FLUCONAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Fluconazole (UNII: 8VZV102JFY) (Fluconazole - UNII:8VZV102JFY)

Available from:

Apothecary Shop Wholesale Inc.

INN (International Name):

Fluconazole

Composition:

Fluconazole 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 . Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. 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 causat

Product summary:

Fluconazole Tablets, 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 150mg - Bottles - 30 tablets     NDC 42852-003-03 Fluconazole 150mg - Bottles - 60 tablets     NDC 42852-003-06 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]. 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-Second Edition. CLSI Document M27-A2, 2002 Volume 22, No 15, CLSI, Wayne, PA, August 2002. 2. Clinical and Laboratory Standards Institute. Methods for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Approved Guideline. CLSI Document M44-A, 2004 Volume 24, No. 15 CLSI, Wayne, PA, May 2004. 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. Manufactured In India By: CIPLA LTD. Kurkumbh, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. A 8/2010

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUCONAZOLE- FLUCONAZOLE TABLET
APOTHECARY SHOP WHOLESALE INC.
----------
FLUCONAZOLE TABLETS
DESCRIPTION
Fluconazole is the first of a new subclass of synthetic triazole
antifungal agents. Fluconazole is
designated chemically as 2,4-difluoro-α,α
-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, 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 (see
DOSAGE AND ADMINISTRATION).
1
13
12
2
6
m