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Merck Sharp & Dohme
[Natrapharm]
Regulatory Class: Rx
C: Per 50 mg/500 mg FC tab Sitagliptin phosphate monohydrate 64.25 mg (equiv to sitagliptin 50 mg as free base), metformin HCl 500 mg. Per 50 mg/1 g FC tab Sitagliptin phosphate monohydrate 64.25 mg (equiv to sitagliptin 50 mg as free base), metformin HCl 1 g
I: Initial therapy in Type 2 DM to improve glycemic control when diet & exercise alone do not provide adequate glycemic control, or inadequately controlled w/ metformin or sitagliptin alone or in patients being treated w/ combination of metformin & sitagliptin. As part of triple combination therapy w/ a sulfonylurea as an adjunct to diet & exercise in patients w/ type 2 DM inadequately controlled w/ any 2 of the 3 agents: metformin, sitagliptin, or a sulfonylurea. As part of triple combination therapy w/ PPAR-γ agonist as an adjunct to diet & exercise in patients w/ type 2 DM inadequately controlled w/ any 2 of the 3 agents: metformin, sitagliptin, or a PPAR-γ agonist. Type 2 DM as an adjunct to diet & exercise to improve glycemic control in combination w/ insulin.
D: Individualized dosing. Initial therapy: Starting dose 50 mg/500 mg bid. May be titrated up to 50 mg/1 g bid. Patient inadequately controlled on metformin monotherapy Sitagliptin 50 mg bid + metformin already taken. Patient inadequately controlled on sitagliptin monotherapy 50 mg/500 mg tab bid. May be titrated up to 50 mg/1 g tab bid. Patient inadequately controlled on dual combination therapy w/ any 2 of the following 3 antihyperglycemic agents: Sitagliptin, metformin or a PPAR-γ agonist (ie thiazolidinediones) Sitagliptin 50 mg bid (100 mg total daily dose). In determining the starter dose of the metformin component, the patient's level of glycemic control & current dose (if any) of metformin should be considered. Gradual dose escalation to reduce GI effects associated w/ metformin should be considered. Patient switching from sitagliptin co-administered w/ metformin Initiate w/ dose of sitagliptin & metformin already being taken. Patient inadequately controlled on dual combination therapy w/ any 2 of the following 3 antihyperglycemic agents: Sitagliptin, metformin or sulfonylurea Sitagliptin 50 mg bid (100 mg total daily dose) + metformin dose based on glycemic control level. Patients currently on or initiating sulfonylurea may require lower doses of sulfonylurea doses to reduce the risk of sulfonylurea-induced hypoglycemia. Gradual dose escalation to reduce GI effects associated w/ metformin should be considered. Patient inadequately controlled on dual combination therapy w/ any 2 of the following 3 antihyperglycemic agents: Sitagliptin, metformin or insulin Sitagliptin 50 mg bid + metformin dose based on glycemic control level & current dose (if any) of metformin. Gradual dose escalation to reduce GI effects associated w/ metformin should be considered. Patients currently on or initiating insulin therapy may require lower doses of insulin to reduce the risk of hypoglycemia.
A:
CI: Hypersensitivity to sitagliptin phosphate or metformin HCl. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, w/ or w/o coma. Discontinue treatment in patients undergoing radiologic studies. Severe renal impairment (eGFR <30 mL/min/1.73 m2). Pregnancy & lactation.
SP: Do not use in type 1 diabetes or treatment of diabetic ketoacidosis. Inform patients of the characteristic symptom of acute pancreatitis. Assess renal function before initiation of therapy & at least annually thereafter. Hypoglycemia in combination w/ sulfonylurea or insulin. Temporarily discontinue therapy at the time or prior the procedure & w/held 48 hr in patients who will be administered w/ intra-arterial iodinated contrast, w/ an eGFR ≥30-60 mL/min/1.73 m2, history of hepatic impairment, alcoholism, heart failure. Hypoxic states. Suspend therapy prior to surgical procedure until resumption of oral intake. Avoid excessive alcohol intake. Impaired hepatic function. Monitor vit B12 levels. Change in clinical status of patients w/ previously controlled type 2 diabetes. Loss of glycemic control may occur. Sitagliptin: Hypersensitivity. Discontinue if bullous pemphigoid is suspected. Metformin: Lactic acidosis. W/held in any condition associated w/ hypoxemia, dehydration or sepsis. Hypoglycemic effects in elderly, debilitated or malnourished patients, & those w/ adrenal or pituitary insufficiency or alcohol intoxication. Concomitant use of medications that may affect renal function. Childn <18 yr. Elderly.
