SPL Set ID: 423c489c-085b-4320-b892-7868ebd6dc6b

QTERN tablets for oral use contain dapagliflozin and saxagliptin. Dapagliflozin propanediol is an active inhibitor of sodium‑glucose cotransporter 2 (SGLT2). It is described chemically as D‑glucitol, 1,5‑anhydro‑1‑C‑[4‑chloro‑3‑[(4‑ethoxyphenyl)methyl]phenyl]‑, (1 S )‑. Dapagliflozin is compounded with (2 S )‑1,2‑propanediol, hydrate (1:1:1) with an empirical formula as C 21 H 25 ClO 6 •C 3 H 8 O 2 •H 2 O and the molecular weight of 502.98. The structural formula is: Saxagliptin is an active inhibitor of the dipeptidyl‑peptidase‑4 (DPP‑4) enzyme. It is isolated in the monohydrate form chemically known as (1 S ,3 S ,5 S )‑2‑[(2 S )‑2‑amino‑2‑(3‑hydroxytricyclo [3.3.1.1] dec‑1‑yl)acetyl]‑2‑azabicyclo[3.1.0]hexane‑3‑carbonitrile, monohydrate or (1 S ,3 S ,5 S )‑2‑[(2 S )‑2‑amino‑2‑(3‑hydroxy‑1‑adamantan‑1‑yl)acetyl]‑2‑azabicyclo[3.1.0]hexane‑3‑carbonitrile hydrate. The empirical formula is C 18 H 25 N 3 O 2 •H 2 O and the molecular weight is 333.43. The structural formula is: QTERN is available as film-coated tablets of two strengths: • 5 mg dapagliflozin/5 mg saxagliptin. Each tablet contains 5 mg dapagliflozin (equivalent to 6.15 mg dapagliflozin propanediol) and 5 mg saxagliptin (exists in the form of HCl salt). • 10 mg dapagliflozin/5 mg saxagliptin. Each tablet contains 10 mg dapagliflozin (equivalent to 12.3 mg dapagliflozin propanediol) and 5 mg saxagliptin (exists in the form of HCl salt). Each tablet also contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, iron oxides, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, silicon dioxide, talc, and titanium dioxide. Hydrochloric acid and sodium hydroxide (if needed) are added for pH adjustment. dapagliflozin chemical structure Saxagliptin checmical structure