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

Interactions
PK
Renal impairment
References

Clemastine

Generic name
Clemastine
Brand name
ATC Code
R06AA04

Pharmacokinetics in children

No data

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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

Prevention and symptomatic treatment of allergic reactions and anaphylaxia
  • Oral
    • 1 month up to 12 years
      • 25 - 50 microg./kg/dose max. twice daily. Max: 1 mg/dose.
      • No studies have been carried out into oral use of clemastine in children

    • 12 years up to 18 years
      • 2 mg/day in 2 doses.
Anaphylaxis and Quincke oedema
  • Intramuscular
    • 1 month up to 18 years
      [4]
      • 25 - 50 microg./kg/dose max. twice daily. Max: 2 mg/dose.
      • No studies have been carried out into intramuscular use of clemastine in children

    • 1 month up to 18 years
      • 25 - 50 microg./kg/dose max. twice daily. Max: 2 mg/dose.
      • No studies have been carried out into intramuscular use of clemastine in children

    • 1 month up to 18 years
      • 25 - 50 microg./kg/dose max. twice daily. Max: 2 mg/dose.
      • No studies have been carried out into intramuscular use of clemastine in children

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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

Irritability and paradoxical stimulation of the central nervous system.

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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

Young children are in general a lot more sensitive to the toxic effects of antihistamines than adults. With classical antihistamines, reversible dyskinesia and paradoxical excitement (restlessness, sleeplessness, tremors, euphoria, nervousness and an increased tendency to convulsions) can also occur at therapeutic doses. Ataxia, restlessness, hallucinations, increased body temperature, cramps followed by coma, possibly resulting in the death are the (parasympathetic) symptoms of intoxication. Use of sedating antihistamines in children aged less than 2 years is contraindicated, given that the use of promethazine and deptropine has been linked to sudden infant death syndrome (SIDS). Caution is also needed when administering it to children with sleep apnoea in their previous history, when SIDS has occurred in the family, in children who wake up less easily and in children who are ill or dehydrated. Although there have been no properly set up and controlled studies in children, it is probable that ‘non-sedating’ antihistamines do not produce central side effects, given that the extent to which they pass the blood-CSF barrier is small to zero.
 

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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. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Brand PLP et al, Werkboek Kinderallergologie, VU Uitgeverij, 2006, 1e druk
  3. Kamps WA et al, Werkboek ondersteundende behandeling kinderoncologie, VU Uitgeverij, 2005
  4. American Academy of Pediatrics, Advanced Pediatric Life Support, Jones and Bartlett Publis, 2007, Revised 4th edition
  5. Centrafarm BV., SmPC Tavegyl 1 mg tabletten ( RVG 05621) 27-06-2021, www.geneesmiddeleninformatiebank.nl
  6. Gebro Pharma GmbH, SmPC Tavegyl injectievloeistof (RVG 06089) 08-12-2020, www.geneesmiddeleninformatiebank.nl

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Changes

Changes