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JANUMET XR (sitagliptin phosphate/metformin HCl extended-release) is contraindicated in patients with: 1. Severe renal impairment (eGFR < 30 mL/min/1.73 m2) (see JANUMET XR: Monitoring of renal function under PRECAUTIONS).
2. Known hypersensitivity to sitagliptin phosphate, metformin hydrochloride or any other component of JANUMET XR (see Sitagliptin phosphate: Hypersensitivity Reactions under PRECAUTIONS and Postmarketing Experience under ADVERSE REACTIONS).
3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
JANUMET XR should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because the use of such products may result in acute alteration of renal function (see Metformin hydrochloride under PRECAUTIONS).
