Gliclazide oral standard release
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Tablets containing gliclazide.
Drugs List
Therapeutic Indications
Uses
Type 2 diabetes (NIDDM) not controlled by diet,weight loss & exercise alone
Dosage
Adults
Dose should be taken before a meal.
Initial dose: 40mg to 80mg daily. Increase until adequate control is achieved.
Maintenance dose: 40mg to 320mg daily. The dose should be titrated according to patient's response.
Maximum dose: 320mg daily or 160mg per dose.
When higher doses are required, gliclazide should be taken twice daily, according to the timing of main meals.
In obese patients or those not showing adequate response to gliclazide alone, additional therapy should be considered.
Children
Type 2 diabetes mellitus and maturity-onset diabetes
Children aged 12 to 18 years (unlicensed)
Initial dose: 20mg once daily with breakfast, titrated to response.
Maintenance dose: 20mg to 160mg once daily with breakfast.
Maximum dose: 320mg daily or 160mg per dose.
The use of gliclazide in children under 18 years should be under specialist management only.
Additional Dosage Information
Switching from another oral antidiabetic agent
Gliclazide standard release tablets can be taken to replace other antidiabetic agents. The dosage and the half-life of the previous drug should be taken into account when switching to gliclazide standard release tablets. Usually a transitional period is not necessary. The starting dose is 40mg to 80mg and this should be adjusted to suit the patient's blood glucose response.
When switching from a sulfonylurea with a prolonged half-life, a treatment free period of a few days may be necessary to avoid an additive effect of the two products, which may cause hypoglycaemia.
Combination treatment with other antidiabetic agents
Standard release gliclazide may be given in combination with biguanides, alpha glucosidase inhibitors or insulin. Patients not adequately controlled with standard release gliclazide may be given concomitant insulin therapy, initiated under close medical supervision.
Contraindications
Children under 12 years
Breastfeeding
Cholestatic jaundice
Diabetic coma
Diabetic ketoacidosis
Diabetic pre-coma
Pregnancy
Severe hepatic impairment
Severe renal impairment
Precautions and Warnings
Children aged 12 to 18 years
Adrenal insufficiency
G6PD deficiency
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hypothyroidism
Lactose intolerance
Malnutrition
Pituitary insufficiency
Porphyria
Renal impairment
Advise ability to drive or operate machinery may initially be impaired
Advise patient to take precautions to avoid hypoglycaemia whilst driving
Some formulations contain lactose
Monitor dosage closely in presence of renal or hepatic impairment
Consider dose reduction to prevent hypoglycaemia if dietary intake reduced
Discontinue if hepatitis develops
May induce severe hypoglycaemia
Risk of hypoglycaemia may be increased by exercise or ingestion of alcohol
Discontinue if cholestatic jaundice occurs
Pregnancy confirmed: Change patient to insulin treatment
Advise patient not to take St John's wort concurrently
Advise patient they have to inform the DVLA of antidiabetic medication
Advise patients of the warning signs of hypoglycaemia
Advise patients on adequate dietary control
This treatment should only be prescribed if the patient is likely to have a regular food intake (including breakfast). Missed meals, low food consumption and consuming food with a low carbohydrate content can increase the risk of hypoglycaemia. Hypoglycaemia is also more likely to occur following prolonged or strenuous exercise, alcohol intake and during low calorie intake diets.
A reduction in dosage should be considered if the patient has an insufficient calorie or glucose intake.
Efficacy of gliclazide treatment may diminish over time (secondary failure) and may require dosage adjustment. This may be due to a reduced response to treatment or to progression in the severity of diabetes.
Some manufacturers contraindicate its use in porphyria, but the Drug Database for Acute Porphyria states that there is insufficient evidence for it to be classified.
Pregnancy and Lactation
Pregnancy
Gliclazide is contraindicated during pregnancy.
Manufacturers recommend to avoid gliclazide during pregnancy. There is little experience with the use of gliclazide during pregnancy.
Animal studies have shown reproductive toxicity.
Lactation
Gliclazide is contraindicated during breastfeeding.
The manufacturers note that it is not known whether gliclazide or its metabolites are excreted in breast milk and there is a possibility of hypoglycaemia in the infant.
Other sulfonylureas are excreted in breast milk.
Counselling
Advise patient to take dose with breakfast and evening meal if daily dose is higher than 160mg (maximum 160mg per dose).
Patients and family members should be advised on the signs and symptoms of hypoglycaemia, as well as the conditions that predispose to its development.
Patient should be reminded of the importance of following dietary advice and of taking regular exercise.
Caution is advised when driving or operating machinery, especially at the beginning of treatment, due to the possibility of hypoglycaemia (e.g. poor concentration, confusion, poor reactions etc.)
Advise patient to report to DVLA if there is a risk of hypoglycaemia, or if fitness to drive may be impaired due to diabetes complications. Guidance can be found by accessing Gov.uk website.
Advise patient to avoid St John's wort concurrently.
Side Effects
Abdominal pain
Anaemia
Angioedema
Bullous reactions
Cholestatic jaundice
Constipation
Diarrhoea
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dyspepsia
Erythema
Granulocytopenia
Hepatitis
Hypoglycaemia
Increases in hepatic enzymes
Leucopenia
Maculopapular rash
Nausea
Pruritus
Rash
Stevens-Johnson syndrome
Thrombocytopenia
Toxic epidermal necrolysis
Urticaria
Visual disturbances
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: April 2019
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Summary of Product Characteristics: Diamicron 80mg Tablets. Servier Laboratories Limited. Revised December 2016.
Summary of Product Characteristics: Gliclazide 80mg Tablets. Wockhardt UK Ltd. Revised February 2017.
Summary of Product Characteristics: Glydex 160mg tablets. Medreich Plc. Revised May 2020.
Summary of Product Characteristics: Zicron 40mg Tablets. Bristol Laboratories Ltd. Revised May 2017.
The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.org
Last accessed: 07 January 2021
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 07 January 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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