1/22/2025

Janusmed kön och genus

Janusmed kön och genus – Tramadol Retard Medartuum

Janusmed kön och genus är ett kunskapsstöd som tillhandahåller information om köns- och genusaspekter på läkemedelsbehandling. Kunskapsstödet är avsedd främst för hälso- och sjukvårdspersonal. Texterna är generella och ska inte ses som behandlingsriktlinjer. Det är alltid behandlande läkare som ansvarar för patientens medicinering.

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Tramadol

Tramadol

Klass : A

Produkter

Dolatramyl, Gemadol, Nobligan, Nobligan retard, Tiparol, Tiparol OD, T......

Dolatramyl, Gemadol, Nobligan, Nobligan retard, Tiparol, Tiparol OD, Tiparol Retard, Tradolan, Tradolan Retard, Tramadol 2care4, Tramadol Actavis, Tramadol Alternova, Tramadol Aurobindo, Tramadol HEXAL, Tramadol Krka, Tramadol Retard Actavis, Tramadol Retard Hexal, Tramadol Retard Krka, Tramadol Retard Medartuum, Tramadol Retard Mylan, Tramadol STADA, Tramadol Vitabalans, Tramuno, Zaldiar
ATC-koder

N02AJ13, N02AX02

N02AJ13, N02AX02
Substanser

tramadol, tramadolhydroklorid

tramadol, tramadolhydroklorid
Sammanfattning

Studier visar likvärdig smärtlindrande effekt av tramadol hos kvinnor och män. Tramadol-inducerade krampanfall är en dosberoende biverkning hos både kvinnor och män.

Studier visar likvärdig smärtlindrande effekt av tramadol hos kvinnor och män. Tramadol-inducerade krampanfall är en dosberoende biverkning hos både kvinnor och män.
Background

The prevalence of several clinical pain conditions is higher in women than in men. Differences in pharmacokinetics, sex hormones, stress response, or socio-cultural aspects may be of importance [1-3]. Therefore, sex and gender differences of pain medications are difficult to interpret [4].
Studies on abuse potential of opioids have not been included in this document.

Pharmacokinetics and dosing
A study in healthy Iranian volunteers (12 men, 12 women) showed no sex differences in pharmacokinetics of a single dose 100 mg tramadol [5]. The original manufacturer reports that for extended-release tramadol capsule, dose-normalized AUC values were slightly higher in healthy women than men [6, 7]. After a single oral dose of tramadol tablet, women had 12% higher peak tramadol concentration and 35% higher AUC (adjusted for body weight) [8].
In a prospective observational study in patients undergoing laparoscopic cholecystectomy (60 men, 60 women), women required a higher dose of tramadol during the first postoperative hour to achieve a similar degree of analgesia (40 mg vs. 27.8 mg). Baseli......

The prevalence of several clinical pain conditions is higher in women than in men. Differences in pharmacokinetics, sex hormones, stress response, or socio-cultural aspects may be of importance [1-3]. Therefore, sex and gender differences of pain medications are difficult to interpret [4]. Studies on abuse potential of opioids have not been included in this document. # Pharmacokinetics and dosing A study in healthy Iranian volunteers (12 men, 12 women) showed no sex differences in pharmacokinetics of a single dose 100 mg tramadol [5]. The original manufacturer reports that for extended-release tramadol capsule, dose-normalized AUC values were slightly higher in healthy women than men [6, 7]. After a single oral dose of tramadol tablet, women had 12% higher peak tramadol concentration and 35% higher AUC (adjusted for body weight) [8]. In a prospective observational study in patients undergoing laparoscopic cholecystectomy (60 men, 60 women), women required a higher dose of tramadol during the first postoperative hour to achieve a similar degree of analgesia (40 mg vs. 27.8 mg). Baseline pain score was similar in men and women [9]. The original manufacturer recommends no dose adjustment based on patient’s sex [6, 8]. # Effects The effect of tramadol is largely due to its metabolite O-desmethyltramadol [10]. Following laparoscopic cholecystectomy (60 men, 60 women), the effect of tramadol 10 mg i.v. on pain perception (numerical rating scale) has been analyzed in men and women. Despite similar baseline pain score, the pain intensity was higher in women than men at 20 and 30 min after the first tramadol administration [9]. A randomized, placebo-controlled trial (63 men, 167 women) showed that the analgesic effect of 200 mg tramadol once daily for osteoarthritis was similar in men and women [11]. The effect of opioids for pain relief may differ between men and women. According to a systematic review, women may require lower doses of opioids, both in treatment of acute and chronic pain [12]. # Adverse effects There is a risk of seizure when using high doses of tramadol in both men and women [10, 13, 14]. Sex differences in adverse effects of opioids were investigated in a large retrospective cohort study (3319 men, 5138 women). Women were more likely than men to report adverse reactions to tramadol, after adjusting for BMI and age (OR 2.8). For opioids in general, women had a higher risk of gastrointestinal issues (OR 3.1), skin and subcutaneous tissue complications (e.g. rash, itching; OR 2.1), and nervous system issues (e.g. migraines, dizziness; OR 2.3) [15]. # Reproductive health issues Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Försäljning på recept

