Pioglitazole and metformin hydrochloride

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Overview

What is Pioglitazole and metformin hydrochloride?

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

Pioglitazone hydrochloride USP is an odorless white crystalline powder that has a molecular formula of CHNOS•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.

Metformin hydrochloride USP (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a white crystalline powder with a molecular formula of CHN•HCl and a molecular weight of 165.62. Metformin hydrochloride USP 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 USP is 6.68. The structural formula is as shown:

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

What does Pioglitazole and metformin hydrochloride look like?

What are the available doses of Pioglitazole and metformin hydrochloride?

Tablets: 15 mg pioglitazone/500 mg metformin HCl and 15 mg pioglitazone/850 mg metformin HCl ()

What should I talk to my health care provider before I take Pioglitazole and metformin hydrochloride?

• Females and Males of Reproductive Potential: Advise premenopausal females of the potential for an unintended pregnancy. () • Pediatrics: Not recommended for use in pediatric patients. () • Geriatric Use: Assess renal function more frequently. () • Hepatic Impairment: Avoid use in patients with hepatic impairment. ()

How should I use Pioglitazole and metformin hydrochloride?

Pioglitazone 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

Important Limitations of Use

Use caution in patients with liver disease

Pioglitazone 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 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 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 three times a day.

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

What interacts with Pioglitazole and metformin hydrochloride?

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What are the warnings of Pioglitazole and metformin hydrochloride?

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What are the precautions of Pioglitazole and metformin hydrochloride?

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What are the side effects of Pioglitazole and metformin hydrochloride?

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What should I look out for while using Pioglitazole and metformin hydrochloride?

• Initiation in patients with established NYHA Class III or IV heart failure [see Boxed Warning]. • Severe renal impairment (eGFR below 30 mL/min/1.73 m) • Use in patients with known hypersensitivity to pioglitazone, metformin or any other component of pioglitazone and metformin hydrochloride tablets. • Metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin.

FULL PRESCRIBING INFORMATION

WARNING: CONGESTIVE HEART FAILURE AND LACTIC ACIDOSIS Congestive Heart Failure • Thiazolidinediones, including pioglitazone, which is a component of pioglitazone and metformin hydrochloride, cause or exacerbate congestive heart failure in some patients • After initiation of pioglitazone and metformin hydrochloride, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone and metformin hydrochloride must be considered • Pioglitazone and metformin hydrochloride is not recommended in patients with symptomatic heart failure. [] • Initiation of pioglitazone and metformin hydrochloride in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated Lactic Acidosis Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (greater than 5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate:pyruvate ratio; and metformin plasma levels generally greater than 5 mcg/mL Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information [see Dosage and Administration If metformin-associated lactic acidosis is suspected, immediately discontinue pioglitazone and metformin hydrochloride tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended

What might happen if I take too much Pioglitazole and metformin hydrochloride?

Pioglitazone

In the event of overdosage, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.

Metformin hydrochloride

[see Warnings and Precautions ()].

How should I store and handle Pioglitazole and metformin hydrochloride?

