Pioglitazone And Metformin label

Pioglitazone And Metformin

Pioglitazone And Metformin Recall

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Manufacturer Warnings

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Uses

Pioglitazone hydrochloride and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitazone and metformin is appropriate [see CLINICAL STUDIES (14)].

Important Limitations of Use

Pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone hydrochloride and metformin hydrochloride 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 (5.5)].

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History

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Other Information

Pioglitazone hydrochloride and metformin hydrochloride tablets are a thiazolidinediones and biguanide combination product that contains two oral antidiabetic medications: pioglitazone hydrochloride and metformin hydrochloride.

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:

Chemical Structure

pioglitazone hydrochloride

Pioglitazone hydrochloride is an odorless white to off white crystalline powder that has a molecular formula of C19H20N2O3S•HCl and a molecular weight of 392.91. 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.

Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a white to almost white crystalline powder with a molecular formula of C4H11N5•HCl and a molecular weight of 165.62. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is as shown:

Chemical Structure

metformin hydrochloride

Pioglitazone hydrochloride and metformin hydrochloride is available as a tablet for oral administration containing 15 mg pioglitazone hydrochloride (as the base) with 500 mg metformin hydrochloride (15 mg/500 mg) or 15 mg pioglitazone hydrochloride (as the base) with 850 mg metformin hydrochloride (15 mg/850 mg) formulated with the following inactive ingredients: croscarmellose sodium, hydroxypropylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide.

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Pioglitazone And Metformin Manufacturers

  • Sandoz Inc
    Pioglitazone And Metformin | Sandoz Inc
    No Recall

    Pioglitazone And Metformin | Sandoz Inc

    Pioglitazone And Metformin | Sandoz Inc
    2.1 Recommendations for All Patients

    Pioglitazone hydrochloride and metformin hydrochloride tablets should be taken with meals to reduce the gastrointestinal side effects associated with metformin.

    If therapy with a combination tablet containing pioglitazone and metformin is considered appropriate the recommended starting dose is:

    • 15 mg/500 mg twice daily or 15 mg/850 mg once daily and gradually titrated, as needed, after assessing adequacy of therapeutic response and tolerability, • for patients with New York Heart Association (NYHA) Class I or Class II congestive heart failure: 15 mg/500 mg or 15 mg/850 mg once daily and gradually titrated, as needed, after assessing adequacy of therapeutic response and tolerability, • for patients inadequately controlled on metformin monotherapy: 15 mg/500 mg twice daily or 15 mg/850 mg once or twice daily (depending on the dose of metformin already being taken) and gradually titrated, as needed, after assessing adequacy of therapeutic response and tolerability, • for patients inadequately controlled on pioglitazone monotherapy: 15 mg/500 mg twice daily or 15 mg/850 mg once daily and gradually titrated, as needed, after assessing adequacy of therapeutic response and tolerability, • for patients who are changing from combination therapy of pioglitazone plus metformin as separate tablets: Pioglitazone hydrochloride and metformin hydrochloride tablets should be taken at doses that are as close as possible to the dose of pioglitazone and metformin already being taken.

    Pioglitazone hydrochloride and metformin hydrochloride tablets may be titrated up to a maximum daily dose of 45 mg of pioglitazone and 2550 mg of metformin.

    Metformin doses above 2000 mg may be better tolerated given 3 times a day.

    After initiation of pioglitazone hydrochloride and metformin hydrochloride tablets 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 (5.1)]. Liver tests (serum alanine and aspartate aminotransferases, alkaline phosphatase, and total bilirubin) should be obtained prior to initiating pioglitazone hydrochloride and metformin hydrochloride tablets. Routine periodic monitoring of liver tests during treatment with pioglitazone hydrochloride and metformin hydrochloride tablets are not recommended in patients without liver disease. Patients who have liver test abnormalities prior to initiation of pioglitazone hydrochloride and metformin hydrochloride tablets or who are found to have abnormal liver tests while taking pioglitazone hydrochloride and metformin hydrochloride tablets should be managed as described under Warnings and Precautions [see WARNINGS AND PRECAUTIONS (5.5) and CLINICAL PHARMACOLOGY (12.3)].

    2.2 Concomitant Use with an Insulin Secretagogue or Insulin

    If hypoglycemia occurs in a patient co-administered pioglitazone hydrochloride and metformin hydrochloride tablets and an insulin secretagogue (e.g., sulfonylurea), the dose of the insulin secretagogue should be reduced.

    If hypoglycemia occurs in a patient co-administered pioglitazone hydrochloride and metformin hydrochloride tablets 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 Concomitant Use with Strong CYP2C8 Inhibitors

    Co-administration of pioglitazone (one of the ingredients in pioglitazone hydrochloride and metformin hydrochloride tablets) and gemfibrozil, a strong CYP2C8 inhibitor, increases pioglitazone exposure approximately 3-fold. Therefore, the maximum recommended dose of pioglitazone hydrochloride and metformin hydrochloride tablets are 15 mg/850 mg daily when used in combination with gemfibrozil or other strong CYP2C8 inhibitors [see DRUG INTERACTIONS (7.1) and CLINICAL PHARMACOLOGY (12.3)].

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