Janumet

Per 50/500 mg FC tab Sitagliptin phosphate 50 mg, metformin HCl 500 mg. Per 50/850 mg FC tab Sitagliptin phosphate 50 mg, metformin HCl 850 mg. Per 50/1,000 mg FC tab Sitagliptin phosphate 50 mg, metformin HCl 1,000 mg

Initial therapy in type 2 DM when diet & exercise do not provide adequate glycemic control. Adjunct to diet & exercise to improve glycemic control in type 2 DM inadequately controlled on metformin or sitagliptin alone, or combination of sitagliptin & metformin, or triple combination therapy w/ sulfonylurea, or max tolerated dose of metformin & PPARγ agonist, or insulin & metformin alone.

Individualized dosage not exceeding max recommended daily dose: Sitagliptin 100 mg. Patient w/ type 2 DM inadequately controlled w/ diet & exercise alone; inadequalely controlled on sitagliptin monotherapy Initially sitagliptin 50 mg/metformin HCl 500 mg bd, may be titrated up to sitagliptin 50 mg/metformin HCl 1,000 mg bd. Patient inadequately controlled on metformin monotherapy; inadequately controlled on dual combination therapy w/ max metformin dose & PPARγ agonist or insulin Initially sitagliptin 50 mg bd + metformin dose already being taken. Switching from co-administration of sitagliptin & metformin May be initiated at previously prescribed dose. Patient inadequately controlled on dual combination therapy w/ any 2 of sitagliptin, metformin or sulfonylurea Initially sitagliptin 50 mg bd. Determine metformin dose based on glycemic control level & current dose. Max daily dose: Renal impairment eGFR 60-89 mL/min Metformin 3,000 mg, sitagliptin 100 mg, 45-59 mL/min Metformin 2,000 mg (initial dose: ½ max dose), sitagliptin 100 mg, 30-44 mL/min Metformin 1,000 mg (initial dose: ½ max dose), sitagliptin 50 mg, <30 mL/min Sitagliptin 25 mg.

Should be taken with food.

Hypersensitivity. Acute or chronic metabolic acidosis including lactic acidosis, diabetic ketoacidosis w/ or w/o coma. Intravascular administration of iodinated contrast materials. Severe renal impairment (eGFR <30 mL/min/1.73 m²).

Not to be used in type 1 DM or diabetic ketoacidosis. Discontinue use if hypersensitivity reaction, bullous pemphigoid, pancreatitis are suspected; lactic acidosis is confirmed; CV collapse, acute CHF & MI, other conditions characterized by hypoxemia occur. Avoid use in patients w/ clinical or lab evidence of hepatic disease. Hypoglycemia due to deficient caloric intake, strenuous exercise uncompensated by caloric supplementation, concomitant use w/ other glucose-lowering agents eg, sulfonylureas, insulin; ethanol. Diabetic patient w/ metabolic acidosis lacking evidence of ketoacidosis (ketonuria & ketonemia). Severe & disabling arthralgia; adrenal or pituitary insufficiency; loss of blood glucose control. Assess renal function prior to & at least annually thereafter. Evaluate & monitor serum electrolytes, ketones, lactate, blood glucose, pH & metformin levels. Measure hematologic parameters annually; routine serum vit B₁₂ at 2-3 yr interval. Discontinue use prior to, during & withheld for 48 hr for any intravascular radiocontrast study or surgical procedures. Avoid excessive alcohol intake. Concomitant use w/ β-adrenergic blockers; drugs affecting renal function or metformin disposition eg, cationic drugs eliminated by renal tubular secretion. Renal impairment. Not recommended during pregnancy. Not to be used during lactation. Childn <18 yr. Elderly, debilitated or malnourished patients.

Diarrhea, nausea, dyspepsia, flatulence, vomiting, headache, hypoglycemia; abdominal pain & discomfort, constipation, URTI, cough, fungal skin infection, peripheral edema, nasopharyngitis, asthenia, indigestion.

Sitagliptin: Increased AUC & C_max of digoxin. Increased AUC & C_max w/ cyclosporine. Metformin: Decreased AUC & C_max of glyburide. Increased plasma, blood C_max & AUC w/ furosemide. Enhanced absorption w/ nifedipine. Increased systemic exposure & risk of lactic acidosis w/ drugs interfering w/ common renal tubular transport systems eg, organic cationic transporter-2/multidrug & toxin extrusion inhibitors eg, ranolazine, vandetanib, dolutegravir, cimetidine. Hyperglycemia & loss of glycemic control w/ thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OC, 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.

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