Sitaplus

Initial therapy in patients w/ type 2 DM to improve glycemic control when diet & exercise alone do not provide adequate glycemic control. Adjunct to diet & exercise to improve glycemic control in patients w/ type 2 DM inadequately controlled on sitagliptin or metformin alone or in patients already being treated w/ combination of sitagliptin & metformin. As part of triple combination therapy w/ a sulfonylurea or w/ a PPARγ agonist (ie, thiazolidinediones) as an adjunct to diet & exercise in patients w/ type 2 DM inadequately controlled w/ any 2 of 3 agents: Metformin, sitagliptin or a sulfonylurea alone or a PPARγ agonist alone. Type 2 DM as an adjunct to diet & exercise to improve glycemic control in combination w/ insulin.

Individualized dosage. Max daily dose: Sitagliptin 100 mg. Patient inadequately controlled w/ diet & exercise Starting dose: 50 mg/500 mg bid. May be titrated w/ up to 50 mg/1 g bid. Patient inadequately controlled on sitagliptin monotherapy 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 + dose of metformin already being taken. Patient inadequately controlled on dual combination therapy w/ any 2 of the following 3 antihyperglycemic agent: sitagliptin, metformin or a PPARγ agonist (ie, thiazolidinediones) Usual starting dose: Sitagliptin 50 mg bid + metformin dose based on glycemic control level. Patient inadequately controlled on dual combination therapy w/ any 2 of the following 3 antihyperglycemic agents: sitagliptin, metformin or a sulfonylurea Sitagliptin 50 mg bid + 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. 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. Patients currently on or initiating insulin therapy may require lower doses of insulin to reduce the risk of hypoglycemia.

Should be taken with food.

Hypersensitivity. Severe renal impairment (eGFR <30 mL/min/1.73 m²). Acute or chronic metabolic acidosis including diabetic ketoacidosis, w/ or w/o coma. Temporarily discontinue treatment in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials.

Do not use in type 1 diabetes or treatment of diabetic ketoacidosis. Discontinue treatment if acute pancreatitis is suspected. Risk of metformin accumulation & lactic acidosis increases w/ degree of impairment of renal function; assess renal function before initiation & at least annually thereafter. Hypoglycemia in combination w/ a sulfonylurea or w/ insulin. Metformin: Increased risk of lactic acidosis in patients w/ CHF requiring pharmacologic management particularly those w/ unstable or acute CHF who are at risk of hypoperfusion & hypoxemia. Hypoglycemic effects in elderly, debilitated, or malnourished patients, & those w/ adrenal or pituitary insufficiency or alcohol intoxication. Concomitant use w/ medications that may affect renal function or metformin disposition eg, cationic drugs. Discontinue at the time of or prior to a radiologic study involving the use of intravascular iodinated material, & withhold for 48 hr subsequent to the procedure in patients w/ eGFR ≥30 to <60 mL/min/1.73 m², history of hepatic impairment, alcoholism or heart failure or in patients who will be administered intra-arterial iodinated contrast. Discontinue if hypoxemia & prerenal azotemia occur. Temporarily suspend use prior to any surgical procedure until resumption of oral intake & renal function is acceptable. Caution in excessive alcohol intake. Routine measurement of serum vit B₁₂ level at 2- to 3-yr interval. Evaluate promptly for evidence of ketoacidosis or lactic acidosis if previously well controlled type 2 DM patient develops lab abnormalities or clinical illness (especially vague & poorly defined illness). Temporary loss of glycemic control may occur when a patient stabilized on any diabetic regimen is exposed to stress eg, fever, trauma, infection, or surgery. Hepatic impairment. Regular monitoring of renal function especially in elderly. Not recommended during pregnancy. No studies have been conducted in lactation. Safety & effectiveness in ped patients <18 yr has not been established.

Metformin HCl: Diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, headache.

Metformin HCl: Increased plasma conc w/ furosemide, nifedipine. Increased systemic exposure to metformin & risk for lactic acidosis in concomitant use w/ drugs that interfere w/ common renal tubular transport systems involved in renal elimination of metformin (eg, OCT2/MATE inhibitors eg, ranolazine, vandetanib, dolutegravir & cimetidine). May lead to loss of glycemic control w/ drugs producing hyperglycemia eg, thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca channel blockers & INH.

Antidiabetic Agents

A10BD07 - metformin and sitagliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

Rx