Pionorm Tablets (Pioglitazone)

• Composition :
  Each uncoated tablet contains: Pioglitazone 15 mg/30mg Tablets.
• Indications :
  As an adjunct to diet & exercise to improve glycaemic control in patients with type-II diabetes (NIDDM).
• Pharmacodynamics :
  Pioglitazone Hydrochloride is a thiazolidinedione antidiabetic agent that depends on the presence of insulin for its mechanism of action. Pioglitazone Hydrochloride decreases insulin resistance in the periphery and in the liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. Unlike sulfonylureas, pioglitazone is not an insulin secretagogue. 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.
• Dosage and administration :
  Pioglitazone may be initiated at 15 mg or 30 mg once daily. The dose may be increased in increments up to 45 mg once daily.
• 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.
• 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.
• Adverse reactions :
  Most common adverse reactions are oedema, headache, upper respiratory tract infection, myalgia, sinusitis, and pharyngitis
• Therapy Area :
  Anti-Diabetic agents