FLUCONAZOLE- fluconazole tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (International Name):

FLUCONAZOLE

Composition:

FLUCONAZOLE 150 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. Prophylaxis. 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 (serology, histopathology) should be obtained prior

Product summary:

Fluconazole Tablets USP: Pink trapezoidal tablets containing 50, 100 or 200 mg of fluconazole USP are packaged in bottles. Fluconazole tablets USP, 150 mg are pink, oval shaped, packaged in a blister card of 1 tablet. Fluconazole Tablets USP are supplied as follows: Fluconazole Tablets USP, 50 mg: Engraved with “50” on one side and plain on the other side. NDC 68462-101-30 Bottles of 30 NDC 68462-101-10 Bottles of 1000 Fluconazole Tablets USP, 100 mg: Engraved with “100” on one side and plain on the other side. NDC 68462-102-30 Bottles of 30 NDC 68462-102-10 Bottles of 1000 Fluconazole Tablets USP, 150 mg: Engraved with “150” on one side and plain on the other side. NDC 68462-103-40 Carton of 12 blister cards of 1 tablet Fluconazole Tablets USP, 200 mg: Engraved with “200” on one side and plain on the other side. NDC 68462-104-30 Bottles of 30 NDC 68462-104-10 Bottles of 1000

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUCONAZOLE- FLUCONAZOLE TABLET
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
----------
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,α
-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl
alcohol with an empirical formula of C
H F N O 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, FD&C Red No. 40
aluminum lake dye, 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.
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 - 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 - 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.)
1
13
12
2
6
max
max
max
Administration of a singl