JANUMET XR tablets for oral use contain two antihyperglycemic medications: sitagliptin and metformin extended-release. Sitagliptin Sitagliptin is an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate drug substance is used to manufacture JANUMET XR. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-α]pyrazine phosphate (1:1)...

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JANUMET ® XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JANUMET XR is a combination of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Not for the treatment of type 1 diabetes. Has not been studied in patients with a history of pancreatiti...

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Tablets: sitagliptin 100 mg and metformin HCl 1000 mg extended-release tablets are blue, bi-convex oval, film-coated tablets with “81” debossed on one side. sitagliptin 50 mg and metformin HCl 500 mg extended-release tablets are light blue, bi-convex oval, film-coated tablets with “78” debossed on one side. sitagliptin 50 mg and metformin HCl 1000 mg extended-release tablets are light green, bi-convex oval, film-coated tablets with “80” debossed on one side. JANUMET XR Tablets: sitagliptin 100 mg a...

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Take JANUMET XR orally once daily with a meal. Patients taking two JANUMET XR tablets should take the tablets together. Individualize the dosage of JANUMET XR on the basis of the patient’s current regimen, effectiveness, and tolerability. The maximum recommended daily dose is 100 mg of sitagliptin and 2000 mg of metformin HCl extended-release. The recommended starting dose in patients not currently treated with metformin is 100 mg sitagliptin and 1000 mg metformin HCl once daily, with gradual dose e...

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JANUMET XR is contraindicated in patients with: Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) . Acute or chronic metabolic acidosis, including diabetic ketoacidosis. History of a serious hypersensitivity reaction to JANUMET XR, sitagliptin, or metformin such as anaphylaxis or angioedema. [See Warnings and Precautions ; Adverse Reactions . ] Severe renal impairment: eGFR below 30 mL/min/1.73 m 2 . Metabolic acidosis, including diabetic ketoacidosis. History of a serious hypersensitivity rea...

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In the event of overdose with JANUMET XR, contact the Poison Control Center. In the event of an overdose, it is reasonable to employ supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy as indicated by the patient's clinical status. Sitagliptin is modestly dialyzable. In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour hemodialys...

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Lactic Acidosis: See boxed warning . Pancreatitis: There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis in patients treated with sitagliptin. If pancreatitis is suspected, promptly discontinue JANUMET XR. Heart Failure: Has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of JANUMET XR in patients who have known risk factors for heart failure. Monitor patients for signs and symp...

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The limited available data with JANUMET XR in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy . No adverse developmental effects were observed when sitagliptin was administered to pregnant rats...

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