FLUCONAZOLE tablet FLUCONAZOLE tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

direct rx

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Fluconazole tablets 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 tablets were 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 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 obtained p

leaflet_short:

Fluconazole Tablets USP, 50 mg are light pink to pink colored, may be spotted, modified oval shaped, biconvex, uncoated tablets, debossed with '1137' on one side and plain on the other side and are supplied as follows: Fluconazole Tablets USP, 100 mg are light pink to pink colored, may be spotted, modified oval shaped, biconvex, uncoated tablets, debossed with '1138' on one side and plain on the other side and are supplied as follows: 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: 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: 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.: 09/20

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

FLUCONAZOLE- FLUCONAZOLE TABLET
FLUCONAZOLE- FLUCONAZOLE TABLET
DIRECT RX
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FLUCONAZOLE
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,α1-bis(1H-1,2,4-triazol-1-ylmethyl)
benzyl alcohol with an molecular formula of C13H12F2N6O and molecular
weight of
306.3. The structural formula is:
[Structure]
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.
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 (Cmax) 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 Cmax 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) are dose proportional.
The Cmax and A