FLUCONAZOLE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Preferred Pharmaceuticals Inc.

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Fluconazole tablets are indicated for the treatment of: 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 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 is 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 to patients with hypersensitivity to other azoles. Coadministration of other drugs known to prolong the Q

Proizvod sažetak:

Fluconazole Tablets USP, 200 mg are light pink to pink colored, may be spotted, modified oval shaped, biconvex, uncoated tablets, debossed with '1140' on one side and plain on the other side and are supplied as follows: NDC 68788-7150-0 in bottles of 1 tablet NDC 68788-7150-5 in bottles of 2 tablets NDC 68788-7150-1 in bottles of 10 tablets NDC 68788-7150-2 in bottles of 20 tablets NDC 68788-7150-3 in bottles of 30 tablets NDC 68788-7150-6 in bottles of 60 tablets NDC 68788-7150-9 in bottles of 90 tablets Storage:  Store  at  20º  to  25º  C  (68º  to  77º  F)  [See  USP  Controlled  Room  Temperature].   Manufactured by: Zydus Lifesciences Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 01/23 Repackaged By: Preferred Pharmaceuticals Inc.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

FLUCONAZOLE- FLUCONAZOLE TABLET
PREFERRED PHARMACEUTICALS INC.
----------
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 an 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
isopropanol and in
chloroform, slightly soluble in water, very slightly soluble in
toluene.
Each fluconazole tablet, USP intended for oral administration contains
50 mg, 100 mg,
150 mg, or 200 mg of fluconazole USP. In addition, each tablet
contains the following
inactive ingredients: croscarmellose sodium, dibasic calcium phosphate
anhydrous, fd&c
red no. 40 aluminum lake, magnesium stearate, microcrystalline
cellulose and povidone.
Fluconazole tablet 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.
1
13
12 2
6
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 mcg/mL to 8.08 mcg/mL) and after
single oral doses of 50 mg to 400 mg, fluconazole plasma
concentrations and area
under the plasma concentration-time curve (AUC)