Four Star
Concise Prescribing Info
Type 2 DM in adults ≥18 yr as monotherapy when diet & exercise alone do not provide adequate glycaemic control for whom use of metformin is considered inappropriate; or in combination w/ other glucose-lowering medicinal products including insulin, when these, together w/ diet & exercise, do not provide adequate glycaemic control.
Dosage/Direction for Use
Recommended dose: 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
Not recommended for use in patients receiving loop diuretics or vol depleted eg, due to acute illness (eg, GI illness). Exercise caution in patients w/ known CV disease, patients on antihypertensive therapy w/ history of hypotension or elderly. Reports of acute kidney injury; elevated haematocrit; diabetic ketoacidosis; necrotising fasciitis of the perineum (Fournier's gangrene); UTI eg, pyelonephritis or urosepsis. Should not be used for treatment of patients w/ type 1 diabetes. Patients w/ cardiac failure. Increased cases of lower limb amputations in ongoing long-term, clinical studies w/ another SGLT2 inhibitor. Not recommended for concomitant use w/ pioglitazone. Tests positive for glucose in urine. Monitoring glycaemic control w/ 1,5-AG assay is not recommended. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption. Should not be initiated in patients w/ GFR <60 mL/min. Discontinue in patients w/ GFR persistently below 45 mL/min. Hepatic impairment. Not recommended during 2nd & 3rd trimesters of pregnancy. Lactation. Elderly ≥65 yr. Childn <18 yr.
Adverse Reactions
Vulvovaginitis, balanitis & related genital infections, UTI; dizziness; rash; back pain; dysuria, polyuria; haematocrit increased, CrCl decreased, dyslipidaemia. Hypoglycaemia (when used w/ sulphonylureas or insulin).
Drug Interactions
Increased diuretic effect of thiazide & loop diuretics (increased risk of dehydration & hypotension). Hypoglycaemia w/ insulin & insulin secretagogues eg, sulphonylurea.
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
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