Glipita-M 50/500 Tablet

The Dosage of Glipita M 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 and 2000 mg Metformin. Initial Combination Therapy or Maintenance of Combination Therapy should be Individualized and Left to the Discretion of the Health Care Provider.
Glipita M should Generally be Given Twice Daily with Meals, with Gradual Dose Escalation, to Reduce the Gastrointestinal (GI) Side Effects Due to Metformin. The Starting Dose of Glipita M should be Based on the Patient’s Current Regimen.The Recommended Starting Dose in Patients NOT Currently Treated with Metformin is 50 mg Sitagliptin/500 mg Metformin Hydrochloride Twice Daily, with Gradual Dose Escalation Recommended to Reduce Gastrointestinal Side Effects Associated with Metformin.
The Starting Dose in Patients Already Treated with Metformin should Provide Sitagliptin Dosed as 50 mg Twice Daily (100 mg
Total Daily Dose) and the Dose of Metformin Already being Taken. For Patients Taking Metformin 850 mg Twice Daily, the Recommended Starting Dose of Glipita M is 50 mg Sitagliptin/1000 mg Metformin Hydrochloride Twice Daily. Co-Administration of Glipita M with an Insulin Secretagogue (e.g., Sulfonylurea) or Insulin may Require Lower Doses of the Insulin Secretagogue or Insulin to Reduce the Risk of Hypoglycemia.
No Studies have been Performed Specifically Examining the Safety and Efficacy of Glipita M in Patients Previously Treated with Other Oral Antihyperglycemic Agents and Switched to Glipita M. Any Change in Therapy of Type 2 Diabetes should be Undertaken with Care and Appropriate Monitoring as Changes in Glycemic Control can Occur.
Use in Elderly: Because Sitagliptin and Metformin are Substantially Excreted by the Kidney, and Because Aging can be Associated with Reduced Renal Function, Sitagliptin/Metformin HCl Combination should be Used with Caution as Age Increases. Care should be Taken in Dose Selection and should be Based on Careful and Regular Monitoring of Renal Function.