pioglitazone 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 they 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 )
mylan pharmaceuticals inc.
ROUND WHITE M 48
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16 HOW SUPPLIED/STORAGE AND HANDLING Pioglitazone Tablets, USP are available containing pioglitazone hydrochloride, USP equivalent to 15 mg, 30 mg or 45 mg of pioglitazone base. The 15 mg tablets are white to off-white, round, unscored tablets debossed with M over 48 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0048-93 bottles of 30 tablets NDC 0378-0048-77 bottles of 90 tablets NDC 0378-0048-05 bottles of 500 tablets The 30 mg tablets are white to off-white, round, unscored tablets debossed with M over 228 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0228-93 bottles of 30 tablets NDC 0378-0228-77 bottles of 90 tablets NDC 0378-0228-05 bottles of 500 tablets The 45 mg tablets are white to off-white, round, unscored tablets debossed with M over 318 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0318-93 bottles of 30 tablets NDC 0378-0318-77 bottles of 90 tablets NDC 0378-0318-05 bottles of 500 tablets 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. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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