JENTADUETO tablets contain 2 oral antihyperglycemic drugs
used in the management of type 2 diabetes mellitus: linagliptin and metformin
Linagliptin is an orally-active inhibitor of the dipeptidyl
peptidase-4 (DPP-4) enzyme.
Linagliptin is described chemically as 1H-Purine-2,6-dione,
The empirical formula is C25H28N8O2
and the molecular weight is 472.54 g/mol. The structural formula is:
Linagliptin is a white to
yellowish, not or only slightly hygroscopic solid substance. It is very
slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca.
60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble
in isopropanol ( < 1 mg/mL), and very slightly soluble in acetone (ca. 1
Metformin hydrochloride (N,N-dimethylimidodicarbonimidic
diamide hydrochloride) is not chemically or pharmacologically related to any
other classes of oral antihyperglycemic agents. Metformin hydrochloride is a
white to off-white crystalline compound with a molecular formula of C4H11N5•HCl
and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in
water and is practically insoluble in acetone, ether, and chloroform. The pKa
of metformin is 12.4. The pH of a 1% aqueous solution of metformin
hydrochloride is 6.68. The structural formula is:
JENTADUETO is available for oral
administration as tablets containing 2.5 mg linagliptin and 500 mg metformin
hydrochloride (JENTADUETO 2.5 mg/500 mg), 850 mg metformin hydrochloride
(JENTADUETO 2.5 mg/850 mg) or 1000 mg metformin hydrochloride (JENTADUETO 2.5
mg/1000 mg). Each film-coated tablet of JENTADUETO contains the following
inactive ingredients: arginine, corn starch, copovidone, colloidal silicon
dioxide, magnesium stearate, titanium dioxide, propylene glycol, hypromellose,
talc, yellow ferric oxide (2.5 mg/500 mg; 2.5 mg/850 mg) and/or red ferric
oxide (2.5 mg/850 mg; 2.5 mg/1000 mg).
Last reviewed on RxList: 2/22/2012
This monograph has been modified to include the generic and brand name in many instances.