Fler kvinnor än män hämtade ut läkemedel innehållande tramadol (ATC-kod N02AX02) på recept i Sverige år 2021, totalt 31 600 kvinnor och 25 321 män. Det motsvarar 6,1 respektive 4,9 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 55-79 år hos båda könen. I genomsnitt var läkemedel innehållande tramadol 1,3 gånger vanligare hos kvinnor [16].
Referenser
  1. Greenspan JD, Craft RM, LeResche L, Arendt-Nielsen L, Berkley KJ, Fillingim RB et al. Studying sex and gender differences in pain and analgesia: a consensus report. Pain. 2007;132 Suppl 1:S26-45.
  2. Bartley EJ, Fillingim RB. Sex differences in pain: a brief review of clinical and experimental findings. Br J Anaesth. 2013;111(1):52-8.
  3. Sorge RE, Totsch SK. Sex Differences in Pain. J Neurosci Res. 2017;95(6):1271-1281.
  4. Dance A. Why the sexes don't feel pain the same way. Nature. 2019;567(7749):448-450.
  5. Ardakani YH, Rouini MR. Pharmacokinetics of tramadol and its three main metabolites in healthy male and female volunteers. Biopharm Drug Dispos. 2007;28:527-34.
  6. Conzip. DailyMed [www]. US national Library of Medicine. [updated 2022-01-20, cited 2022-12-16].
  7. Ultram. DailyMed [www]. US National Library of Medicine. [updated 2022-06-07, cited 2022-12-16].
  8. Lintz W, Becker R, Gerloff J, Terlinden R. Pharmacokinetics of tramadol and bioavailability of enteral tramadol formulations 4th communication: drops (without ethanol). Arzneimittelforschung. 2000;50(2):99-108.
  9. Hussain AM, Khan FA, Ahmed A, Chawla T, Azam SI. Effect of gender on pain perception and analgesic consumption in laparoscopic cholecystectomy: An observational study. J Anaesthesiol Clin Pharmacol. 2013;29:337-41.
  10. Nobligan (tramadol). Summary of Product Characteristics. Medical Products Agency Sweden; 2014.
  11. Malonne H, Coffiner M, Sonet B, Sereno A, Vanderbist F. Efficacy and tolerability of sustained-release tramadol in the treatment of symptomatic osteoarthritis of the hip or knee: a multicenter, randomized, double-blind, placebo-controlled study. Clin Ther. 2004;26:1774-82.
  12. Pisanu C, Franconi F, Gessa GL, Mameli S, Pisanu GM, Campesi I et al. Sex differences in the response to opioids for pain relief: A systematic review and meta-analysis. Pharmacol Res. 2019;148:104447.
  13. Taghaddosinejad F, Mehrpour O, Afshari R, Seghatoleslami A, Abdollahi M, Dart RC. Factors related to seizure in tramadol poisoning and its blood concentration. J Med Toxicol. 2011;7:183-8.
  14. Farajidana H, Hassanian-Moghaddam H, Zamani N, Sanaei-Zadeh H. Tramadol-induced seizures and trauma. Eur Rev Med Pharmacol Sci. 2012;16 Suppl 1:34-7.
  15. Lopes GS, Bielinski S, Moyer AM, Jacobson DJ, Wang L, Jiang R et al. Sex differences in type and occurrence of adverse reactions to opioid analgesics: a retrospective cohort study. BMJ Open. 2021;11(6):e044157.
  16. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2021 [cited 2022-03-15.]
Uppdaterat

Litteratursökningsdatum: 12/16/2022

Litteratursökningsdatum: 12/16/2022