FLUCONAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Major Pharmaceuticals

INN (International Name):

FLUCONAZOLE

Composition:

FLUCONAZOLE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluconazole tablets are indicated for the treatment of:  1. Vaginal candidiasis (vaginal yeast infections due to Candida ) 2. 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.  3. 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 obtai

Product summary:

Fluconazole tablets USP, 100 mg are peach colored, oval, flat, bevelled edged, uncoated tablets debossed ‘R’ on one side and “144’ on other side and are supplied: Carton of 50 tablets (10 tablets per blister pack x 5), NDC 0904-6500-06 Carton of 100 tablets (10 tablets per blister pack x 10), NDC 0904-6500-61 Fluconazole tablets USP, 200 mg are peach colored, oval, flat, bevelled edged, uncoated tablets debossed ‘R’ on one side and “146’ on other side and are supplied: Carton of 50 tablets (10 tablets per blister pack x 10), NDC 0904-6501-06 Carton of 100 tablets (10 tablets per blister pack x 10), NDC 0904-6501-61 Storage: Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Maalox®is a registered trademark of Novartis Consumer Health, Inc. XELJANZ®is a registered trademark of Pfizer Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUCONAZOLE- FLUCONAZOLE TABLET
MAJOR PHARMACEUTICALS
----------
FLUCONAZOLE TABLETS USP
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 a 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
isopropyl alcohol and in
chloroform. Slightly soluble in water, very slightly soluble in
toluene.
Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of
fluconazole USP
and the following inactive ingredients: dibasic calcium phosphate
anhydrous, ferric oxide
(iron oxide, red), magnesium stearate, microcrystalline cellulose,
povidone, sodium
starch glycolate, and starch.
Fluconazole tablets meets USP _Dissolution_ Test 2.
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 area
under the plasma
concentration-time curve (AUC) are dose proportional.
1
13
12 2
6
max
max
The C
and AUC data from a food-effect study in