Janumet XR

Per 50/500 mg FC tab Sitagliptin 50 mg, metformin HCl ER 500 mg. Per 50/1,000 mg FC tab Sitagliptin 50 mg, metformin HCl ER 1,000 mg. Per 100/1,000 mg FC tab Sitagliptin 100 mg, metformin HCl ER 1,000 mg

Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM.

Individualize dose based on patient's current regimen, effectiveness, & tolerability. Max daily dose: 100 mg sitagliptin & 2,000 mg metformin HCl ER. Patient not currently treated w/ metformin Starting dose: 100 mg sitagliptin & 1,000 mg metformin HCl ER once daily, w/ gradual dose escalation to reduce GI side effects. Patient already treated w/ metformin Starting dose: 100 mg sitagliptin & previously prescribed metformin dose. Patient taking metformin HCl IR 850 mg bd or 1,000 mg bd Starting dose: 2 tab of 50 mg sitagliptin & 1,000 mg metformin HCl ER taken together once daily.

Should be taken with food: Do not split/crush/chew.

History of serious hypersensitivity reaction (eg, anaphylaxis or angioedema). Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Severe renal impairment (eGFR <30 mL/min/1.73 m²).

Should not be used in patients w/ type 1 DM. Risk of metformin-associated lactic acidosis. Immediately discontinue treatment if metformin-associated lactic acidosis is suspected. Assess renal function prior to treatment initiation & at least annually thereafter. Assess renal function more frequently in elderly patients. Treatment initiation is not recommended in patients w/ eGFR 30-45 mL/min/1.73 m². Assess benefit/risk of continuing therapy if eGFR falls <45 mL/min/1.73 m², & limit dose of sitagliptin component to 50 mg once daily. Discontinue treatment if eGFR falls <30 mL/min/1.73 m². Intravascular administration of iodinated contrast agents may lead to contrast-induced nephropathy, resulting in metformin accumulation & increased risk of lactic acidosis. Discontinue treatment prior to or at the time of imaging procedure & do not restart treatment until at least 48 hr after, provided that renal function has been re-evaluated & found to be stable. Temporarily discontinue treatment while patients have restricted food & fluid intake during surgical or other procedures. Discontinue treatment in case of hypoxic states. Avoid excessive alcohol intake while on treatment. Avoid use in patients w/ clinical or lab evidence of hepatic disease. Risk of acute pancreatitis. Promptly discontinue treatment if pancreatitis is suspected. Has not been studied in patients w/ history of pancreatitis. Risk of subnormal serum vit B₁₂ levels associated w/ metformin. Measurement of hematologic parameters on an annual basis is advised while on treatment. Promptly evaluate for evidence of ketoacidosis or lactic acidosis in patients w/ type 2 diabetes previously well controlled on Janumet XR who develop lab abnormalities or clinical 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. Discontinue treatment if a hypersensitivity reaction is suspected. Caution in patients w/ history of angioedema to another dipeptidyl peptidase-4 (DPP4) inhibitor. Risk of bullous pemphigoid. Discontinue treatment if bullous pemphigoid is suspected. No clinical studies establishing conclusive evidence of macrovascular risk reduction w/ Janumet XR or any other antidiabetic drug. Pregnancy & lactation. Safety & effectiveness have not been established in ped patients.

Diarrhea, URTI, headache; nausea, vomiting, abdominal pain.

Concomitant use w/ topiramate or other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide) may increase risk of lactic acidosis. Concomitant use w/ drugs that interfere w/ common renal tubular transport systems involved in the renal elimination of metformin (eg, OCT2/MATE inhibitors eg, ranolazine, vandetanib, dolutegravir, cimetidine) may increase risk of lactic acidosis. Alcohol potentiates the effect of metformin on lactate metabolism. Co-administration w/ an insulin secretagogue (eg, sulfonylurea) or insulin increases risk of hypoglycemia. Co-administration w/ thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca channel blockers, & INH may lead to loss of glycemic control.

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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