflect the rates
observed in practice.
The safety of DIFICID 200 mg tablets taken twice a day for 10 days was
evaluated in 564 patients with CDAD in two active-comparator controlled trials
with 86.7% of patients receiving a full course of treatment.
Thirty-three patients receiving DIFICID (5.9%) withdrew from trials as a result
of adverse reactions (AR). The types of AR resulting in withdrawal from the
study varied considerably. Vomiting was the primary adverse reaction leading
to discontinuation of dosing this occurred at an incidence of 0.5% in both the
fidaxomicin and vancomycin patients in Phase 3 studies.