FLUCYTOSINE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Vensun Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Flucytosine Capsules, USP 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, USP 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, USP (See MICROBIOLOGY). Flucytosine Capsules, USP should not be used in patients with a known hypersensitivity to the drug.

Product summary:

Flucytosine Capsules, USP are supplied as capsules containing 250 mg and 500 mg flucytosine. 250 mg: Capsule with green body and green cap imprinted with 'K' on cap and '110' on body of capsule, available in bottles of 100 (NDC 42543-902-01) 500 mg: Capsule with gray body and gray cap imprinted with 'K' on cap and '111' on body of capsule, available in bottles of 100 (NDC 42543-901-01): Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature] Dispense in a tight, light-resistant container. Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067 Manufactured by: Recipharm Pharmaservices Pvt. Ltd. Bangalore, India Rev. 00, Mar 2018

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUCYTOSINE - FLUCYTOSINE CAPSULE
VENSUN PHARMACEUTICALS, INC.
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FLUCYTOSINE CAPSULES, USP
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,
USP.
DESCRIPTION
Flucytosine, an antifungal agent, is 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
250mg capsule shell contains FD&C Blue 1, titanium dioxide, FD&C
Yellow 6, D&C Yellow 10,
gelatin, and water. The 500 mg capsule shell contains black iron
oxide, titanium dioxide, gelatin, and
water.
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 radioactivi