Glibenclamide oral suspension
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral suspension of glibenclamide.
Drugs List
Therapeutic Indications
Uses
Treatment of neonatal diabetes mellitus in newborns, infants and children
Dosage
When using this agent, product literature, national guidelines and trust policies should be consulted.
Maximum dose 1ml/kg/day. The 0.6mg/ml formulation should not be used for doses higher than 0.6mg/kg/day, due to the significant amount of sodium benzoate in the formulation.
Children
Inpatient treatment introduction
Initially 0.2mg/kg daily in two divided doses before feeding.
Increasing by increments of 0.2mg/kg daily. Maximum dose 1mg/kg.
Specific dosing information regarding titration is not included. See product literature.
Patients can be discharged once insulin is no longer required or when stable on either insulin alone or a combination of glibenclamide and insulin.
Outpatient treatment introduction
Increase by 0.2mg/kg daily in divided doses. Maximum dose 1mg/kg.
Specific dosing information regarding titration is not included. See product literature.
Additional Dosage Information
Missed dose
Check blood glucose immediately and take glibenclamide as soon as possible.
Contraindications
Diabetic ketoacidosis
Porphyria
Severe hepatic impairment
Severe renal impairment
Precautions and Warnings
Restricted sodium intake
G6PD deficiency
Mild hepatic impairment
Mild renal impairment
Sodium content of formulation may be significant
Contains sodium benzoate: may increase risk of jaundice in neonates
Treatment to be initiated by specialist
Administer 15 minutes before child's milk feeding
Ensure correct strength and syringe are used for each administration
Use designated delivery device only
Monitor blood glucose before and during treatment
Monitor dosage closely in presence of renal or hepatic impairment
Monitoring of glycosylated haemoglobin is recommended
Bioavailability differs with preparations;caution on changing formulations
Cases of haemolytic anaemia have been reported in patients with G6PD enzyme deficiency, alternative treatment is recommended in these patients. Alternatively, a decision should be made taking into consideration the potential risks and benefits of treatment.
Initial diarrhoea may occur upon increasing glibenclamide.
If major vomiting occurs, a fast acting insulin should be used to treat patients. In minor vomiting, an antiemetic medicinal product should be given and glibenclamide treatment should continue.
If blood glucose levels exceed 16.5 mmol/L monitor for the presence of ketonuria or ketonaemia. If ketone bodies are present, administer an insulin injection to restore metabolic situation. Patients with ketoacidosis should be placed on continuous intravenous insulin injection and intravenous infusion of physiologic saline.
Pregnancy and Lactation
Pregnancy
Glibenclamide suspension is indicated only to treat newborns, infants and children.
Use glibenclamide with caution during pregnancy.
The manufacturer does not recommend using glibenclamide during pregnancy.
At the time of writing there is limited published information regarding the use of glibenclamide during pregnancy. Available data does not indicate an increased risk of congenital malformations during the first trimester or fetotoxic effects in the second or third trimesters. Animal studies do not indicate a teratogenic potential. Glibenclamide crosses the placenta in small amounts, however this is variable between patients.
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
Glibenclamide suspension is indicated only to treat newborns, infants and children.
Use glibenclamide with caution during breastfeeding.
The manufacturer states glibenclamide is compatible with breastfeeding, but advises blood sugar levels are monitored in breastfed infants.
Available data indicates glibenclamide is not expressed in human breast milk, but the actual levels are unknown.
Side Effects
Abdominal pain
Agranulocytosis
Allergic skin reactions
Anaphylactic reaction
Bone marrow aplasia
Bullous eruption
Diarrhoea - transient
Dyspepsia
Dyspnoea
Erythema multiforme
Exfoliative dermatitis
Hypereosinophilia
Hypoglycaemia
Hypotension
Increases in serum transaminases (transient)
Leucopenia
Neutropenia
Pancytopenia
Pruritus
Rash
Shock
Skin photosensitivity
Superficial tooth discolouration
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: August 2019
Reference Sources
Summary of Product Characteristics: Amglidia 0.6mg/ml oral suspension. Amring Sarl Ltd. Revised December 2018.
Summary of Product Characteristics: Amglidia 6mg/ml oral suspension. Amring Sarl Ltd. Revised December 2018.
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