Sitaphil Plus

Metformin HCl, sitagliptin phosphate

Adults w/ type 2 DM as adjunct to diet & exercise in patients inadequately controlled on maximal tolerated dose of metformin alone or those already being treated in combination w/ sitagliptin & metformin. In combination w/ sulfonylurea as an adjunct to diet & exercise in patients inadequately controlled on maximal tolerated dose of metformin & sulfonylurea. In triple combination therapy w/ peroxisome proliferator-activated receptor γ (PPARγ) agonist (eg, thiazolidinedione) as an adjunct to diet & exercise in patients inadequately controlled on maximal tolerated dose of metformin & PPARγ agonist. As add-on to insulin (eg, triple combination therapy) as an adjunct to diet & exercise to improve glycemic control in patients when stable dose of insulin & metformin alone do not provide adequate glycemic control.

Individualized dosage. Patient inadequately controlled on metformin monotherapy Total daily starting dose: Sitagliptin 100 mg + previously prescribed dose of metformin. Patient switching from co-administration of sitagliptin & metformin May be initiated w/ previously prescribed dose of sitagliptin & metformin. Patient inadequately controlled on dual combination therapy w/ any 2 of the following 3 antihyperglycemic agents: metformin, PPARγ agonist or sulfonylurea Initially sitagliptin 100 mg total daily dose + metformin dose based on glycemic control level & current dose (if any) of metformin. Patients currently on or initiating sulfonylurea therapy may require lower sulfonylurea doses to reduce the risk of sulfonylurea-induced hypoglycemia. Patient inadequately controlled on dual combination therapy w/ any 2 of the following 3 antihyperglycemic agents: sitagliptin, metformin or a PPARγ agonist (ie, thiazolidinediones) Initially sitagliptin 100 mg total daily dose + metformin dose based on glycemic control level & current dose (if any) of metformin. Consider gradual dose escalation to reduce GI effects associated w/ metformin. Patient inadequately controlled on dual combination therapy w/ insulin Initially sitagliptin 100 mg total daily dose + metformin current dose. Patients currently on or initiating insulin therapy may require lower insulin doses to reduce the risk of hypoglycemia.

Should be taken with food.

Hypersensitivity. Any type of acute metabolic acidosis (eg, lactic acidosis, diabetic ketoacidosis); diabetic pre-coma; severe renal failure (GFR <30 mL/min); acute conditions w/ potential to alter renal function eg, dehydration, severe infection, shock, intravascular administration of iodinated contrast agents; acute or chronic disease which may cause tissue hypoxia eg, cardiac or resp failure, recent MI, shock; hepatic impairment; acute alcohol intoxication, alcoholism; lactation.

Do not use in patients w/ type 1 diabetes & for treatment of diabetic ketoacidosis. Risk of developing acute pancreatitis; history of pancreatitis. Discontinue if pancreatitis is suspected & if confirmed treatment should not be restarted. Lactic acidosis may occur. Risk of hypoglycemia when used in combination w/ sulfonylurea or insulin. Concomitant use w/ medicines that can acutely impair renal function (eg, antihypertensives, diuretics & NSAIDs). Patients w/ GFR <30 mL/min. Pregnancy. Childn & adolescents <18 yr.

Hypoglycemia; diarrhea, flatulence, vomiting.

Increased risk of lactic acidosis w/ alcohol, NSAIDs, including selective COX II inhibitors, ACE inhibitors, AIIA & diuretics, especially loop diuretics. Metformin: Increased systemic exposure w/ organic cationic transporter-2 (OCT2)/multidrug and toxin extrusion (MATE) inhibitors eg, ranolazine, vandetanib, dolutegravir, and cimetidine.

Antidiabetic Agents

Rx