FLUCONAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rising Pharmaceuticals, 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 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 t

Product summary:

Fluconazole Tablets USP: White to off-white, circular, flat, beveled edges, uncoated tablets containing 50 mg, 100 mg or 200 mg of fluconazole are packed in bottles. White to off-white, capsule shaped, biconvex uncoated tablets containing 150 mg of fluconazole are packaged in a single dose unit blister. Fluconazole Tablets are supplied as follows: Fluconazole Tablets USP 50 mg: Engraved with "P" on the front and "50" on the back. NDC 16571-210-30 Bottles of 30 NDC 16571-210-10 Bottles of 100 Fluconazole Tablets USP 100 mg: Engraved with "P" on the front and "100" on the back. NDC 16571-211-30 Bottles of 30 NDC 16571-211-10 Bottles of 100 Fluconazole Tablets USP 150 mg: Engraved with "P" on the front and "150" on the back. NDC 16571-212-12 Unit dose package of 1 Fluconazole Tablets USP 200 mg: Engraved with "P" on the front and "200" on the back. NDC 16571-213-30 Bottles of 30 NDC 16571-213-10 Bottles of 100

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUCONAZOLE- FLUCONAZOLE TABLET
RISING PHARMACEUTICALS, 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-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl
alcohol with an empirical formula of C13H12F2N6O and molecular weight
of 306.3. The structural
formula is:
Fluconazole USP is a white crystalline solid which is slightly soluble
in water and saline.
Fluconazole tablets USP contain 50, 100, 150, or 200 mg of fluconazole
USP and the following
inactive ingredients: croscarmellose sodium, dibasic calcium phosphate
anhydrous, 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 μg/mL (range: 4.12 to 8.08 μg/mL) and after single oral
doses of 50 to 400 mg,
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 volunteers under fasting conditions and with a high-fat meal
indicated that exposure to the drug
is not affected by food. Therefore, fluconazole tablets may be taken
without regard to meals. (see
DOSAGE