Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
FLUCONAZOLE (UNII: 8VZV102JFY) (FLUCONAZOLE - UNII:8VZV102JFY)
Preferred Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Fluconazole tablets are indicated for the treatment of: 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 terfenadine is contraindicated in
Fluconazole Tablets USP: Pink trapezoidal tablets containing 50, 100, or 200 mg of fluconazole, USP are packaged in bottles. Fluconazole tablets USP, 150 mg are pink, oval shaped, packaged in a blister card of Fluconazole tablets USP, 150 mg: Engraved with “150” on one side and plain on the other side. Bottle of 1 - 68788-9190-1 Bottle of 2 - 68788-9190-5 Bottle of 10 - 68788-9190-0 Bottle of 20 - 68788-9190-2 Bottle of 30 - 68788-9190-3 Bottle of 60 - 68788-9190-6 Bottle of 90 - 68788-9190-9 Storage: Store at 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888) 721-7115 www.glenmarkpharma.com/usa April 2019 Repackaged By: Preferred Pharmaceuticals Inc.
Abbreviated New Drug Application
FLUCONAZOLE- FLUCONAZOLE TABLET PREFERRED PHARMACEUTICALS, INC. ---------- FLUCONAZOLE TABLETS, FOR ORAL USE RX ONLY DESCRIPTION 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(1_H_-1,2,4-triazol-1-ylmethyl)benzyl alcohol with an empirical formula of C H F N O and molecular weight of 306.27. 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. Fluconazole Tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, FD&C Red No. 40 HT 15-17%, magnesium stearate, microcrystalline cellulose and povidone K-30. 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. 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. ’ ’ 13 12 2 6 max 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 area under the plasma concentration-time curve (AUC) 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 Lire le document complet