FLUCONAZOLE- fluconazole tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Nucare Pharmaceuticals,Inc

INN (International Name):

FLUCONAZOLE

Composition:

FLUCONAZOLE 150 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, 150 mg are peach colored, oval, flat, bevelled edged, uncoated tablets debossed ‘R’ on one side and “145’ on other side and are supplied in unit dose package of 12 (12 x 1). Unit Dose Package of 12 (12 x 1) NDC 68071-3344-1 Blister Pack of 1 Storage: Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUCONAZOLE- FLUCONAZOLE TABLET
NUCARE PHARMACEUTICALS,INC
----------
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 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, 100, 150, 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.
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 Cmax 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