Precautions and warnings

Pioglitazone lowers blood sugar only when there is insulin in the body. Because of this, it should not be used by people with type 1 diabetes or to treat diabetic ketoacidosis. Extra care is needed when using pioglitazone, especially in people who have liver problems, heart disease, or are also using insulin.

Metformin is mostly removed from the body by the kidneys. If the kidneys are not working well, metformin can build up and increase the risk of lactic acidosis, a serious condition. Therefore, people with high serum creatinine levels for their age should not use this combination of medicines.

Drug Interactions

Taking metformin with sulfonylureas can increase its effects. Certain medicines like thiazide diuretics, corticosteroids, phenothiazines, birth control pills, sympathomimetics, niacin, calcium channel blockers, and isoniazid can make it harder to control blood sugar. ACE inhibitors may help lower fasting blood sugar. Taking cimetidine with metformin may raise metformin levels in the blood.

**Serious Warning:** Using metformin together with iodinated contrast agents can increase the risk of a dangerous condition called lactic acidosis.

Contraindications

1. Kidney disease or kidney problems (such as having a blood creatinine level higher than 1.5 mg/dl for men or 1.4 mg/dl for women, or having unusual creatinine clearance), which can also be caused by conditions like shock, heart attack, or severe infections in the blood.

2. Allergy to Pioglitazone, Metformin, or any other ingredient in this medicine.

3. Having a sudden or ongoing problem with too much acid in the body, such as diabetic ketoacidosis, whether or not you are in a coma.

Mode of actions

Pioglitazone is a strong and specific activator of the peroxisome proliferator activated receptor-gamma (PPAR-gamma). When these receptors are activated, they help produce proteins that play a role in controlling fats and sugars in the body. Pioglitazone also helps the body’s cells respond better to insulin without making the pancreas produce more insulin.

Metformin works differently. It reduces the amount of glucose made by the liver, decreases how much glucose is absorbed from the gut, and helps the body’s cells use insulin more effectively by increasing how much sugar they take in and use from the blood.

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.

It 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 it 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. It 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.

Pregnancy & Lactation

Although animal reproduction studies have shown an adverse effect even sometimes unable to demonstrate the risk on the fetus and there are no adequate and well-controlled studies in pregnant women, but during pregnancy, this medicine can be used just when definitely required.

Discuss with your doctors and tell them feedback about this medicine.

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