Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
FLUCONAZOLE (UNII: 8VZV102JFY) (FLUCONAZOLE - UNII:8VZV102JFY)
Unit Dose Services
FLUCONAZOLE
FLUCONAZOLE 150 mg
ORAL
PRESCRIPTION DRUG
Fluconazole is 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 was also effective for the treatment of urinary tract infections, peritonitis, and systemic infections including candidemia, disseminated candidiasis, and pneumonia. Candida Candida - Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. CLINICAL STUDIES Fluconazole is 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,
NDC:50436-5128-1 in a CARTON of 1 TABLETS Pink trapezoidal tablets containing 50, 100, or 200 mg of fluconazole are packaged in bottles or unit dose blisters. The 150 mg fluconazole tablets are pink and oval shaped, packaged in a single dose unit blister. Fluconazole Tablets are supplied as follows: Fluconazole 50 mg Tablets: Embossed with "FLZ 50" on one side with no markings on the other side. NDC 59762-5015-1 Bottles of 30 Fluconazole 100 mg Tablets: Embossed with "FLZ 100" on one side with no markings on the other side. NDC 59762-5016-1 Bottles of 30 Fluconazole 150 mg Tablets: Embossed with "FLZ 150" on one side with no markings on the other side. NDC 59762-5017-1 Unit dose package of 12 Fluconazole 200 mg Tablets: Embossed with "FLZ 200" on one side with no markings on the other side. NDC 59762-5018-1 Bottles of 30 Store tablets below 86°F (30°C). Storage: Fluconazole for Oral Suspension is supplied as an orange-flavored powder to provide 35 mL per bottle as follows: NDC 59762-5029-1 Fluconazole 350 mg per bottle NDC 59762-5030-1 Fluconazole 1400 mg per bottle Store dry powder below 86°F (30°C). Store reconstituted suspension between 86°F (30°C) and 41°F (5°C) and discard unused portion after 2 weeks. Protect from freezing. Storage:
New Drug Application Authorized Generic
FLUCONAZOLE- FLUCONAZOLE TABLET UNIT DOSE SERVICES ---------- FLUCONAZOLE FLUCONAZOLE TABLETS FLUCONAZOLE FOR ORAL SUSPENSION DESCRIPTION Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration and as a powder for oral suspension. Fluconazole is designated chemically as 2,4-difluoro-α,α -bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C H F N O and molecular weight of 306.3. The structural formula is: Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Tablets contain 50, 100, 150, or 200 mg of fluconazole and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum lake dye, and magnesium stearate. Fluconazole for Oral Suspension contains 350 mg or 1400 mg of fluconazole and the following inactive ingredients: sucrose, sodium citrate dihydrate, citric acid anhydrous, sodium benzoate, titanium dioxide, colloidal silicon dioxide, xanthan gum, and natural orange flavor. After reconstitution with 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 (Cmax) in fasted normal volunteers occur between 1 and 2 hours with a terminal plasma elimination half-life of approximately 30 hours (range: 20–50 hours) after oral administration. In fasted normal volunteers, administration of a single oral 400 mg dose of fluconazole leads to a mean Cmax of 6.72 Прочитайте повний документ