pioglitazone as pioglitazone hydrochloride 45 MG Oral Tablet
1 INDICATIONS AND USAGE Monotherapy and Combination Therapy Pioglitazone tablets, USP 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 )] . Important Limitations of Use Pioglitazone tablets, USP exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets USP 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 )]. Pioglitazone hydrochloride, USP is 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 Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis. ( 1 )
Ranbaxy Pharmaceuticals Inc
ROUND WHITE ML 91
ML 91 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING Pioglitazone hydrochloride USP is available in 15 mg, 30 mg, and 45 mg tablets as follows: 15 mg tablet: white to off white, circular, flat face, bevelled edge, uncoated tablet debossed with "ML 86" on one side and plain on the other side available in: NDC 63304-254-30 Bottles of 30 NDC 63304-254-90 Bottles of 90 NDC 63304-254-05 Bottles of 500 30 mg tablet: white to off white, circular, flat face, bevelled edge, uncoated tablet debossed with "ML 87" on one side and plain on the other side available in: NDC 63304-255-30 Bottles of 30 NDC 63304-255-90 Bottles of 90 NDC 63304-255-05 Bottles of 500 45 mg tablet: white to off white, circular, flat face, bevelled edge, uncoated tablet debossed with "ML 91" on one side and plain on the other side available in: NDC 63304-261-30 Bottles of 30 NDC 63304-261-90 Bottles of 90 NDC 63304-261-05 Bottles of 500 Storage: Store at 20° - 25°C (68° - 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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