pioglitazone 45 MG Oral Tablet
1 INDICATIONS AND USAGE 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) ] . Important Limitations 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) ] . 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 , 14 ) Important Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis. ( 1 )
CELLTRION USA, INC.
ROUND WHITE W 45
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16 HOW SUPPLIED/ STORAGE AND HANDLING Pioglitazone tablets USP are available in 15 mg, 30 mg, and 45 mg tablets as follows: 15 mg tablet: white, round, flat face beveled edge, non-scored tablet with “ W ” on one side, and “ 15 ” on the other, available in: Bottles of 30: NDC 72606-501-01 Bottles of 90: NDC 72606-501-02 Bottles of 500: NDC 72606-501-03 30 mg tablet: white, round, flat face beveled edge, non-scored tablet with “ W ” on one side, and “ 30 ” on the other, available in: Bottles of 30: NDC 72606-502-01 Bottles of 90: NDC 72606-502-02 Bottles of 500: NDC 72606-502-03 45 mg tablet: white, round, flat face beveled edge, non-scored tablet with “ W ” on one side, and “ 45 ” on the other, available in: Bottles of 30: NDC 72606-503-01 Bottles of 90: NDC 72606-503-02 Bottles of 500: NDC 72606-503-03 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed, and protect from light, moisture and humidity.
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