FLUCYTOSINE capsule

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Strides Pharma Science Limited

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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 ).

Каталог на резюме:

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

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

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)