Uses of Rezulin: - Type 2 diabetes mellitus Type 2 DM Renal disease or renal dysfunction (e.g. as suggested by serum creatinine levels >1.5 mg/dl in male, >1.4 mg/dl in females or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction and septicemia.Current or history of cardiac failure, active or history of bladder cancer, Known hypersensitivity to Pioglitazone, Metformin or any other component of this combination. Acute or chronic metabolic acidosis including diabetic ketoacidosis with or without coma.

How to use Metformin Hydrochloride + Pioglitazone: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Metformin Hydrochloride + Pioglitazone is to be taken with food. Adult Dose: Oral Type 2 diabetes mellitus Adult: Tab contains pioglitazone 15 mg and metformin 500 mg or 850 mg: Initially, 15 mg/500 mg bid or 15 mg/850 mg once daily. Patients inadequately controlled on metformin monotherapy: Initially, 15 mg/500 mg bid or 15 mg/850 mg 1-2 times daily, depending on current metformin dose. Patients inadequately controlled on pioglitazone monotherapy: Initially, 15 mg/500 mg bid or 15 mg/850 mg once daily. Max: Pioglitazone 45 mg and metformin 2,550 mg daily. Hepatic impairment: Contraindicated. Child Dose: Safety and efficacy not established Renal Dose: Renal impairment Obtain eGFR before starting metformin eGFR <30 mL/min/1.73 m²: Contraindicated eGFR 30-45 mL/min/1.73 m²: Not recommended to initiate treatment Monitor eGFR at least annually or more often for those at risk for renal impairment (eg, elderly) If eGFR falls below 45mL/min/1.73 m² while taking metformin, risks and benefits of continuing therapy should be evaluated If eGFR falls below 30 mL/min/1.73 m²: while taking metformin, discontinue the drug

Additive effect w/ sulfonylureas. Thiazide diuretics, corticosteroids, phenothiazines, OC, sympathomimetics, niacin, Ca channel blockers and isoniazid may exacerbate loss of glycaemic control. ACE inhibitors may reduce fasting blood glucose concentrations. May increase serum level w/ cimetidine. Potentially Fatal: Concurrent use w/ iodinated contrast agents may increase the risk of metformin-induced lactic acidosis.

Renal disease or renal dysfunction (e.g. as suggested by serum creatinine levels >1.5 mg/dl in male, >1.4 mg/dl in females or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction and septicemia.Current or history of cardiac failure, active or history of bladder cancer, Known hypersensitivity to Pioglitazone, Metformin or any other component of this combination. Acute or chronic metabolic acidosis including diabetic ketoacidosis with or without coma.

Common - Nausea - Loss of appetite - Taste change - Stomach pain - Diarrhea - Edema (swelling) - Weight gain - Respiratory tract infection - Bone fracture - Blurred vision >10% Lower limb edema (2.9-11.3%),Upper respiratory infection (12-16) 1-10% Weight gain (2.9-6.7%),Diarrhea (4.8-5.8%),Nausea (3.6-5.8%),Urinary tract infection (5.3-5.8%),Dizziness (4.8-5.4%),Headache (4.6-5.3%),Sinusitis (4.4-5%),Edema (3%)

Precaution: Patient w/ oedema, anaemia. Premenopausal, anovulatory women. Pregnancy. Patient Counselling This drug may cause visual disturbance, if affected, do not drive or operate machinery. Monitoring Parameters Monitor HbA1c, serum glucose; signs and symptoms of oedema or heart failure, bladder cancer; liver enzymes, haematologic parameters, renal function; vit B12 and folate if anaemia is present. Routine ophth examination. Lactation: not known if crosses into breast milk, avoid using in nursing women

Pioglitazone is as a potent and highly selective agonist for the peroxisome proliferator activated receptor-gamma. Activation of these receptors promotes the production of gene products involved in lipid and glucose metabolism. It also improves insulin response to target cells witho increasing the pancreatic secretion of insulin. Metformin decreases hepatic gluconeogenesis, decreases intestinal absorption of glucose and improves insulin sensitivity (increases peripheral glucose uptake and utilisation).