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QTERN

QTERN

Manufacturer:

AstraZeneca

Distributor:

AstraZeneca
Concise Prescribing Info
Contents
Saxagliptin HCl 5 mg, dapagliflozin propanediol monohydrate 10 mg
Indications/Uses
Adjunct to diet & exercise to improve glycaemic control in adults w/ type 2 DM.
Dosage/Direction for Use
1 tab once daily taken at any time of the day.
Administration
May be taken with or without food: Swallow whole.
Contraindications
Hypersensitivity to saxagliptin or dapagliflozin, including anaphylaxis or angioedema following exposure to any dipeptidyl peptidase-4 inhibitor.
Special Precautions
Do not use in patients w/ type 1 DM. Serious hypersensitivity reactions including anaphylaxis & angioedema. Discontinue or consider temporary interruption if ketoacidosis is suspected. Predisposing factors to ketoacidosis including low β-cell function reserve resulting from pancreatic disorders (eg, type 1 diabetes, history of pancreatitis or pancreatic surgery), insulin dose reduction, reduced caloric intake or increased insulin requirements due to infections, illness or surgery, & alcohol abuse. Combination w/ medications known to cause hypoglycaemia eg, insulin & insulin secretagogues (eg, sulfonylureas). Discontinue if pancreatitis is suspected. Patients w/ known risk factors for hospitalization for heart failure eg, history of heart failure or moderate to severe renal impairment. Arthralgia. Discontinue & institute prompt treatment if necrotizing fasciitis of perineum (Fournier's gangrene) is suspected. Discontinue & consider referral to dermatologist for diagnosis & appropriate treatment if patient develops blisters or erosions while receiving treatment & bullous pemphigoid is suspected. Interference w/ 1,5-anhydroglucitol assay. Evaluate renal function prior to initiation of therapy & periodically thereafter. Not to be used in patients w/ eGFR persistently <45 mL/min/1.73 m2, severe renal impairment (eGFR <30 mL/min/1.73 m2) or ESRD. Severe hepatic impairment. Do not use during pregnancy or lactation. Adolescents <18 yr & ped patients. Elderly.
Adverse Reactions
URTI. UTI, genital infection, gastroenteritis; diarrhoea, vomiting; back pain, arthralgia; headache; dyslipidaemia; polyuria.
Drug Interactions
Saxagliptin: Increased plasma AUC & Cmax of norgestrel. Dapagliflozin: Decreased systemic exposure w/ rifampicin. Increased systemic exposure w/ mefenamic acid. May lead to reduction in serum lithium conc.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BD21 - saxagliptin and dapagliflozin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.
Presentation/Packing
Form
QTERN FC tab
Packing/Price
30's
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