Janumet XR Dosage/Direction for Use

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 HCI 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 HCI 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.
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 m². Discontinue JANUMET XR if the patient's eGFR later falls below 30 mL/min/1.73 m² (see Contraindications and Lactic Acidosis under Precautions).
Initiation of JANUMET XR in patients with an eGFR between 30 and 45 mL/min/1.73 m² is not recommended.
In patients taking JANUMET XR whose eGFR later falls below 45 mL/min/1.73 m², assess the benefit risk of continuing therapy and limit dose of the sitagliptin component to 50 mg once daily.
An eGFR should be assessed before initiation of treatment with metformin-containing products and at least annually thereafter. In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g., every 3-6 months.
If no adequate strength of JANUMET XR is available, individual monocomponents should be used instead of the fixed-dose combination. (See Table 5.)

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Discontinuation for Iodinated Contrast Imaging Procedures: Intravascular administration of iodinated contrast agents may lead to contrast-induced nephropathy, resulting in metformin accumulation and an increased risk of lactic acidosis. JANUMET XR should be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see Lactic Acidosis under Precautions).