Fluconazole 200 MG Oral Tablet
INDICATIONS AND USAGE Fluconazole Tablets are indicated for the treatment of: Vaginal candidiasis (vaginal yeast infections due to Candida ). 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 Tablets 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 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.
Teva Pharmaceuticals USA, Inc.
OVAL PINK 5413 200
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HOW SUPPLIED Fluconazole Tablets USP, 50 mg are available as pink, modified oval-shaped, unscored tablets, debossed “5410†on one side and “Ivax hourglass logo†“50†on the other side and packaged in bottles of 30 (NDC 0172-5410-46) tablets. Fluconazole Tablets USP, 100 mg are available as pink, modified oval-shaped, unscored tablets, debossed “5411†on one side and “Ivax hourglass logo†“100†on the other side and packaged in bottles of 30 (NDC 0172-5411-46) and 100 (NDC 0172-5411-60) tablets. Fluconazole Tablets USP, 150 mg are available as pink, modified oval-shaped, unscored tablets, debossed “5412†on one side and “Ivax hourglass logo†“150†on the other side and packaged in a carton of 12 (NDC 0172-5412-11) unit-of-use cards of 1 tablet. Fluconazole Tablets USP, 200 mg are available as pink, modified oval-shaped, unscored tablets, debossed “5413†on one side and “Ivax hourglass logo†“200†on the other side and packaged in bottles of 30 (NDC 0172-5413-46) and 100 (NDC 0172-5413-60) tablets. Store at 20˚ to 25˚C (68˚ to 77˚F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Brands listed are the trademarks of their respective owners. Manufactured In India By: Cipla Ltd. Kurkumbh, India Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. N 3/2022
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