FLUCONAZOLE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

BluePoint Laboratories

INN (International Adı):

FLUCONAZOLE

Kompozisyon:

FLUCONAZOLE 50 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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)

Ürün özeti:

Fluconazole Tablets, USP, 50 mg are pink, trapezoidal shaped tablets, engraved with “50” on one side and plain on the other side, supplied as follows: NDC 68001-251-04 Bottles of 30 Fluconazole Tablets, USP 100 mg are pink, trapezoidal shaped tablets, engraved with “100” on one side and plain on the other side, supplied as follows: NDC 68001-252-04 Bottles of 30 Fluconazole Tablets, USP 150 mg are pink, oval shaped tablets, engraved with “150” on one side and plain on the other side, supplied as follows: NDC 68001-253-44 Carton of 1 blister pack of 1 tablet (1 X 1 unit-dose) NDC 68001-253-17 Carton of 12 blister packs of 1 tablet (12 X 1 unit-dose) Fluconazole Tablets, USP 200 mg are pink, trapezoidal shaped tablets, engraved with “200” on one side and plain on the other side, supplied as follows: NDC 68001-254-04 Bottles of 30 Storage: Store at 20 o C to 25 o C (68 o F to 77 o F). [see USP Controlled Room Temperature]. Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa 403513, India. Manufactured for: BluePoint Laboratories Questions? 1(888)721-7115 Rev: 08/2023

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

FLUCONAZOLE- FLUCONAZOLE TABLET
BLUEPOINT LABORATORIES
----------
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. 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
13
12
2
6
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