Generic Name: Dapagliflozin
Regulatory Class: Rx
Formulations: Dapagliflozin 5 mg and 10 mg
Indications or Uses: Type 2 Diabetes Mellitus ( DM) in adults ≥18 yr as: Monotherapy when diet & exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance; in combination with other glucose-lowering medicinal products including insulin, when these, together with diet & exercise, do not provide adequate glycaemic control; initial combination therapy with metformin, as adjunct to diet & exercise, to improve glycaemic control when diet & exercise have failed to provide adequate glycaemic control & there are poor prospects for response to metformin monotherapy or to reduce risk of hospitalization for heart failure in adults with type 2 DM & established CV disease or multiple Cardio Vascular (CV ) risk factors. Reduces risk of CV death & hospitalization for heart failure in adults with heart failure (NYHA class II-IV) w/ reduced ejection fraction. Chronic Kidney Disease (CKD) in adults.
Dosage or Directions for use: The recommended dose is 10 mg dapagliflozin once daily. Patient with severe hepatic impairment, Initially 5 mg, may be increased to 10 mg if well tolerated. Tablets are to be swallowed whole.
Administration: Dapagliflozin can be taken orally once daily at anytime of day with or without food. 
Contraindications: Hypersensitivity.
Special Precautions: Should not be used in treatment of patients w/ type 1 Diabetes Mellitus (DM). Caution in patients for whom dapagliflozin-induced drop in BP could pose a risk; with increased risk of diabetic ketoacidosis. Carefully monitor volume status in cases of intercurrent conditions that may lead to volume depletion (eg, GI illness); temporary interruption of treatment is recommended for patients who develop volume depletion until depletion is corrected. Interrupt treatment in patients who are hospitalised for major surgical procedures or acute serious medical illness. Discontinue treatment immediately if diabetic ketoacidosis is suspected or diagnosed. Discontinue use & institute prompt treatment if Fournier's gangrene is suspected. Urinary glucose excretion may be associated w/ increased risk of UTI; consider temporary treatment interruption when treating pyelonephritis or urosepsis. Limited experience in NYHA class IV. No experience in treatment of Chronic Kidney Disease (CKD) in patients without diabetes who do not have albuminuria. Increased cases of lower limb amputation (primarily toe) in long-term, clinical studies in type 2 DM with another SGLT2 inhibitor; counsel patients with DM on routine preventative foot care. Positive test for glucose in urine. Should not be taken by patients with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Caution when driving & using machines due to risk of hypoglycaemia when used with sulphonylurea or insulin. Not recommended to initiate in patients w/ GFR <25 mL/min. Glucose-lowering efficacy is reduced in patients with GFR <45 mL/min & is likely absent in patients with severe renal impairment. Increased exposure in patients with severe hepatic impairment. Not recommended during 2nd & 3rd trimesters of pregnancy. Discontinue treatment when pregnancy is detected. Should not be used while breast-feeding. Safety & efficacy in childn 0 to <18 yr have not been established. Elderly may be at greater risk for volume depletion & are more likely to have renal impairment.
Adverse Reaction: Hypoglycaemia (when used with sulphonylurea or insulin). Vulvovaginitis, balanitis & related genital infections, UTI; dizziness; rash; back pain; dysuria, polyuria; increased haematocrit, decreased renal creatinine clearance (CrCl) during initial treatment, dyslipidaemia.
Interactions: May add to diuretic effect of thiazide & loop diuretics & may increase risk of dehydration & hypotension. Risk of hypoglycaemia with insulin & insulin secretagogues eg, sulphonylureas. Interference w/ 1,5-anhydroglucitol assay.
Presentation or Packaging: Apliva® 5mg, 10mg Film Coated Tablet (Box of 28's)
For more information on this product, please see the product insert.
