FLUCONAZOLE- fluconazole tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, 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: 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 to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly. Fluconazole tablets are contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients. There is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents. Caution should be used in prescribing fluconazole tablets to patients with hypersensitivity to other azoles. Coadministration of terfe

Product summary:

Fluconazole Tablets USP, 200 mg are pink mottled, biconvex, capsule shaped uncoated tablets with “C” debossed on one side and “07” debossed on other side. Bottles of 1 - 68788-9245-0 Bottles of 2 - 68788-9245-5 Bottles of 10 - 68788-9245-1 Bottles of 20 - 68788-9245-2 Bottles of 30 - 68788-9245-3 Bottles of 60 - 68788-9245-6 Bottles of 90 - 68788-9245-9             Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUCONAZOLE- FLUCONAZOLE TABLET
PREFERRED PHARMACEUTICALS, INC.
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FLUCONAZOLE TABLETS USP
RX ONLY
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 crystalline solid which is slightly soluble
in water and saline.
Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of
fluconazole USP and the following inactive ingredients:
microcrystalline cellulose, dibasic calcium phosphate anhydrous,
povidone, croscarmellose sodium, FD&C Red
No. 40 aluminum lake dye, and magnesium stearate.
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
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,
flu