FLUCONAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Blenheim Pharmacal, Inc.

INN (International Name):

FLUCONAZOLE

Composition:

FLUCONAZOLE 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluconazole Tablets USP 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 USP 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 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 (

Product summary:

Fluconazole Tablets USP, 50 mg are available as pink, modified oval-shaped, unscored tablets, debossed “5410” on one side and “50” on the other side and packaged in bottles of 30 (NDC 0172-5410-46) and 100 (NDC 0172-5410-60) tablets. Fluconazole Tablets USP, 100 mg are available as pink, modified oval-shaped, unscored tablets, debossed “5411” on one side and “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 “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 “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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUCONAZOLE- FLUCONAZOLE TABLET
BLENHEIM PHARMACAL, INC.
----------
FLUCONAZOLE TABLETS USP
5410
5411
5412
5413
RX ONLY
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
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 may be taken without
regard to meals (see DOSAGE
AND ADMINISTRATION).
Administration of a single oral 150 mg tablet of fluconazole to ten
lactating women resulted in a mean C
of 2.61 mcg/mL (range: 1.57 to 3.65 mcg/mL).
Steady-state concentrations are reached within 5 to 10 days following
oral doses of 50 to 400 mg given
once daily. Administration of a loading dose (on day 1) of twice the
usual daily dose results in plasma
concentrations close to steady-state by the second day. The apparent
volume of distribution of
fluconazole approximates that of total body water. Plasma protein
binding is low (11 to 12%). Following
either single- or multiple-oral doses for up to 14 days, fluconazole
penetrates into all body fluids
s