metformin + sitagliptin


CCL Pharma


Concise Prescribing Info
Per 50/500 mg Sitagliptin 50 mg, metformin HCl 500 mg. Per 50/1,000 mg Sitagliptin 50 mg, metformin HCl 1,000 mg
Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 diabetes.
Dosage/Direction for Use
Individualized dosage not exceeding max daily dose sitagliptin 100 mg & metformin 2,000 mg. Patient inadequately controlled on metformin monotherapy Initially sitagliptin 50 mg bd plus the current dose of metformin. Patient taking metformin 850 mg bd: 50 mg/metformin 1,000 mg bd. Patient inadequately controlled on sitagliptin monotherapy Initially sitagliptin 50 mg/metformin 500 mg bd. Dose may be titrated up to sitagliptin 50 mg/metformin 1,000 mg bd. Patient inadequately controlled on dual combination therapy w/ any 2 of the following antihyperglycemic agents: sitagliptin, metformin, or a sulfonylurea Usual starting dose: 50 mg bd. Patient inadequately controlled w/ diet & exercise alone Initially sitagliptin 50 mg/metformin 500 mg bd. May be titrated up to sitagliptin 50 mg/metformin 1,000 mg bd. Patient switching from sitagliptin coadministered w/ metformin May be initiated w/ the dose of sitagliptin & metformin already being taken.
Should be taken with food.
Hypersensitivity. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, w/ or w/o coma. Renal impairment.
Special Precautions
Hypersensitivity reactions eg, anaphylaxis, angioedema & exfoliative skin conditions including Stevens-Johnson syndrome. Discontinue if lactic acidosis or pancreatitis is suspected; any condition characterized by hypoxemia eg, acute CHF, MI. Temporarily suspend treatment for any surgical procedure. Metformin may decrease vit B12 levels. Periodically measure blood glucose & HbA1c levels. Monitor hematologic parameters & renal function initially & at least annually thereafter. Patients w/ adrenal or pituitary insufficiency or alcohol intoxication are susceptible to hypoglycemic effects. Promptly evaluate patients w/ previously well-controlled type 2 diabetes who develop ketoacidosis or lactic acidosis. Avoid in patients w/ clinical or laboratory incidence of hepatic disease. Renal dysfunction. Pregnancy & lactation. Childn. Debilitated, malnourished or elderly patients.
Adverse Reactions
Headache; diarrhea, nausea, abdominal pain, vomiting, acute pancreatitis, including fatal & nonfatal hemorrhagic & necrotizing pancreatitis; angioedema, cutaneous vasculitis, exfoliative skin conditions including Stevens-Johnson syndrome, hypersensitivity; hypoglycemia; upper resp tract infection; hepatic enzyme elevations.
Drug Interactions
May increase AUC & Cmax of digoxin. Closely monitor to maintain adequate glycemic control of patients concomitantly taking drugs that produce hyperglycemia eg, Ca channel blockers, corticosteroids, diuretics [eg, thiazides], estrogen, hormonal contraceptives, INH, nicotinic acid, phenothiazines, phenytoin, sympathomimetics, thyroid products. May decrease AUC and Cmax of glyburide. Increased risk of hypoglycemia w/ meglitinides [eg, nateglinide, repaglinide], & sulfonylureas. Metformin: Potentiated hypoglycemic effects & effects on lactic acidosis w/ alcohol. May compete for renal tubular transport w/ cationic drugs  eg, amiloride, digoxin, morphine, procainamide, quinidine, ranitidine, triamterene, trimethoprim & vancomycin. Increased plasma levels w/ cimetidine. Decreased extent of & slightly delayed absorption w/ food. Increased AUC & Cmax w/ furosemide, decreased AUC & Cmax of furosemide. Increased AUC & Cmax w/ nifedipine. Decreased GFR & increased risk of lactic acidosis w/ NSAIDs eg, indomethacin & rofecoxib. Increased risk of lactic acidosis w/ parenteral iodinated contrast media. Sitagliptin: Increased AUC & Cmax w/ cyclosporine.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BD07 - metformin and sitagliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.
Sita-Met 50/1000 mg FC tab
2 × 7's
Sita-Met 50/500 mg FC tab
2 × 7's
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