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Mirtazapin

Klassificering: B

Preparat: Mirtazapin 2care4, Mirtazapin Actavis, Mirtazapin Alternova, Mirtazapin Arrow, Mirtazapin Aurobindo, Mirtazapin Bluefish, Mirtazapin Ebb, Mirtazapin Ethypharm, Mirtazapin Hexal, Mirtazapin Imi Pharma®, Mirtazapin Krka, Mirtazapin Mylan, Mirtazapin Orion, Mirtazapin ratiopharm, Mirtazapin Sandoz, Mirtazapin STADA, Mirtazapin STADA®, Mirtazapin Teva, Mirtazapine, Mirtin, Remeron SolTab, Remeron®, Remeron®-S

ATC kod: N06AX11

Substanser: mirtazapin

Sammanfattning

Det saknas publicerade kontrollerade studier om skillnader mellan könen avseende effekt av mirtazapin.

Mirtazapin bryts ned långsammare hos kvinnor som därmed får högre koncentrationer än män.
En studie visade att fler män än kvinnor avbröt sin antidepressiva medicinering.
 
Vår bedömning är att de beskrivna skillnaderna inte motiverar olika dosering eller behandling hos kvinnor och män.

Additional information

Pharmacokinetics and dosing

Several studies have shown the pharmacokinetics properties of mirtazapine to be different in men and women [1,2,3]. The mean elimination half-life of mirtazapine is longer in women than in men (37 h vs. 26 h) [4]. In a study of 30 mg mirtazapine daily to 32 women and 13 men for 14 days, women had higher plasma concentrations of the enantiomers of mirtazapine and its demethyl metabolite [2]. In another pharmacokinetic study (36 men, 36 women), the concentration of mirtazapine was analyzed after intake of a single 30 mg dose of mirtazapine. Dose-weight adjusted AUC was about 15% lower in women and the dose/weight adjusted Cmax was slightly higher in women [3].

Pharmacokinetic variations of mirtazapine and its demethyl metabolite were examined in a therapeutic drug monitoring (TDM) study (110 men, 253 women). Median dose-corrected concentrations of mirtazapine, demethylmirtazapine and demethylmirtazapine/mirtazapine ratio were significantly higher in women than in men [5]. In another TDM study (303 men, 357 women), women had higher mirtazapine (30 mg/day) concentrations than men (107 vs. 92 nmol/L) [6].

Effects

No studies with a clinically relevant sex analysis regarding effects of mirtazapine have been found.

Adverse effects

No studies with a clinically relevant sex analysis regarding adverse effects of mirtazapine have been found.

Reproductive health issues

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

Other information

In a Spanish study based on a prescription database, 7525 patients who had received one or more antidepressant drug were included. Male sex was associated with a greater risk of treatment drop-out compared to women [7]. The prescription history during the first year after the introduction of mirtazapine, sertraline and venlafaxine were collected from 20 pharmacies in the Netherlands. No differences between men or women were observed [8]. In an Australian national survey, the prevalence and treatment of affective and anxiety disorder were estimated. Both prevalence and treatment were higher in women (5.25 vs. 4.53 DDD/1000 population/day) [9].

Försäljning på recept

Fler kvinnor än män hämtade ut tabletter innehållande mirtazapin (ATC-kod N06AX11) på recept i Sverige år 2015, totalt 107 955 kvinnor och 76 109 män. Det motsvarar 22 respektive 16 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 85 år och äldre hos båda könen. I genomsnitt var tabletter innehållande mirtazapin 1,3 gånger vanligare hos kvinnor [10].

Uppdaterat: 2020-08-28

Litteratursökningsdatum: 2013-04-05

Referenser

  1. Timmer CJ, Sitsen JM, Delbressine LP. Clinical pharmacokinetics of mirtazapine. Clin Pharmacokinet 2000 Jun;38(6):461-74 PubMed
  2. Jaquenoud Sirot E, Harenberg S, Vandel P, Lima CA, Perrenoud P, Kemmerling K et al. Multicenter study on the clinical effectiveness, pharmacokinetics, and pharmacogenetics of mirtazapine in depression. J Clin Psychopharmacol. 2012;32:622-9. PubMed
  3. Borobia AM, Novalbos J, Guerra-López P, López-Rodríguez R, Tabares B, Rodríguez V et al. Influence of sex and CYP2D6 genotype on mirtazapine disposition, evaluated in Spanish healthy volunteers. Pharmacol Res. 2009;59:393-8. PubMed
  4. Mirtazapine Remedyrepack inc (mirtazapine). DailyMed [www]. US National Library of Medicine. [updated 2012-10-01, cited 2013-04-18]. länk
  5. Reis M, Prochazka J, Sitsen A, Ahlner J, Bengtsson F. Inter- and intraindividual pharmacokinetic variations of mirtazapine and its N-demethyl metabolite in patients treated for major depressive disorder: a 6-month therapeutic drug monitoring study. Ther Drug Monit. 2005;27:469-77. PubMed
  6. Reis M, Aamo T, Spigset O, Ahlner J. Serum concentrations of antidepressant drugs in a naturalistic setting: compilation based on a large therapeutic drug monitoring database. Ther Drug Monit. 2009;31:42-56. PubMed
  7. Serna MC, Cruz I, Real J, Gascó E, Galván L. Duration and adherence of antidepressant treatment (2003 to 2007) based on prescription database. Eur Psychiatry. 2010;25:206-13. PubMed
  8. Egberts AC, Lenderink AW, de Koning FH, Leufkens HG. Channeling of three newly introduced antidepressants to patients not responding satisfactorily to previous treatment. J Clin Psychopharmacol. 1997;17:149-55. PubMed
  9. Hollingworth SA, Burgess PM, Whiteford HA. Affective and anxiety disorders: prevalence, treatment and antidepressant medication use. Aust N Z J Psychiatry. 2010;44:513-9. PubMed
  10. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-29] länk

Författare: Fadiea Al-Aieshy, Desirée Loikas

Faktagranskat av: Expertrådet för psykiatriska sjukdomar, Expertrådet för geriatriska sjukdomar

Godkänt av: Mia von Euler

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