FLUCONAZOLE tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

RPK Pharmaceuticals, Inc.

INN（国际名称）:

FLUCONAZOLE

组成:

FLUCONAZOLE 150 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Fluconazole tablets, USP 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, USP 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, USP for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis. Fluconazole tablets, USP 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

產品總結:

Product: 53002-1198 NDC: 53002-1198-1 1 TABLET in a BLISTER PACK NDC: 53002-1198-2 2 TABLET in a BLISTER PACK Product: 53002-4400 NDC: 53002-4400-1 3 TABLET in a BOTTLE

授权状态:

Abbreviated New Drug Application

产品特点

FLUCONAZOLE- FLUCONAZOLE TABLET
RPK 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 empirical formula of C
H
F N O and molecular weight of 306.3.
The structural formula is:
Fluconazole is a white crystalline solid which is slightly soluble in
water and saline.
Each fluconazole tablet, USP contains either 50 mg, 100 mg, 150 mg, or
200 mg of
fluconazole and the following inactive ingredients: croscarmellose
sodium, dibasic
calcium phosphate anhydrous, FD&C Red No. 40 aluminum lake, magnesium
stearate,
microcrystalline cellulose and povidone.
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.
1
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 healthy volunteers under fasting conditions and with a
high-fat meal indicated
that exposure to the drug is not affected by food. Therefore,
fluconazole tablets m