FLUCONAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Harris Pharmaceutical, Inc.

INN (International Name):

Fluconazole

Composition:

Fluconazole 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluconazole tablets, USP are indicated for the treatment of: Prophylaxis. Fluconazole tablets, USP 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 is 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 terfenadine is contraind

Product summary:

Fluconazole Tablets, USP: Pink to light pink round biconvex tablets containing 50 mg, 100 mg, 150 mg or 200 mg of fluconazole. The 50 mg, 100 mg, 150 mg and 200 mg fluconazole tablets, USP are packaged in bottles. The 150 mg fluconazole tablets, USP are also packaged in a single dose unit blister. Fluconazole Tablets, USP are supplied as follows: Fluconazole Tablets, USP 50 mg : Debossed 'H' above '01' on one side and plain on the other. Bottles of 30 count NDC 67405-601-03 Fluconazole Tablets, USP 100 mg : Debossed 'H' above '602' on one side and plain on the other. Bottles of 30 count NDC 67405-602-03 Fluconazole Tablets, USP 150 mg : Debossed 'H' above '603' on one side and plain on the other. Bottles of 100 count NDC 67405-603-10 Carton of 12 blister cards of 1 tablet NDC 67405-603-01 Fluconazole Tablets, USP 200 mg : Debossed 'H' above '604' on one side and plain on the other. Bottles of 30 count NDC 67405-604-03 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense contents with a child-resistant closure (if required) and in a tight container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUCONAZOLE- FLUCONAZOLE TABLET
HARRIS PHARMACEUTICAL, INC.
----------
FLUCONAZOLE TABLETS, USP
RX ONLY
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 an empirical formula of C
H
F N O and molecular weight of 306.3.
The structural formula is:
Fluconazole is a white crystalline solid which is slightly soluble in
water and saline.
Each fluconazole tablet, USP contains either 50 mg, 100 mg, 150 mg, or
200 mg of
fluconazole and the following inactive ingredients: croscarmellose
sodium, dibasic
calcium phosphate anhydrous, FD&C Red No. 40 aluminum lake, magnesium
stearate,
microcrystalline cellulose and povidone.
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
1
13
12 2
6
max
max
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 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 tab