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Pioglitazone Hydrochloride and Metformin Hydrochloride

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Overview

What is Pioglitazone Hydrochloride and Metformin Hydrochloride?

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

Pioglitazone hydrochloride, USP [(±)-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, USP is a white to off-white crystalline powder that has a molecular formula of CHNOS•HCl and a molecular weight of 392.9 daltons. It is soluble in dimethylformamide and anhydrous ethanol, very slightly soluble in acetone and acetonitrile, practically insoluble in water and ether.

Metformin hydrochloride, USP (N,N-Dimethylimidodicarbonimidic diamide Monochloride) is a white crystalline powder with a molecular formula of CHN•HCl and a molecular weight of 165.62. Metformin hydrochloride is freely soluble in water, slightly soluble in ethanol, and is practically insoluble in ether, and chloroform. The structural formula is as shown:

Pioglitazone and metformin hydrochloride tablets are available 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 excipients: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, titanium dioxide and triacetin.



What does Pioglitazone Hydrochloride and Metformin Hydrochloride look like?



What are the available doses of Pioglitazone Hydrochloride and Metformin Hydrochloride?

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

What should I talk to my health care provider before I take Pioglitazone Hydrochloride and Metformin Hydrochloride?

How should I use Pioglitazone Hydrochloride 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

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

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:

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 tablets is not recommended in patients without liver disease. Patients who have liver test abnormalities prior to initiation of pioglitazone and metformin hydrochloride tablets 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 Pioglitazone Hydrochloride and Metformin Hydrochloride?

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What are the warnings of Pioglitazone Hydrochloride and Metformin Hydrochloride?

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What are the precautions of Pioglitazone Hydrochloride and Metformin Hydrochloride?

Sorry No Records found


What are the side effects of Pioglitazone Hydrochloride and Metformin Hydrochloride?

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What should I look out for while using Pioglitazone Hydrochloride and Metformin Hydrochloride?

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What might happen if I take too much Pioglitazone Hydrochloride and Metformin Hydrochloride?

Pioglitazone:

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

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How should I store and handle Pioglitazone Hydrochloride and Metformin Hydrochloride?

Store in a refrigerator 2° to 8°C (36° to 46°F).Pioglitazone and Metformin Hydrochloride Tablets, USP are available in 15 mg pioglitazone hydrochloride, USP (as the base)/500 mg metformin hydrochloride, USP or 15 mg pioglitazone hydrochloride, USP (as the base)/850 mg metformin hydrochloride, USP tablets.The 15 mg/500 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1550-91bottles of 60 tabletsThe 15 mg/850 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1575-91bottles of 60 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture and humidity.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Pioglitazone and Metformin Hydrochloride Tablets, USP are available in 15 mg pioglitazone hydrochloride, USP (as the base)/500 mg metformin hydrochloride, USP or 15 mg pioglitazone hydrochloride, USP (as the base)/850 mg metformin hydrochloride, USP tablets.The 15 mg/500 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1550-91bottles of 60 tabletsThe 15 mg/850 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1575-91bottles of 60 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture and humidity.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Pioglitazone and Metformin Hydrochloride Tablets, USP are available in 15 mg pioglitazone hydrochloride, USP (as the base)/500 mg metformin hydrochloride, USP or 15 mg pioglitazone hydrochloride, USP (as the base)/850 mg metformin hydrochloride, USP tablets.The 15 mg/500 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1550-91bottles of 60 tabletsThe 15 mg/850 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1575-91bottles of 60 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture and humidity.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Pioglitazone and Metformin Hydrochloride Tablets, USP are available in 15 mg pioglitazone hydrochloride, USP (as the base)/500 mg metformin hydrochloride, USP or 15 mg pioglitazone hydrochloride, USP (as the base)/850 mg metformin hydrochloride, USP tablets.The 15 mg/500 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1550-91bottles of 60 tabletsThe 15 mg/850 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1575-91bottles of 60 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture and humidity.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Pioglitazone and Metformin Hydrochloride Tablets, USP are available in 15 mg pioglitazone hydrochloride, USP (as the base)/500 mg metformin hydrochloride, USP or 15 mg pioglitazone hydrochloride, USP (as the base)/850 mg metformin hydrochloride, USP tablets.The 15 mg/500 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1550-91bottles of 60 tabletsThe 15 mg/850 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1575-91bottles of 60 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture and humidity.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Pioglitazone and Metformin Hydrochloride Tablets, USP are available in 15 mg pioglitazone hydrochloride, USP (as the base)/500 mg metformin hydrochloride, USP or 15 mg pioglitazone hydrochloride, USP (as the base)/850 mg metformin hydrochloride, USP tablets.The 15 mg/500 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1550-91bottles of 60 tabletsThe 15 mg/850 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1575-91bottles of 60 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture and humidity.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Pioglitazone and Metformin Hydrochloride Tablets, USP are available in 15 mg pioglitazone hydrochloride, USP (as the base)/500 mg metformin hydrochloride, USP or 15 mg pioglitazone hydrochloride, USP (as the base)/850 mg metformin hydrochloride, USP tablets.The 15 mg/500 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1550-91bottles of 60 tabletsThe 15 mg/850 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1575-91bottles of 60 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture and humidity.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Pioglitazone and Metformin Hydrochloride Tablets, USP are available in 15 mg pioglitazone hydrochloride, USP (as the base)/500 mg metformin hydrochloride, USP or 15 mg pioglitazone hydrochloride, USP (as the base)/850 mg metformin hydrochloride, USP tablets.The 15 mg/500 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1550-91bottles of 60 tabletsThe 15 mg/850 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1575-91bottles of 60 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture and humidity.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Pioglitazone and Metformin Hydrochloride Tablets, USP are available in 15 mg pioglitazone hydrochloride, USP (as the base)/500 mg metformin hydrochloride, USP or 15 mg pioglitazone hydrochloride, USP (as the base)/850 mg metformin hydrochloride, USP tablets.The 15 mg/500 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1550-91bottles of 60 tabletsThe 15 mg/850 mg tablets are white to off-white, film-coated, oval, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1575-91bottles of 60 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from moisture and humidity.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Pioglitazone and metformin hydrochloride tablets combine 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.

Non-Clinical Toxicology
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A possible drug interaction of FOSCAVIR and intravenous pentamidine has been described. Concomitant treatment of four patients in the United Kingdom with FOSCAVIR and intravenous pentamidine may have caused hypocalcemia; one patient died with severe hypocalcemia. Toxicity associated with concomitant use of aerosolized pentamidine has not been reported.

Because of foscarnet's tendency to cause renal impairment, the use of FOSCAVIR should be avoided in combination with potentially nephrotoxic drugs such as aminoglycosides, amphotericin B, cyclosporine, acyclovir, methotrexate, tacrolimus and intravenous pentamidine (see above) unless the potential benefits outweigh the risks to the patient.

When diuretics are indicated, thiazides are recommended over loop diuretics because the latter inhibit renal tubular secretion, and may impair elimination of FOSCAVIR, potentially leading to toxicity.

Abnormal renal function has been observed in clinical practice during the use of FOSCAVIR and ritonavir, or FOSCAVIR, ritonavir, and saquinavir. (See )

Because of the risk of QT prolongation and the potential for torsades de pointes, the use of FOSCAVIR should be avoided in combination with agents known to prolong the QT interval including Class IA (e.g., quinidine or procainamide) or Class III (e.g., dofetilide, amiodarone, sotalol) antiarrhythmic agents, phenothiazines, tricyclic antidepressants, and certain macrolides and fluoroquinolones.



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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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Tips

Tips

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Interactions

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).