pioglitazone and glimepiride

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Overview

What is pioglitazone and glimepiride?

Pioglitazone and glimepiride tablets are a thiazolidinedione and a sulfonylurea combination product that contains two oral antihyperglycemic agents: pioglitazone and glimepiride. The concomitant use of pioglitazone and a sulfonylurea, the class of drugs that includes glimepiride, has been previously approved based on clinical trials in patients with type 2 diabetes inadequately controlled on a sulfonylurea. Additional efficacy and safety information about pioglitazone and glimepiride monotherapies may be found in the prescribing information for each individual drug.

Pioglitazone is an oral antidiabetic medication.

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 . No differences were found in the pharmacologic activity between the two enantiomers. The structural formula is as shown:

Pioglitazone hydrochloride 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 -dimethylformamide, slightly soluble in anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water, and insoluble in ether.

Glimepiride is an oral sulfonylurea chemically identified as 1-[[-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)-urea (CHNOS) with a molecular weight of 490.62. Glimepiride is a white to yellowish-white, crystalline, odorless to practically odorless powder and is practically insoluble in water. The structural formula is:

Pioglitazone and glimepiride tablets are available as a tablet for oral administration containing 30 mg pioglitazone (as the base) with 2 mg glimepiride (30 mg/2 mg) or 30 mg pioglitazone (as the base) with 4 mg glimepiride (30 mg/4 mg) formulated with the following excipients: croscarmellose sodium NF, lactose monohydrate NF, magnesium stearate NF, hydroxypropyl cellulose NF, polysorbate 80 NF, and microcrystalline cellulose NF.

What does pioglitazone and glimepiride look like?

What are the available doses of pioglitazone and glimepiride?

What should I talk to my health care provider before I take pioglitazone and glimepiride?

How should I use pioglitazone and glimepiride?

Pioglitazone and glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone .

Pioglitazone and glimepiride tablets should be taken once daily with the first main meal.

Pioglitazone and glimepiride tablets are available as a 30 mg pioglitazone plus 2 mg glimepiride or a 30 mg pioglitazone plus 4 mg glimepiride tablet. If therapy with a combination tablet containing pioglitazone and glimepiride is considered appropriate the recommended starting dose is:

After initiation of pioglitazone and glimepiride tablets or with dose increase, monitor patients carefully for hypoglycemia and adverse reactions related to fluid retention such as weight gain, edema, and signs and symptoms of congestive heart failure and .

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

What interacts with pioglitazone and glimepiride?

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What are the warnings of pioglitazone and glimepiride?

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What are the precautions of pioglitazone and glimepiride?

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What are the side effects of pioglitazone and glimepiride?

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What should I look out for while using pioglitazone and glimepiride?

Reported hypersensitivity reactions with glimepiride include cutaneous eruptions with or without pruritus as well as more serious reactions (e.g., anaphylaxis, angioedema, Stevens-Johnson Syndrome, dyspnea)

What might happen if I take too much pioglitazone and glimepiride?

How should I store and handle pioglitazone and glimepiride?

