Lupigliptin Plus

Per 50 mg/500 mg FC tab Sitagliptin phosphate monohydrate 50 mg, metformin HCl 500 mg. Per 50 mg/1 g FC tab Sitagliptin phosphate monohydrate 50 mg, metformin HCl 1 g

Type 2 DM as initial therapy to improve glycemic control when diet & exercise alone do not provide adequate glycemic control. Type 2 DM as adjunct to diet & exercise to improve glycemic control in patients who cannot be controlled w/ metformin or sitagliptin 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 (eg, thiazolidinediones) as an adjunct to diet & exercise in patients w/ type 2 DM inadequately controlled w/ any 2 of 3 agents: sitagliptin, metformin, 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.

Starting dose 50 mg/500 mg bid. May be titrated w/ sitagliptin 50 mg + metformin 1,000 mg bid. Patient inadequately controlled on sitagliptin monotherapy 50 mg/500 mg tab bid. May be titrated up to 50 mg/1,000 mg tab bid. Patient inadequately controlled on metformin monotherapy Sitagliptin 50 mg bid + metformin already taken. Patient inadequately controlled on dual combination therapy w/ any 2 of the following 3 antihyperglycemic agents: Sitagliptin, metformin or thiazolidinediones Usual starting dose: 50 mg bid (100 mg total daily dose). In determining the starting dose of the metformin component, the patient's level of glycemic control & current dose (if any) of metformin should be considered. Patient inadequately controlled on dual combination therapy w/ any 2 of the following 3 antihyperglycemic agents: Metformin, sitagliptin or 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. Gradual dose escalation to reduce GI effects associated w/ metformin. Patient inadequately controlled on dual combination therapy w/ any 2 of the following 3 antihyperglycemic agents: metformin, sitagliptin or insulin Sitagliptin 50 mg bid + metformin dose based on glycemic control level & current dose (if any) of metformin. Gradual dose escalation to reduce the GI side 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.

Should be taken with food.

Hypersensitivity. 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. Severe renal impairment (eGFR <30 mL/min/1.73 m²).

Do not use in type 1 diabetes or treatment of diabetic ketoacidosis. Acute pancreatitis, fatal & non-fatal hemorrhagic or necrotizing pancreatitis w/c is persistent, severe abdominal pain. Risk of metformin accumulation & lactic acidosis increases w/ degree of impairment of renal function. Not recommended in patients w/ eGFR <30 mL/min/1.73 m². Hypoglycemia in combination w/ insulin or sulfonylurea. Hypoglycemic effects in elderly, debilitated, or malnourished patients, & those w/ adrenal or pituitary insufficiency or alcohol intoxication. Concomitant use of cationic drugs that are eliminated by renal tubular secretion. Discontinue prior to & w/hold for 48 hr subsequent to an iodinated contrast imaging 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. Acute CHF, acute MI & other conditions characterized by hypoxemia. Suspend therapy prior to surgical procedure until resumption of oral intake & renal function is acceptable. Avoid excessive alcohol intake. Impaired hepatic function. Monitor vit B₁₂ level. Evaluate patient for ketoacidosis or lactic acidosis. W/hold therapy if fever, trauma, infection or surgery, temporary loss of glycemic control may occur. Monitor renal function especially in elderly. Pregnancy & lactation. Childn <18 yr.

Diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort & headache.

Metformin HCl: Decrease in AUC & C_max w/ glyburide. Increased plasma conc w/ furosemide, nifedipine. Increased systemic exposure to metformin & risk for lactic acidosis in concomitant 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