Pioglitazone
Therapeutic Class: Anti Diabetic
Therapeutic Class: Anti Diabetic
Indications:
Pioglitazone is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type II diabetes (NIDDM). Pioglitazone is indicated for monotherapy and also indicated for use in combination with a sulfonylurea, metformin, or insulin when diet and exercise plus the single agent do not result in adequate glycemic control.
Presentation:
Pioglitazone 15 : Each tablet contains Pioglitazone Hydrochloride INN equivalent to Pioglitazone 15 mg.
Description:
Pioglitazone is a member of the newest class of oral antidiabetic agents called thiazolidinediones which depend 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. It also improves abnormality in lipid metabolism by activating the PPAR-γ receptor.
Dosage & Administration:
Pioglitazone can be taken once daily without regard to meals. The management of antidiabetic therapy should be individualized. Pioglitazone monotherapy in patients not adequately controlled with diet and exercise may be initiated at 15 mg or 30 mg once daily. 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.
Side Effects:
The overall incidence and types of adverse events reported in placebo-controlled clinical trials of pioglitazone monotherapy at doses of 7.5 mg, 15 mg, 30 mg, or 45 mg once daily are shown below:-
Upper respiratory tract infections13.2%, headache 9.1%, sinusitis 6.3%,myalgia 5.4%, tooth disorder 5.3%, pharyngitis 5.1%.
Precautions:
Pioglitazone exerts its hypoglycemic effect only in the presence of insulin. Therefore it should not be used in patients with type I diabetes or for the treatment of diabetic ketoacidosis. Pioglitazone should be used with caution in case of combination therapy, hepatic insufficiency, and heart diseases.
Pregnancy & Lactation:
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.
Nursing Mothers: It is not known whether pioglitazone is secreted in human milk. Because many drugs are excreted in human milk, they should not be administered to a breastfeeding woman.
Interaction:
Administration of another thiazolidinedione with an oral contraceptive containing Ethinyl estradiol and norethindrone reduces the plasma concentrations of both hormones by approximately 30%, which could result in loss of contraception.
Overdose:
In the event of overdosage, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.
Pioglitazone is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type II diabetes (NIDDM). Pioglitazone is indicated for monotherapy and also indicated for use in combination with a sulfonylurea, metformin, or insulin when diet and exercise plus the single agent do not result in adequate glycemic control.
Presentation:
Pioglitazone 15 : Each tablet contains Pioglitazone Hydrochloride INN equivalent to Pioglitazone 15 mg.
Description:
Pioglitazone is a member of the newest class of oral antidiabetic agents called thiazolidinediones which depend 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. It also improves abnormality in lipid metabolism by activating the PPAR-γ receptor.
Dosage & Administration:
Pioglitazone can be taken once daily without regard to meals. The management of antidiabetic therapy should be individualized. Pioglitazone monotherapy in patients not adequately controlled with diet and exercise may be initiated at 15 mg or 30 mg once daily. 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.
Side Effects:
The overall incidence and types of adverse events reported in placebo-controlled clinical trials of pioglitazone monotherapy at doses of 7.5 mg, 15 mg, 30 mg, or 45 mg once daily are shown below:-
Upper respiratory tract infections13.2%, headache 9.1%, sinusitis 6.3%,myalgia 5.4%, tooth disorder 5.3%, pharyngitis 5.1%.
Precautions:
Pioglitazone exerts its hypoglycemic effect only in the presence of insulin. Therefore it should not be used in patients with type I diabetes or for the treatment of diabetic ketoacidosis. Pioglitazone should be used with caution in case of combination therapy, hepatic insufficiency, and heart diseases.
Pregnancy & Lactation:
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.
Nursing Mothers: It is not known whether pioglitazone is secreted in human milk. Because many drugs are excreted in human milk, they should not be administered to a breastfeeding woman.
Interaction:
Administration of another thiazolidinedione with an oral contraceptive containing Ethinyl estradiol and norethindrone reduces the plasma concentrations of both hormones by approximately 30%, which could result in loss of contraception.
Overdose:
In the event of overdosage, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.
Store at 25° C.