FLUCYTOSINE capsule

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Hikma Pharmaceuticals USA Inc.

ІПН (Міжнародна Ім'я):

FLUCYTOSINE

Склад:

FLUCYTOSINE 250 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 ).

Огляд продуктів:

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

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

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