Each uncoated bilayered tablet contains Pioglitazone Hydrochloride IP equivalent to Pioglitazone 15 mg + Glibenclamide IP 5 mg + Metformin Hydrochloride IP 500 mg (in sustained-release form).
As 3rd line treatment of Type-2 Diabetes Mellitus when diet, exercise and the single agents and second line therapy with two drugs do not results in adequate glycemic control.
Pioglitazone is a thiazolidinedione antidiabetic agent. Pioglitazone decreases insulin resistance in the periphery and in the liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. Metformin is an antihyperglycemic agent which 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.Glibenclamide also known as glyburide is one of a group of medicines called sulphonylurea and it acts by promoting insulin secretion in the body, so that the blood sugars are utilized by various organs, leading to a fall in blood levels of sugar
One tablet, once daily with meal.
Hypersensitivity to the active substance or to any of the excipients, Cardiac failure or history of cardiac failure (NYHA stages I to IV), Hepatic impairment, Diabetic ketoacidosis, Patients with active bladder cancer or with a history of bladder cancer, and those with un-investigated haematuria. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma, type 1 diabetes mellitus
Fluid retention may occur and can exacerbate or lead to congestive heart failure, dose-related oedema may occur. increased incidence of fractures in female patients. Risk factors for development of bladder cancer should be assessed before initiating pioglitazone, Dose related weight gain was observed with pioglitazone alone and in combination with other hypoglycaemic agents.Precaution to be taken While using insulin or renal hypoglycemics, Blurred vision
Pregnancy Category C. There are no adequate and well-controlled studies inpregnant women. Should be used during pregnancy only if thepotential benefit justifies the potential risk to the fetus. A decision should be made todiscontinue nursing or discontinue, taking into account the importance to themother. Safety and efficacy is not established in children.
The pioglitazone dose may need to be increased when rifampicin is concomitantly administered and decrease in the dose of pioglitazone may be needed when gemfibrozil is co- administered. Close monitoring of glycaemic control should be considered. Nifedipine appears to enhance the absorption of metformin. May impair vit B12 absorption
Most common adverse reactions are hypoglycaemia, oedema, headache, upper respiratory tract infection, myalgia, sinusitis, abnormal stools, myalgia and pharyngitis
Doctors
Nurses
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