FLUCONAZOLE tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Blenheim Pharmacal, Inc.

INN:

FLUCONAZOLE

composition:

FLUCONAZOLE 200 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Fluconazole is 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 was 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 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 is 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 prior to therapy to isolate and identify

leaflet_short:

Fluconazole Tablets USP: Pink trapezoidal tablets containing 50, 100 or 200 mg of fluconazole USP are packaged in bottles. The 150 mg fluconazole tablets are pink, oval shaped, packaged in a blister card of 1 tablet. Fluconazole Tablets USP are supplied as follows: Fluconazole Tablets USP 50 mg: Engraved with “50” on one side and plain on the other side. NDC 68462-101-30 Bottles of 30 NDC 68462-101-10 Bottles of 1000 Fluconazole Tablets USP 100 mg: Engraved with “100” on one side and plain on the other side. NDC 68462-102-30 Bottles of 30 NDC 68462-102-10 Bottles of 1000 Fluconazole Tablets USP 150 mg: Engraved with “150” on one side and plain on the other side. NDC 68462-103-40 Carton of 12 blister cards of 1 tablet Fluconazole Tablets USP 200 mg: Engraved with “200” on one side and plain on the other side. NDC 68462-104-30 Bottles of 30 NDC 68462-104-10 Bottles of 1000

authorization_status:

Abbreviated New Drug Application

SPC

FLUCONAZOLE - FLUCONAZOLE TABLET
BLENHEIM PHARMACAL, INC.
----------
FLUCONAZOLE TABLETS USP
RX ONLY
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-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 306.3. The structural
formula is:
Fluconazole USP is a white crystalline solid which is slightly soluble
in water and saline.
Fluconazole tablets USP contain 50, 100, 150, or 200 mg of fluconazole
USP and the following
inactive ingredients: croscarmellose sodium, dibasic calcium phosphate
anhydrous, FD&C Red No. 40
aluminum lake dye, 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.
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 - 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 μg/mL (range: 4.12 to 8.08 μg/mL) and after single oral
doses of 50 - 400 mg,
fluconazole plasma concentrations and AUC (area under the plasma
concentration-time curve) are dose
proportional.
Administration of a single oral 150 mg tablet of fluconazole to ten
lactating women resulted in a mean
C
of 2.61 μg/mL (range: 1.57 to 3.65 μg/mL).
Steady-state concentrations are reached within 5 - 10 days following
oral doses of 50 - 400 mg given
once daily. Administration of a loading dose (on day 1) of twice the
usual daily dose results in plasma
1
13
12
2
6
max
max
max
concentrations close to steady-s