Pharmacokinetics in children

After a single administration of 10 mg to healthy adolescents (12-17 years) (Rao 2007), the following kinetic parameters were found:
Cmax: average of 13.1 ng/ml.
Tmax: 2.9 hours.
T½: 19.0 hours
Cl/F: 2.2 ml/min [4].

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

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

No information is present at this moment.

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

Summary
Results in a reduced capacity to react and concentrate; weigh up the benefits and potential risks carefully when using it for depressive complaints; monitor patients closely and high-risk patients in particular (suicidal thoughts, suicide attempts) due to the increased risk of suicide. When escitalopram is being used, be aware also of the possibility of serotonin syndrome occurring.

Using it can result in reduced capacity to react and concentrate. This can hinder numerous day-to-day activities. Caution should be exercised when prescribing escitalopram to children and adolescents with depressive symptoms. This is above all because of severe psychiatric side effects such as hostility, aggression, self-harming behaviour, suicidal thoughts and suicide attempts. Screening for suicide risks is indicated before the treatment. Antidepressant treatment can increase the risk of suicide (made greater by the depression) yet further during the early stages of recovery. Patients – particularly those at high risk because of suicidal thoughts or suicide attempts – 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 must not be allowed to have large amounts of this drug available. Other psychiatric conditions for which escitalopram is prescribed can also be associated with an increased risk of suicide-related events. Moreover, there may be comorbidity of these conditions with episodes of more severe depression. The same precautionary measures that need to be considered when treating patients with severe depression disorders must therefore be considered when treating patients with other psychiatric conditions. There have been rare reports of serotonin syndrome with SSRIs; this should be borne in mind if there is a combination of symptoms such as agitation, tremors, myoclonic episodes and hyperthermia. If there are seizures, the medication should be discontinued.

Interactions

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

• NERVOUS SYSTEM
• PSYCHOANALEPTICS

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.

References

1. H. Lundbeck A/S, SmPC Lexapro (RVG 30494-30497) 05-09-2013, www.geneesmiddeleninformatiebank.nl
2. Rao N., The clinical pharmacokinetics of escitalopram, , Clin Pharmacokinet, 2007, 46, 281-90
3. Findling RL. et al, Escitalopram in the treatment of adolescent depression: a randomized, double-blind, placebo-controlled extension trial., J Child Adolesc Psychopharmacol, 2013, 23, 468-80
4. Wagner KD. et al, A double-blind, randomized, placebo-controlled trial of escitalopram in the treatment of pediatric depression., J Am Acad Child Adolesc Psychiatry., 2006, 45, 280-8
5. Emslie GJ, et al, Escitalopram in the treatment of adolescent depression: a randomized placebo-controlled multisite trial., J Am Acad Child Adolesc Psychiatry., 2009, 48, 721-9
6. Lundbeck, SmPC Cipralex 10/20 mg Filmtabletten (55880.01.00/55880.03.00), 01/2016
7. Lundbeck, SmPC Cipralex 20 mg/ml Tropfen, Lösung zum Einnehmen, (69241.00.00), 03/2017
8. Lundbeck, SmPC Cipralex 10/20 mg Filmtabletten (55880.01.00/55880.03.00), 01/2016
9. Lundbeck, SmPC Cipralex 20 mg/ml Tropfen, Lösung zum Einnehmen, (69241.00.00), 03/2017
10. Rao N., The clinical pharmacokinetics of escitalopram,, Clin Pharmacokinet, 2007, 46, 281-90

Changes

Therapeutic Drug Monitoring

Overdose