6/10/2023

Janusmed kön och genus

Janusmed kön och genus – Burana Comp

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.

För att komma till startsidan för Janusmed kön och genus och för att göra sökningar klicka här.

Tillbaka till index
B B
B B

Kodein

Kodein

Klass: B

Produkter

Altermol, Ardinex, Burana Comp, Citodon, Citodon forte,......

Altermol, Ardinex, Burana Comp, Citodon, Citodon forte, Citodon minor, Codalvonil, Kodein Alternova, Kodein EQL Pharma, Kodein RPH Pharma, Kodeinfosfat APL, Panocod, Paracetamol/Kodein Evolan, Treo comp
ATC-koder

A07DA, N02AJ06, N02AJ08, N02AJ09, R05DA04

A07DA, N02AJ06, N02AJ08, N02AJ09, R05DA04
Substanser

kodein, kodein n-oxid, kodeinfosfat, kodeinfosfat anhyd......

kodein, kodein n-oxid, kodeinfosfat, kodeinfosfat anhydrat, kodeinfosfathemihydrat, kodeinfosfatseskvihydrat, kodeinhydrobromid, kodeinhydrokloriddihydrat, kodeinsulfat
Sammanfattning

Det saknas kontrollerade studier om skillnader mellan könen avseende effekt, biverkningar och farmakokinetik för kodein. Kodein är en prodrug och måste omvandlas till morfin för att ha effekt.

Det saknas kontrollerade studier om skillnader mellan könen avseende effekt, biverkningar och farmakokinetik för kodein. Kodein är en prodrug och måste omvandlas till morfin för att ha effekt.
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
Codeine is metabolized to its active metabolite morphine by the CYP2D6 isoenzyme. No sex differences in CYP2D6 activity has been reported [5, 6]. Clinical studies have shown effect with similar doses in men and women and no sex differentiation in dosing has been suggested [7].

Effects
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. However, no specific data on codeine in acute pain were presented [8]. No other studies with a clinically relevant sex analysis of codeine efficacy have been found.

Adverse effects
Codeine is contraindicated in childr......

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 Codeine is metabolized to its active metabolite morphine by the CYP2D6 isoenzyme. No sex differences in CYP2D6 activity has been reported [5, 6]. Clinical studies have shown effect with similar doses in men and women and no sex differentiation in dosing has been suggested [7]. # Effects 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. However, no specific data on codeine in acute pain were presented [8]. No other studies with a clinically relevant sex analysis of codeine efficacy have been found. # Adverse effects Codeine is contraindicated in children <12 years of age due to increased risk for morphine overdose [7]. In a double-blind trial evaluating the analgesic effect and adverse events of 1000 mg paracetamol/60 mg codeine after tooth extraction (44 men, 50 women) women were found to report more adverse events when not adjusting for body weight. A lower mean body weight in women might explain this (76 kg in men and 62 kg in women) [9]. Sex differences in adverse effects of opioid were investigated in a large retrospective cohort study (3319 men, 5138 women). Women had a higher tendency (OR 1.4 after adjusting for BMI and age) to report adverse reactions to codeine, however the sex difference was not significant. 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) [10]. # 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 kodein (ATC-kod R05DA04) på recept i Sverige år 2021, totalt 2 863 kvinnor och 1 888 män. Det motsvarar 6 respektive 4 patienter per tiotusen invånare. Andelen som hämtat ut läkemedlet ökade med stigande ålder hos båda könen. I genomsnitt var kodein 1,7 gånger vanligare hos kvinnor [11].
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. Franconi F, Brunelleschi S, Steardo L, Cuomo V. Gender differences in drug responses. Pharmacol Res. 2007;55:81-95.
  6. Nicolson TJ, Mellor HR, Roberts RR. Gender differences in drug toxicity. Trends Pharmacol Sci. 2010;31:108-14.
  7. Kodein Alternova (codeine). Summary of Product Characteristics. Swedish Medical Products Agency [updated 2019-01-22, cited 2022-12-13]
  8. 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.
  9. Sagne S, Henrikson PA, Kahnberg KE, Thilander H, Bertilson SO. Analgesic efficacy and side-effect profile of paracetamol/codeine and paracetamol/dextropropoxyphene after surgical removal of a lower wisdom tooth. J Int Med Res. 1987;15:83-8.
  10. 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.
  11. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2021 [cited 2022-03-15.]
Uppdaterat

