FLUCONAZOLE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Mylan Pharmaceuticals Inc.

INN (International namn):

FLUCONAZOLE

Sammansättning:

FLUCONAZOLE 50 mg

Receptbelagda typ:

PRESCRIPTION DRUG

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

FLUCONAZOLE- FLUCONAZOLE TABLET
MYLAN PHARMACEUTICALS INC.
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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-l-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.
Each tablet, for oral administration, contains 50 mg, 100 mg, 150 mg
or 200 mg of fluconazole, USP. In
addition, each tablet contains the following inactive ingredients:
anhydrous lactose, colloidal silicon
dioxide, croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake,
magnesium stearate,
microcrystalline cellulose, povidone and sodium lauryl sulfate.
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 mg to 400 mg,
fluconazole plasma concentrations and AUC (area under the plasma
concentration-time curve) are dose
1
13
12
2
6
max
max
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 volunte