Pioglitazone and glimepiride tablets are available in 30 mg pioglitazone plus 2 mg glimepiride or 30 mg pioglitazone plus 4 mg glimepiride tablets as follows: 30 mg/2 mg tablet: white to off-white, round, convex tablets, debossed with 4833G on one side and 30/2 on the other, available in: NDC 66993-821-30 Bottles of 3030 mg/4 mg tablet: white to off-white, round, convex tablets, debossed with 4833G on one side and 30/4 on the other, available in: NDC 66993-822-30 Bottles of 30Pioglitazone and glimepiride tablets are available in 30 mg pioglitazone plus 2 mg glimepiride or 30 mg pioglitazone plus 4 mg glimepiride tablets as follows: 30 mg/2 mg tablet: white to off-white, round, convex tablets, debossed with 4833G on one side and 30/2 on the other, available in: NDC 66993-821-30 Bottles of 3030 mg/4 mg tablet: white to off-white, round, convex tablets, debossed with 4833G on one side and 30/4 on the other, available in: NDC 66993-822-30 Bottles of 30Pioglitazone and glimepiride tablets are available in 30 mg pioglitazone plus 2 mg glimepiride or 30 mg pioglitazone plus 4 mg glimepiride tablets as follows: 30 mg/2 mg tablet: white to off-white, round, convex tablets, debossed with 4833G on one side and 30/2 on the other, available in: NDC 66993-821-30 Bottles of 3030 mg/4 mg tablet: white to off-white, round, convex tablets, debossed with 4833G on one side and 30/4 on the other, available in: NDC 66993-822-30 Bottles of 30Pioglitazone and glimepiride tablets are available in 30 mg pioglitazone plus 2 mg glimepiride or 30 mg pioglitazone plus 4 mg glimepiride tablets as follows: 30 mg/2 mg tablet: white to off-white, round, convex tablets, debossed with 4833G on one side and 30/2 on the other, available in: NDC 66993-821-30 Bottles of 3030 mg/4 mg tablet: white to off-white, round, convex tablets, debossed with 4833G on one side and 30/4 on the other, available in: NDC 66993-822-30 Bottles of 30Pioglitazone and glimepiride tablets are available in 30 mg pioglitazone plus 2 mg glimepiride or 30 mg pioglitazone plus 4 mg glimepiride tablets as follows: 30 mg/2 mg tablet: white to off-white, round, convex tablets, debossed with 4833G on one side and 30/2 on the other, available in: NDC 66993-821-30 Bottles of 3030 mg/4 mg tablet: white to off-white, round, convex tablets, debossed with 4833G on one side and 30/4 on the other, available in: NDC 66993-822-30 Bottles of 30

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Pioglitazone and glimepiride tablets combine 2 antihyperglycemic agents with different mechanisms of action to improve glycemic control in patients with type 2 diabetes: pioglitazone, a member of the thiazolidinedione class, and glimepiride, a member of the sulfonylurea class. Thiazolidinediones are insulin-sensitizing agents that act primarily by enhancing peripheral glucose utilization, whereas sulfonylureas are insulin secretagogues that act primarily by stimulating release of insulin from functioning pancreatic beta cells.

Non-Clinical Toxicology

Reported hypersensitivity reactions with glimepiride include cutaneous eruptions with or without pruritus as well as more serious reactions (e.g., anaphylaxis, angioedema, Stevens-Johnson Syndrome, dyspnea)

Congestive heart failure: Fluid retention may occur and can exacerbate or lead to congestive heart failure. Combination use with insulin and use in congestive heart failure NYHA Class I and II may increase risk. Monitor patients for signs and symptoms. ()

Hypoglycemia: May be severe. When insulin or an insulin secretagogue is used with pioglitazone, a lower dose of the insulin or insulin secretagogue may be needed to reduce the risk of hypoglycemia. ()

Hypersensitivity Reactions: Postmarketing reports for glimepiride, a component of pioglitazone and glimepiride tablets, include anaphylaxis, angioedema and Stevens-Johnson Syndrome. Promptly discontinue pioglitazone and glimepiride tablets, assess for other cases, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes. ()

Potential increased risk of cardiovascular mortality with sulfonylureas: Inform patients of risk, benefits, and treatment alternatives. ()

Hepatic effects: Postmarketing reports of hepatic failure, sometimes fatal. Causality cannot be excluded. If liver injury is detected, promptly interrupt pioglitazone and glimepiride tablets and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart pioglitazone and glimepiride tablets if liver injury is confirmed and no alternate etiology can be found. ()

Bladder cancer: May increase the risk of bladder cancer. Do not use in patients with active bladder cancer. Use caution when using in patients with a prior history of bladder cancer. ()

Edema: Dose-related edema may occur. ()

Fractures: Increased incidence in female patients. Apply current standards of care for assessing and maintaining bone health. ()

Hemolytic anemia: Can occur if glucose 6-phosphate dehydrogenase (GP6D) deficient. Use with caution in patients with GP6D deficiency. ()

Macular edema: Postmarketing reports. Recommend regular eye exams in all patients with diabetes according to current standards of care with prompt evaluation for acute visual changes. ()

Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with pioglitazone and glimepiride tablets. ()

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

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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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Professional

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

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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