RVP

Drug Catalog - Product Detail

PIOGLITAZONE HCL TB 15MG 30

NDC Mfr Size Str Form
00781-5420-31 SANDOZ 30 15MG NA
Product Image
Generic Name
Substance Name
Product Type
Route
Application Number
Description
11 DESCRIPTION Pioglitazone tablets, USP are a thiazolidinedione and an agonist for peroxisome proliferatoractivated receptor (PPAR) gamma that contains an oral antidiabetic medication: pioglitazone. Pioglitazone [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-] thiazolidinedione monohydrochloride contains one asymmetric carbon and the compound is synthesized and used as the racemic mixture. The two enantiomers of pioglitazone interconvert in vivo . No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown: Pioglitazone is an odorless, white to off white, crystalline powder that has a molecular formula of C 19 H 20 N 2 O 3 S•HCl and a molecular weight of 392.90 daltons. It is soluble in N,N-dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether. Pioglitazone tablets, USP contain 15 mg, 30 mg, and 45 mg of pioglitazone (as the base). In addition, each tablet contains the following inactive ingredients: carboxymethyl cellulose calcium, hydroxypropyl cellulose, lactose monohydrate, and magnesium stearate. Pioglitazone Structural Formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Pioglitazone Tablets, USP are available are available as follows: 15 mg tablet: white, oval shaped tablets debossed with ‘SZ 244’ on one side and 15 on the other side. NDC 0781-5420-31, bottle of 30 tablets NDC 0781-5420-92, bottle of 90 tablets NDC 0781-5420-10, bottle of 1000 tablets NDC 0781-5420-64, carton of 30 tablets (3 x 10 Unit-Dose) 30 mg tablet: white, oval shaped tablets debossed with ‘SZ 245’ on one side and 30 on the other side. NDC 0781-5421-31, bottle of 30 tablets NDC 0781-5421-92, bottle of 90 tablets NDC 0781-5421-10, bottle of 1000 tablets NDC 0781-5421-64, carton of 30 tablets (3 x 10 Unit-Dose) 45 mg tablet: white, oval shaped tablets debossed with ‘SZ 246’ on one side and 45 on the other side. NDC 0781-5422-31, bottle of 30 tablets NDC 0781-5422-92, bottle of 90 tablets NDC 0781-5422-10, bottle of 1000 tablets NDC 0781-5422-64, carton of 30 tablets (3 x 10 Unit-Dose) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.
Indications & Usage
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 Limitation 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 tablets, USP 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 Limitation of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Initiate pioglitazone tablets at 15 mg or 30 mg once daily. Limit initial dose to 15 mg once daily in patients with NYHA Class I or II heart failure. ( 2.1 ) If there is inadequate glycemic control, the dose can be increased in 15 mg increments up to a maximum of 45 mg once daily. ( 2.1 ) Obtain liver tests before starting pioglitazone tablets. If abnormal, use caution when treating with pioglitazone tablets, investigate the probable cause, treat (if possible) and follow appropriately. Monitoring liver tests while on pioglitazone tablets is not recommended in patients without liver disease. ( 5.3 ) 2.1 Recommendations for All Patients Pioglitazone tablets, USP should be taken once daily and can be taken without regard to meals. The recommended starting dose for patients without congestive heart failure is 15 mg or 30 mg once daily. The recommended starting dose for patients with congestive heart failure (NYHA Class I or II) is 15 mg once daily. The dose can be titrated in increments of 15 mg up to a maximum of 45 mg once daily based on glycemic response as determined by HbA1c. After initiation of pioglitazone tablets, USP or with dose increase, monitor patients carefully for adverse reactions related to fluid retention such as weight gain, edema, and signs and symptoms of congestive heart failure [see Boxed Warning and Warnings and Precautions ( 5.5 )]. Liver tests (serum alanine and aspartate aminotransferases, alkaline phosphatase, and total bilirubin) should be obtained prior to initiating pioglitazone tablets, USP. Routine periodic monitoring of liver tests during treatment with pioglitazone tablets, USP is not recommended in patients without liver disease. Patients who have liver test abnormalities prior to initiation of pioglitazone tablets, USP or who are found to have abnormal liver tests while taking pioglitazone tablets, USP should be managed as described under Warnings and Precautions [see Warnings and Precautions ( 5.3 ) and Clinical Pharmacology ( 12.3 )]. 2.2 Concomitant Use with an Insulin Secretagogue or Insulin If hypoglycemia occurs in a patient coadministered pioglitazone tablets, USP and an insulin secretagogue (e.g., sulfonylurea), the dose of the insulin secretagogue should be reduced. If hypoglycemia occurs in a patient coadministered pioglitazone tablets, USP and insulin, the dose of insulin should be decreased by 10% to 25%. Further adjustments to the insulin dose should be individualized based on glycemic response. 2.3 Coadministration with Strong CYP2C8 Inhibitors Coadministration of pioglitazone tablets, USP and gemfibrozil, a strong CYP2C8 inhibitor, increases pioglitazone exposure approximately 3-fold. Therefore, the maximum recommended dose of pioglitazone tablets, USP is 15 mg daily when used in combination with gemfibrozil or other strong CYP2C8 inhibitors [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )].