Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
FLUCONAZOLE (UNII: 8VZV102JFY) (FLUCONAZOLE - UNII:8VZV102JFY)
Zydus Lifesciences Limited
FLUCONAZOLE
FLUCONAZOLE 50 mg
ORAL
PRESCRIPTION DRUG
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. )
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
Abbreviated New Drug Application
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 Lesen Sie das vollständige Dokument