FLUCONAZOLE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

REMEDYREPACK INC.

INN (International Adı):

Fluconazole

Kompozisyon:

Fluconazole 200 mg

Reçete türü:

PRESCRIPTION DRUG

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

FLUCONAZOLE - FLUCONAZOLE TABLET
REMEDYREPACK INC.
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FLUCONAZOLE TABLETS USP
DESCRIPTION
Fluconazole, 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-α,α
-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl
alcohol with a molecular formula of C
H F N O and molecular weight 306.3. The structural formula
is:
Fluconazole USP is a white crystalline solid which is slightly soluble
in water and saline.
Fluconazole tablets USP contain 50, 100, 150, or 200 mg of fluconazole
USP and the following
inactive ingredients: dibasic calcium phosphate anhydrous, ferric
oxide (iron oxide, red), magnesium
stearate, microcrystalline cellulose, povidone, sodium starch
glycolate, and starch.
Fluconazole tablets meets USP _Dissolution_ Test 2.
CLINICAL PHARMACOLOGY
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.
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 Cmax 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 may be taken without
regard to meals. (See DOSAGE
AND ADMINISTRATION.)
Administration of a single oral 150 mg tablet of fluconazole to ten
lactating women