Zuellig Pharma
Concise Prescribing Info
Adjunct to diet & exercise to improve glycaemic control in adults ≥18 yr w/ type 2 DM as monotherapy; add-on combination w/ glucose-lowering medicinal products eg, insulin; as initial combination therapy w/ metformin (includes poor prospects for response to metformin monotherapy). Reduce risk of hospitalization for heart failure in adults w/ type 2 DM & established CV disease or multiple CV risk factors. Reduce risk of CV death & hospitalization for heart failure in adults w/ NYHA class II-IV heart failure w/ reduced ejection fraction.
Dosage/Direction for Use
Type 2 DM Monotherapy & add-on combination therapy 10 mg once daily. Combination w/ insulin or insulin secretagogue Lower dose of insulin or insulin secretagogue may be considered. Initial combination therapy Dapagliflozin 10 mg + metformin 500 mg once daily. Heart failure 10 mg once daily. Severe hepatic impairment Initially 5 mg, may be increased to 10 mg if well tolerated.
May be taken with or without food.
Special Precautions
Discontinue use if diabetic ketoacidosis & necrotising perineum fasciitis/Fournier's gangrene is suspected or diagnosed. Not to be used in patients w/ type 1 diabetes. Not recommended in diabetic patients w/ persistent eGFR <45 mL/min/1.73 m2. Consider additional glucose-lowering treatment if eGFR falls persistently <45 mL/min/1.73 m2 in patients w/ heart failure & type 2 DM. Vol-depletion risk due to acute disease eg, GI illness, history of hypotension; patients w/ low β-cell function reserve, conditions leading to restricted food intake or severe dehydration, reduced insulin doses, increased insulin requirements due to acute medical illness, surgery or alcohol abuse; UTI, pyelonephritis or urosepsis; cardiac failure (NYHA class IV). Positive glucose urine test. Evaluate renal function prior to initiation & periodically thereafter. Monitor vol status eg, physical exam, BP, haematocrit & electrolytes during treatment. Counsel patients on routine preventative foot care. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Risk of hypoglycaemia in combination w/ sulphonylurea or insulin. Concomitant use w/ antihypertensives. May affect ability to drive & use machines. Severe renal impairment (eGFR <30 mL/min/1.73 m2) or end-stage renal disease. Hepatic impairment. Not recommended during 2nd & 3rd trimesters of pregnancy. Not to be used during lactation. Elderly ≥65 yr. Childn <18 yr.
Adverse Reactions
Hypoglycaemia (combination w/ sulfonylurea or insulin). Vulvovaginitis, balanitis & related genital infections, UTI; dizziness; rash; back pain; dysuria, polyuria; increased haematocrit, decreased creatinine renal clearance, dyslipidaemia.
Drug Interactions
Additive diuretic effect, increased risk of dehydration & hypotension w/ thiazide & loop diuretics. Hypoglycaemia w/ insulin & insulin secretagogues eg, sulphonylureas. Interference w/ 1,5-anhydroglucitol assay.
MIMS Class
ATC Classification
A10BK01 - dapagliflozin ; Belongs to the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors. Used in the treatment of diabetes.
Forxiga FC tab 10 mg
Forxiga FC tab 5 mg
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