FLUCONAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals (USA) Inc.

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: - Vaginal candidiasis (vaginal yeast infections due to Candida ). - Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. - Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. 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 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 other drugs known to prolong the QT interval and which are metabolized via the enzyme CYP3A4 such as erythromycin, pimozide, and quinidine are contraindicated in patients receiving fluconazole. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies   and PRECAUTIONS. )

Product summary:

Fluconazole Tablets USP, 50 mg are light pink to pink colored, may be spotted, modified oval shaped, biconvex, uncoated tablets, debossed with '1137' on one side and plain on the other side and are supplied as follows: NDC 70710-1137-3 in bottles of 30 tablets with child resistant closure NDC 70710-1137-1 in bottles of 100 tablets with child resistant closure NDC 70710-1137-5 in bottles of 500 tablets NDC 70710-1137-4 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose) Fluconazole Tablets USP, 100 mg are light pink to pink colored, may be spotted, modified oval shaped, biconvex, uncoated tablets, debossed with '1138' on one side and plain on the other side and are supplied as follows: NDC 70710-1138-3 in bottles of 30 tablets with child resistant closure NDC 70710-1138-1 in bottles of 100 tablets with child resistant closure NDC 70710-1138-5 in bottles of 500 tablets NDC 70710-1138-4 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose) Fluconazole Tablets USP, 150 mg are light pink to pink colored, may be spotted, modified oval shaped, biconvex, uncoated tablets, debossed with '1139' on one side and plain on the other side and are supplied as follows: NDC 70710-1139-3 in bottles of 30 tablets with child resistant closure NDC 70710-1139-1 in bottles of 100 tablets with child resistant closure NDC 70710-1139-5 in bottles of 500 tablets NDC 70710-1139-8 in unit-dose blister cartons of 12 tablets (12 X 1 Unit-dose) NDC 70710-1139-7 in unit-dose blister cartons of 1 tablets (1 X 1 Unit-dose) Fluconazole Tablets USP, 200 mg are light pink to pink colored, may be spotted, modified oval shaped, biconvex, uncoated tablets, debossed with '1140' on one side and plain on the other side and are supplied as follows: NDC 70710-1140-3 in bottles of 30 tablets with child resistant closure NDC 70710-1140-1 in bottles of 100 tablets with child resistant closure NDC 70710-1140-5 in bottles of 500 tablets NDC 70710-1140-4 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose) Storage:  Store  at  20º  to  25º  C  (68º  to  77º  F)  [See  USP  Controlled  Room  Temperature].   Manufactured by: Zydus Lifesciences Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 03/24

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUCONAZOLE- FLUCONAZOLE TABLET
ZYDUS PHARMACEUTICALS (USA) 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 molecular formula of C
H
F N O and molecular weight of
306.3. 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.
Each fluconazole tablet, USP intended 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: croscarmellose sodium, dibasic calcium phosphate
anhydrous, fd&c
red no. 40 aluminum lake, magnesium stearate, microcrystalline
cellulose and povidone.
FDA approved dissolution test specifications differ from USP
CLINICAL PHARMACOLOGY
PHARMACOKINETICS AND METABOLISM
The pharmacokinetic properties (PK) 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.
1
13
12 2
6
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 mcg/mL to 8.08 mcg/mL) and after
single or multiple oral doses of 50 mg to 400 mg, fluconazole plasma
concentrations
and area under the plasma