April 24, 2017
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Qtern

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Qtern

QTERN®
(dapagliflozin and saxagliptin) Tablets

DRUG DESCRIPTION

QTERN

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

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.

Structural formula:

Dapagliflozin - Structural Formula Illustration

Saxagliptin

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 [3.3.1.1] 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.

Structural formula:

Saxagliptin - Structural Formula Illustration

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.

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.


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