Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
FLUCONAZOLE (UNII: 8VZV102JFY) (FLUCONAZOLE - UNII:8VZV102JFY)
Hikma Pharmaceuticals USA Inc.
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 Injection, USP 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 ins
Fluconazole Injection, USP for intravenous infusion administration is formulated as a sterile iso-osmotic solution containing 2 mg/mL of Fluconazole, USP. It is supplied in glass vials containing a volume of 100 mL, affording a dose of 200 mg of Fluconazole, USP. It is also supplied in plastic containers containing volumes of 100 mL or 200 mL, affording doses of 200 mg and 400 mg of Fluconazole, USP, respectively. Fluconazole Injection, USP in plastic containers are available in both Sodium Chloride, USP and Dextrose, USP diluents. Fluconazole in Sodium Chloride Injection, USP in glass vials: NDC 0143-9899-91 Fluconazole in iso-osmotic Sodium Chloride Diluent 200 mg/100 mL packaged in cartons of 6 vials. Storage: Store at 5º to 30ºC (41º to 86ºF). Protect from freezing. Fluconazole Injections in Plastic Containers: NDC 0143-9669-10 Fluconazole in Sodium Chloride Diluent 200 mg/100 mL Carton of 10 NDC 0143-9668-10 Fluconazole in Sodium Chloride Diluent 400 mg/200 mL Carton of 10 NDC 0143-9667-06 Fluconazole in Dextrose Diluent 200 mg/100 mL Carton of 6 NDC 0143-9666-06 Fluconazole in Dextrose Diluent 400 mg/200 mL Carton of 6 Storage: Store between 77°F (25°C) and 41°F (5°C). Brief exposure up to 104°F (40°C) does not adversely affect the product. Protect from freezing. Brands listed are the trademarks of their respective owners.
Abbreviated New Drug Application
FLUCONAZOLE- FLUCONAZOLE INJECTION HIKMA PHARMACEUTICALS USA INC. ---------- FLUCONAZOLE INJECTION, USP Rx Only DESCRIPTION Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and 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 is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. 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., cis-13- docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 "Indirect Food Additives". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers. 1 13 12 2 6 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. Bioequiv Lestu allt skjalið