Posinorm M (Pioglitazone + Metformin)

• Composition :
  Each uncoated tablet contains: Pioglitazone 15 mg + Metformin 500mg SR Tablets.
• Indications :
  For second line therapy in type-II diabetes.
• Pharmacodynamics :
  Pioglitazone Hydrochloride is a thiazolidinedione antidiabetic agent. Pioglitazone Hydrochloride decreases insulin resistance in the periphery and in the liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. Pioglitazone is a potent and highly selective agonist for peroxisome proliferator-activated receptor-gamma (PPARγ). Activation of PPARγ nuclear receptors modulates the transcription of a number of insulin responsive genes involved in the control of glucose and lipid metabolism.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.
• Dosage and administration :
  One tablet, once daily with meal.
• Contraindications :
  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.
• Precautions and warnings :
  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.
• Use in pregnancy, lactation & pediatrics :
  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.
• Drug interactions :
  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
• Adverse reactions :
  Most common adverse reactions are hypoglycaemia, oedema, headache, upper respiratory tract infection, myalgia, sinusitis, abnormal stools, myalgia and pharyngitis
• Therapy Area :
  Anti-Diabetic agents