fluconazole 100 MG Oral Tablet
INDICATIONS AND USAGE Fluconazole tablets are indicated for the treatment of: 1. Vaginal candidiasis (vaginal yeast infections due to Candida ). 2. 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. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets 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 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.
Glenmark Pharmaceuticals Inc., USA
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HOW SUPPLIED
FLUCONAZOLE Tablets, USP 50 mg are pink, trapezoidal shaped tablets, engraved with “50” on one side and plain on the other side, supplied as follows: NDC 68462-101-30 Bottles of 30 NDC 68462-101-10 Bottles of 1000
FLUCONAZOLE Tablets, USP 100 mg are pink, trapezoidal shaped tablets, engraved with “100” on one side and plain on the other side, supplied as follows: NDC 68462-102-30 Bottles of 30 NDC 68462-102-10 Bottles of 1000
FLUCONAZOLE Tablets, USP 150 mg are pink, oval shaped tablets, engraved with “150” on one side and plain on the other side, supplied as follows: NDC 68462-119-40 Carton of 1 blister pack of 1 tablet (1 x 1 unit-dose) NDC 68462-119-44 Carton of 12 blister packs of 1 tablet (12 x 1 unit-dose) NDC 68462-103-40 Carton of 12 blister cards of 1 tablet
FLUCONAZOLE Tablets, USP 200 mg are pink trapezoidal shaped tablets, engraved with “200” on one side and plain on the other side, supplied as follows: NDC 68462-104-30 Bottles of 30 NDC 68462-104-10 Bottles of 1000 Storage: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com March 2024 logo
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