Drug products: Atarax, Atyxine, Hydroxizin Alternova, Hydroxyzine Bluefish, Hydroxyzine EQL Pharma, Hydroxyzine Orifarm, Hydroxyzine Orion
ATC code: N05BB01
Substances: hydroxyzine, hydroxyzine hydrochloride
Studies on sex differences in hydroxyzine efficacy, safety and pharmacokinetics are lacking.
Hydroxyzine is contraindicated in patients with pre-existing prolonged QT interval. A sex difference has not been shown for hydroxyzine but female sex is a known risk factor for the dysrhythmia Torsade de pointes ventricular tachycardia.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
No studies with a clinically relevant sex analysis regarding the pharmacokinetics or dosing of hydroxyzine have been found.
No studies with a clinically relevant sex analysis regarding the effects of hydroxyzine have been found.
The Pharmacovigilance Risk Assessment Committee at the The European Medicines Agency has reviewed medicines containing hydroxyzine and the risk of possible effects on hearth rhythm. Hydroxyzine was associated with a small risk of QT interval prolongation and Torsade de pointes ventricular tachycardia, even at the lowest effective dose. Hydroxyzine should be avoided in patients who already have risk factors for heart rhythm disturbances . Women have been associated with a longer baseline QT interval and have an increased risk for drug-induced Torsade de pointes .
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Hydroxyzine was compared with diazepam as premedication before surgery (49 men, 59 women) in a double-blind randomized manner. In men, there was no difference between the effect of diazepam and hydroxyzine. In women, hydroxyzine was better than diazepam in relieving anxiety .
Date of litterature search: 2015-08-11
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson