FLUCONAZOLE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

NuCare Pharmaceuticals,Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 la

Dettagli prodotto:

Fluconazole Tablets, USP 200 mg: Engraved with “200” on one side and plain on the other side. Storage: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 [phone] www.glenmarkpharma-us.com November 2021

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

FLUCONAZOLE- FLUCONAZOLE TABLET
NUCARE PHARMACEUTICALS,INC.
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FLUCONAZOLE TABLETS
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-1 ,1 -bis(1
_H_-1,2,4-triazol-1-
ylmethyl)benzyl alcohol with an empirical formula of C
H
F
N
O and molecular
weight of 306.27 g/mol. 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.
Fluconazole Tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of
fluconazole,
USP and the following inactive ingredients: croscarmellose sodium,
dibasic calcium
phosphate anhydrous, FD&C Red No. 40, magnesium stearate,
microcrystalline cellulose
and povidone K-30.
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 area
under the
plasma concentration-time curve (AUC) are dose proportional.
The C
and AUC data from a food-effect study involving administration of
fluconazole
tablets to healthy volunteers under fa