Store at 20° to 25°C (68° to 77° F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER. Pioglitazone and metformin hydrochloride tablets USP are available in 15 mg pioglitazone (as the base)/500 mg metformin hydrochloride and 15 mg pioglitazone (as the base)/850 mg metformin hydrochloride tablets as follows: Pioglitazone and metformin hydrochloride tablets USP 15 mg / 500 mg: White to off-white colored, capsule shaped, film-coated tablets debossed with 'C27' on one side and plain on the other side and are available as follows: Bottles of 60 tablets (NDC 33342-176-09) Bottles of 100 tablets (NDC 33342-176-11) Bottles of 180 tablets (NDC 33342-176-57) Bottles of 1000 tablets (NDC 33342-176-44) Cartons of 100 unit dose tablets (10×10) (NDC 33342-176-12)Pioglitazone and Metformin hydrochloride tablets USP 15 mg / 850 mg: White to off-white colored, capsule shaped, film-coated tablets debossed with 'C28' on one side and plain on the other side.Bottles of 60 tablets (NDC 33342-177-09) Bottles of 100 tablets (NDC 33342-177-11) Bottles of 180 tablets (NDC 33342-177-57) Bottles of 1000 tablets (NDC 33342-177-44) Cartons of 100 unit dose tablets (10×10) (NDC 33342-177-12)Storage:Pioglitazone and metformin hydrochloride tablets USP are available in 15 mg pioglitazone (as the base)/500 mg metformin hydrochloride and 15 mg pioglitazone (as the base)/850 mg metformin hydrochloride tablets as follows: Pioglitazone and metformin hydrochloride tablets USP 15 mg / 500 mg: White to off-white colored, capsule shaped, film-coated tablets debossed with 'C27' on one side and plain on the other side and are available as follows: Bottles of 60 tablets (NDC 33342-176-09) Bottles of 100 tablets (NDC 33342-176-11) Bottles of 180 tablets (NDC 33342-176-57) Bottles of 1000 tablets (NDC 33342-176-44) Cartons of 100 unit dose tablets (10×10) (NDC 33342-176-12)Pioglitazone and Metformin hydrochloride tablets USP 15 mg / 850 mg: White to off-white colored, capsule shaped, film-coated tablets debossed with 'C28' on one side and plain on the other side.Bottles of 60 tablets (NDC 33342-177-09) Bottles of 100 tablets (NDC 33342-177-11) Bottles of 180 tablets (NDC 33342-177-57) Bottles of 1000 tablets (NDC 33342-177-44) Cartons of 100 unit dose tablets (10×10) (NDC 33342-177-12)Storage:Pioglitazone and metformin hydrochloride tablets USP are available in 15 mg pioglitazone (as the base)/500 mg metformin hydrochloride and 15 mg pioglitazone (as the base)/850 mg metformin hydrochloride tablets as follows: Pioglitazone and metformin hydrochloride tablets USP 15 mg / 500 mg: White to off-white colored, capsule shaped, film-coated tablets debossed with 'C27' on one side and plain on the other side and are available as follows: Bottles of 60 tablets (NDC 33342-176-09) Bottles of 100 tablets (NDC 33342-176-11) Bottles of 180 tablets (NDC 33342-176-57) Bottles of 1000 tablets (NDC 33342-176-44) Cartons of 100 unit dose tablets (10×10) (NDC 33342-176-12)Pioglitazone and Metformin hydrochloride tablets USP 15 mg / 850 mg: White to off-white colored, capsule shaped, film-coated tablets debossed with 'C28' on one side and plain on the other side.Bottles of 60 tablets (NDC 33342-177-09) Bottles of 100 tablets (NDC 33342-177-11) Bottles of 180 tablets (NDC 33342-177-57) Bottles of 1000 tablets (NDC 33342-177-44) Cartons of 100 unit dose tablets (10×10) (NDC 33342-177-12)Storage:Pioglitazone and metformin hydrochloride tablets USP are available in 15 mg pioglitazone (as the base)/500 mg metformin hydrochloride and 15 mg pioglitazone (as the base)/850 mg metformin hydrochloride tablets as follows: Pioglitazone and metformin hydrochloride tablets USP 15 mg / 500 mg: White to off-white colored, capsule shaped, film-coated tablets debossed with 'C27' on one side and plain on the other side and are available as follows: Bottles of 60 tablets (NDC 33342-176-09) Bottles of 100 tablets (NDC 33342-176-11) Bottles of 180 tablets (NDC 33342-176-57) Bottles of 1000 tablets (NDC 33342-176-44) Cartons of 100 unit dose tablets (10×10) (NDC 33342-176-12)Pioglitazone and Metformin hydrochloride tablets USP 15 mg / 850 mg: White to off-white colored, capsule shaped, film-coated tablets debossed with 'C28' on one side and plain on the other side.Bottles of 60 tablets (NDC 33342-177-09) Bottles of 100 tablets (NDC 33342-177-11) Bottles of 180 tablets (NDC 33342-177-57) Bottles of 1000 tablets (NDC 33342-177-44) Cartons of 100 unit dose tablets (10×10) (NDC 33342-177-12)Storage:Pioglitazone and metformin hydrochloride tablets USP are available in 15 mg pioglitazone (as the base)/500 mg metformin hydrochloride and 15 mg pioglitazone (as the base)/850 mg metformin hydrochloride tablets as follows: Pioglitazone and metformin hydrochloride tablets USP 15 mg / 500 mg: White to off-white colored, capsule shaped, film-coated tablets debossed with 'C27' on one side and plain on the other side and are available as follows: Bottles of 60 tablets (NDC 33342-176-09) Bottles of 100 tablets (NDC 33342-176-11) Bottles of 180 tablets (NDC 33342-176-57) Bottles of 1000 tablets (NDC 33342-176-44) Cartons of 100 unit dose tablets (10×10) (NDC 33342-176-12)Pioglitazone and Metformin hydrochloride tablets USP 15 mg / 850 mg: White to off-white colored, capsule shaped, film-coated tablets debossed with 'C28' on one side and plain on the other side.Bottles of 60 tablets (NDC 33342-177-09) Bottles of 100 tablets (NDC 33342-177-11) Bottles of 180 tablets (NDC 33342-177-57) Bottles of 1000 tablets (NDC 33342-177-44) Cartons of 100 unit dose tablets (10×10) (NDC 33342-177-12)Storage:Pioglitazone and metformin hydrochloride tablets USP are available in 15 mg pioglitazone (as the base)/500 mg metformin hydrochloride and 15 mg pioglitazone (as the base)/850 mg metformin hydrochloride tablets as follows: Pioglitazone and metformin hydrochloride tablets USP 15 mg / 500 mg: White to off-white colored, capsule shaped, film-coated tablets debossed with 'C27' on one side and plain on the other side and are available as follows: Bottles of 60 tablets (NDC 33342-176-09) Bottles of 100 tablets (NDC 33342-176-11) Bottles of 180 tablets (NDC 33342-176-57) Bottles of 1000 tablets (NDC 33342-176-44) Cartons of 100 unit dose tablets (10×10) (NDC 33342-176-12)Pioglitazone and Metformin hydrochloride tablets USP 15 mg / 850 mg: White to off-white colored, capsule shaped, film-coated tablets debossed with 'C28' on one side and plain on the other side.Bottles of 60 tablets (NDC 33342-177-09) Bottles of 100 tablets (NDC 33342-177-11) Bottles of 180 tablets (NDC 33342-177-57) Bottles of 1000 tablets (NDC 33342-177-44) Cartons of 100 unit dose tablets (10×10) (NDC 33342-177-12)Storage:

