PioMet 850 tablet
DESCRIPTION: PIOMET 500 and PIOMET 850 constitute two oral antihyperglycemic agents in tablets containing Pioglitazone 15mg with Metformin HCl 500mg and Pioglitazone15mg with Metformin HCl 850mg, respectively for oral administration.
Mechanism of action
PIOMET combines two antihyperglycemic agents with different mechanisms of action to improve glycemic control in patients with type II diabetes: Pioglitazone Hydrochloride, a member of the thiazolidinedione class, and Metformin Hydrochloride, a member of the biguanide class.
Pioglitazone depends 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.
Metformin Hydrochloride improves glucose tolerance in patients with type II 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.
Rationality for Combination of Pioglitazone and Metformin
The concomitant use of Pioglitazone and Metformin has been previously approved in patients with type II diabetes inadequately controlled on Metformin.
PIOMET is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type II diabetes who are already treated with a combination of Pioglitazone and Metformin or whose diabetes is not adequately controlled with Metformin alone, or for those patients who have initially responded to Pioglitazone alone and require additional glycemic control.
Management of type II diabetes should also include nutritional counseling, weight reduction as needed, and exercise. These efforts are important not only in the primary treatment of type II diabetes, but also to maintain the efficacy of drug therapy.
DOSAGE AND ADMINISTRATION
The maximum recommended dose for Pioglitazone is 45 mg daily & the maximum recommended daily dose for Metformin is 2550 mg in adults. PIOMET should be given in divided daily doses with meals to reduce the gastrointestinal side effects associated with Metformin.
Starting dose for patients inadequately controlled on Metformin monotherapy Based on the usual starting dose of Pioglitazone (15-30 mg daily), PIOMET may be initiated at either the 15 mg/500 mg or 15 mg/850 mg tablet strength once or twice daily, and gradually titrated after assessing adequacy of therapeutic response.
Starting dose for patients who initially responded to Pioglitazone monotherapy and require additional glycemic control Based on the usual starting doses of Metformin (500 mg twice daily or 850 mg daily), PIOMET may be initiated at either the 15 mg/500 mg twice daily or 15 mg/850 mg tablet strength once daily, and gradually titrated after assessing adequacy of therapeutic response.
Starting dose for patients switching from combination therapy of Pioglitazone plus Metformin as separate tablets
PIOMET may be initiated with either the 15 mg/500 mg or 15 mg /850 mg tablet strengths based on the dose of Pioglitazone and Metformin already being taken.