Metformindosage

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 escalation recommended to reduce the gastrointestinal effects due to metformin. The starting dose in patients already treated with metformin should provide sitagliptin dosed as 100 mg and the dose of metformin already being taken once daily. For patients taking metformin HCl 850 mg twice daily or 1000 mg twice daily, the recommended starting dose of JANUMET XR is two 50 mg sitagliptin and 1000 mg metformin HCl extended-release tablets once daily. Maintain the same total daily dose of sitagliptin and metformin when changing between JANUMET and JANUMET XR. Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) Do not use in patients with eGFR below 30 mL/min/1.73 m 2. Discontinue if eGFR later falls below 30 mL/min/1.73 m 2. Initiation is not recommended in patients with eGFR between 30 – 45 mL/min/1.73 m 2. Assess risk/benefit of continuing if eGFR falls below 45 mL/min/1.73 m 2. Limit dose of sitagliptin to 50 mg once daily if eGFR falls below 45 mL/min/1.73 m 2. JANUMET XR may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures.

2.1 Recommended

Dosing Take JANUMET XR orally once daily with a meal. Patients taking two JANUMET XR tablets should take the two tablets together once daily. 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 hydrochloride (HCl) extended-release. The recommended starting dose in patients not currently treated with metformin is 100 mg sitagliptin and 1000 mg metformin HCl extended-release once daily, with gradual dose escalation recommended to reduce gastrointestinal side effects associated with metformin. The starting dose in patients already treated with metformin should provide 100 mg sitagliptin and the previously prescribed dose of metformin. For patients taking metformin HCl immediate-release 850 mg twice daily or 1000 mg twice daily, the recommended starting dose of JANUMET XR is two 50 mg sitagliptin and 1000 mg metformin HCl extended-release tablets taken together once daily. Maintain the same total daily dose of sitagliptin and metformin when changing between JANUMET (sitagliptin and metformin HCl immediate-release) and JANUMET XR. Do not split, crush or chew JANUMET XR tablets.

2.2 Recommendations for

Use in Renal Impairment Assess renal function prior to initiation of JANUMET XR and periodically thereafter. JANUMET XR is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m 2. Discontinue JANUMET XR if the patient's eGFR later falls below 30 mL/min/1.73 m 2. Initiation of JANUMET XR in patients with an eGFR between 30 and 45 mL/min/1.73 m 2 is not recommended. In patients taking JANUMET XR whose eGFR later falls below 45 mL/min/1.73 m 2, assess the benefit risk of continuing therapy and limit dose of the sitagliptin component to 50 mg once daily.

2.3 Discontinuation for

Iodinated Contrast Imaging Procedures Discontinue JANUMET XR at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m 2; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart JANUMET XR if renal function is stable.