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Tramadol

Klassificering: A

Preparat: Dolatramyl, Gemadol, Nobligan®, Nobligan® retard, Tiparol®, Tiparol® OD, Tiparol® Retard, Tradolan®, Tradolan® Retard, Tramadol 2care4, Tramadol Actavis, Tramadol Alternova, Tramadol AstraZeneca, Tramadol Aurobindo, Tramadol Hexal, Tramadol HEXAL, Tramadol Krka, Tramadol Meda, Tramadol Retard Actavis, Tramadol Retard AstraZeneca, Tramadol Retard Hexal, Tramadol Retard Krka, Tramadol Retard Medartuum, Tramadol Retard Mylan, Tramadol Scand Pharm, Tramadol STADA®, Tramadol Vitabalans, Tramuno, Zaldiar

ATC kod: N02AJ13, N02AX02

Substanser: tramadol, tramadolhydroklorid

Sammanfattning

Det finns studier som visar likvärdig smärtlindrande effekt av tramadol hos kvinnor och män. I en observationell studie på patienter som genomgått titthålskirurgi rapporterade kvinnor och män samma smärtnivå före tramadolinjektion. Kvinnor rapporterade mer smärta och fick en högre medeldos av tramadol under första timmen postoperativt. Minskningen i smärta var dock densamma hos kvinnor och män efter 30 min.

Tramadol-inducerade krampanfall är dosberoende på ett likartat sätt hos kvinnor och män.
 
Kunskapsunderlaget avseende skillnader mellan kvinnor och män är begränsat och motiverar inte olika dosering eller behandling.

Additional information

The literature indicates that women and men differ in pain behavior. This could be influenced by differences in pharmacokinetics, sex hormones, differences in stress response, or type of pain test. Also, many variables other than a person’s sex/gender account for individual differences in pain sensitivity. The prevalence of several clinical pain conditions are higher in women than men suggests that either different clinical pain mechanisms may operate in men vs. women, or different or additional risk factors are relevant in one sex, or a combination of differences [1].

Pharmacokinetics and dosing

A study in healthy Iranian volunteers (12 men, 12 women) showed no differences in pharmacokinetics of a single dose of 100 mg tramadol [2]. The original manufacturer reports that dose-normalized AUC values for tramadol are higher in healthy women than men, but that the results shows considerable overlap in AUC values between men and women. The scientific data backing this statement has not been presented [3].

In a prospective observational study in patients undergoing laparoscopic cholecystectomy (60 men, 60 women), mean dose of tramadol was higher in women during the first postoperative hour in order to achieve a similar degree of analgesia (40 mg vs. 27.8 mg). Baseline pain score was similar in men and women. The difference in doses was not significant during the later period [4]. The original manufacturer recommends no dosage adjustment based on sex [3].

Effects

The effect of sex on pain perception has been analyzed in a prospective observational study in patients after laparoscopic cholecystectomy (60 men, 60 women). Patients assessed postoperative pain based on a numerical rating score and also indicated the degree of pain improvement after receiving tramadol 10 mg i.v. Baseline pain score was similar in men and women. Women expressed more pain at 20 and 30 min after first tramadol administration and required more tramadol during the first postoperative hour (see Pharmacokinetics and dosing). The decrease in pain was similar in men and women after 30 min postoperatively [4].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 [5].

Adverse effects

No studies on differences between men and women using therapeutic recommended doses have been found. There is a risk of seizure when using high doses of tramadol in both men and women (see Other information).

Reproductive health issues

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

Other information

There is a risk of seizure when using high doses of tramadol [6]. An observational study (112 men, 23 women) analyzed the relation between seizure and tramadol intoxication in Iranian patients with a history of tramadol overdose and experience of seizure or loss of consciousness. Seizures correlated with higher reported doses in a similar way in men and women [7]. Another Iranian study (197 men, 35 women), retrospectively analyzed the prevalence, type and site of injuries due to tramadol-induced seizures. The prevalence of trauma was 24.6% and the occurrence of trauma was independent of sex [8].

Försäljning på recept

Fler kvinnor än män hämtade ut läkemedel innehållande tramadol (ATC-kod N02AX02) på recept i Sverige år 2015, totalt 95 215 kvinnor och 73 822 män. Det motsvarar 20 respektive 15 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 50-84 år hos båda könen. I genomsnitt var läkemedel innehållande tramadol 1,3 gånger vanligare hos kvinnor [9].

Uppdaterat: 2019-02-26

Litteratursökningsdatum: 2015-02-23

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. PubMed
  2. 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. PubMed
  3. Conzip (tramadol hydrochloride). DailyMed [www]. US national Library of Medicine. [updated 2014-10-01, cited 2015-02-23]. länk
  4. 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. PubMed
  5. 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. PubMed
  6. Nobligan (tramadol). Summary of Product Characteristics. Medical Products Agency Sweden; 2014.
  7. 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. PubMed
  8. 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. PubMed
  9. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-29] länk

Författare: Linnéa Karlsson Lind, Desirée Loikas

Faktagranskat av: Mia von Euler, Karin Schenck-Gustafsson

Godkänt av: Karin Schenck-Gustafsson