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

Interactions
PK
Renal impairment
References

Alimemazine

Generic name
Alimemazine
Brand name
ATC Code
R06AD01

Pharmacokinetics in children

There is just a single study in which the pharmacokinetics of alimemazine have been investigated in children (N = 6, median age 6.8 years). The kinetic parameters from this study show wide variations between individuals (t½ = 4.4 to 18.5 hours, median 6.8 hours).

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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

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Dosages

Premedication
  • Oral
    • 3 years up to 18 years
      • 2 - 4 mg/kg/dose in 1 dose. Max: 50 mg/day.
      • Administer 2 hours prior to procedure or anesthesia

Prophylaxis and symptomatic treatment for allergic conditions in which non-sedating antihistamines have proved ineffective or insufficiently effective
  • Oral
    • 3 years up to 5 years
      • 2.5 - 10 mg/day in 3 doses.
      • The daily dose should be divided into a morning, noon and evening dose, with a larger dose given the evening.

    • 5 years up to 12 years
      • 2.5 - 15 mg/day in 3 doses.
      • The daily dose should be divided into a morning, noon and evening dose, with a larger dose given the evening.

    • 12 years up to 18 years
      • 10 - 20 mg/day in 2 - 4 doses.
      • The daily dose should be divided into a morning, noon and evening dose, with a larger dose given the evening.

As an adjuvant with other sedatives
  • Oral
    • 2 years up to 18 years
      • 0.2 - 0.5 mg/kg/dose, once only. Max single dose: 10 mg/dose.
      • Directions for administration:

        Take in the evening

      • Not a drug of first choice. Because of the limited number of studies that have been carried out into this, the dose recommendation is based on the Wilhelmina Children’s Hospital formulary.

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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

Paradoxical stimulation of the central nervous system can occur in young children in particular, which can cause sleeplessness, nervousness, confusion, tachycardia, tremors and convulsions.

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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 in children

Children younger than 2 years because of a possible link with sudden infant death syndrome.

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

Do not use in children aged under 2 years because of the risk of sedation and respiratory depression; there is a correlation with sudden infant death syndrome. Be careful in children aged less than 6 years because of the greater risk of neuropsychiatric side effects. Be careful in children with sleep apnoea in their previous history, when sudden infant death syndrome is known in the family, when children wake up spontaneously less easily than normal and in very sick or dehydrated children, because such children have an increased incidence of dystonia.
Do not combine with deptropine.

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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. Kahn A, et al, Phenothiazines and Sudden Infant Death Syndrome., Pediatrics, 1982, 70, 75-78.
  2. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  3. Mitchell V, et al, A comparison of midazolam with trimeprazine as an oral premedicant for children., Anaesthesia, 1997, 52, 416-21
  4. Patel D, et al, Oral midazolam compared with diazepam-droperidol and trimeprazine as premedicants in children., Paediatr Anaesth, 1997, 7:, 287-93
  5. Sponheim S, et al., Pharmacokinetics of trimeprazine in children, Pharmacol Toxicol, 1990, 67, 243-5
  6. van der Walt JH, et al, The perioperative effects of oral premedication in children, Anaesth Intensive Care, 1990, 18, 5-10
  7. Expert opinie Landelijk Werkgroep Wiegendood, Correspondentie met NKFK dd 29 feb 2008
  8. Sanofi-Aventis Netherlands B.V, SmPC Nedeltran (RVG 01751) 4 oktober 2011, www.cbg-meb.nl
  9. Evolan Pharma AB, SmPC Alimemazin Evolan (18-12189) 10.05.2021 (Norwegian SMPC), https://www.legemiddelsok.no/

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Changes

Changes