- 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 |
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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
| Severe sleep problems/insomnia with underlying depression. |
|---|
|
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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.
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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
Weight gain, urticaria, hypertriglyceridaemia.
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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
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.
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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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| 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 | ||
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References
- CMDh, Rapporteur’s Public Assessment Report for paediatric data in EU Worksharing procedure: Mirtazapine, http://www.hma.eu/269.html, 18-6-2010
- 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
- Kennis Centrum voor Kind,- en Jeugdpsychiatrie, Expert opinie depressies met ernstige comorbide slaapproblemen, 18 dec 2017
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Changes
Changes
