Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
FLUCYTOSINE (UNII: D83282DT06) (FLUCYTOSINE - UNII:D83282DT06)
Bryant Ranch Prepack
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 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 ).
Flucytosine Capsules are supplied as 500 mg flucytosine as follows: NDC: 72162-1327-01 - 100 Capsules in a BOTTLE. Gray and white capsules imprinted with "ANCOBON® 500 ICN". Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
New Drug Application Authorized Generic
FLUCYTOSINE- FLUCYTOSINE CAPSULE BRYANT RANCH PREPACK ---------- FLUCYTOSINE CAPSULES 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, an antifungal agent, are 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 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. 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 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 subjects ranged between 2.4 and 4.8 hours. Flucytosine is excreted via the kidneys by means of glomerular filtration without significant tubular reabsorption. More than 90% of the total radioactivity Soma hati kamili