Litteratursökningsdatum 12/13/2022

Litteratursökningsdatum 12/13/2022
Se även
A A
A A

Ibuprofen

Ibuprofen

Klass: A

Produkter

Alindrin, Ardinex, Brufen, Brufen Retard, Burana, Buran......

Alindrin, Ardinex, Brufen, Brufen Retard, Burana, Burana Comp, Childrens Ibuprofen, Comboval, Dolerin, Ibetin, Ibumax, Ibumetin, Ibuprofen 2care4, Ibuprofen ABECE, Ibuprofen Accord, Ibuprofen Actavis, Ibuprofen Apofri, Ibuprofen Aristo, Ibuprofen B. Braun, Ibuprofen Bril, Ibuprofen Evolan, Ibuprofen Fyro, Ibuprofen NET, Ibuprofen Orifarm, Ibuprofen Orion, Ibuprofen Pfleger, Ibuprofen Zentiva, Ibuprofen ratiopharm, Ibux, Ifenin, Ipren, Iprensa, Neoprofen, Nurofen, Nurofen Apelsin, Nurofen Jordgubb, Nurofen Junior, Nurofen voor Kinderen, Nurofen voor Kinderen suppo, Pedea, Perdophen Pediatrie
ATC-koder

C01EB, C01EB16, M01AE01, M02AA13, N02AJ08, N02BE51

C01EB, C01EB16, M01AE01, M02AA13, N02AJ08, N02BE51
Substanser

ibuprofen, ibuprofen dc 85, ibuprofen-D,L-lysin, ibupro......

ibuprofen, ibuprofen dc 85, ibuprofen-D,L-lysin, ibuprofenarginin, ibuprofennatriumdihydrat
Sammanfattning

Ibuprofen ger smärtlindring hos båda könen. Studier har dock visat motsägande resultat om ibuprofens effekt hos kvinnor och män. En omfattande metaanalys på tandsmärta visar att ibuprofen har likartad effekt hos män och kvinnor. Det finns dock ett par mindre studier där män/pojkar påvisats ha bättre effekt.
En stor epidemiologisk smärtstudie med flera olika analgetika har visat att kvinnor får mer biverkningar. Män hade högre risk än kvinnor för magblödning av NSAID-behandling i en stor retrospektiv studie. Kvinnor hade högre risk för NSAID-inducerad leverskada i en liten fall-kontrollstudie, medan en stor kohortstudie inte visade någon könsskillnad. Inga könsskillnader i risken för kardiovaskulära bieffekter har visats.

Ibuprofen ger smärtlindring hos båda könen. Studier har dock visat motsägande resultat om ibuprofens effekt hos kvinnor och män. En omfattande metaanalys på tandsmärta visar att ibuprofen har likartad effekt hos män och kvinnor. Det finns dock ett par mindre studier där män/pojkar påvisats ha bättre effekt. En stor epidemiologisk smärtstudie med flera olika analgetika har visat att kvinnor får mer biverkningar. Män hade högre risk än kvinnor för magblödning av NSAID-behandling i en stor retrospektiv studie. Kvinnor hade högre risk för NSAID-inducerad leverskada i en liten fall-kontrollstudie, medan en stor kohortstudie inte visade någon könsskillnad. Inga könsskillnader i risken för kardiovaskulära bieffekter har visats.
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].

Pharmacokinetics and dosing
The effect of patient’s sex on the pharmacokinetics after a single dose 600 mg ibuprofen was evaluated in healthy volunteers (18 men, 19 women). Patient’s sex did not influence peak plasma concentration or the extent of binding to plasma protein. However, half-life was shorter and oral clearance was higher in young men compared to elderly men and women of all ages [5]. No sex differentiation in dosing is recommended by the pharmaceutical company [6].

