FLUCYTOSINE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvPAK

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Flucytosine Capsules USP 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. 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, 250 mg are size 2 hard gelatin capsule with blue opaque cap and grey opaque body imprinted with "NL 771" on the cap with black ink and "250" on the body with red ink filled with white to off white powder. NDC 50268-331-12 (10 capsules per card, 2 cards per carton). Flucytosine Capsules USP, 500 mg are size 0 hard gelatin capsule with grey opaque cap and white opaque body imprinted "NL 770" on the cap with black ink and "500" on the body with red ink, filled with white to off white powder. NDC 50268-332-12 (10 capsules per card, 2 cards per carton). For Institutional Use Only. Dispensed in Unit Dose Package. Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F). Manufactured for: AvKARE Pulaski, TN 38478 Mfg. Rev. 02/20 AV 04/21 (P)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUCYTOSINE- FLUCYTOSINE CAPSULE
AVPAK
----------
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, an antifungal agent, is available as 250 mg
and 500 mg
capsules for oral administration. Each capsule also contains lactose
monohydrate,
colloidal silicon dioxide, talc, sodium starch glycolate, magnesium
stearate and hard
gelatin capsule shell which contains gelatin, purified water, black
iron oxide, FD&C Blue
No.1, titanium dioxide and sodium lauryl sulfate for 250 mg strength;
gelatin, purified
water, black iron oxide and titanium dioxide for 500 mg strength. The
imprinting ink
contains black iron oxide, shellac, potassium hydroxide, titanium
dioxide, povidone,
sodium hydroxide and FD &C Red No. 40 aluminum lake for 250 mg and 500
mg
strengths. 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 Capsules USP 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 amph