Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Zolmitriptan

Klassificering: A

Preparat: Zolmitriptan 2care4, Zolmitriptan Actavis, Zolmitriptan Arrow, Zolmitriptan Ebb, Zolmitriptan Jubilant, Zolmitriptan STADA, Zolmitriptan Teva, Zomig, Zomig Nasal, Zomig Rapimelt, Zomig®, Zomig® Nasal, Zomig® Rapimelt, Zomigon, Zomigoro Rapimelt

ATC kod: N02CC03

Substanser: zolmitriptan

Sammanfattning

Effekten av zolmitriptan vid akut migrän är likvärdig hos kvinnor och män.
Biverkningsprofilen av zolmitriptan är likartad mellan könen.
 
Kunskapsunderlaget avseende skillnader mellan kvinnor och män är begränsat och motiverar inte olika dosering eller behandling.

Additional information

Pharmacokinetics and dosing

There are small pharmacokinetic studies of zolmitriptan that shows varying results and of which none were judged to be of clinical importance [1, 2]. Other studies found differences in pharmacokinetics only between young men and women (18-39 years) but not in the elderly (65-75 years) [3, 4]. Although some sex differences in zolmitriptan pharmacokinetics have been reported in young adults [4-7], no dosage adjustment based on sex has been recommended [5].

Effects

Headache relief after administration of zolmitriptan has been evaluated in open-label clinical trials [6, 7]. Two-hour headache response rates to an initial dose of 2.5 mg or 5 mg zolmitriptan were 85% and 79-81%, respectively. Responses were unaffected by sex.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 [8].

Adverse effects

Tolerability of zolmitriptan was evaluated in an international, open-label study (288 men, 1769 women). The types of adverse events observed were similar in men and women, although the incidence of adverse events was slightly higher in women (78%) than men (61%) [7].A placebo-controlled clinical trial (1540 men, 1210 women) reported that the nature and type of adverse events were similar in men and women, although the frequency of reported adverse events was higher in women (48%) than in men (30%). This sex difference was also observed in patients who received placebo and may reflect a difference between the sexes in adverse event reporting. The frequency of serious adverse events did not differ between men and women [9].

Reproductive health issues

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

Försäljning på recept

Fler kvinnor än män hämtade ut läkemedel innehållande zolmitriptan (ATC-kod N02CC03) på recept i Sverige år 2015, totalt 18 418 kvinnor och 4 643 män. Det motsvarar 3,8 respektive 1,0 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 40-59 år hos båda könen. I genomsnitt var läkemedel innehållande zolmitriptan 3,5 gånger vanligare hos kvinnor [10].

Sumatriptan och zolmitriptan kan köpas utan recept, men cirka 90 % av alla triptaner hämtas ut på recept [11]. Ettårsprevalensen av migrän i Sverige har uppskattats till 16,7% hos kvinnor och 9,5 % hos män [12].

Uppdaterat: 2019-02-26

Litteratursökningsdatum: 2014-06-26

Referenser

  1. Seaber EJ, Peck RW, Smith DA, Allanson J, Hefting NR, van Lier JJ et al. The absolute bioavailability and effect of food on the pharmacokinetics of zolmitriptan in healthy volunteers. Br J Clin Pharmacol. 1998;46:433-9. PubMed
  2. Lionetto L, Casolla B, Mastropietri F, D'Alonzo L, Negro A, Simmaco M et al. Pharmacokinetic evaluation of zolmitriptan for the treatment of migraines. Expert Opin Drug Metab Toxicol. 2012;8:1043-50. PubMed
  3. Peck RW, Seaber EJ, Dixon RM, Layton GR, Weatherley BC, Jackson SH et al. The pharmacodynamics and pharmacokinetics of the 5HT1B/1D-agonist zolmitriptan in healthy young and elderly men and women. Clin Pharmacol Ther. 1998;63:342-53. PubMed
  4. Yates RA, Tateno M, Nairn K, Ikegami A, Dane A, Kemp J. The pharmacokinetics of the antimigraine compound zolmitriptan in Japanese and Caucasian subjects. Eur J Clin Pharmacol. 2002;58:247-52. PubMed
  5. Zomig (zolmitriptan). Summary of Product Characteristics. Medical Products Agency Sweden; 2015.
  6. Tuchman M, Edvinsson L, Geraud G, Korczyn A, Mauskop A, Pfaffenrath V. Zolmitriptan provides consistent migraine relief when used in the long-term. Curr Med Res Opin. 1999;15:272-81. PubMed
  7. The International 311C90 Long-term Study Group. The long-term tolerability and efficacy of oral zolmitriptan (Zomig, 311C90) in the acute treatment of migraine An international study The International 311C90 Long-term Study Group. Headache. 1998;38:173-83.
  8. Franconi F, Finocchi C, Allais G, Omboni S, Tullo V, Campesi I et al. Gender and triptan efficacy: a pooled analysis of three double-blind, randomized, crossover, multicenter, Italian studies comparing frovatriptan vs other triptans. Neurol Sci. 2014;35 Suppl 1:99-105. PubMed
  9. Edmeads JG, Millson DS. Tolerability profile of zolmitriptan (Zomig; 311C90), a novel dual central and peripherally acting 5HT1B/1D agonist International clinical experience based on > 3000 subjects treated with zolmitriptan. Cephalalgia. 1997;17 Suppl 18:41-52. PubMed
  10. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-29] länk
  11. von Euler, M, Keshani, S, Baatz, K, Wettermark, B. PP261 - Utilization of triptanes in Sweden; analyses of over the counter and prescriptions sales. Clinical Therapeutics. 2013;8, Suppl(35):e99.
  12. Dahlöf C, Linde M. One-year prevalence of migraine in Sweden: a population-based study in adults. Cephalalgia. 2001;21:664-71. PubMed

Författare: Linnéa Karlsson Lind, Desirée Loikas

Faktagranskat av: Mia von Euler

Godkänt av: Karin Schenck-Gustafsson