Pharmacokinetics in children

Pharmacokinetic parameters have not been studied in children.

Metabolization: to relatively inactive metabolites via (inter alia) CYP2C19 and CYP2D6.

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 in children

Reduced appetite [Shirman], elevated energy level, uncontrolled or impulsive or obtrusive behaviour, hyperactivity, stereotypical behaviour, dry skin [King], sedation and impotence.

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 citalopram 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 citalopram 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 citalopram 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. Thomsen PH, et al, Long-term experience with citalopram in the treatment of adolescent OCD, J. Am. Acad. Child Adolesc. Psychiatry, 2001, 40:, 895–902
2. Thomsen PH., Child and adolescent obsessive–compulsive disorder treated with citalopram. Finding from an open trial of 23 cases., J. Child Adolesc. Psychopharmacol., 1997, 7, 157–166
3. Namerow LB, et al, Use of citalopram in pervasive developmental disorders, J Dev Behav Pediatr, 2003, Apr;24(2), 104-8
4. Couturier JL, et al, A retrospective assessment of citalopram in children and adolescents with pervasive developmental disorders, J Child Adolesc Psychopharmacol., 2002, 12, 243-8
5. Mukaddes NM, et al, Citalopram treatment of children and adolescents with obsessive-compulsive disorder: a preliminary report., Psychiatry Clin Neurosci., 2003, 57, 405-8
6. Lundbeck BV, SmPC Cipramil (RVG 19593) 01-09-2015, www.geneesmiddeleninformatiebank.nl
7. Shirman S, et al, Effectiveness and tolerability of citalopram for the treatment of depression and anxiety disorders in children and adolescents: an open-label study., J Neural Transm (Vienna), 2010, 117, 139-45
8. King BH. et al, Lack of efficacy of citalopram in children with autism spectrum disorders and high levels of repetitive behavior: citalopram ineffective in children with autism, Arch Gen Psychiatry, 2009, 66, 583-90
9. Heumann, SmPC Citalopram Heumann 10 mg Filmtabletten (59743.00.00), 09/2013
10. Heumann, Citalopram Heumann 20/30/40 mg Filmtabletten (78443.00.00), 09/2013
11. Neuraxpharm, SmPC Citalopram-neuraxpharm 30 mg Filmtabletten (63286.00.00), 08/2014
12. Neuraxpharm, SmPC Citalopram-neuraxpharm 10/20/40 mg Filmtabletten (53078.00.00), 08/2014
13. Hormosan Pharma, SmPC Citalopram-Hormosan 20 mg/ml Tropfen zum Einnehmen Lösung (95290.00.00), 02/2018
14. Lundbeck, SmPC Cipramil® 20/40 mg Filmtabletten (43145.01.00/43145.02.00), 11/2014
15. Lundbeck, SmPC Cipramil® Infusionslösungskonzentrat 20 mg, Konzentrat zur Herstellung einer Infusionslösung (43451.00.00), 11/2014
16. HEXAL, SmPC Citalopram HEXAL® (10, 20, 30, 40 mg) Filmtabletten (59364.00.00/59364.01.00/59364.02.00/59364.03.00), 06/2014
17. Gerlach M, Mehler-Wex C, Walitza S, Warnke A, Wewetzer C. , Neuro-/Psychopharmaka im Kindes- und Jugendalter: Grundlagen und Therapie. , Springer-Verlag Berlin Heidelberg , 2016, 3.Auflage, 144-145
18. Hormosan Pharma, SmPC Citalopram-Hormosan 20 mg/ml Tropfen zum Einnehmen Lösung (95290.00.00), 02/2018
19. Gerlach M, Mehler-Wex C, Walitza S, Warnke A, Wewetzer C., Neuro-/Psychopharmaka im Kindes- und Jugendalter: Grundlagen und Therapie., Springer-Verlag Berlin Heidelberg, 2016, 3.Auflage, 144-145

Changes

Therapeutic Drug Monitoring

Overdose