国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
Fluconazole (UNII: 8VZV102JFY) (Fluconazole - UNII:8VZV102JFY)
Sagent Pharmaceuticals
Fluconazole
Fluconazole 2 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Fluconazole Injection, USP is indicated for the treatment of: - Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was 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 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 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, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before t
Fluconazole Injection, USP (in 0.9% Sodium Chloride) is supplied as follows: Fluconazole Injection, USP (in 0.9% Sodium Chloride) for intravenous infusion administration is formulated as iso-osmotic solutions containing 2 mg per mL of fluconazole. Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. Maalox® is a registered trademark of Aventis Pharmaceuticals Products Inc.
Abbreviated New Drug Application
FLUCONAZOLE- FLUCONAZOLE INJECTION, SOLUTION SAGENT PHARMACEUTICALS ---------- FLUCONAZOLE INJECTION, USP (IN 0.9% SODIUM CHLORIDE) FOR INTRAVENOUS INFUSION ONLY SAGENT™ Rx only DESCRIPTION Fluconazole Injection, USP (in 0.9% Sodium Chloride), the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in plastic containers. 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 Injection, USP (in 0.9% Sodium Chloride) is an iso-osmotic, sterile, nonpyrogenic solution of fluconazole in a sodium chloride diluent. Each mL contains 2 mg of fluconazole and 9 mg of sodium chloride. The pH ranges from 4.0 to 8.0. Injection volumes of 100 mL and 200 mL are packaged in plastic containers. The plastic container is fabricated from a specially formulated polyvinyl chloride. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2- ethylhexylphthalate (DEHP), up to 5 parts per million. However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers. 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 fa 完全なドキュメントを読む