Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
FLUCYTOSINE (UNII: D83282DT06) (FLUCYTOSINE - UNII:D83282DT06)
Strides Pharma Science Limited
ORAL
PRESCRIPTION DRUG
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 capsules (see MICROBIOLOGY ). Flucytosine capsule is contraindicated in patients with a known hypersensitivity to the drug. Flucytosine capsule is contraindicated in patients with known complete dihydropyrimidine dehydrogenase (DPD) enzyme deficiency (see WARNINGS ).
Flucytosine capsules, USP are supplied as capsules containing 250 mg and 500 mg flucytosine as follows: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Manufactured by: Strides Pharma Science Limited Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Revised: 04/2023
Abbreviated New Drug Application
FLUCYTOSINE - FLUCYTOSINE CAPSULE STRIDES PHARMA SCIENCE LIMITED ---------- FLUCYTOSINE CAPSULES, USP 250 MG AND 500 MG 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, 250 MG AND 500 MG 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, each capsule contains, corn starch, lactose monohydrate, and talc. The 250 mg capsule shell contains black iron oxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6, gelatin and titanium dioxide. The 500 mg capsule shell contains black iron oxide, gelatin and titanium dioxide. The imprinting ink Tekprint™ SW-9008 Black contains, black iron oxide, propylene glycol, potassium hydroxide and shellac. 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: FDA approved dissolution specification differs from the USP dissolution specification. 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) Soma hati kamili