FLUCONAZOLE tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Zydus Lifesciences Limited

INN (International Nazwa):

FLUCONAZOLE

Skład:

FLUCONAZOLE 50 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly. Fluconazole is contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients. There is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents. Caution should be used in prescribing fluconazole to patients with hypersensitivity to other azoles. Coadministration of other drugs known to prolong the QT interval and which are metabolized via the enzyme CYP3A4 such as erythromycin, pimozide, and quinidine are contraindicated in patients receiving fluconazole. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies and PRECAUTIONS. )

Podsumowanie produktu:

Fluconazole Tablets USP, 50 mg are light pink to pink colored, may be spotted, modified oval shaped, biconvex, uncoated tablets, debossed with '1137' on one side and plain on the other side and are supplied as follows: NDC 70771-1063-3 in bottles of 30 tablets with child-resistant closure NDC 70771-1063-1 in bottles of 100 tablets with child-resistant closure NDC 70771-1063-5 in bottles of 500 tablets NDC 70771-1063-4 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose) Fluconazole Tablets USP, 100 mg are light pink to pink colored, may be spotted, modified oval shaped, biconvex, uncoated tablets, debossed with '1138' on one side and plain on the other side and are supplied as follows: NDC 70771-1064-3 in bottles of 30 tablets with child-resistant closure NDC 70771-1064-1 in bottles of 100 tablets with child-resistant closure NDC 70771-1064-5 in bottles of 500 tablets NDC 70771-1064-4 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose) Fluconazole Tablets USP, 150 mg are light pink to pink colored, may be spotted, modified oval shaped, biconvex, uncoated tablets, debossed with '1139' on one side and plain on the other side and are supplied as follows: NDC 70771-1065-3 in bottles of 30 tablets with child-resistant closure NDC 70771-1065-1 in bottles of 100 tablets with child-resistant closure NDC 70771-1065-5 in bottles of 500 tablets NDC 70771-1065-8 in unit-dose blister cartons of 12 tablets (12 X 1 Unit-dose) NDC 70771-1065-7 in unit-dose blister cartons of 1 tablets (1 X 1 Unit-dose) Fluconazole Tablets USP, 200 mg are light pink to pink colored, may be spotted, modified oval shaped, biconvex, uncoated tablets, debossed with '1140' on one side and plain on the other side and are supplied as follows: NDC 70771-1066-3 in bottles of 30 tablets with child-resistant closure NDC 70771-1066-1 in bottles of 100 tablets with child-resistant closure NDC 70771-1066-5 in bottles of 500 tablets NDC 70771-1066-4 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose) Storage: Store at 20º to 25º C (68º to 77º F) [See USP Controlled Room Temperature].  Manufactured by: Zydus Lifesciences Ltd., India Rev.: 03/24

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

FLUCONAZOLE- FLUCONAZOLE TABLET
ZYDUS LIFESCIENCES LIMITED
----------
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,α1-bis(1H-1,2,4-triazol-1-ylmethyl)
benzyl alcohol with an molecular formula of C13H12F2N6O and molecular
weight of
306.3. The structural formula is:
Fluconazole USP is a white or almost white crystalline powder which is
freely soluble in
methanol, soluble in alcohol and in acetone, sparingly soluble in
isopropanol and in
chloroform, slightly soluble in water, very slightly soluble in
toluene.
Each fluconazole tablet, USP intended for oral administration contains
50 mg, 100 mg,
150 mg, or 200 mg of fluconazole USP. In addition, each tablet
contains the following
inactive ingredients: croscarmellose sodium, dibasic calcium phosphate
anhydrous, fd&c
red no. 40 aluminum lake, magnesium stearate, microcrystalline
cellulose and povidone.
Fluconazole tablet meets USP Dissolution Test 2.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS AND METABOLISM
The pharmacokinetic properties (PK) 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 or multiple
oral 400 mg dose of
fluconazole leads to a mean C
of 6.72 mcg/mL (range: 4.12 mcg/mL to 8.08
mcg/mL) and after single oral doses of 50 mg to 400 mg, fluconazole
plasma
concentrations and area under the plasma concentration-time curve
(AU