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Ancobon Indications, Dosage, Storage, Stability - Flucytosine

Ancobon Indications, Dosage, Storage, Stability - Flucytosine

INDICATIONS AND USAGE

Ancobon is indicated only in the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus.

Candida: Septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. Limited trials in pulmonary infections justify the use of flucytosine.

Cryptococcus: Meningitis and pulmonary infections have been treated effectively. Studies in septicemias and urinary tract infections are limited, but good responses have been reported.

With the exception of urinary tract infection, Ancobon should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of rapid emergence of resistance to Ancobon in Candida and Cryptococcus isolates in patients receving Ancobon alone.

DOSAGE AND ADMINISTRATION

The usual dosage of Ancobon is 50 to 150 mg/kg/day administered in divided doses at 6-hour intervals. Nausea or vomiting may be reduced or avoided if the capsules are given a few at a time over a 15-minute period. If the BUN or the serum creatinine is elevated, or if there are other signs of renal impairment, the initial dose should be at the lower level (see WARNINGS).

HOW SUPPLIED

Capsules, 250 mg (gray and green), imprinted ANCOBON® 250 ICN, bottles of 100 (NDC 0187-3554-10). Capsules, 500 mg (gray and white), imprinted ANCOBON® 500 ICN, bottles of 100 (NDC 0187-3555-10).

Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F).

REFERENCE: 1. Shadomy S. Appl Microbiol. June 1969; 17: 871 - 877.

ICN Pharmaceuticals, Inc. Costa Mesa, CA 92626 ICN Pharmaceuticals, Inc. ICN Plaza 3300 Hyland Avenue Costa Mesa, California 92626 714-545-0100 3355497EX04 Rev. March 2003

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