Ebastine

Classification: B

Drug products: Abetip, Ebastin 2care4, Ebastin ABECE, Ebastin Apofri, Ebastin Brown, Ebastin Ebb, Ebastin Orifarm, Kestine

ATC code: R06AX22

Substances: ebastine

Summary

Controlled studies regarding sex differences in efficacy and safety of ebastine are lacking.

Additional information

Pharmacokinetics and dosing

An analysis in healthy individuals (26 men, 63 women) receiving 20 mg ebastine showed that women excreted higher amounts of the inactive metabolite desalkylebastine than men. After adjustment of body weight, the sex difference disappeared [1]. Another study in healthy individuals (8 men, 4 women) found no clinically relevant sex differences in pharmacokinetic parameters after treatment with 20 mg ebastine once daily for 5 days [2].

Effects

No studies with a clinically relevant sex analysis regarding the effects of ebastine has been found.

Adverse effects

No studies with a clinically relevant sex analysis regarding adverse effects of ebastine has been found.

Reproductive health issues

Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).

Updated: 2020-08-28

Date of litterature search: 2018-12-14

References

Gervasini G, Vizcaino S, Carrillo JA, Caballero MJ, Benitez J. The effect of CYP2J2, CYP3A4, CYP3A5 and the MDR1 polymorphisms and gender on the urinary excretion of the metabolites of the H-receptor antihistamine ebastine: a pilot study. Br J Clin Pharmacol. 2006;62(2):177-86. PubMed
Rohatagi S, Gillen M, Aubeneau M, Jan C, Pandit B, Jensen BK et al. Effect of age and gender on the pharmacokinetics of ebastine after single and repeated dosing in healthy subjects. Int J Clin Pharmacol Ther. 2001;39(3):126-34. PubMed
Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2017 [cited 2018-12-17.] länk

Authors: Linnéa Karlsson Lind

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson