Pioglitazone hydrochloride and glimepiride

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Overview

What is Pioglitazone hydrochloride and glimepiride?

Pioglitazone and glimepiride tablets, USP 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, USP are available 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, lactose monohydrate, magnesium stearate, hydroxypropyl cellulose, polysorbate 80, and microcrystalline cellulose.

USP dissolution Test 2 was used.

What does Pioglitazone hydrochloride and glimepiride look like?

What are the available doses of Pioglitazone hydrochloride and glimepiride?

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

How should I use Pioglitazone hydrochloride 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

Important Limitations of Use

Pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone and glimepiride 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

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

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 are 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

What interacts with Pioglitazone hydrochloride and glimepiride?

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What are the warnings of Pioglitazone hydrochloride and glimepiride?

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What are the precautions of Pioglitazone hydrochloride and glimepiride?

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What are the side effects of Pioglitazone hydrochloride and glimepiride?

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What should I look out for while using Pioglitazone hydrochloride 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 hydrochloride and glimepiride?

Pioglitazone

During controlled clinical trials, one case of overdose with pioglitazone was reported. A male patient took 120 mg per day for four days, then 180 mg per day for seven days. The patient denied any clinical symptoms during this period.

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

Glimepiride

An overdosage of glimepiride, as with other sulfonylureas, can produce severe hypoglycemia. Mild episodes of hypoglycemia can be treated with oral glucose. Severe hypoglycemic reactions constitute medical emergencies requiring immediate treatment. Severe hypoglycemia with coma, seizure, or neurological impairment can be treated with glucagon or intravenous glucose. Continued observation and additional carbohydrate intake may be necessary because hypoglycemia may recur after apparent clinical recovery

How should I store and handle Pioglitazone hydrochloride and glimepiride?

Store at 20° to 25°C (68° to 77° F). [See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Pioglitazone and glimepiride tablets, USP 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 tablets are, white, oval, biconvex, embossed with ‘SZ 468’ on one side.NDC 0781-5634-31, bottle of 30 tabletsNDC 0781-5634-10, bottle of 1000 tabletsNDC 0781-5634-08, carton of 28 tablets (4 x 7 Unit-Dose)30 mg/4 mg tablets are white, oval, biconvex, embossed with “SZ 469” on one side. NDC 0781-5635-31, bottle of 30 tabletsNDC 0781-5635-10, bottle of 1000 tabletsNDC 0781-5635-08, carton of 28 tablets (4 x 7 Unit-Dose)StorageStore at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protect from moisture and humidity.Pioglitazone and glimepiride tablets, USP 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 tablets are, white, oval, biconvex, embossed with ‘SZ 468’ on one side.NDC 0781-5634-31, bottle of 30 tabletsNDC 0781-5634-10, bottle of 1000 tabletsNDC 0781-5634-08, carton of 28 tablets (4 x 7 Unit-Dose)30 mg/4 mg tablets are white, oval, biconvex, embossed with “SZ 469” on one side. NDC 0781-5635-31, bottle of 30 tabletsNDC 0781-5635-10, bottle of 1000 tabletsNDC 0781-5635-08, carton of 28 tablets (4 x 7 Unit-Dose)StorageStore at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protect from moisture and humidity.Pioglitazone and glimepiride tablets, USP 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 tablets are, white, oval, biconvex, embossed with ‘SZ 468’ on one side.NDC 0781-5634-31, bottle of 30 tabletsNDC 0781-5634-10, bottle of 1000 tabletsNDC 0781-5634-08, carton of 28 tablets (4 x 7 Unit-Dose)30 mg/4 mg tablets are white, oval, biconvex, embossed with “SZ 469” on one side. NDC 0781-5635-31, bottle of 30 tabletsNDC 0781-5635-10, bottle of 1000 tabletsNDC 0781-5635-08, carton of 28 tablets (4 x 7 Unit-Dose)StorageStore at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protect from moisture and humidity.Pioglitazone and glimepiride tablets, USP 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 tablets are, white, oval, biconvex, embossed with ‘SZ 468’ on one side.NDC 0781-5634-31, bottle of 30 tabletsNDC 0781-5634-10, bottle of 1000 tabletsNDC 0781-5634-08, carton of 28 tablets (4 x 7 Unit-Dose)30 mg/4 mg tablets are white, oval, biconvex, embossed with “SZ 469” on one side. NDC 0781-5635-31, bottle of 30 tabletsNDC 0781-5635-10, bottle of 1000 tabletsNDC 0781-5635-08, carton of 28 tablets (4 x 7 Unit-Dose)StorageStore at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protect from moisture and humidity.Pioglitazone and glimepiride tablets, USP 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 tablets are, white, oval, biconvex, embossed with ‘SZ 468’ on one side.NDC 0781-5634-31, bottle of 30 tabletsNDC 0781-5634-10, bottle of 1000 tabletsNDC 0781-5634-08, carton of 28 tablets (4 x 7 Unit-Dose)30 mg/4 mg tablets are white, oval, biconvex, embossed with “SZ 469” on one side. NDC 0781-5635-31, bottle of 30 tabletsNDC 0781-5635-10, bottle of 1000 tabletsNDC 0781-5635-08, carton of 28 tablets (4 x 7 Unit-Dose)StorageStore at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protect from moisture and humidity.Pioglitazone and glimepiride tablets, USP 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 tablets are, white, oval, biconvex, embossed with ‘SZ 468’ on one side.NDC 0781-5634-31, bottle of 30 tabletsNDC 0781-5634-10, bottle of 1000 tabletsNDC 0781-5634-08, carton of 28 tablets (4 x 7 Unit-Dose)30 mg/4 mg tablets are white, oval, biconvex, embossed with “SZ 469” on one side. NDC 0781-5635-31, bottle of 30 tabletsNDC 0781-5635-10, bottle of 1000 tabletsNDC 0781-5635-08, carton of 28 tablets (4 x 7 Unit-Dose)StorageStore at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protect from moisture and humidity.Pioglitazone and glimepiride tablets, USP 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 tablets are, white, oval, biconvex, embossed with ‘SZ 468’ on one side.NDC 0781-5634-31, bottle of 30 tabletsNDC 0781-5634-10, bottle of 1000 tabletsNDC 0781-5634-08, carton of 28 tablets (4 x 7 Unit-Dose)30 mg/4 mg tablets are white, oval, biconvex, embossed with “SZ 469” on one side. NDC 0781-5635-31, bottle of 30 tabletsNDC 0781-5635-10, bottle of 1000 tabletsNDC 0781-5635-08, carton of 28 tablets (4 x 7 Unit-Dose)StorageStore at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protect from moisture and humidity.Pioglitazone and glimepiride tablets, USP 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 tablets are, white, oval, biconvex, embossed with ‘SZ 468’ on one side.NDC 0781-5634-31, bottle of 30 tabletsNDC 0781-5634-10, bottle of 1000 tabletsNDC 0781-5634-08, carton of 28 tablets (4 x 7 Unit-Dose)30 mg/4 mg tablets are white, oval, biconvex, embossed with “SZ 469” on one side. NDC 0781-5635-31, bottle of 30 tabletsNDC 0781-5635-10, bottle of 1000 tabletsNDC 0781-5635-08, carton of 28 tablets (4 x 7 Unit-Dose)StorageStore at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protect from moisture and humidity.Pioglitazone and glimepiride tablets, USP 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 tablets are, white, oval, biconvex, embossed with ‘SZ 468’ on one side.NDC 0781-5634-31, bottle of 30 tabletsNDC 0781-5634-10, bottle of 1000 tabletsNDC 0781-5634-08, carton of 28 tablets (4 x 7 Unit-Dose)30 mg/4 mg tablets are white, oval, biconvex, embossed with “SZ 469” on one side. NDC 0781-5635-31, bottle of 30 tabletsNDC 0781-5635-10, bottle of 1000 tabletsNDC 0781-5635-08, carton of 28 tablets (4 x 7 Unit-Dose)StorageStore at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protect from moisture and humidity.Pioglitazone and glimepiride tablets, USP 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 tablets are, white, oval, biconvex, embossed with ‘SZ 468’ on one side.NDC 0781-5634-31, bottle of 30 tabletsNDC 0781-5634-10, bottle of 1000 tabletsNDC 0781-5634-08, carton of 28 tablets (4 x 7 Unit-Dose)30 mg/4 mg tablets are white, oval, biconvex, embossed with “SZ 469” on one side. NDC 0781-5635-31, bottle of 30 tabletsNDC 0781-5635-10, bottle of 1000 tabletsNDC 0781-5635-08, carton of 28 tablets (4 x 7 Unit-Dose)StorageStore at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protect from moisture and humidity.Pioglitazone and glimepiride tablets, USP 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 tablets are, white, oval, biconvex, embossed with ‘SZ 468’ on one side.NDC 0781-5634-31, bottle of 30 tabletsNDC 0781-5634-10, bottle of 1000 tabletsNDC 0781-5634-08, carton of 28 tablets (4 x 7 Unit-Dose)30 mg/4 mg tablets are white, oval, biconvex, embossed with “SZ 469” on one side. NDC 0781-5635-31, bottle of 30 tabletsNDC 0781-5635-10, bottle of 1000 tabletsNDC 0781-5635-08, carton of 28 tablets (4 x 7 Unit-Dose)StorageStore at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protect from moisture and humidity.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Pioglitazone and glimepiride tablets combines 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.

