Fluconazole Tablets, USP

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva 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 was 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 to amphotericin B in non-HIV infected patients have not been conducted. 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

Product summary:

Fluconazole Tablets USP, 50 mg are available as pink, modified oval-shaped, unscored tablets, debossed “5410” on one side and “Ivax hourglass logo” “50” on the other side and packaged in bottles of 30 (NDC 0172-5410-46) tablets. Fluconazole Tablets USP, 100 mg are available as pink, modified oval-shaped, unscored tablets, debossed “5411” on one side and “Ivax hourglass logo” “100” on the other side and packaged in bottles of 30 (NDC 0172-5411-46) and 100 (NDC 0172-5411-60) tablets. Fluconazole Tablets USP, 150 mg are available as pink, modified oval-shaped, unscored tablets, debossed “5412” on one side and “Ivax hourglass logo” “150” on the other side and packaged in a carton of 12 (NDC 0172-5412-11) unit-of-use cards of 1 tablet. Fluconazole Tablets USP, 200 mg are available as pink, modified oval-shaped, unscored tablets, debossed “5413” on one side and “Ivax hourglass logo” “200” on the other side and packaged in bottles of 30 (NDC 0172-5413-46) and 100 (NDC 0172-5413-60) tablets. Store at 20˚ to 25˚C (68˚ to 77˚F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Brands listed are the trademarks of their respective owners. Manufactured In India By: Cipla Ltd. Kurkumbh, India Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. N 3/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUCONAZOLE- FLUCONAZOLE TABLET
TEVA PHARMACEUTICALS USA, INC.
----------
FLUCONAZOLE TABLETS, USP
RX ONLY
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(1H-1,2,4-triazol-1-
ylmethyl) benzyl alcohol and has the following structural formula:
C
H F N O M.W. 306.27
Fluconazole, USP is a white crystalline solid which is slightly
soluble in water and saline.
Fluconazole Tablets USP, for oral administration, contain 50 mg, 100
mg, 150 mg, or
200 mg of fluconazole, USP and have the following inactive
ingredients: colloidal silicon
dioxide, corn starch, croscarmellose sodium, FD&C red #40 aluminum
lake, lactose
monohydrate, magnesium stearate, microcrystalline cellulose, and talc.
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 mcg/mL 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 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,