FLUCONAZOLE tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

NuCare Pharmaceuticals,Inc.

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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

उत्पाद समीक्षा:

Fluconazole Tablets, USP 150 mg: Engraved with 150 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 2020

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

FLUCONAZOLE- FLUCONAZOLE TABLET
NUCARE PHARMACEUTICALS,INC.
----------
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.
’
’
13
12
2
6
max
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
healt