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

Interactions
PK
Renal impairment
References

Citalopram

Generic name
Citalopram
Brand name
ATC Code
N06AB04

Pharmacokinetics in children

Pharmacokinetic parameters have not been studied in children.

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

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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

Obsessive-compulsive disorder, depression and autism spectrum disorder (ASD)
  • Oral
    • Drops for oral use, solution
      • 6 years up to 18 years
        • Initial dose: 4 - 8 mg/day in 1 dose In the evening.
        • Maintenance dose: the initial dose can be raised depending on the clinical response and the tolerance once every 1-2 weeks by 4-8 mg (2-4 drops) to a maximum of 32 mg/day in 1 - 2 doses.

        • 4 mg = 2 drops
          16 mg in drops is equivalent to a 20 mg tablet

          Only use the maximum dose in individual cases.

          If the treatment is discontinued, it is recommended that the treatment should be phased out over one to two weeks.
          Information about the use of citalopram in obsessive compulsive disorders in children is limited to a number of small open-label studies. Information about the use of citalopram in autism spectrum disorders in children is limited to a number of small open-label studies (no effect on the core symptoms).

          Citalopram should only be prescribed by a child and youth psychiatry specialist. The dosage should be set individually and the lowest possible dose should be used.

           

      • 6 years up to 18 years
        [1] [2] [3] [4] [5] [7] [8]
        • Initial dose: 4 - 8 mg/day in 1 dose In the evening.
        • Maintenance dose: the initial dose can be raised depending on the clinical response and the tolerance once every 1-2 weeks by 4-8 mg (2-4 drops) to a maximum of 32 mg/day in 1 - 2 doses.

        • 4 mg = 2 drops
          16 mg in drops is equivalent to a 20 mg tablet

          Only use the maximum dose in individual cases.

          If the treatment is discontinued, it is recommended that the treatment should be phased out over one to two weeks.
          Information about the use of citalopram in obsessive compulsive disorders in children is limited to a number of small open-label studies. Information about the use of citalopram in autism spectrum disorders in children is limited to a number of small open-label studies (no effect on the core symptoms).

          Citalopram should only be prescribed by a child and youth psychiatry specialist. The dosage should be set individually and the lowest possible dose should be used.

           

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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

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

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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

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.

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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
N06AB10
N06AB03
N06AB08
N06AB06
Monoamine oxidase A inhibitors
N06AG02
Other antidepressants
N06AX01
N06AX12
N06AX21
N06AX11
N06AX11
N06AX16

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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

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Changes

Changes