FLUCONAZOLE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Apotheca Inc.

INN (Internationale Bezeichnung):

FLUCONAZOLE

Zusammensetzung:

FLUCONAZOLE 150 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 tablets USP 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.

Produktbesonderheiten:

Fluconazole Tablets USP, 50 mg are pink mottled, biconvex, capsule shaped uncoated tablets with “C” debossed on one side and “04” debossed on other side.             Bottles of 30                            NDC 57237-003-30 Fluconazole Tablets USP, 100 mg are pink mottled, biconvex, capsule shaped uncoated tablets with “C” debossed on one side and “05” debossed on other side.             Bottles of 30                            NDC 57237-004-30             Fluconazole Tablets USP, 150 mg are pink mottled, biconvex, capsule shaped uncoated tablets with “C” debossed on one side and “10” debossed on other side.             Unit dose package of 1          NDC 57237-005-11 Fluconazole Tablets USP, 200 mg are pink mottled, biconvex, capsule shaped uncoated tablets with “C” debossed on one side and “07” debossed on other side.             Bottles of 30                            NDC 57237-006-30             Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

FLUCONAZOLE- FLUCONAZOLE TABLET
APOTHECA 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 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
1
13
12
2
6
max
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 AUC (area under the plasma
concentration-time curve) 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, fluco