Description : Per 50 mg/1,000 mg tab Sitagliptin phosphate monohydrate 64.25 mg (equiv to sitagliptin 50 mg as free base), metformin HCl 1,000 mg
Indications / Uses : 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 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 PPAR? 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 PPAR? agonist alone. Type 2 DM as an adjunct to diet & exercise to improve glycemic control in combination w/ insulin; sitagliptin & metformin.
Administration : Should be taken with food.
Contraindications : Hypersensitivity. Renal disease or dysfunction, which may also result from conditions eg, CV collapse (shock), acute MI & septicemia. Acute or chronic metabolic acidosis including diabetic ketoacidosis, w/ or w/o coma. Discontinue treatment in patients undergoing radiologic studies.
Special Precautions :
Patients should be informed of the characteristic symptom of acute pancreatitis, fatal & non-fatal hemorrhagic or necrotizing pancreatitis & persistent, severe abdominal pain. Risk of metformin accumulation & lactic acidosis increases w/ degree of impairment of renal function, renal function should be assessed & monitored regularly. Hypoglycemia in combination w/ a sulfonylurea or w/ insulin. Discontinue if hypersensitivity reactions occur eg, anaphylaxis, angioedema, exfoliative skin conditions including Stevens-Johnson syndrome. Use min effective dose of metformin to reduce risk of lactic acidosis. Hypoglycemia, debilitated/malnourished patients. Concomitant use of cationic drugs that are eliminated by renal tubular secretion. Intravascular contrast studies w/ iodinated materials may lead to acute alteration of renal functions & have been associated w/ lactic acidosis in patients receiving metformin. Heart failure, unstable or acute CHF at risk of hypoperfusion & hypoxemia. Suspend therapy prior to surgical procedure until resumption of oral intake. Avoid excessive alcohol intake. Impaired hepatic function. Monitor vit B12 level. W/hold therapy if fever, trauma, infection or surgery, temporary loss of glycemic control may occur. Monitor renal function esp in elderly =80 yr. Childn <18 yr.