Fluconazole 100 MG Oral Tablet
INDICATIONS AND USAGE Fluconazole tablets, USP 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, USP 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, USP 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 tablets, USP 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.
harris pharmaceutical, inc.
ROUND PINK H 602
H 602 ROUND PINK
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HOW SUPPLIED Fluconazole Tablets, USP: pink to light pink round biconvex tablets containing 50 mg, 100 mg, 150 mg or 200 mg of fluconazole. The 50 mg, 100 mg, 150 mg and 200 mg fluconazole tablets, USP are packaged in bottles. The 150 mg fluconazole tablets, USP are also packaged in a single dose unit blister. Fluconazole Tablets, USP are supplied as follows: Fluconazole Tablets, USP 50 mg : debossed 'H' above '01' on one side and plain on the other. Bottles of 30 count NDC 67405-601-03 Fluconazole Tablets, USP 100 mg : debossed 'H' above '602' on one side and plain on the other. Bottles of 30 count NDC 67405-602-03 Fluconazole Tablets, USP 150 mg : debossed 'H' above '603' on one side and plain on the other. Bottles of 100 count NDC 67405-603-10 Carton of 12 blister cards of 1 tablet NDC 67405-603-01 Fluconazole Tablets, USP 200 mg : debossed 'H' above '604' on one side and plain on the other. Bottles of 30 count NDC 67405-604-03 STORAGE Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense contents with a child-resistant closure (if required) and in a tight container as defined in the USP.
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