FLUCYTOSINE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLUCYTOSINE (UNII: D83282DT06) (FLUCYTOSINE - UNII:D83282DT06)

Available from:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Flucytosine Capsules are 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. Flucytosine Capsules should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to Flucytosine Capsules (see MICROBIOLOGY ). Flucytosine Capsules should not be used in patients with a known hypersensitivity to the drug.

Product summary:

Flucytosine Capsules are supplied as capsules containing 250 mg flucytosine. 250 mg Capsules (gray and green), imprinted ANCOBON® 250 ICN, available in bottles of 100 (NDC 63629-2147-1). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

FLUCYTOSINE- FLUCYTOSINE CAPSULE
BRYANT RANCH PREPACK
----------
FLUCYTOSINE
CAPSULES
RX ONLY
WARNING
USE WITH EXTREME CAUTION IN PATIENTS WITH IMPAIRED RENAL FUNCTION.
CLOSE
MONITORING OF HEMATOLOGIC, RENAL AND HEPATIC STATUS OF ALL PATIENTS IS
ESSENTIAL. THESE INSTRUCTIONS SHOULD BE THOROUGHLY REVIEWED BEFORE
ADMINISTRATION OF FLUCYTOSINE CAPSULES.
DESCRIPTION
Flucytosine Capsules, an antifungal agent, are available as 250 mg and
500 mg capsules
for oral administration. In addition to the active ingredient of
flucytosine, each capsule
contains corn starch, lactose and talc. The 250 mg capsule shell
contains black iron
oxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6, gelatin
and titanium
dioxide. The 500 mg capsule shell contains black iron oxide, gelatin
and titanium dioxide.
Chemically, flucytosine is 5-fluorocytosine, a fluorinated pyrimidine
which is related to
fluorouracil and floxuridine. It is a white to off-white crystalline
powder with a molecular
weight of 129.09 and the following structural formula:
CLINICAL PHARMACOLOGY
Flucytosine is rapidly and virtually completely absorbed following
oral administration.
Flucytosine Capsules are not metabolized significantly when given
orally to man.
Bioavailability estimated by comparing the area under the curve of
serum concentrations
after oral and intravenous administration showed 78% to 89% absorption
of the oral
dose. Peak serum concentrations of 30 to 40 mcg/mL were reached within
2 hours of
administration of a 2 g oral dose to normal subjects. Other studies
revealed mean serum
concentrations of approximately 70 to 80 mcg/mL 1 to 2 hours after a
dose in patients
with normal renal function receiving a 6-week regimen of flucytosine
(150 mg/kg/day
given in divided doses every 6 hours) in combination with amphotericin
B. The half-life in
the majority of healthy subjects ranged between 2.4 and 4.8 hours.
Flucytosine is
excreted via the kidneys by means of glomerular filtration without
significant tubular
reabsorption. More than 90% of the total radio