Drug products: Maxalt, Maxalt Rapitab, Maxalt®, Maxalt® Rapitab®, Rizasmelt, Rizatriptan 2care4, Rizatriptan Actavis, Rizatriptan Aurobindo, Rizatriptan Glenmark, Rizatriptan Mylan, Rizatriptan Orifarm, Rizatriptan Sandoz, Rizatriptan STADA, Rizatriptan Teva
ATC code: N02CC04
Substances: rizatriptan, rizatriptan benzoate
The effect of rizatriptan in acute migraine is similar in men and women.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
The pharmacokinetics of single oral doses of rizatriptan 2.5-15 mg administrated to healthy volunteers was studied in a randomized, crossover study (12 men, 12 women). The mean AUC of oral rizatriptan was 19-35% higher in women than in men. However, the difference is not likely to be of clinical relevance. Plasma clearance of rizatriptan was ~25% higher in men than in women. No difference in the dose-effect relationship between men and women was noted . In another study (6 men, 6 women), where healthy volunteers received a single dose rizatriptan 10 mg, half-life was longer in men. Other pharmacokinetic parameters showed no sex differences [2, 3]. No pharmacokinetic differences between elderly men and women have been found .
The efficacy of rizatriptan 5 mg in adolescents (12-17 years old) was established in two randomized, placebo-controlled trials (212 men, 263 women). Rizatriptan 5 mg was shown to be more effective than standard care (patient’s usual migraine therapy) during long-term use. Treatment effects for pain relief were not dependent on sex .Time to pain freedom with rizatriptan 10 mg compared to usual care was evaluated in a prospective, open-label study (197 men, 1292 women; mean age 41.7 years). There were no differences in time to pain freedom between men and women .Results from randomized, double-blind studies of migraineurs (66 men, 280 women) show no sex differences in response to frovatriptan 2.5 mg, rizatriptan 10 mg, zolmitriptan 2.5 mg or almotriptan 12.5 mg .
According to trials done by the original manufacturer, incidence of adverse reactions did not differ between men and women .
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2014-06-17
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson