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Actoplus Met is used along with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Actoplus Met

Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Actoplus Met

Indications

Pioglitazone & Metformin combination 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.

Pharmacology

Pioglitazone 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.

Activation of PPARg nuclear receptors modulates the transcription of several insulin responsive genes involved in the control of glucose and lipid metabolism.

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.

Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects and does not cause hyperinsulinemia.

Dosage & Administration

General: The use of antihyperglycemic therapy in the management of type 2 diabetes should be individualized based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of Pioglitazone 45 mg and Metformin 2550 mg.

Dosage Recommendations: Selecting the starting dose of Pioglitazone & Metformin should be based on the patient’s current regimen of Pioglitazone and/or Metformin.

Pioglitazone & Metformin should be given in divided daily doses with meals to reduce the gastrointestinal side effects associated with Metformin.

Interaction

May impair vit B12 absorption. Increased plasma levels with strong CYP2C8 inhibitors (e.g., gemfibrozil). Decreased plasma levels with CYP2C8 inducers (e.g., rifampicin). Reduced metabolism with cationic drugs eliminated by renal tubular secretion.

Contraindications

Contraindicated in patients with:

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),

Known hypersensitivity to Pioglitazone, Metformin or any other component of this combination.

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.

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.

Precautions & Warnings

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.

Overdose Effects

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

Therapeutic Class

Combination Oral hypoglycemic preparations

Storage Conditions

Store in a cool and dry place. Protect from light and moisture. Keep out of the reach of the children.