pioglitazone tablet
1 INDICATIONS AND USAGE Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. ( 1.1 , 14 ) Important Limitation of Use: • Not for treatment of type 1 diabetes or diabetic ketoacidosis. ( 1.2 ) 1.1 Monotherapy and Combination Therapy Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14) ] . 1.2 Important Limitation of Use Pioglitazone tablets exert their antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3) ] .
ranbaxy pharmaceuticals inc.
ROUND WHITE ML 87
ML 87 ROUND WHITE
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pioglitazone tablet
ranbaxy pharmaceuticals inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING Pioglitazone Tablets are available in 15 mg, 30 mg, and 45 mg tablets as follows: 15-mg tablet: white to off-white, round, convex, nonscored tablet with "ACTOS" on one side, and "15" on the other, available in: NDC 63304-311-30 Bottles of 30 NDC 63304-311-90 Bottles of 90 NDC 63304-311-05 Bottles of 500 30-mg tablet: white to off-white, round, flat, nonscored tablet with "ACTOS" on one side, and "30" on the other, available in: NDC 63304-312-30 Bottles of 30 NDC 63304-312-90 Bottles of 90 NDC 63304-312-05 Bottles of 500 45-mg tablet: white to off-white, round, flat, nonscored tablet with "ACTOS" on one side, and "45" on the other, available in: NDC 63304-313-30 Bottles of 30 NDC 63304-313-90 Bottles of 90 NDC 63304-313-05 Bottles of 500 Storage Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed, and protect from light, moisture and humidity.
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