देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
FLUCONAZOLE (UNII: 8VZV102JFY) (FLUCONAZOLE - UNII:8VZV102JFY)
Teva Pharmaceuticals USA Inc
FLUCONAZOLE
FLUCONAZOLE 10 mg in 1 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
FLUCONAZOLE- FLUCONAZOLE POWDER, FOR SUSPENSION TEVA PHARMACEUTICALS USA INC ---------- FLUCONAZOLE FOR ORAL SUSPENSION RX ONLY DESCRIPTION Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available for oral administration as a powder for oral suspension. Fluconazole USP is designated chemically as 2,4-difluoro-α,α -bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with the following structural formula: C H F N O M.W. 306.3 Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline. Fluconazole for Oral Suspension contains 350 mg or 1400 mg of fluconazole USP and the following inactive ingredients: citric acid, colloidal silicon dioxide, dl-alpha-Tocopherol, maltodextrin, natural and artificial flavors, sodium benzoate, sodium citrate, sucrose, titanium dioxide and xanthum gum. After reconstitution with 26 mL or 24 mL of distilled water or Purified Water (USP), each mL of reconstituted suspension contains 10 mg or 40 mg of fluconazole. 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 flucon पूरा दस्तावेज़ पढ़ें