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

Interactions
PK
Renal impairment
References

Pimozide

Generic name
Pimozide
Brand name
ATC Code
N05AG02

Pharmacokinetics in children

Longer plasma elimination half-lives with a wide range have been observed in children (23–115 hours, n=4, age 6–13 years).

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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

Psychosis, tics, autism
  • Oral
    • 3 years up to 12 years
      • Initial dose: 0.5 - 1 mg/day in 1 dose
      • Maintenance dose: depending on the effect and the side effects, the initial dose can be increased weekly by 0.5–1 mg/day until the desired result is achieved; maximum 0.1 mg/kg/day in 1 dose. Max: 4 mg/day.
      • Pimozide should be prescribed by a specialist in child and youth psychiatry. The dose should be set individually. Always attempt to find the lowest possible effective dose.

        ...read more
    • 12 years up to 18 years
      • Initial dose: 1 - 2 mg/day in 1 dose
      • Maintenance dose: depending on the effect and the side effects, the initial dose can be increased weekly by 0.5–1 mg/day until the desired result is achieved; maximum 20 mg/day in 1 dose
      • The average daily maintenance dose is usually between 2 and 6 mg/day.

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

        ...read more

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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

Sedation, transpiration

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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
Because of the cardiac side effects, and ECG should be taken regularly. Electrolyte levels should also be checked. Be aware also of the possibility of malignant neuroleptic syndrome occurring. Do not increase the dose if akathisia occurs.

Because of the risk of the QTc interval being extended, an ECG should be made before treatment with pimozide and also periodically during treatment. This is especially true if there is any doubt about cardiac function, family history, hepatic impairment and/or the use of other agents that may extend the QT interval or affect the metabolism of pimozide. The electrolyte levels should also be checked at the beginning of the treatment and periodically during the treatment.

As with other antipsychotics, when using pimozide you should be aware of the occurrence of what is known as ‘malignant neuroleptic syndrome’, in which hyperthermia, extreme muscle rigidity and autonomic instability are key.

It is sensible to consider new or increased feelings of unease or restlessness in the patient as potentially being akathisia before increasing the dose.

If severe side effects occur, it is possible that the metabolization of the drug may be different. CYP2D6 can determine the variation in response. Genotyping can be considered.

 


 
  

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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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References

  1. Gilbert DL, et al, Tic reduction with risperidone versus pimozide in a randomized, double-blind, crossover trial, J Am Acad Child Adolesc Psychiatry, 2004, 43, 206-14
  2. Bruggeman R et al, Risperidone versus pimozide in Tourette\'s disorder: a comparative double-blind parallel-group study, J Clin Psychiatry., 2001, 62, 50-6
  3. Robertson MM, et al, Gilles de la Tourette syndrome: symptomatic treatment based on evidence., Eur Child Adolesc Psychiatry, 2000, 9 Suppl 1, I60-75
  4. Sallee FR, et al, Relative efficacy of haloperidol and pimozide in children and adolescents with Tourette\'s disorder. Am J Psychiatry., 1997, 154, 1057-62
  5. Sallee FR, et al, Prolactin monitoring of haloperidol and pimozide treatment in children with Tourette\'s syndrome, Biol Psychiatry, 1996, 40, 1044-50
  6. Sallee FR, et al, Pharmacokinetics of pimozide in adults and children with Tourette\'s syndrome., J Clin Pharmacol., 1987, 27, 776-81
  7. Eumedica, SPC Orap, RVG 06149, 28-12-2015, www.geneesmiddeleninformatiebank.nl, http://db.cbg-meb.nl/IB-teksten/h06149.pdf (20 jan 2009)

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Changes

Changes