Pioglitazone And Metformin Hydrochloride

Pioglitazone And Metformin Hydrochloride

Pioglitazone And Metformin Hydrochloride Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Pioglitazone and metformin hydrochloride tablets USP 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 and metformin hydrochloride 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 (5.5)].

History

There is currently no drug history available for this drug.

Other Information

Pioglitazone and metformin hydrochloride tablets USP contain two oral antidiabetic medications used in the management of type 2 diabetes: pioglitazone hydrochloride, USP and metformin hydrochloride, USP.

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:

structural formula

C19H20N2O3S•HCl M.W. 392.90

Pioglitazone hydrochloride, USP is an odorless white crystalline powder. 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, USP (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a white crystalline powder. 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:

structual formula

C4H11N5•HCl M.W. 165.62

Pioglitazone and metformin hydrochloride tablets USP are available as a tablet for oral administration containing 15 mg pioglitazone hydrochloride, USP (as the base) with 500 mg metformin hydrochloride, USP (15 mg/500 mg) or 15 mg pioglitazone hydrochloride, USP (as the base) with 850 mg metformin hydrochloride, USP (15 mg/850 mg) formulated with the following excipients: colloidal silicon dioxide, cornstarch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, and titanium dioxide.

The USP Dissolution Test is pending.

Pioglitazone And Metformin Hydrochloride Manufacturers


  • Avkare, Inc.
    Pioglitazone And Metformin Hydrochloride (Pioglitazone And Metformin Hydrochloride) Tablet, Film Coated [Avkare, Inc.]

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