Janumet XR Description

JANUMET XR 50 mg/500 mg (sitagliptin phosphate/metformin HCl extended-release) Film-coated Tablets: Light blue, bi-convex oval, film coated tablet, debossed "78" on one side and plain on the other.
JANUMET XR 50 mg/1000 mg (sitagliptin phosphate/metformin HCl extended-release) Film-coated Tablets: Light green, bi-convex oval, film coated tablet, debossed "80" on one side and plain on the other.
JANUMET XR 100 mg/1000 mg (sitagliptin phosphate/metformin HCl extended-release) Film-coated Tablets: Blue, bi-convex oval, film coated tablet, debossed "81" on one side and plain on the other.
JANUMET XR consists of an extended-release metformin core tablet coated with an immediate release layer of sitagliptin. The sitagliptin layer is coated with a soluble polymeric film that provides taste masking.
JANUMET XR is available for oral administration as tablets containing 64.25 mg sitagliptin phosphate monohydrate (equivalent to 50 mg sitagliptin as free base) and either 500 mg metformin hydrochloride extended-release (JANUMET XR 50 mg/500 mg), or 1000 mg metformin hydrochloride extended-release (JANUMET XR 50 mg/1000 mg). Additionally, JANUMET XR is available for oral administration as tablets containing 128.5 mg sitagliptin phosphate monohydrate (equivalent to 100 mg sitagliptin as free base) and 1000 mg metformin hydrochloride extended-release (100 mg/1000 mg).
Excipients/Inactive Ingredients: All doses of JANUMET XR contain the following inactive ingredients: povidone, hypromellose, colloidal silicon dioxide, sodium stearyl fumarate, propyl gallate, polyethylene glycol, and kaolin. The JANUMET XR 50 mg/500 mg tablet contains the additional inactive ingredient microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: hypromellose, hydroxypropyl cellulose, titanium dioxide, FD&C Blue #2/Indigo Carmine Aluminum Lake and carnauba wax. The JANUMET XR 50 mg/1000 mg tablet contains the additional inactive ingredient yellow iron oxide.