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

Interactions
PK
Renal impairment
References

Pizotifen

Generic name
Pizotifen
Brand name
ATC Code
N02CX01

Pharmacokinetics in children

There is no data known about the kinetics of this drug in children.

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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

Maintenance treatment for migraine and migraine-like headaches
  • Oral
    • 2 years up to 18 years
      • 0.5 - 1.5 mg/day in 1 - 3 doses.
      • Directions for administration:

        Doses of up to 1 mg may be given in one go, in the evening

      • The dosage above is equivalent to the dosing that has been listed for pizotifen in the authorization dossier. The study by Gillies et al. shows that this dosage is not effective in older children (7-14 years). Further studies are required regarding the effectiveness of this dosage in older 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

Sleepiness and increased appetite. 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 in children

Children aged < 2 years.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

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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. Cuvellier JC, et al., Drug treatment of migraine in children: state of the art, Arch Pediatr, 2004, 11, 449-55
  2. Eiland LS, et al, Pediatric migraine: pharmacologic agents for prophylaxis, Ann Pharmacother, 2007, 41, 1181-90
  3. Gillies D, et al, Pizotifen (Sanomigran) in childhood migraine. A double-blind controlled trial, Eur Neurol, 1986, 25, 32-5
  4. Lewis D, et al., Practice parameter: pharmacological treatment of migraine headache in children and adolescents: report of the American Academy of Neurology Quality Standards Subcommittee and the Practice Committee of the Child Neurology Society, Neurology, 2004(28), 63, 2215-24
  5. Salmon MA., Pizotifen (BC 105 Sandomigran) in the prophylaxis of childhood migraine., Cephalalgia, 1985, 5, 178
  6. Samenvatting van de productkenmerken

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Changes

Changes