Pioglitazone

Pioglitazone is a thiazolidinedione that depends on the presence of insulin for its mechanism of action. Pioglitazone decreases insulin resistance in the periphery and in the liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. Pioglitazone is not an insulin secretagogue. Pioglitazone is an agonist for peroxisome proliferator-activated receptor-gamma (PPARγ). PPAR receptors are found in tissues important for insulin action such as adipose tissue, skeletal muscle, and liver. Activation of PPARγ nuclear receptors modulates the transcription of a number of insulin responsive genes involved in the control of glucose and lipid metabolism.

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.

Glimepiride

Glimepiride primarily lowers blood glucose by stimulating the release of insulin from pancreatic beta cells. Sulfonylureas bind to the sulfonylurea receptor in the pancreatic beta cell plasma membrane, leading to closure of the ATP-sensitive potassium channel, thereby stimulating the release of insulin.

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)

Use with Opioids

Use with Other CNS Depressants

Use with Imipramine and Desipramine

Drugs that inhibit alprazolam metabolism via cytochrome P450 3A

Drugs demonstrated to be CYP3A inhibitors of possible clinical significance on the basis of clinical studies involving alprazolam (caution is recommended during coadministration with alprazolam)

Fluoxetine—Coadministration of fluoxetine with alprazolam increased the maximum plasma concentration of alprazolam by 46%, decreased clearance by 21%, increased half-life by 17%, and decreased measured psychomotor performance.

Propoxyphene—Coadministration of propoxyphene decreased the maximum plasma concentration of alprazolam by 6%, decreased clearance by 38%, and increased half-life by 58%.

Oral Contraceptives—Coadministration of oral contraceptives increased the maximum plasma concentration of alprazolam by 18%, decreased clearance by 22%, and increased half-life by 29%.

Drugs and other substances demonstrated to be CYP3A inhibitors on the basis of clinical studies involving benzodiazepines metabolized similarly to alprazolam or on the basis of studies with alprazolam or other benzodiazepines (caution is recommended during coadministration with alprazolam)

Available data from clinical studies of benzodiazepines other than alprazolam suggest a possible drug interaction with alprazolam for the following: diltiazem, isoniazid, macrolide antibiotics such as erythromycin and clarithromycin, and grapefruit juice. Data from studies of alprazolam suggest a possible drug interaction with alprazolam for the following: sertraline and paroxetine. However, data from an drug interaction study involving a single dose of alprazolam 1 mg and steady state dose of sertraline (50 to 150 mg/day) did not reveal any clinically significant changes in the pharmacokinetics of alprazolam. Data from studies of benzodiazepines other than alprazolam suggest a possible drug interaction for the following: ergotamine, cyclosporine, amiodarone, nicardipine, and nifedipine. Caution is recommended during the coadministration of any of these with alprazolam (see ).

Drugs demonstrated to be inducers of CYP3A

Pioglitazone

Pioglitazone, like other thiazolidinediones, can cause dose-related fluid retention when used alone or in combination with other antidiabetic medications and is most common when pioglitazone and glimepiride is used in combination with insulin. Fluid retention may lead to or exacerbate congestive heart failure. Patients should be observed for signs and symptoms of congestive heart failure. If congestive heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone and glimepiride must be considered

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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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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