FLUCONAZOLE tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Preferred Pharmaceuticals Inc.

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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

उत्पाद समीक्षा:

Fluconazole Tablets USP, 150 mg are light pink to pink colored, may be spotted, modified oval shaped, biconvex, uncoated tablets, debossed with '1139' on one side and plain on the other side and are supplied as follows: Storage:  Store  at  20º  to  25º  C  (68º  to  77º  F)  [See  USP  Controlled  Room  Temperature].   Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 03/22

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

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)