FLUCYTOSINE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sigmapharm Laboratories, LLC

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 of flucytosine. Flucytosine Capsules, USP 250 mg have an opaque green cap and opaque white body and are imprinted Σ9 on cap and body. Bottles of 30 capsules (NDC 42794-009-08) Flucytosine Capsules, USP 500 mg have an opaque grey cap and opaque yellow body and are imprinted Σ10 on cap and body. Bottles of 30 capsules (NDC 42794-010-08) Store at 25°C (77°F); excursions permitted between 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]. KEEP OUT OF REACH OF CHILDREN Sigmapharm Laboratories, LLC Bensalem, PA 19020 OS010A-03 REV.0219

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUCYTOSINE- FLUCYTOSINE CAPSULE
SIGMAPHARM LABORATORIES, LLC
----------
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 Capsules, USP are an antifungal agent 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 monohydrate and talc. The 250 mg
capsule shell
contains FD&C Yellow No. 6, FD&C Green No. 3, D&C Yellow No. 10,
titanium dioxide,
sodium lauryl sulfate and gelatin. The 500 mg capsule shell contains
iron oxide yellow,
iron oxide black, titanium dioxide, carboxymethylcellulose, sodium
lauryl sulfate and
gelatin. The imprinting ink used for 250 mg and 500 mg capsules
contains black iron
oxide.
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, USP 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