Name of Medicine
Gliclazide Modified Release Tablets
Presentation
- Gliclazide is available in a 30mg and a 60mg modified release tablet
Key Practice Points
Therapeutic Indications:
- As an adjunct to healthy eating and physical activity in the treatment of type 2 diabetes.
Dose:
- Initially the starting dose is half a tablet of the 60 mg modified release (30mg) at breakfast. If the dose is forgotten the dose should be taken on the next day with breakfast. Make up doses should not occur. Doses should be tailored to the individual (person centred care) depending on glucose levels. Dose should be increased by half a tablet (30mg) every two weeks up to a maximum dose of 120mg (two tablets) once a day.
- Gliclazide modified release tablets should not be chewed or crushed.
- Gliclazide 30 MR is equivalent to 80mg immediate release formulation.
- Renal impairment – The efficacy and tolerance of Gliclazide MR 30mg tablets has been confirmed in clinical trials people with mild to moderate renal failure (creatinine clearance of between 15 -80 mL/min) who were given the same dosage regimen as the general population. No dosage adjustment is therefore required in individuals with mild to moderate renal impairment. Use of Gliclazide MR 30 mg in those with severe renal impairment is contraindicated.
- 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.
Elderly:
- There does not appear to be any need to adjust the dose in an individual simply due to age. Consideration however may need to be given to the increase risk of hypoglycaemia.
Precautions:
- 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.
Adverse Effects:
- 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.
Contraindications:
- Hypersensitivity to gliclazide, other sulfonylureas or sulfonamides.
- Type I diabetes, Ketoacidosis
- Severe renal dysfunction
- Severe liver dysfunction
- Pregnancy or lactation
Pharmacokinetic Properties-Summary
Absorption:
Absorption of the tablet requires hydration and subsequent formation of a gel to release the active ingredient. Absorption does not appear to be impacted by food.
Distribution:
Duration of action of Gliclazide MR is 16 to 24 hours. Gliclazide seem to be highly protein bound.
Excretion:
Gliclazide is metabolised almost entirely in the liver. Its metabolites are then excreted in the urine.
More Information
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