"The new formulation, meant to be used as an adjunct to diet and exercise to improve glycemic control, combines sitagliptin (the active component of Januvia [Merck]), with extended-release metformin.

FDA approval was based on a clinical bioequivalence study showing that the new tablets were equivalent to coadministration of corresponding doses of the 2 individual medications, sitagliptin and metformin HCl extended release.

The manufacturer advises physicians to maintain the same total daily dose of sitagliptin and metformin when changing between Janumet and Janumet XR, and to titrate the dose up gradually to the maximum recommended dose to reduce gastrointestinal adverse effects.

The new extended-release tablets should be taken once daily with food (preferably in the evening) to reduce the gastrointestinal adverse effects associated with the metformin component. Patients should be warned that the tablets must not be split, broken, crushed, or chewed before swallowing, the company said."

SOURCE: http://www.clinicaladvisor.com/janumet-xr-approved-for-type-2-diabetes/article/226350/