FLUCONAZOLE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

DIRECT RX

INN (Algemene Internationale Benaming):

FLUCONAZOLE

Samenstelling:

FLUCONAZOLE 100 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Fluconazole Tablets USP are indicated for the treatment of: 1.Vaginal candidiasis (vaginal yeast infections due to Candida).2.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.3.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 obtained p

Product samenvatting:

Fluconazole Tablets USP, 50 mg are available as pink, modified oval-shaped, unscored tablets, debossed “5410” on one side and “50” on the other side and packaged in bottles of 30 and 100 tablets. Fluconazole Tablets USP, 100 mg are available as pink, modified oval-shaped, unscored tablets, debossed “5411” on one side and “100” on the other side and packaged in bottles of 30 and 100 tablets. Fluconazole Tablets USP, 150 mg are available as pink, modified oval-shaped, unscored tablets, debossed “5412” on one side and “150” on the other side and packaged in unit-of-use cards of 1 tablet. Fluconazole Tablets USP, 200 mg are available as pink, modified oval-shaped, unscored tablets, debossed “5413” on one side and “200” on the other side and packaged in bottles of 30 and 100 tablets. Store at 20˚ to 25˚C (68˚ to 77˚F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

FLUCONAZOLE- FLUCONAZOLE TABLET
DIRECT RX
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FLUCONAZOLE
DESCRIPTION SECTION
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(1H-1,2,4-triazol-1-ylmethyl)
benzyl alcohol and has the following structural formula:
Fluconazole, USP is a white crystalline solid which is slightly
soluble in water and saline.
Fluconazole Tablets USP, for oral administration, contain 50, 100,
150, or 200 mg of fluconazole, USP
and have the following inactive ingredients: colloidal silicon
dioxide, corn starch, croscarmellose
sodium, FD&C red #40 aluminum lake, lactose monohydrate, magnesium
stearate, microcrystalline
cellulose, and talc.
CLINICAL PHARMACOLOGY SECTION
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 (Cmax) 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
Cmax 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 AUC (area under the plasma
concentration-time curve) are dose
proportional.
The Cmax 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 may be taken without
regard to meals (see D