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dapagliflozin and saxagliptin
What is 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) .
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: CHClO•CHO•HO. 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 [18.104.22.168] 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: CHNO•HO. 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).
What does QTERN look like?
What are the available doses of QTERN?
Tablet: 10 mg dapagliflozin/5 mg saxagliptin
What should I talk to my health care provider before I take QTERN?
How should I use QTERN?
QTERN (dapagliflozin and saxagliptin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) who have inadequate control with dapagliflozin or who are already treated with dapagliflozin and saxagliptin .
Limitations of Use
QTERN is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
QTERN should only be used in patients who tolerate 10 mg dapagliflozin.
In patients with volume depletion, correct this condition prior to initiation of QTERN .
The recommended dose of QTERN is a 10 mg dapagliflozin/5 mg saxagliptin tablet taken orally once daily in the morning with or without food.
Do not split or cut QTERN tablets.
What interacts with QTERN?
Sorry No Records found
What are the warnings of QTERN?
Sorry No Records found
What are the precautions of QTERN?
Sorry No Records found
What are the side effects of QTERN?
Sorry No records found
What should I look out for while using QTERN?
QTERN is contraindicated in patients with:
What might happen if I take too much QTERN?
There is no information available on overdose with QTERN. In the event of an overdose, contact the Poison Control Center. Appropriate supportive treatment should be initiated as dictated by the patient’s clinical status. Saxagliptin and its major metabolite can be removed by hemodialysis (23% of dose over 4 hours). The removal of dapagliflozin by hemodialysis has not been studied.
How should I store and handle QTERN?
Store at How SuppliedQTERN (dapagliflozin and saxagliptin) tablets for oral use are available in packages as listed:Storage and HandlingStore at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .How SuppliedQTERN (dapagliflozin and saxagliptin) tablets for oral use are available in packages as listed:Storage and HandlingStore at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .How SuppliedQTERN (dapagliflozin and saxagliptin) tablets for oral use are available in packages as listed:Storage and HandlingStore at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .How SuppliedQTERN (dapagliflozin and saxagliptin) tablets for oral use are available in packages as listed:Storage and HandlingStore at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .
Chemical StructureNo Image found
QTERN combines two antihyperglycemic agents to improve glycemic control in patients with type 2 diabetes mellitus: dapagliflozin, a sodium-glucose cotransporter 2 (SGLT-2) inhibitor, and saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor.
Sodium-glucose cotransporter 2 (SGLT-2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. Dapagliflozin is an inhibitor of SGLT-2. By inhibiting SGLT-2, dapagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
Increased concentrations of the incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are released into the bloodstream from the small intestine in response to meals. These hormones cause insulin release from the pancreatic beta cells in a glucose-dependent manner but are inactivated by the DPP-4 enzyme within minutes. GLP-1 also lowers glucagon secretion from pancreatic alpha cells, reducing hepatic glucose production. In patients with type 2 diabetes, concentrations of GLP-1 are reduced but the insulin response to GLP-1 is preserved. Saxagliptin is a competitive DPP-4 inhibitor that slows the inactivation of the incretin hormones, thereby increasing their bloodstream concentrations and reducing fasting and postprandial glucose concentrations in a glucose-dependent manner in patients with type 2 diabetes mellitus.
Non-Clinical ToxicologyQTERN is contraindicated in patients with:
No drug interactions have been identified. Studies with famotidine in man, in animal models, and in vitro have shown no significant interference with the disposition of compounds metabolized by the hepatic microsomal enzymes, e.g., cytochrome P450 system. Compounds tested in man include warfarin, theophylline, phenytoin, diazepam, aminopyrine and antipyrine. Indocyanine green as an index of hepatic drug extraction has been tested and no significant effects have been found.
There have been postmarketing reports of acute pancreatitis in patients taking saxagliptin. In a cardiovascular outcomes trial enrolling participants with established atherosclerotic cardiovascular disease (ASCVD) or multiple risk factors for ASCVD (SAVOR trial), cases of definite acute pancreatitis were confirmed in 17 of 8240 (0.2%) patients receiving saxagliptin compared to 9 of 8173 (0.1%) receiving placebo. Pre-existing risk factors for pancreatitis were identified in 88% (15/17) of those patients receiving saxagliptin and in 100% (9/9) of those patients receiving placebo.
After initiation of QTERN, observe patients for signs and symptoms of pancreatitis. If pancreatitis is suspected, promptly discontinue QTERN and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using QTERN.
The following important adverse reactions are described below or elsewhere in the labeling:
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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