Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Glibenclamid

Generic name
Glibenclamid
Brand name
ATC Code
A10BB01

Pharmacokinetics in children

The plasma glibenclamide levels in the simulated paediatric population (10-30 kg, 0.9 mg twice daily) were approximately 30%-60% lower than the adult levels (1.25 mg twice daily). With smaller bodyweight the concentration increased but exceeded the adult plasma levels in minimal extents only for poor metabolizers.
cmax(6 mg/mL Suspension): 201,71 ng/mL±71,43 ng/mL
cmax(0,6 mg/mL Suspension): 206,93 ng/mL±67,33 ng/mL

T1/2: ∼ 8 h

[EPAR Amglidia]

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Neonatal diabetes mellitus
  • Oral
    • Term neonate
      • Initial dose: 0.2 mg/kg/day in 2 doses.

      • Inpatient treatment introduction: if necessary, increase in steps of 0.2 mg/kg per day in 2 doses up to max. 1 mg/kg per day  until insulin independence is achieved. If insuline independence is not reached at day 6 maintain 1 mg/kg/day as outpatient treatment from day 6 for at least 4 weeks, then further increase if necessary up to max. 2.8 mg/kg per day;

        Outpatient treatment introduction: increase every week in steps of 0.2 mg/kg per day in 2 doses up to max. 1 mg/kg per day  until insulin independence is achieved. If insuline independence is not reached after 5-6 weeks administer 2 mg/kg per day for 1 week or longer if necessary (in rare cases up to 4 months). Max 2,8 mg/kg/day

        • during dose accrual, insulin dosage is reduced;
        • As soon as insulin is discontinued, the dose of AMGLIDIA is adjusted according to capillary blood glucose
        • Amglidia® with the strength of 0.6 mg/ml may be dosed max. up to 0.6 mg/kg body weight per day due to the amount of benzoic acid in it;
    • 1 month up to 18 years
      • Initial dose 0.2 mg/kg/day in 2 doses.

      • Inpatient treatment introduction: if necessary, increase in steps of 0.2 mg/kg per day in 2 doses up to max. 1 mg/kg per day until insulin independence is achieved. If insuline independence is not reached at day 6 maintain 1 mg/kg/day as outpatient treatment from day 6 for at least 4 weeks, then further increase if necessary up to max. 2.8 mg/kg per day;


        Outpatient treatment introduction: increase every week in steps of 0.2 mg/kg per day in 2 doses up to max. 1 mg/kg per day until insulin independence is achieved. If insuline independence is not reached after 5-6 weeks administer 2 mg/kg per day for 1 week or longer if necessary (in rare cases up to 4 months). Max 2,8 mg/kg/day

        • during dose accrual, insulin dosage is reduced;
        • As soon as insulin is discontinued, the dose of AMGLIDIA is adjusted according to capillary blood glucose
        • Amglidia® with the strength of 0.6 mg/ml may be dosed max. up to 0.6 mg/kg body weight per day due to the sodium benzoate exposure

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Very common (≥ 10 %): Neutropenia, Hypoglycaemia, transitory diarrhoea, abdominal pain, Vomiting, Dyspepsia, Transitory increased transaminases, Skin rash

Common (1-10 %): Vision blurred, Tooth discolouration

[EPAR AMGLIDIA 0.6 mg/mL oral suspension]

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Special care should be taken when calculating the dose. Before each administration, it should be verified that the correct strength and syringe are used. Glibenclamide should not be used in patients with insulin dependent type 1 diabetes mellitus with evidence of auto-immune destruction of beta cells.

Patients with G6PD enzyme deficiency
In patients carrying a G6PD enzyme deficiency, cases of acute haemolytic anaemia have been reported with glibenclamide. It should therefore not be prescribed for these patients, and the use of an alternative treatment is strongly recommended, if available. If there is no alternative, the decision for each patient must consider the danger of haemolysis and the potential benefit expected from the treatment. If it is necessary to prescribe this medicinal product, screening should be conducted for the occurrence of any haemolysis.

Biological analyses
Blood-glucose should be monitored periodically throughout treatment with glibenclamide. If the blood-glucose level exceeds 16.5 mmol/L, the presence of ketonuria or ketonaemia must also be checked. If ketone bodies are present, an insulin injection must be given rapidly to restore the metabolic situation. The glycosylated haemoglobin level should be measured every three months to assess the child’s metabolic equilibrium.

Hepatic impairment
Patients with hepatic impairment should be monitored periodically during treatment due to the increased risk of hypoglycaemia. Dose adjustment is required in patients with mild to moderate hepatic impairment.

[EPAR Amglidia]

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Biguanides
A10BA02
Combinations of oral blood glucose lowering drugs
A10BD20
Glucagon-like peptide-1 (GLP-1) analogues
A10BJ05
A10BJ01
A10BJ02
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10BK01
A10BK03

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References

  1. AMMTeK, SmPC AMGLIDIA 0,6 mg/ml Suspension zum Einnehmen (EU/1/18/1279/001), www.ema.europa.eu, 09/2019
  2. ratiopharm GmbH, SmPC Glib-ratiopharm® S Tabletten (3412.00.00), 07/2018

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Changes

Changes