FLUCONAZOLE tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

STAT Rx USA LLC

SNN (starptautisko nepatentēto nosaukumu):

FLUCONAZOLE

Kompozīcija:

FLUCONAZOLE 200 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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 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 conduct 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 prior to therapy to isolate and id

Produktu pārskats:

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 1 - NDC # 16590-283-01 Bottles of 3 - NDC # 16590-283-03 Bottles of 30 - NDC # 16590-283-30 Dispense in a tight container as defined in the USP, with a child resistant closure (as required). Store at 20˚ to 25˚C (68˚ to 77˚F) [See USP Controlled Room Temperature]. REFERENCES 1. Clinical and Laboratory Standards Institute. Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved Standard-Third Edition. CLSI Document M27-A3, (ISBN 1-56238-666-2), CLSI, 940 West Valley Road, Suite 1400, Wayne, PA, 19087-1898 USA, 2008. 2. Clinical and Laboratory Standards Institute. Methods for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Approved Guideline-Second Edition. CLSI Document M44-A2, (ISBN 1-56238-703-0), CLSI, 940 West Valley Road, Suite 1400, Wayne, PA, 19087-1898 USA, 2009. 3. Pfaller, M. A., Messer, S. A., Boyken, L., Rice, C., Tendolkar, S., Hollis, R. J., and Diekema1, D. J. Use of Fluconazole as a Surrogate Marker To Predict Susceptibility and Resistance to Voriconazole Among 13,338 Clinical Isolates of Candida spp. Tested by Clinical and Laboratory Standard Institute-Recommended Broth Microdilution Methods. 2007. Journal of Clinical Microbiology. 45:70–75. Rev. E 4/2012 Manufactured In India By: CIPLA LTD. Kurkumbh, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Relabeling and Repackaging by: STAT Rx USA LLC Gainesville, GA 30501

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

FLUCONAZOLE - FLUCONAZOLE TABLET
STAT RX USA LLC
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FLUCONAZOLE TABLETS
DESCRIPTION
Fluconazole USP, 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-1′,1′-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl
alcohol and has the following structural formula:
C
H F N O M.W. 306.3
Fluconazole 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 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
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 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, fluconazole tablets may be taken
without regard to meals (s