FLUCYTOSINE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

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 (see MICROBIOLOGY ). Flucytosine capsules are contraindicated in patients with a known hypersensitivity to the drug. Flucytosine capsules are contraindicated in patients with known complete dihydropyrimidine dehydrogenase (DPD) enzyme deficiency (see WARNINGS ).

Product summary:

Flucytosine Capsules, USP 250 mg are grey opaque cap and green opaque body size ‘2’ hard gelatin capsules, imprinted FLU on cap and 250 on body filled with white to off white powder.  Unit dose packages of 30 (3 x 10) NDC 60687-599-21 Flucytosine Capsules, USP 500 mg are grey opaque cap and white opaque body size ‘0’ hard gelatin capsules, imprinted FLU on cap and 500 on body filled with white to off white powder.  Unit dose packages of 30 (3 x 10) NDC 60687-610-21 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUCYTOSINE- FLUCYTOSINE CAPSULE
AMERICAN HEALTH PACKAGING
----------
FLUCYTOSINE CAPSULES, USP
RX ONLY
8459901/0822F
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.
DESCRIPTION
Flucytosine Capsules USP, an antifungal agent, is available as 250 mg
and 500 mg
capsules for oral administration. In addition to the active ingredient
of flucytosine USP,
each capsule contains anhydrous lactose, gelatin, iron oxide black,
potassium
hydroxide, potato starch, shellac, silicon dioxide, talc and titanium
dioxide. In addition,
the 250 mg capsule shell contains D&C yellow 10, FD&C blue 1 and FD&C
yellow 6.
Chemically, flucytosine is 5-fluorocytosine, a fluorinated pyrimidine
which is related to
fluorouracil and floxuridine. It is a white or almost 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 is 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
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 f