Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
FLUCYTOSINE (UNII: D83282DT06) (FLUCYTOSINE - UNII:D83282DT06)
Hikma Pharmaceuticals USA Inc.
FLUCYTOSINE
FLUCYTOSINE 250 mg
ORAL
PRESCRIPTION DRUG
Flucytosine 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 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 is contraindicated in patients with a known hypersensitivity to the drug. Flucytosine is contraindicated in patients with known complete dihydropyrimidine dehydrogenase (DPD) enzyme deficiency (see WARNINGS ).
Flucytosine Capsules, USP The 250 mg capsules are supplied as green opaque cap and grey opaque body with “54 986” printed in black ink on the cap and body, containing a white to off-white powder. NDC 0054-0427-25: Bottle of 100 Capsules The 500 mg capsules are supplied as grey opaque cap and white opaque body with “54 866” printed in black ink on the cap and body, containing a white to off-white powder. NDC 0054-0428-25: Bottle of 100 Capsules Store at 20˚ to 25°C (68˚ to 77°F). [See USP Controlled Room Temperature.] Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000572/01 Revised February 2022
Abbreviated New Drug Application
FLUCYTOSINE- FLUCYTOSINE CAPSULE HIKMA PHARMACEUTICALS USA INC. ---------- 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. 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: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and pregelatinized starch. The gelatin capsule shells contains: D&C Yellow #10, FD&C Green #3, FD&C Red #40, gelatin and titanium dioxide. The 250 mg capsule also contains: FD&C Blue #1 and FD&C Yellow #6. In addition to the ingredients listed above, each capsule contains: ammonium hydroxide, ethanol, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze used in the black monogramming ink. Chemically, flucytosine is 5-Fluorocytosine, a fluorinated pyrimidine which is related to fluorouracil and floxuridine. It is a white to off-white 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 Soma hati kamili