"The US Food and Drug Administration (FDA) has approved two new competing combination products containing fixed doses of glucagonlike-peptide 1 (GLP-1) receptor agonists and long-acting insulins, from Sanofi and Novo Nordisk respectively, for the "...
(dapagliflozin and saxagliptin) Tablets
QTERN tablets for oral use contain dapagliflozin and saxagliptin.
Each film-coated tablet of QTERN for oral administration contains 10 mg dapagliflozin (equivalent to 12.3 mg dapagliflozin propanediol) and 5 mg saxagliptin (equivalent to 5.95 mg saxagliptin hydrochloride) [see Dosage Forms and Strengths].
Inactive ingredients: The product contains anhydrous lactose, croscarmellose sodium, iron oxides, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, silicon dioxide, talc, and titanium dioxide.
Dapagliflozin is an active inhibitor of sodium-glucose cotransporter 2 (SGLT-2).
Dapagliflozin propanediol is described chemically as D-glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1S)-, compounded with (2S)-1,2-propanediol, hydrate (1:1:1).
Empirical formula: C21H25ClO6•C3H8O2•H2O.Molecular weight: 502.98.
Saxagliptin is an active inhibitor of the dipeptidyl-peptidase-4 (DPP-4) enzyme.
Saxagliptin is described chemically as (1S,3S,5S)-2-[(2S)-2-amino-2-(3-hydroxytricyclo [188.8.131.52] dec-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile, monohydrate or (1S,3S,5S)-2-[(2S)-2-amino-2-(3-hydroxy-1-adamantan-1-yl)acetyl]-2-azabicyclo[3.1.0]hexane-3 -carbonitrile hydrate.
Empirical formula: C18H25N3O2•H2O. Molecular weight: 333.43.
Saxagliptin monohydrate is a white to light yellow or light brown, non-hygroscopic, crystalline powder. It is sparingly soluble in water at 24°C ± 3°C, slightly soluble in ethyl acetate, and soluble in methanol, ethanol, isopropyl alcohol, acetonitrile, acetone, and polyethylene glycol 400 (PEG 400).
Last reviewed on RxList: 3/8/2017
This monograph has been modified to include the generic and brand name in many instances.
Additional Qtern Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.