Qtern

Qtern

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Saxagliptin 5 mg, dapagliflozin 10 mg
Indications/Uses
Adults ≥18 yr w/ type 2 DM inadequately controlled on metformin alone or when already treated w/ fixed-dose combination.
Dosage/Direction for Use
Administration
May be taken with or without food: Swallow whole.
Contraindications
Hypersensitivity to saxagliptin, dapagliflozin or any DPP4 inhibitor.
Special Precautions
Hypersensitivity. Not to be used in patients w/ type 1 diabetes or diabetic ketoacidosis. Discontinue use if pancreatitis, ketoacidosis, recurrent UTI, Fournier's gangrene, bullous pemphigoid are suspected. Risk of vol depletion, hypotension &/or electrolyte imbalance; GI illness, heat stress, severe infections; known CV disease; on antihypertensive therapy w/ history of hypotension; dehydration; increased/decreased insulin requirements, reduced caloric intake, low carbohydrate diet, acute illness, surgery, alcohol abuse; ulcerative & necrotic skin lesions; cardiac failure; arthralgia. Immunocompromised patients. Monitor renal function prior to & at least yrly thereafter. Monitor vol status eg, physical exam, BP, hematocrit & electrolytes. Not recommended in concomitant use w/ loop diuretics; pioglitazone. Combination w/ glucagon-like peptide 1, insulin & insulin secretagogues eg, sulfonylureas. Counsel patients on routine preventive foot care. May affect ability to drive & use machines. Not recommended in moderate or severe renal impairment or end-stage renal disease. Not to be used in severe hepatic impairment. Not to be used during pregnancy & lactation. Paed & adolescents <18 yr. Not recommended in elderly ≥75 yr.
Adverse Reactions
Upper resp tract infection, UTI, genital infection; dyslipidemia, hyperuricaemia; headache; diarrhoea, nausea, dyspepsia; back pain, arthralgia, pain in extremity, muscle spasms; cough; depression; gastroenteritis, vomiting, polyuria.
Drug Interactions
Increased risk of hypoglycaemia w/ insulin & insulin secretagogues eg, sulphonylureas. α-glucosidase inhibitors; orlistat.
MIMS Class
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
28's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in