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Compimet (Pioglitazone & Metformin)
Therapeutic Group: Anti Diabetic » Oral hypoglycaemic
Presentation

Compimet 500: Each tablet contains Pioglitazone Hydrochloride INN 16.53 mg equivalent to Pioglitazone 15 mg and Metformin Hydrochloride BP 500 mg.

Compimet 850: Each tablet contains Pioglitazone Hydrochloride INN 16.53 mg equivalent to Pioglitazone 15 mg and Metformin Hydrochloride BP 850 mg.

Descriptions
Compimet combines two antihyperglycemic agents with different mechanism of action to improve glycemic control in patients with type 2 diabetes; Pioglitazone Hydrochloride, a member of the Thiazolidinedione class and Metformin Hydrochloride, a member of the Biguanide class.

Pioglitazone, for its mechanism of action, depends on the presence of insulin. Pioglitazone decreases insulin resistance in the periphery and in the liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. It also improves abnormality in lipid metabolism by activating PPAR-g receptor.

Metformin Hydrochloride improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin Hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Indications
Compimet is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes who are already treated with a combination of Pioglitazone and Metformin or whose diabetes is not adequately controlled with Metformin alone or for those patients who have initially responded to Pioglitazone and require additional glycemic control.
Dosage & Administration
Dosage of this preparation must be individualized on the basis of effectiveness and tolerability while not exceeding the maximum recommended daily dose of Pioglitazone 45 mg and Metformin 2550 mg. Compimet may be initiated at either the 15 mg/500 mg twice daily or 15 mg/850 mg once daily with meals to reduce the gastrointestinal side effects associated with Metformin and gradually titrated after assessing adequacy of therapeutic response.

The initial and maintenance dose of Compimet should be carefully selected in patients with advanced age due to the potential for decreased renal function in these populations. Monitoring of renal function is necessary to aid in prevention of Metformin associated lactic acidosis, particularly in the elderly. Compimet should not be initiated if the patients exhibit clinical evidence of active liver disease. Liver enzyme monitoring is recommended in all patients prior to initiation of therapy with combination of Pioglitazone and Metformin and periodically thereafter.
Side Effects
Generally this combined preparation is well tolerated. However, the most common side effects are upper respiratory tract infection, diarrhea, peripheral edema and headache, respectively. These are mild in severity.
Precautions
Pioglitazone exerts its antihyperglycemic effect only in the presence of insulin. Therefore, Pioglitazone should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Pioglitazone should be used with caution in combination especially with insulin, hepatic insufficiency and heart diseases.

Metformin is known to be substantially excreted by the kidney and the risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Thus patients with serum creatinine levels above the upper limit of normal for their age should not receive this combination.
Contraindications
Compimet is contraindicated in patients with:
1. Renal disease or renal dysfunction (e.g. as suggested by serum creatinine levels >1.5 mg/dl in male, >1.4 mg/dl in females or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction and septicemia.
2. Known hypersensitivity to Pioglitazone, Metformin or any other component of this combination.
3. Acute or chronic metabolic acidosis including diabetic ketoacidosis with or without coma.
Use in Pregnancy & Lactation
Pregnancy: There are no adequate and well-controlled studies in pregnant women with this combination or its individual components. So, it should only be used if the potential benefit justifies the potential risk to the fetus.
Nursing mother: It is not known whether Pioglitazone and/or Metformin are secreted in human milk. Because many drugs are excreted in human milk, this combination should not be administered to a breastfeeding woman.
Overdose
In the event of Overdosage, appropriate supportive treatment should be initiated according to patient's clinical signs and symptoms.
Storage
Store in a cool and dry place. Protect from light and moisture. Keep out of the reach of the children.
Commercial Packaging
Compimet 500: Each box contains 3 blister strips of 10 tablets.
Compimet 850: Each box contains 3 blister strips of 10 tablets.
Others
Use in pediatric patients
Safety and efficacy of this preparation in pediatric patients have not been established.
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