Fluconazole 200 mg
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 tablets were 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 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.
Zydus Pharmaceuticals (USA) Inc.
OVAL PINK 1140
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HOW SUPPLIED
FLUCONAZOLE Tablets USP, 50 mg are light pink to pink colored, may be spotted, modified oval shaped, biconvex, uncoated tablets, debossed with '1137' on one side and plain on the other side and are supplied as follows: NDC 70710-1137-3 in bottles of 30 tablets with child resistant closure NDC 70710-1137-1 in bottles of 100 tablets with child resistant closure NDC 70710-1137-5 in bottles of 500 tablets NDC 70710-1137-4 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose)
FLUCONAZOLE Tablets USP, 100 mg are light pink to pink colored, may be spotted, modified oval shaped, biconvex, uncoated tablets, debossed with '1138' on one side and plain on the other side and are supplied as follows: NDC 70710-1138-3 in bottles of 30 tablets with child resistant closure NDC 70710-1138-1 in bottles of 100 tablets with child resistant closure NDC 70710-1138-5 in bottles of 500 tablets NDC 70710-1138-4 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose)
FLUCONAZOLE Tablets USP, 150 mg are light pink to pink colored, may be spotted, modified oval shaped, biconvex, uncoated tablets, debossed with '1139' on one side and plain on the other side and are supplied as follows: NDC 70710-1139-3 in bottles of 30 tablets with child resistant closure NDC 70710-1139-1 in bottles of 100 tablets with child resistant closure NDC 70710-1139-5 in bottles of 500 tablets NDC 70710-1139-8 in unit-dose blister cartons of 12 tablets (12 X 1 Unit-dose) NDC 70710-1139-7 in unit-dose blister cartons of 1 tablets (1 X 1 Unit-dose)
FLUCONAZOLE Tablets USP, 200 mg are light pink to pink colored, may be spotted, modified oval shaped, biconvex, uncoated tablets, debossed with '1140' on one side and plain on the other side and are supplied as follows: NDC 70710-1140-3 in bottles of 30 tablets with child resistant closure NDC 70710-1140-1 in bottles of 100 tablets with child resistant closure NDC 70710-1140-5 in bottles of 500 tablets NDC 70710-1140-4 in unit-dose blister cartons of 100 tablets (10 X 10 Unit-dose) Storage: Store at 20º to 25º C (68º to 77º F) [See USP Controlled Room Temperature]. Manufactured by: Zydus Lifesciences Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 03/24
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