FLUCONAZOLE tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

FLUCONAZOLE (UNII: 8VZV102JFY) (FLUCONAZOLE - UNII:8VZV102JFY)

Sẵn có từ:

Bryant Ranch Prepack

INN (Tên quốc tế):

FLUCONAZOLE

Thành phần:

FLUCONAZOLE 150 mg

Loại thuốc theo toa:

PRESCRIPTION DRUG

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

FLUCONAZOLE- FLUCONAZOLE TABLET
BRYANT RANCH PREPACK
----------
FLUCONAZOLE TABLETS
DESCRIPTION
Fluconazole USP, the first of a new subclass of synthetic triazole
antifungal agents, is available as
tablets for oral administration.
Fluconazole is designated chemically as
2,4-difluoro-1′,1′-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl
alcohol and has the following structural formula:
C
H F N O M.W. 306.3
Fluconazole is a white crystalline solid which is slightly soluble in
water and saline.
Fluconazole Tablets USP, for oral administration, contain 50, 100,
150, or 200 mg of fluconazole and
have the following inactive ingredients: colloidal silicon dioxide,
corn starch, croscarmellose sodium,
FD&C red #40 aluminum lake, lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
and talc.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS AND METABOLISM
The pharmacokinetic properties of fluconazole are similar following
administration by the intravenous
or oral routes. In normal volunteers, the bioavailability of orally
administered fluconazole is over 90%
compared with intravenous administration. Bioequivalence was
established between the 100 mg tablet
and both suspension strengths when administered as a single 200 mg
dose.
Peak plasma concentrations (C
) in fasted normal volunteers occur between 1 and 2 hours with a
terminal plasma elimination half-life of approximately 30 hours
(range: 20 to 50 hours) after oral
administration.
In fasted normal volunteers, administration of a single oral 400 mg
dose of fluconazole leads to a mean
C
of 6.72 mcg/mL (range: 4.12 to 8.08 mcg/mL) and after single oral
doses of 50 to 400 mg,
fluconazole plasma concentrations and AUC (area under the plasma
concentration-time curve) are dose
proportional.
The C
and AUC data from a food-effect study involving administration of
fluconazole tablets to
healthy volunteers under fasting conditions and with a high-fat meal
indicated that exposure to the drug
is not affected by food. Therefore, fluconazole tablets may be taken
without regard to meal