canagliflozin hemihydrate + metformin: clinical use

Prescribing considerations

• Licensed for adults with type 2 diabetes; not for type 1 diabetes or diabetic ketoacidosis.
• Assess renal function, hydration status, lactic-acidosis and ketoacidosis risks before prescribing.
• Consider age, cardiovascular disease, diuretic use and susceptibility to volume depletion.
• Review preventive foot care and lower-limb risk factors.
• Interrupt SGLT2-inhibitor treatment during hospitalisation for major surgery or acute serious illness; monitor blood ketones and restart only after ketones normalise and the patient is stable.

Contraindications and cautions

• Hypersensitivity to either active substance or an excipient
• Acute metabolic acidosis, including lactic acidosis or diabetic ketoacidosis
• Diabetic pre-coma
• Severe renal failure with eGFR below 30 mL/min/1.73 m²
• Acute conditions likely to alter renal function, including dehydration, severe infection or shock
• Acute or chronic disease causing tissue hypoxia
• Hepatic impairment, acute alcohol intoxication or alcoholism

Monitoring

• Renal function
• Glycaemic response and hypoglycaemia risk with insulin or an insulin secretagogue
• Volume status and blood pressure in susceptible patients
• Blood ketones when ketoacidosis is suspected and during hospital interruption for surgery or serious illness
• Vitamin B12 when deficiency is suspected and in patients with risk factors
• Foot condition in at-risk patients
• Haematocrit when already elevated

Clinical pharmacology

Canagliflozin inhibits renal SGLT2, increasing urinary glucose excretion independently of insulin. Metformin reduces hepatic glucose output, improves peripheral insulin sensitivity and delays intestinal glucose absorption. The fixed tablet is bioequivalent to corresponding separate components.

Formulation and product differences

• The fixed-combination film-coated tablet must be swallowed whole.
• The fixed combination does not allow independent adjustment of each active ingredient; separate components may be needed when available combinations do not match clinical requirements.
• Food reduces metformin-related gastrointestinal intolerance without a clinically important reduction in overall canagliflozin exposure.

Tablet

Route: Oral

Strengths: 50 mg + 1000 mg, 50 mg + 850 mg