Pioglitazone is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type II diabetes mellitus (NIDDM). It is used as monotherapy and also in combination with sulphonylureas, metformin, or insulin when diet, exercise, and a single agent do not provide adequate glycaemic control.

Pioglitazone belongs to the thiazolidinedione class of oral antidiabetic drugs. Its mechanism of action is dependent on the presence of insulin. It reduces insulin resistance in peripheral tissues and in the liver, thereby increasing insulin-dependent glucose uptake and decreasing hepatic glucose production. It also improves abnormalities in lipid metabolism by activating the peroxisome proliferator-activated receptor gamma (PPAR-γ).

Pioglitazone can be taken once daily without regard to meals. The management of antidiabetic therapy should be individualized. Pioglitazone monotherapy may be initiated at 15 mg or 30 mg once daily dosages in patients not adequately controlled with diet and exercise alone. For patients who respond inadequately to the initial dose of Pioglitazone, the dose can be increased up to 45 mg once daily. For patients not responding adequately to monotherapy, combination therapy should be considered.

Maximum recommended daily dose of Pioglitazone should not exceed 45 mg since doses higher than 45 mg have not been studied in placebo controlled clinical studies. Besides, no placebo controlled clinical studies of more than 30 mg once daily have been conducted in combination therapy.

Coadministration of thiazolidinediones with an oral contraceptive containing ethinyl estradiol and norethindrone may reduce plasma concentrations of both hormones by about 30%, which may lead to reduced contraceptive efficacy.

Pioglitazone is contraindicated in patients with known hypersensitivity to pioglitazone or any of its components.

In placebo-controlled clinical trials of pioglitazone monotherapy (7.5 mg, 15 mg, 30 mg, or 45 mg once daily), the most commonly reported adverse effects include upper respiratory tract infection (13.2%), headache (9.1%), sinusitis (6.3%), myalgia (5.4%), tooth disorders (5.3%), and pharyngitis (5.1%).

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Pioglitazone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is not known whether pioglitazone is excreted in human breast milk. Since many drugs are excreted in milk, it should not be used in breastfeeding women.

Pioglitazone works only in the presence of insulin and should not be used in type 1 diabetes or diabetic ketoacidosis. It should be used cautiously in combination therapy and in patients with hepatic impairment. Liver enzymes should be monitored regularly.

Thiazolidinedione group

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