Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: AstraZeneca AB, SE-151 85, Södertälje, Sweden
Qtern 5 mg/10 mg film-coated tablets.
Pharmaceutical Form |
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Film-coated tablet (tablet). Light brown to brown, biconvex, 0.8 cm round, film-coated tablet, with “5/10” printed on one side, and “1122” printed on the other side, in blue ink. |
Each tablet contains saxagliptin hydrochloride equivalent to 5 mg saxagliptin and dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.
Excipient with known effect: Each tablet contains 40 mg of lactose.
For the full list of excipients, see section 6.1.
Active Ingredient | Description | |
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Dapagliflozin |
Dapagliflozin is a highly potent, selective and reversible inhibitor of SGLT2. SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Dapagliflozin improves both fasting and post-prandial plasma glucose levels by reducing renal glucose reabsorption leading to urinary glucose excretion. |
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Saxagliptin |
Saxagliptin is a highly potent (Ki: 1.3 nM), selective, reversible, competitive, DPP4 inhibitor. Saxagliptin improves glycaemic control by reducing fasting and postprandial glucose concentrations in patients with type 2 diabetes. |
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Saxagliptin and Dapagliflozin |
Combination of saxagliptin and dapagliflozin with complementary mechanisms of action to improve glycaemic control. Saxagliptin, through the selective inhibition of dipeptidyl peptidase-4 (DPP-4), enhances glucose-mediated insulin secretion (incretin effect). Dapagliflozin, a selective inhibitor of sodium-glucose co-transporter 2 (SGLT2), inhibits renal glucose reabsorption independently of insulin. Actions of both medicinal products are regulated by the plasma glucose level. |
List of Excipients |
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Tablet core: Microcrystalline cellulose (E460i) Film-coating: Poly(vinyl alcohol) (E1203) Printing ink: Shellac |
PA/Alu/PVC-Alu blister.
Pack sizes of 14, 28, and 98 film-coated tablets in calendar blisters.
Pack size of 30 film-coated tablets in blisters.
Not all pack sizes may be marketed.
AstraZeneca AB, SE-151 85, Södertälje, Sweden
EU/1/16/1108/001 14 film-coated tablets
EU/1/16/1108/002 28 film-coated tablets
EU/1/16/1108/003 98 film-coated tablets
EU/1/16/1108/004 30 film-coated tablets
Date of first authorisation: 15 July 2016
Date of latest renewal: 19 May 2021
Drug | Countries | |
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QTERN | Austria, Australia, Brazil, Estonia, Finland, Ireland, Lithuania, Poland, Romania, Turkey, United Kingdom, United States |
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