Pharmacy Diabetes

S-9.3 sulfonylureus-formulations_Gliclazide immediate release

Gliclazide immediate release tablet

  • Gliclazide comes in an 80mg tablet.
  • The dose of gliclazide should be individualised (person centred care) and based on glucose levels.
  • 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 where possible.
  • The lowest dose that maintains effective glucose levels within range should be considered.

  • As an adjunct to healthy eating and physical activity in the treatment of type 2 diabetes.

For the latest PBS indications for gliclazide please see

https://www.pbs.gov.au/medicine/item/2449X-8535F-9302N

  • Initially the starting dose is half a tablet (40mg) at breakfast. Depending on the response, the dose can be adjusted to 160mg once a day or 320mg in two divided doses (breakfast and the evening meal). Doses should be taken with or soon after food.
  • Gliclazide 30 MR is equivalent to 80mg immediate release formulation.
  • Renal impairment - Severe renal impairment may affect the distribution of gliclazide. This may increase the risk of severe hypoglycaemic reactions. A hypoglycaemic episode in these individuals may be prolonged and appropriate management should be initiated.
  • Hepatic impairment - Severe hepatic impairment may reduce the capacity for neoglucogenesis. This may increase the risk of severe hypoglycaemic reactions. A hypoglycaemic episode in these individuals may be prolonged an appropriate management should be initiated.

  • The daily dose may vary from 40 to 320 mg taken orally. The initial recommended dose is 40 mg (half tablet) daily even in elderly individuals (≥ 65 years) and may be increased if necessary up to 320 mg (4 tablets) daily. Doses up to 160 mg daily may be taken in a single dose but preferably at the same time each morning. Dose’s in excess of 160 mg should be taken in divided doses in the morning and evening.

  • 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.
  • Treatment with azole antifungals. (Azole antifungals inhibit the metabolism of sulfonylureas resulting in increased systemic exposure and consequent toxicity). This may increase the risk of hypoglycaemia and must be considered.
  • Glucose-6-phosphate Dehydrogenase Deficiency (G6PD)
  • Treatment of patients with G6PD-deficiency with sulfonylurea agents can lead to haemolytic anaemia. Since gliclazide belongs to the chemical class of sulfonylurea drugs, caution should be used in those with G6PD-deficiency and a non-sulfonylurea alternate should be considered.

  • Hypoglycaemia
  • Gastrointestinal reactions- 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 gliclazide.

  • Hypersensitivity to gliclazide, other sulfonylureas or, sulfonamides
  • Type I diabetes, diabetic ketoacidosis
  • Severe renal dysfunction
  • Severe liver dysfunction
  • Pregnancy or lactation

Peak effect of gliclazide appears to be within 4-6 hours after oral administration.

Gliclazide is found in liver, kidneys, skin, lungs, skeletal muscle, intestinal and cardiac tissue. Duration of action of Gliclazide immediate release is 12 to 16 hours.

After oral administration, 70% is excreted in the urine and 11%in the faeces. Metabolites are detected in the urine 120 hours and in the faeces 144 hours after dosing. For more detailed information on this product please consult the product information. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&t=&q=gliclazide