Gliclazide oral modified release
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Modified release tablets containing gliclazide.
Drugs List
Therapeutic Indications
Uses
Type 2 diabetes (NIDDM) not controlled by diet,weight loss & exercise alone
Dosage
As with any hypoglycaemic agent, the dose should be adjusted according to the individual patient's metabolic response (blood glucose, HbA1c).
Daily dose should be taken in a single intake at breakfast time.
Adults
Initial dose: 30mg daily with breakfast.
The dose may be increased in steps of 30mg if necessary.
Maximum dose: 120mg daily with breakfast.
The interval between each dose increment should be at least one month. However, in patients whose blood glucose has not reduced after two weeks at a particular dose, the dose may be increased at the end of the second week of treatment.
Additional Dosage Information
Switching from gliclazide standard release tablets to modified release tablets
1 tablet of gliclazide 80mg is comparable to 1 modified release tablet of gliclazide 30mg. Consequently the switch can be performed provided careful blood monitoring is carried out.
Switching from another oral antidiabetic agent to gliclazide modified release tablets
Gliclazide 30mg modified release tablets can be used to replace other antidiabetic agents. The dosage and the half-life of the previous agent should be taken into account when switching to gliclazide modified release tablets. A transitional period is not generally necessary. A starting dose of 30mg should be used 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. A starting dose of 30mg daily is recommended, followed by a stepwise increase in dose, depending on the metabolic response.
Combination treatment with other antidiabetic agents
Modified release gliclazide may be given in combination with biguanides, alpha glucosidase inhibitors or insulin. Patients not adequately controlled with modified release gliclazide may receive concomitant insulin therapy, initiated under close medical supervision.
Missed doses
If a dose is missed, continue with scheduled regimen, with no additional dose.
Contraindications
Children under 18 years
Breastfeeding
Cholestatic jaundice
Diabetic coma
Diabetic ketoacidosis
Diabetic pre-coma
Pregnancy
Severe hepatic impairment
Severe renal impairment
Precautions and Warnings
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.
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.
A hypoglycaemic episode occurring in patients with renal and hepatic impairment may be prolonged, so appropriate management should be initiated. In patients with hepatic impairment or severe renal impairment, the use of insulin is recommended as treatment for non-insulin dependent diabetes mellitus.
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.
The manufacturer does not recommend using gliclazide during pregnancy. There is no experience with the use of gliclazide during human pregnancy, although some data is available for other sulfonylureas. Animal studies have shown no risk of teratogenic effects, however reproductive toxicity has been observed.
Detailed guidance on the treatment of diabetes during pregnancy is available from the National Institute for Health and Clinical Excellence (NICE) at https://www.nice.org.uk/guidance/ng3.
Lactation
Gliclazide is contraindicated during breastfeeding.
The manufacturers note that it is not known whether gliclazide or its metabolites are excreted in breast milk. Other sulfonylureas are excreted in breast milk, therefore there is a possibility of hypoglycaemia in the infant.
Counselling
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, taking regular exercise and regular monitoring of blood glucose levels.
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 not to take St John's wort concurrently.
Side Effects
Abdominal pain
Anaemia
Angioedema
Bullous reactions
Constipation
Diarrhoea
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dyspepsia
Eosinophilia
Erythema
Granulocytopenia
Hepatitis
Hypoglycaemia
Increases in hepatic enzymes
Jaundice
Leucopenia
Maculopapular rash
Nausea
Pruritus
Rash
Thrombocytopenia
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: January 2020
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: Bilxona 60mg Modified-release Tablets. Accord UK Ltd. Revised November 2019.
Summary of Product Characteristics: Bilxona 30mg Modified-release Tablets. Accord UK Ltd. Revised November 2019.
Summary of Product Characteristics: Dacadis MR 30mg Tablets. Generics UK Limited. Revised May 2019.
Summary of Product characteristics: Diamicron 30mg MR. Servier Laboratories Limited. Revised October 2016.
Summary of Product Characteristics: Edicil MR 30 mg modified-release tablets. Ratiopharm GmbH. Revised October 2011.
Summary of Product characteristics: Laaglyda MR 60mg modified-release tablets. Consilient Health Ltd. Revised January 2013.
Summary of Product characteristics: Lamzarin MR 30mg modified-release tablets. Key Pharmaceuticals Ltd. Revised October 2018.
Summary of Product characteristics: Lamzarin MR 60mg modified-release tablets. Key Pharmaceuticals Ltd. Revised October 2018.
Summary of Product Characteristics: Nazdol MR 30mg Tablets. Consilient Health Ltd. Revised December 2012.
Summary of Product Characteristics: Vamju 30 mg & 60 mg modified release tablets. Advanz. Revised September 2014.
Summary of Product characteristics: Ziclaseg 30mg prolonged release tablets. Lupin (Europe) Ltd. Revised February 2016.
Summary of Product characteristics: Zicron PR 30 mg prolonged-release tablets. Bristol Laboratories Ltd. Revised August 2017.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 16 January 2020
The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.org
Last accessed: 16 January 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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