Mirtazapine

Generic name
Mirtazapine
Brand name
ATC Code
N06AX11
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Mirtazapine

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The following kinetic parameters have been observed after a one-time administration) of a tablet of 15 mg (EPAR Mirtazapine):

  7-11 years (n=8) 12-17 years (n=8)
Cmax (ng/ml) 51.8–62.5 28.1–41.1
Tmax (hours) 1.50–1.55 1.65–2.39
t½ (hours) 22.7–23.7 31.7–35.3
Cl (l/hour/kg) 0.719–0.858 0.470–0.608
Vd (l/kg) 24.6–27.9 22.5–24.3

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

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Severe sleep problems/insomnia with underlying depression.
  • Oral
    • 12 years up to 18 years
      • Initial dose: For the night: 7.5 mg/day in 1 dose
      • Maintenance dose: increase the starting dose weekly if necessary by steps of 7.5 mg/day to 15 - 45 mg/day in 1 dose. Max: 45 mg/day.
        • Treatment with mirtazapine must not be stopped suddenly; the dose must be reduced gradually.
        • Use only if other options have proved to be ineffective.
        • Mirtazapine should be prescribed by a child and youth psychiatry specialist. The dosage should be set individually and the lowest possible dose should be used.

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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

Weight gain, urticaria, hypertriglyceridaemia.

 

 

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

Results in reduced reaction and concentration capacity; do not give to depressive patients with suicidal thoughts; observe patients closely because of the increased suicide risk. Be aware also of the possibility of serotonin syndrome occurring.

Two brief clinical studies did not demonstrate efficacy in children. Mirtazapine can be an option in individual cases for severe sleeping disorders in depression, where other options have not proved to be effective.

Using it can result in reduced capacity to react and concentrate. This can hinder numerous day-to-day activities.

Screening for suicide risks is indicated before the treatment. Patients must be monitored closely during treatment with these drugs, in particular when treatment is commenced and after dosage changes. Patients must be made aware of the need to keep an eye on any clinical exacerbation, suicidal behaviour or suicidal thoughts and unusual behavioural changes and of the need to obtain medical advice immediately if these symptoms occur. Patients should not have large amounts of this drug available, in order to prevent misuse.

There have been rare reports of serotonin syndrome with mirtazapine; this should be borne in mind if there is a combination of symptoms such as agitation, tremors, myoclonic episodes and hyperthermia.

Suicidal behaviour (suicide attempts and suicidal thoughts), hostility (aggression, oppositional behaviour and anger) are more frequently observed in children and adolescents treated with antidepressants.

Interactions

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

ANTIDEPRESSANTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Non-selective monoamine reuptake inhibitors
N06AA09
N06AA04
N06AA02
N06AA10
Selective serotonin reuptake inhibitors
N06AB04
N06AB10
N06AB03
N06AB08
N06AB06
Monoamine oxidase A inhibitors
N06AG02
Other antidepressants
N06AX01
N06AX12
N06AX21
N06AX11
N06AX16

References

  1. CMDh, Rapporteur’s Public Assessment Report for paediatric data in EU Worksharing procedure: Mirtazapine, http://www.hma.eu/269.html, 18-6-2010
  2. Haapasalo-Pesu KM et al., Mirtazapine in the treatment of adolescents with major depression: an open-label, multicenter pilot study, J Child Adolesc Psychopharmacol, 2004, 14(2), 175-84
  3. Kennis Centrum voor Kind,- en Jeugdpsychiatrie, Expert opinie depressies met ernstige comorbide slaapproblemen, 18 dec 2017

Changes

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