Pharmacokinetics in children
There is no data known about the kinetics of this drug in children.
dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
Available formulations
No information is present at this moment.
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.
|
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.
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
The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
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
No information available on specific warnings and precautions in children.
Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
ANTIMIGRAINE PREPARATIONS
This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.
| Selective serotonin (5HT1) agonists |
|
|
|
N02CC04
|
|
|
|
N02CC01
|
|
|
|
N02CC03
|
References
-
Cuvellier JC, et al., Drug treatment of migraine in children: state of the art, Arch Pediatr, 2004, 11, 449-55
-
Eiland LS, et al, Pediatric migraine: pharmacologic agents for prophylaxis, Ann Pharmacother, 2007, 41, 1181-90
-
Gillies D, et al, Pizotifen (Sanomigran) in childhood migraine. A double-blind controlled trial, Eur Neurol, 1986, 25, 32-5
-
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
-
Salmon MA., Pizotifen (BC 105 Sandomigran) in the prophylaxis of childhood migraine., Cephalalgia, 1985, 5, 178
-
Samenvatting van de productkenmerken
Therapeutic Drug Monitoring
Overdose