देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
FLUCONAZOLE (UNII: 8VZV102JFY) (FLUCONAZOLE - UNII:8VZV102JFY)
Aurobindo Pharma Limited
FLUCONAZOLE
FLUCONAZOLE 10 mg in 1 mL
ORAL
PRESCRIPTION DRUG
Fluconazole for oral suspension is indicated for the treatment of: 1. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole for oral suspension was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 2. Cryptococcal meningitis . Before prescribing fluconazole for oral suspension for AIDS patients with cryptococcal meningitis , please see CLINICAL STUDIES section. Studies comparing fluconazole for oral suspension to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole for oral suspension 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 the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly. Fluconazole for oral suspension is contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients. There is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents. Caution should be used in prescribing fluconazole for oral suspension to patients with hypersensitivity to other azoles. Coadministration of other drugs known to prolong the QT interval and which are metabolized via the enzyme CYP3A4 such as erythromycin, pimozide, and quinidine are contraindicated in patients receiving fluconazole. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies and PRECAUTIONS .)
Fluconazole for Oral Suspension USP, 10 mg/mL is supplied as an orange flavored white to off-white powder to provide 35 mL per bottle as follows: 35 mL Bottle NDC 65862-299-35 Fluconazole for Oral Suspension USP, 40 mg/mL is supplied as an orange flavored white to off-white powder to provide 35 mL per bottle as follows: 35 mL Bottle NDC 65862-300-35 Before Reconstitution: Store dry powder at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. After Reconstitution: Store reconstituted suspension between 5°C (41°F) and 25°C (77°F). Protect from freezing. Discard unused portion after 2 weeks. Maalox® is a registered trademark of Novartis Consumer Health, Inc. XELJANZ® is a registered trademark of Pfizer Inc. LYNPARZA® is a registered trademark of AstraZeneca group of companies. Distributed by: Aurobindo Pharma USA, Inc . 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 03/2024
Abbreviated New Drug Application
FLUCONAZOLE - FLUCONAZOLE POWDER, FOR SUSPENSION AUROBINDO PHARMA LIMITED ---------- FLUCONAZOLE FOR ORAL SUSPENSION USP RX ONLY DESCRIPTION Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available 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 a molecular formula of C H F N O and molecular weight of 306.3. The structural formula is: Fluconazole USP is a white or almost white, crystalline powder which is slightly soluble in water and saline. Fluconazole for oral suspension USP contains 350 mg or 1400 mg of fluconazole USP and the following inactive ingredients: sodium benzoate, citric acid anhydrous, sodium citrate, xanthan gum, titanium dioxide, natural orange flavor, colloidal silicon dioxide, and sucrose. 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 (PK) 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 1 13 12 2 6 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 or multiple oral doses of 50 to 400 mg, fluconazole plasma concentrations and area under the plasma concentration time curve (AUC) are dose proportional (Table 1). The C and AUC data from a food-effect study involv पूरा दस्तावेज़ पढ़ें