Uses

Indicated as adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 and older with type 2 diabetes mellitus. Canagliflozin also reduces risk of major adverse cardiovascular events and heart failure hospitalization in adults with established cardiovascular disease or multiple cardiovascular risk factors.

Do not use if

Contraindicated in severe renal impairment (eGFR less than 30 mL/min/1.73 m²), acute or chronic metabolic acidosis including diabetic ketoacidosis, and serious hypersensitivity to either component. Metformin is contraindicated in conditions predisposing to lactic acidosis.

Side effects

Common side effects include genital mycotic infections, urinary tract infections, increased urination, and nausea from metformin. Serious risks include lactic acidosis (metformin), diabetic ketoacidosis, lower limb amputation (canagliflozin), volume depletion, and hyperkalemia.

Warnings

Boxed warning for lactic acidosis associated with metformin. Risk of lower limb amputation, Fournier's gangrene, and urosepsis with canagliflozin. Hold therapy before iodinated contrast procedures. Monitor renal function regularly. Risk of volume depletion in elderly and patients on diuretics.

How it works

Canagliflozin inhibits SGLT2 in the proximal renal tubule, reducing glucose reabsorption and lowering the renal glucose threshold, thereby increasing urinary glucose excretion. Metformin decreases hepatic glucose production, reduces intestinal glucose absorption, and improves peripheral insulin sensitivity.

Storage

Store at 20°C to 25°C with excursions permitted between 15°C and 30°C. Keep out of reach of children.