FLUCONAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Glenmark Pharmaceuticals Inc., USA

INN (International Name):

FLUCONAZOLE

Composition:

FLUCONAZOLE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluconazole tablets are indicated for the treatment of: Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly. Fluconazole tablets are contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients. There is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents. Caution should be used in prescribing fluconazole to patients with hypersensitivity to other azoles. Coadministration of other drugs known to prol

Product summary:

Fluconazole Tablets, USP 50 mg are pink, trapezoidal shaped tablets, engraved with “50” on one side and plain on the other side, supplied as follows: Fluconazole Tablets, USP 100 mg are pink, trapezoidal shaped tablets, engraved with “100” on one side and plain on the other side, supplied as follows: Fluconazole Tablets, USP 150 mg are pink, oval shaped tablets, engraved with “150” on one side and plain on the other side, supplied as follows: Fluconazole Tablets, USP 200 mg are pink trapezoidal shaped tablets, engraved with “200” on one side and plain on the other side, supplied as follows: Storage: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 [phone] www.glenmarkpharma-us.com September 2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUCONAZOLE- FLUCONAZOLE TABLET
GLENMARK PHARMACEUTICALS INC., USA
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FLUCONAZOLE TABLETS
DESCRIPTION
Fluconazole, USP the first of a new subclass of synthetic triazole
antifungal agents, is
available as tablets for oral administration.
Fluconazole, USP is designated chemically as 2,4-difluoro-1 ,1
-bis(1_H_-1,2,4-triazol-1-
ylmethyl)benzyl alcohol with an empirical formula of C
H
F N O and molecular weight
of 306.27. The structural formula is:
Fluconazole, USP is a white or almost white crystalline powder which
is freely soluble in
methanol; soluble in alcohol and in acetone; sparingly soluble in
isopropanol and in
chloroform; slightly soluble in water; very slightly soluble in
toluene.
Fluconazole Tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of
fluconazole,
USP and the following inactive ingredients: croscarmellose sodium,
dibasic calcium
phosphate anhydrous, FD&C Red No. 40, magnesium stearate,
microcrystalline cellulose
and povidone K-30.
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
’
’
13
12 2
6
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 area
under the plasma
concentration-time curve (AUC) are dose proportional.
The C
and AUC data