Pioglitazone and Metformin Hydrochloride

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Overview

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

CHNOS•HCl M.W. 392.90

Pioglitazone hydrochloride, USP is white crystals or crystalline powder. 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.

Metformin hydrochloride, USP (Imidodicarbonimidic diamide, -dimethyl-, monohydrochloride) is a white crystalline powder. Metformin hydrochloride, USP is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. 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:

CHN•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.

Pioglitazone and metformin hydrochloride tablets USP meet USP .

What does Pioglitazone and Metformin Hydrochloride look like?

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

How should I use Pioglitazone 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 and Metformin Hydrochloride?

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What are the warnings of Pioglitazone and Metformin Hydrochloride?

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What are the precautions of Pioglitazone and Metformin Hydrochloride?

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What are the side effects of Pioglitazone and Metformin Hydrochloride?

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

Initiation in patients with established New York Heart Association (NYHA) Class III or IV heart failure []. ()

Severe renal impairment: (eGFR below 30mL/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. (, )

Congestive Heart Failure

Lactic Acidosis

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

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.

Metformin hydrochloride

Overdose of metformin hydrochloride has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases []. Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated metformin from patients in whom metformin overdosage is suspected.

How should I store and handle Pioglitazone and Metformin Hydrochloride?

Store LONHALA Inhalation Solution in the protective foil pouch at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Always use the MAGNAIR Replacement Handset parts that come with each LONHALA MAGNAIR refill prescription. Keep out of the reach of children. Store LONHALA Inhalation Solution in the protective foil pouch at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Always use the MAGNAIR Replacement Handset parts that come with each LONHALA MAGNAIR refill prescription. Keep out of the reach of children. Store LONHALA Inhalation Solution in the protective foil pouch at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Always use the MAGNAIR Replacement Handset parts that come with each LONHALA MAGNAIR refill prescription. Keep out of the reach of children. Pioglitazone and metformin hydrochloride tablets USP are available in 15 mg pioglitazone hydrochloride (as the base)/500 mg metformin hydrochloride and 15 mg pioglitazone hydrochloride (as the base)/850 mg metformin hydrochloride tablets as follows:15 mg (base) and 500 mg: white to off-white, oval-shaped tablet, film-coated, debossed with “TV” on one side of the tablet and “7677” on the other side, in bottles of 60 (NDC 0093-7677-06) and 180 (NDC 0093-7677-86).15 mg (base) and 850 mg: white to off-white, oval-shaped tablet, film-coated, debossed with “TV” on one side of the tablet and “7678” on the other side, in bottles of 60 (NDC 0093-7678-06) and 180 (NDC 0093-7678-86).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.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Pioglitazone and metformin hydrochloride tablets USP are available in 15 mg pioglitazone hydrochloride (as the base)/500 mg metformin hydrochloride and 15 mg pioglitazone hydrochloride (as the base)/850 mg metformin hydrochloride tablets as follows:15 mg (base) and 500 mg: white to off-white, oval-shaped tablet, film-coated, debossed with “TV” on one side of the tablet and “7677” on the other side, in bottles of 60 (NDC 0093-7677-06) and 180 (NDC 0093-7677-86).15 mg (base) and 850 mg: white to off-white, oval-shaped tablet, film-coated, debossed with “TV” on one side of the tablet and “7678” on the other side, in bottles of 60 (NDC 0093-7678-06) and 180 (NDC 0093-7678-86).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.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Pioglitazone and metformin hydrochloride tablets USP are available in 15 mg pioglitazone hydrochloride (as the base)/500 mg metformin hydrochloride and 15 mg pioglitazone hydrochloride (as the base)/850 mg metformin hydrochloride tablets as follows:15 mg (base) and 500 mg: white to off-white, oval-shaped tablet, film-coated, debossed with “TV” on one side of the tablet and “7677” on the other side, in bottles of 60 (NDC 0093-7677-06) and 180 (NDC 0093-7677-86).15 mg (base) and 850 mg: white to off-white, oval-shaped tablet, film-coated, debossed with “TV” on one side of the tablet and “7678” on the other side, in bottles of 60 (NDC 0093-7678-06) and 180 (NDC 0093-7678-86).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.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Pioglitazone and metformin hydrochloride tablets USP are available in 15 mg pioglitazone hydrochloride (as the base)/500 mg metformin hydrochloride and 15 mg pioglitazone hydrochloride (as the base)/850 mg metformin hydrochloride tablets as follows:15 mg (base) and 500 mg: white to off-white, oval-shaped tablet, film-coated, debossed with “TV” on one side of the tablet and “7677” on the other side, in bottles of 60 (NDC 0093-7677-06) and 180 (NDC 0093-7677-86).15 mg (base) and 850 mg: white to off-white, oval-shaped tablet, film-coated, debossed with “TV” on one side of the tablet and “7678” on the other side, in bottles of 60 (NDC 0093-7678-06) and 180 (NDC 0093-7678-86).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.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Pioglitazone and metformin hydrochloride tablets USP are available in 15 mg pioglitazone hydrochloride (as the base)/500 mg metformin hydrochloride and 15 mg pioglitazone hydrochloride (as the base)/850 mg metformin hydrochloride tablets as follows:15 mg (base) and 500 mg: white to off-white, oval-shaped tablet, film-coated, debossed with “TV” on one side of the tablet and “7677” on the other side, in bottles of 60 (NDC 0093-7677-06) and 180 (NDC 0093-7677-86).15 mg (base) and 850 mg: white to off-white, oval-shaped tablet, film-coated, debossed with “TV” on one side of the tablet and “7678” on the other side, in bottles of 60 (NDC 0093-7678-06) and 180 (NDC 0093-7678-86).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.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Pioglitazone and metformin hydrochloride tablets USP are available in 15 mg pioglitazone hydrochloride (as the base)/500 mg metformin hydrochloride and 15 mg pioglitazone hydrochloride (as the base)/850 mg metformin hydrochloride tablets as follows:15 mg (base) and 500 mg: white to off-white, oval-shaped tablet, film-coated, debossed with “TV” on one side of the tablet and “7677” on the other side, in bottles of 60 (NDC 0093-7677-06) and 180 (NDC 0093-7677-86).15 mg (base) and 850 mg: white to off-white, oval-shaped tablet, film-coated, debossed with “TV” on one side of the tablet and “7678” on the other side, in bottles of 60 (NDC 0093-7678-06) and 180 (NDC 0093-7678-86).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.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

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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.

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.

Metformin hydrochloride

Metformin hydrochloride improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Metformin does not produce hypoglycemia in either patients with type 2 diabetes or healthy subjects [except in specific circumstances, ] and does not cause hyperinsulinemia. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease.

Non-Clinical Toxicology

Initiation in patients with established New York Heart Association (NYHA) Class III or IV heart failure []. ()

Severe renal impairment: (eGFR below 30mL/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. (, )

Congestive Heart Failure

Lactic Acidosis

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.

The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective.

Administration of isotretinoin should be avoided shortly before, during, and shortly after minocycline therapy. Each drug alone has been associated with pseudotumor cerebri (See ).

Increased risk of ergotism when ergot alkaloids or their derivatives are given with tetracyclines.

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 is used in combination with insulin. Fluid retention may lead to or exacerbate congestive heart failure. Patients treated with pioglitazone and metformin hydrochloride tablets 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 metformin hydrochloride tablets 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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