Ülke: ABD
Dil: İngilizce
Kaynak: 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 other drugs known to prolong the Q
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 68788-7150-0 in bottles of 1 tablet NDC 68788-7150-5 in bottles of 2 tablets NDC 68788-7150-1 in bottles of 10 tablets NDC 68788-7150-2 in bottles of 20 tablets NDC 68788-7150-3 in bottles of 30 tablets NDC 68788-7150-6 in bottles of 60 tablets NDC 68788-7150-9 in bottles of 90 tablets Storage: Store at 20º to 25º C (68º to 77º F) [See USP Controlled Room Temperature]. Manufactured by: Zydus Lifesciences Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 01/23 Repackaged By: Preferred Pharmaceuticals Inc.
Abbreviated New Drug Application
FLUCONAZOLE- FLUCONAZOLE TABLET PREFERRED PHARMACEUTICALS 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 an molecular formula of C H F N O 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 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. 1 13 12 2 6 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 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 (AUC) Belgenin tamamını okuyun