INDICATIONS AND USAGE:
PIOGLIT MET is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 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 2 diabetes should also include nutritional counseling, weight reduction as needed, and exercise. These efforts are important not only in the primary treatment of type 2 diabetes, but also to maintain the efficacy of drug therapy.
PIOGLIT MET is contraindicated in patients with:
1. Renal disease or renal dysfunction which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia.
2. Known hypersensitivity to pioglitazone, metformin or any other component of PIOGLIT MET.
3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
The most common adverse events reported were upper respiratory tract infection, diarrhea, combined edema/peripheral edema and headache.
Other adverse events reported included myalgia, tooth disorder, diabetes mellitus aggravated and pharyngitis.
Anemia was reported with pioglitazone plus metformin.
Edema was reported with pioglitazone. Most of these events were considered mild or moderate in intensity.
Pioglitazone hydrochloride: In the event of overdosage, appropriate supportive treatment should be initiated according to patient's clinical signs and symptoms.
Metformin hydrochloride: Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated metformin from patients in whom metformin overdosage is suspected.
DOSAGE AND ADMINISTRATION:
- General: The use of antihyperglycemic therapy in the management of type 2 diabetes should be individualized on the basis of effectiveness and tolerability while not exceeding the maximum recommended daily dose of pioglitazone 45 mg and metformin 2550 mg.
- Dosage Recommendations: Selecting the starting dose of PIOGLIT MET should be based on the patient's current regimen of pioglitazone and/or metformin. PIOGLIT MET 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), PIOGLIT MET 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), PIOGLIT MET 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
PIOGLIT MET 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.
Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.
Maximum Recommended Dose
The maximum recommended dose for pioglitazone is 45 mg daily. The maximum recommended daily dose for metformin is 2550 mg in adults.
Boxes of 30 or 60 or 180 film coated tablets.