Drug products: Alimemazin APL, Alimemazin Evolan, Alimemazin Orifarm, Theralen, Theralen®, THERALENE 4 POUR CENT, Vallergan
ATC code: R06AD01
Substances: alimemazine, alimemazine hemitartrate
The sedative effect of trimeprazine in children has been shown to be similar in boys and girls. Studies on adults with sex-divided analysis are lacking. Alimemazine (trimeprazine) has anticholinergic effect and may induce acute urinary retention in men with prostatic hypertrophy, and worsen glaucoma or cause paralytic ileus in both men and women.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
Alimemazine is also known as trimeprazinein English literature.
No studies with a clinically relevant sex analysis regarding the pharmacokinetics of trimeprazine have been found. A reduced dose should be used in the elderly due to the anticholinergic effects of trimeprazine (see Effects) .
In the major outcome trials of trimeprazine [2, 3], no sex analysis of the results have been performed. The influence of sex on the outcome of sedation using trimeprazine during dental treatment of children has been investigated in a retrospective analysis of sedation records (21 boys, 27 girls; age 3-8 years). The children received oral trimeprazine dosage of 3.8 mg/kg. There was no difference in sedation outcome between boys and girls. Both boys and girls had similar rates of both successful and unsuccessful sedation sessions .A double-blind placebo-controlled study evaluated the effects of trimeprazine on infant sleep disturbance (7 boys, 5 girls; age 6-27 months). Children without prior sedative medication received the low-dose (15 mg/10 ml for 21 nights), whereas children with previous experience of sedative medication received the high-dose (30 mg/10 ml for 10 nights). The results showed that trimeprazine was not a clinically effective treatment for infant sleeps disturbance. Although girls tended to have slightly more severe sleeps problems than boys, the response was the same for both boys and girls .
Trimeprazine has anticholinergic activity and may induce acute urinary retention in men with prostatic hypertrophy, and worsen glaucoma or cause paralytic ileus in both men and women .
No studies with a clinically relevant sex analysis regarding adverse effects of trimeprazine have been found.
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
A Norwegian registry study has examined the dispensing of trimeprazine to children aged 0-3 years and investigated the association between dispensing of trimeprazine to children and dispensed hypnotics to their parents during 12 months prior to pregnancy (1022 boys, 755 girls). Hypnotics use in mothers increased the risk of the child receiving trimeprazine (odds ratio 2.3 for boys and 1.7 for girls). When both parents had used hypnotics, the risk increased (odds ratio 2.8 for boys and 2.9 for girls) .
Date of litterature search: 2015-10-14
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson