pioglitazone 15 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 )
Teva Pharmaceuticals USA, Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
PIOGLITAZONE Tablets, USP are available as follows: 15 mg: white to off-white, round convex tablets, debossed with βTEVAβ on one side of the tablet and β7271β on the other side, available in bottles of 30 (NDC 0093-7271-56), 90 (NDC 0093-7271-98), and 500 (NDC 0093-7271-05). 30 mg: white to off-white, round flat tablets, debossed with βTEVAβ on one side of the tablet and β7272β on the other side, available in bottles of 30 (NDC 0093-7272-56), 90 (NDC 0093-7272-98), and 500 (NDC 0093-7272-05). 45 mg: white to off-white, round flat tablets, debossed with βTEVAβ on one side of the tablet and β7273β on the other side, available in bottles of 30 (NDC 0093-7273-56), 90 (NDC 0093-7273-98), and 500 (NDC 0093-7273-05).
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