País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
FLUCONAZOLE (UNII: 8VZV102JFY) (FLUCONAZOLE - UNII:8VZV102JFY)
Rising Pharmaceuticals, Inc.
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 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 t
Fluconazole Tablets USP: White to off-white, circular, flat, beveled edges, uncoated tablets containing 50 mg, 100 mg or 200 mg of fluconazole are packed in bottles. White to off-white, capsule shaped, biconvex uncoated tablets containing 150 mg of fluconazole are packaged in a single dose unit blister. Fluconazole Tablets are supplied as follows: Fluconazole Tablets USP 50 mg: Engraved with "P" on the front and "50" on the back. NDC 16571-210-30 Bottles of 30 NDC 16571-210-10 Bottles of 100 Fluconazole Tablets USP 100 mg: Engraved with "P" on the front and "100" on the back. NDC 16571-211-30 Bottles of 30 NDC 16571-211-10 Bottles of 100 Fluconazole Tablets USP 150 mg: Engraved with "P" on the front and "150" on the back. NDC 16571-212-12 Unit dose package of 1 Fluconazole Tablets USP 200 mg: Engraved with "P" on the front and "200" on the back. NDC 16571-213-30 Bottles of 30 NDC 16571-213-10 Bottles of 100
Abbreviated New Drug Application
FLUCONAZOLE- FLUCONAZOLE TABLET RISING PHARMACEUTICALS, INC. ---------- FLUCONAZOLE TABLETS, USP 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-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is: Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline. Fluconazole tablets USP contain 50, 100, 150, or 200 mg of fluconazole USP and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose and povidone. 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 μg/mL (range: 4.12 to 8.08 μg/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 Leer el documento completo