FLUCONAZOLE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

A-S Medication Solutions

INN (International Name):

FLUCONAZOLE

Sammensetning:

FLUCONAZOLE 150 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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) should be ob

Produkt oppsummering:

Product: 50090-2195 NDC: 50090-2195-0 1 TABLET in a BLISTER PACK / 1 in a CARTON NDC: 50090-2195-1 12 TABLET in a BLISTER PACK / 1 in a CARTON NDC: 50090-2195-2 2 TABLET in a BLISTER PACK / 1 in a CARTON NDC: 50090-2195-3 4 TABLET in a BLISTER PACK / 1 in a CARTON

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

FLUCONAZOLE - FLUCONAZOLE TABLET
A-S MEDICATION SOLUTIONS
----------
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 a molecular formula of C
H
F N O and molecular weight of 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 mg, 100 mg, 150 mg, or 200 mg of
fluconazole
USP and the following inactive ingredients: microcrystalline
cellulose, dibasic calcium
phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40
aluminum
lake dye, and magnesium stearate.
Meets USP Dissolution Test 2.
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
1
13
12 2
6
max
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. Ther