Reditn M Dosage/Direction for Use

Recommended Dose: General: The dosage of antihyperglycemic therapy with Sitagliptin + metformin 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 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 + metformin should be based on the patient's current regimen.
Sitagliptin + metformin should be given twice daily with meals. The following doses are available: 50 mg sitagliptin/500 mg metformin hydrochloride; 50 mg sitagliptin/1000 mg metformin hydrochloride.
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 + metformin is 50 mg sitagliptin/500 mg metformin hydrochloride twice daily. Patients may be titrated up to 50 mg sitagliptin/1000 mg metformin hydrochloride twice daily.
For patients inadequately controlled on metformin monotherapy: For patients inadequately controlled on metformin alone, the usual starting dose of Sitagliptin + metformin 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 sitagliptin monotherapy: For patients inadequately controlled on sitagliptin alone, the usual starting dose of Sitagliptin + metformin is 50 mg sitagliptin/500 mg metformin hydrochloride twice daily. Patients may be titrated up to 50 mg sitagliptin/1000 mg metformin hydrochloride twice daily.
Patients taking sitagliptin monotherapy dose-adjusted for renal insufficiency should not be switched to sitagliptin + metformin.
For patients switching from coadministration of sitagliptin and metformin: For patients switching from coadministration of sitagliptin and metformin, sitagliptin + metformin may be initiated at the dose of sitagliptin and metformin already being taken.
For patients inadequately controlled on dual combination therapy with any two of the following three antihyperglycemic agents: sitagliptin, metformin or a sulfonylurea: The usual starting dose of Sitagliptin + metformin 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: sitagliptin, metformin or a PPARγ agonist (i.e. thiazolidinediones): The usual starting dose of Sitagliptin + metformin 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.
For patients inadequately controlled on dual combination therapy with any two of the following three antihyperglycemic agents: sitagliptin, metformin or insulin: The usual starting dose of Sitagliptin + metformin 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 insulin therapy may require lower doses of insulin to reduce the risk of hypoglycemia (see Precautions). No studies have been performed specifically examining the safety and efficacy of Sitagliptin + metformin in patients previously treated with other oral antihyperglycemic agents and switched to Sitagliptin + metformin. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.
Recommendations for use in renal impairment: Assess renal function prior to initiation of Sitagliptin + metformin and periodically thereafter.
Sitagliptin + metformin is contraindicated in patients with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m². Sitagliptin + metformin is not recommended in patients with an eGFR ≥30 mL/min/1.73 m² and <45 mL/min/1.73 m² because these patients require a lower dosage of sitagliptin than what is available in the fixed combination Sitagliptin + metformin product.
Discontinuation for iodinated contrast imaging procedures: Discontinue Sitagliptin + metformin at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR ≥30 to <60 mL/min/1.73 m²; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart Sitagliptin + metformin if renal function is acceptable.
Mode of Administration: Oral use, Sitagliptin + metformin should be given twice daily with meals.