glibenclamide: clinical use

Prescribing considerations

• Initiate under a clinician experienced in very-early-onset diabetes.
• Confirm the prescribed strength, volume and supplied syringe at every transition of care to prevent mg–mL errors.
• Do not use for autoimmune type 1 diabetes or treatment of ketoacidosis.
• Consider haemolysis risk in G6PD deficiency; an alternative is strongly preferred where available.
• Account for sodium benzoate exposure and its potential to worsen neonatal jaundice.
• Mild or moderate renal or hepatic impairment increases hypoglycaemia risk and requires close individualised management.

Contraindications and cautions

• Hypersensitivity to glibenclamide, another sulphonylurea, a sulphonamide or an excipient
• Diabetic ketoacidosis
• Porphyria
• Concurrent bosentan
• Severe renal impairment
• Severe hepatic impairment

Monitoring

• Capillary blood glucose and clinical signs of hypo- or hyperglycaemia
• Blood or urine ketones when glucose is markedly raised or during significant illness or vomiting
• HbA1c and overall metabolic control
• Renal and hepatic function where impairment is present
• Evidence of haemolysis if treatment is unavoidable in G6PD deficiency
• Blood count or liver tests when clinically indicated by symptoms or adverse effects

Clinical pharmacology

Glibenclamide is a sulphonylurea that inhibits ATP-sensitive potassium channels in pancreatic beta cells, stimulating insulin secretion. Hypoglycaemia may be prolonged, particularly with impaired clearance or interacting medicines.

Formulation and product differences

• The selected product is a ready-to-use white oral suspension supplied with a graduated oral syringe and bottle adaptor.
• The suspension does not require shaking and should generally not be administered through a feeding tube.
• The oral suspension is not bioequivalent to crushed glibenclamide tablets; direct substitution is inappropriate.
• The formulation contains sodium and sodium benzoate, which are relevant when assessing neonatal exposure and jaundice risk.

Oral suspension

Route: Oral

Strengths: 0.6 mg/mL, 6 mg/mL