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Pioglitazone and metformin hydrochloride tablets combines two antidiabetic medications with different mechanisms of action to improve glycemic control in adults with type 2 diabetes: pioglitazone, a thiazolidinedione, and metformin hydrochloride, a biguanide. Thiazolidinediones are insulin-sensitizing agents that act primarily by enhancing peripheral glucose utilization, whereas biguanides act primarily by decreasing endogenous hepatic glucose production.

Pioglitazone

In animal models of diabetes, pioglitazone reduces the hyperglycemia, hyperinsulinemia, and hypertriglyceridemia characteristic of insulin-resistant states such as type 2 diabetes. The metabolic changes produced by pioglitazone result in increased responsiveness of insulin-dependent tissues and are observed in numerous animal models of insulin resistance.

Because pioglitazone enhances the effects of circulating insulin (by decreasing insulin resistance), it does not lower blood glucose in animal models that lack endogenous insulin.

Metformin hydrochloride

see Warnings and Precautions ()]

Non-Clinical Toxicology

• Initiation in patients with established NYHA Class III or IV heart failure [see Boxed Warning]. • Severe renal impairment (eGFR below 30 mL/min/1.73 m) • Use in patients with known hypersensitivity to pioglitazone, metformin or any other component of pioglitazone and metformin hydrochloride tablets. • Metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin.

FULL PRESCRIBING INFORMATION

WARNING: CONGESTIVE HEART FAILURE AND LACTIC ACIDOSIS Congestive Heart Failure • Thiazolidinediones, including pioglitazone, which is a component of pioglitazone and metformin hydrochloride, cause or exacerbate congestive heart failure in some patients • After initiation of pioglitazone and metformin hydrochloride, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone and metformin hydrochloride must be considered • Pioglitazone and metformin hydrochloride is not recommended in patients with symptomatic heart failure. [] • Initiation of pioglitazone and metformin hydrochloride in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated Lactic Acidosis Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (greater than 5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate:pyruvate ratio; and metformin plasma levels generally greater than 5 mcg/mL Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information [see Dosage and Administration If metformin-associated lactic acidosis is suspected, immediately discontinue pioglitazone and metformin hydrochloride tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended

Pioglitazone

[see Boxed Warning, Contraindications (), and Adverse Reactions ()].

The following serious adverse reactions are discussed elsewhere in the labeling:

• Congestive heart failure • Lactic acidosis • Edema • Fractures

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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