"The U.S. Food and Drug Administration today approved Invokana (canagliflozin) tablets, used with diet and exercise, to improve glycemic control in adults with type 2 diabetes.

Type 2 diabetes is the most common form of the disease, affe"...

Jentadueto®
(linagliptin and metformin hydrochloride) Tablets, Film-Coated

Lactic acidosis is a rare,but serious, complication that can occur due to metformin accumulation. Therisk increases with conditions such as renal  impairment, sepsis,dehydration, excess alcohol intake, hepatic impairment, and acute congestiveheart failure.

The onset is often subtle,accompanied only by nonspecific symptoms such as malaise, myalgias, respiratorydistress, increasing somnolence, and nonspecific abdominal distress.

Laboratory abnormalitiesinclude low pH, increased anion gap, and elevated blood lactate.

If acidosis is suspected,JENTADUETO should be discontinued and the patient hospitalized immediately [seeWARNINGS AND PRECAUTIONS].

JENTADUETO tablets contain 2 oral antihyperglycemic drugsused in the management of type 2 diabetes mellitus: linagliptin and metforminhydrochloride.

Linagliptin is an orally-active inhibitor of thedipeptidyl peptidase-4 (DPP-4) enzyme.

Linagliptin is described chemically as 1H-Purine-2,6-dione,8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2quinazolinyl)methyl]

The empirical formula is C25H28N8O2and the molecular weight is 472.54 g/mol. The structural formula is:

Linagliptin is a white toyellowish, not or only slightly hygroscopic solid substance. It is veryslightly 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 solublein isopropanol ( < 1 mg/mL), and very slightly soluble in acetone (ca. 1mg/mL).

Metformin hydrochloride(N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically orpharmacologically related to any other classes of oral antihyperglycemicagents. Metformin hydrochloride is a white to off-white crystalline compoundwith a molecular formula of C4H11N5•HCl and amolecular weight of 165.63. Metformin hydrochloride is freely soluble in waterand is practically insoluble in acetone, ether, and chloroform. The pKa ofmetformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochlorideis 6.68. The structural formula is:

JENTADUETO is available fororal administration as tablets containing 2.5 mg linagliptin and 500 mgmetformin hydrochloride (JENTADUETO 2.5 mg/500 mg), 850 mg metforminhydrochloride (JENTADUETO 2.5 mg/850 mg) or 1000 mg metformin hydrochloride(JENTADUETO 2.5 mg/1000 mg). Each film-coated tablet of JENTADUETO contains thefollowing inactive ingredients: arginine, corn starch, copovidone, colloidalsilicon dioxide, magnesium stearate, titanium dioxide, propylene glycol,hypromellose, talc, yellow ferric oxide (2.5 mg/500 mg; 2.5 mg/850 mg) and/orred ferric oxide (2.5 mg/850 mg; 2.5 mg/1000 mg).

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