S-9.2 sulfonyluerus-Formulations-Glibenclamide

• As an adjunct to healthy eating and physical activity in the treatment of type 2 diabetes. Due to its broad and predictable action, glibenclamide is often used when other forms of management have not been successful.

For the latest PBS indications for glibenclamide please see

https://www.pbs.gov.au/pbs/search?term=glibenclamide&analyse=false&search-type=medicines

• The dose of glibenclamide should be individualised (person centred care) and based on glucose levels.
• In newly treated individuals with type 2 diabetes, starting dose of glibenclamide is usually 2.5mg with an increase of 2.5mg every 7 days up to a maximum of 15g (sometimes 20mg).
• Maximum dose of glibenclamide in healthy individuals is 20mg daily.
• Daily doses of up to 10mg are usually taken at or just after breakfast. Doses exceeding 10mg are more likely to be taken after the evening meal.
• Due to the fact this medicine can cause hypoglycaemia, it should be given with or soon after breakfast. Regular meals should then be eaten at regular intervals throughout the day if possible.
• If an individual only has a small breakfast, the tablet should be taken with lunch.
• The lowest dose that maintains effective glucose levels within range should be considered.
• Renal impairment – glibenclamide is contraindicated in severe renal impairment.
• Hepatic impairment – glibenclamide is contraindicated in severe hepatic impairment.

• Glibenclamide (duration of action 18-24 hours) may have an increased risk of prolonged hypoglycaemia in suspectable individuals. Risk increased in elderly, avoid use if possible.

• Known hypersensitivity or allergy to glibenclamide or any of the tablet’s ingredients.
• Type 1 diabetes
• Ketoacidosis due to diabetes, or metabolic acidosis
• Severe renal dysfunction
• Severe hepatic dysfunction.
• Pregnancy or lactation
• Individuals treated with bosentan (used to treat pulmonary hypertension)

• • Any blood glucose level under 4mmol/ L is known as a hypoglycaemic episode when being treated with a sulfonylurea. Counselling how to recognise and treat a hypoglycaemic episode is recommended when starting an individual on a sulfonylurea for the first time. Consideration should also be given to blood glucose monitoring for those who wish to participate.
  • Glucose-6-phosphate Dehydrogenase Deficiency (G6PD)

• Hypoglycaemia
• Gastrointestinal reactions Occasional (0.1 to 1%) -nausea, diarrhoea, abdominal pain and vomiting.
• Dermatologic reactions. Allergic skin reactions (e.g., pruritus, or urticaria). If the reaction continues, the medicine should be stopped. In the event of urticaria, a physician should be consulted.
• Haematologic reactions. Many reactions have been reported. For further information please consult the full information sheet on glibenclamide.
• Haemolytic anaemia. Treatment of individuals with glucose-6-phospate dehydrogenase (G6PD) deficiency with sulfonylurea agents can lead to haemolytic anaemia. Since glibenclamide belongs to the class of sulfonylurea agents, caution should be used in those with G6PD-deficiency. An alternative class of medicine should be considered.