Lupigliptin Plus Dosage/Direction for Use

The dosage of antihyperglycemic therapy with Sitagliptin + Metformin HCl should be individualized on the basis of the patient's current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin.
Sitagliptin + Metformin HCl should generally be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal (GI) side effects associated with metformin.
Dosing Recommendations: The starting dose of Sitagliptin phosphate + Metformin HCl should be on the patient's current regimen. Sitagliptin phosphate + Metformin HCl should be given twice daily meals. The following doses are available: 50 mg Sitagliptin phosphate/500 mg Metformin HCl; 50 mg Sitagliptin phosphate/850 mg Metformin HCl; 50 mg Sitagliptin phosphate/1 g Metformin HCl.
As initial therapy: For patients with type 2 diabetes mellitus, whose hyperglycemia is inadequately controlled with diet and exercise alone, the recommended starting dose of Sitagliptin phosphate + Metformin HCl is 50 mg sitagliptin/500 mg metformin hydrochloride twice daily. Patients may be titrated up to 50 mg Sitagliptin phosphate/1 g Metformin HCl twice daily.
For patients inadequately controlled on sitagliptin monotherapy: For patients inadequately controlled on sitagliptin alone, the usual starting dose of Sitagliptin phosphate + Metformin HCl is 50 mg Sitagliptin phosphate/500 mg Metformin HCl twice daily. Patients may be titrated up to 50 mg Sitagliptin phosphate/1 g Metformin HCl twice daily. Patients taking sitagliptin monotherapy dose-adjusted for renal insufficiency should not be switched to Sitagliptin phosphate + Metformin HCl.
For patients inadequately controlled on metformin monotherapy: For patients not adequately controlled on metformin alone, the usual starting dose of Sitagliptin phosphate + Metformin HCl should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.
For patients inadequately controlled on dual combination therapy with any two of the following three antihyperglycemic agent: sitagliptin, metformin or a PPARγ agonist (i.e., thiazolidinediones): The usual starting dose of Sitagliptin phosphate + Metformin HCl should provide sitagliptin dosed at 50 mg twice daily (100 mg total daily dose). In determining the starting dose of the metformin component, the patient's level of glycemic control and current dose (if any) of metformin should be considered. Gradual dose escalation to reduce the gastrointestinal (GI) side effects associated with metformin should be considered.
For patients inadequately controlled on dual combination therapy with any two of the following three antihyperglycemic agents: metformin, sitagliptin or a sulfonylurea: The usual starting dose of Sitagliptin phosphate + Metformin HCl should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose). In determining the starting dose of the metformin component, the patient's level of glycemic control and current dose (if any) of metformin should be considered. Gradual dose escalation to reduce the gastrointestinal (GI) side effects associated with metformin should be considered. Patients currently on or initiating a sulfonylurea may require lower sulfonylurea doses to reduce the risk of sulfonylurea-induced hypoglycemia.
For patients inadequately controlled on dual combination therapy with any two of the following three antihyperglycemic agents: metformin, sitagliptin or insulin: The usual starting dose of Sitagliptin phosphate + Metformin HCl should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose). In determining the starting dose of the metformin component, the patient's level of glycemic control and current dose (if any) of metformin should be considered. Gradual dose escalation to reduce the gastrointestinal (GI) side effects associated with metformin should be considered. Patents currently on or initiating insulin therapy may require lower doses of insulin to reduce the risk of hypoglycemia.
No studies have been performed specifically examining the safety and efficacy of Sitagliptin phosphate + Metformin HCl in patients previously treated with other oral antihyperglycemic agents and switched to Sitagliptin phosphate + Metformin HCl. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.
Mode of Administration: Sitagliptin phosphate + Metformin HCl is available for oral administration as tablets. It should generally be given twice daily with meals.