Effects
A meta-analysis evaluated the effect of patient’s sex on ibuprofen 400 mg in men and non-pregnant women with moderate to severe dental pain (119 men, 195 women, 15-35 years of age). No sex differences in analgesic response to ibuprofen were found [7]. A small study investigated the analgesic efficacy of ibuprofen......

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]. # Pharmacokinetics and dosing The effect of patient’s sex on the pharmacokinetics after a single dose 600 mg ibuprofen was evaluated in healthy volunteers (18 men, 19 women). Patient’s sex did not influence peak plasma concentration or the extent of binding to plasma protein. However, half-life was shorter and oral clearance was higher in young men compared to elderly men and women of all ages [5]. No sex differentiation in dosing is recommended by the pharmaceutical company [6]. # Effects A meta-analysis evaluated the effect of patient’s sex on ibuprofen 400 mg in men and non-pregnant women with moderate to severe dental pain (119 men, 195 women, 15-35 years of age). No sex differences in analgesic response to ibuprofen were found [7]. A small study investigated the analgesic efficacy of ibuprofen 600 mg on postoperative endodontic pain (8 men, 7 women). There were no differences in pain reduction between men or women in the ibuprofen and placebo group [8]. Pain relief in children with migraine was examined in a randomized, double-blind, placebo-controlled study (49 boys, 35 girls, age 6-12 years). They were given ibuprofen 7.5 mg/kg or placebo. Boys taking ibuprofen responded effectively while girls did not. No analysis of pharmacokinetics variables was performed [9]. Small experimental studies in healthy individuals have shown that men receiving ibuprofen responded to electrically induced pain while women did not [10, 11]. # Adverse effects The PAIN study (3611 men, 5009 women) was a large randomized double-blind trial of the tolerability of paracetamol, aspirin and ibuprofen. Analysis of potential risk factors for all adverse events among patients in the PAIN study shows that female sex is one risk factor [12]. A nested control study estimated the risk of upper gastrointestinal complications associated with selective cox 2-inhibitors and non-selective NSAIDs (including diclofenac, ibuprofen, ketoprofen, naproxen) compared with non-use of NSAIDs. In all > 600 000 individuals contributed to >1 million person-years of observation and 726 upper gastrointestinal complications were identified. Male sex and high age carried a higher risk of complication and suggested a synergistic effect between these factors and NSAIDs on the risk of upper gastrointestinal complications. The risk for upper gastrointestinal complications differed between the various NSAIDs. Adjusted for male sex and age, the OR for ketoprofen was 3.4, compared to 2.2 for diclofenac, 4.0 for naproxen, and 1.6 for ibuprofen [13]. A retrospective cohort study (625 307 patients with 2 130 820 prescriptions, one third of these were to men) found that incidence rates of NSAID-induced acute liver injury were similar for men and women and for the young and the elderly [14]. However, a case-control study (136 men, 130 women) found an association between NSAID exposure and liver injury in women but not in men (OR 6.49 vs. 1.06). This may be due to differences in pharmacokinetics or circulating level hormones and/or greater use of multiple medications in women [15] or to a generally higher risk of drug-induced liver injury in women [16]. The large PRECISION trial (8636 men, 15445 women) compared the cardiovascular safety of celecoxib, naproxen, or ibuprofen. No sex differences were shown [17]. A post hoc study of the PRECISION trial (8591 men, 15359 women) enrolled patients with known cardiovascular disease or risk factors as well as osteoarthritis or rheumatoid arthritis and required regular daily treatment with an NSAID. The risk score was designed to predict the 1-year occurrence of major toxicity including major adverse cardiovascular events, clinically significant gastrointestinal events, acute kidney injury, and death. Male sex and higher age were correlated to higher risk of major toxicities. However, sex-stratified data were not presented for each NSAID and therefore information about which of the studied substances caused the changes in effect and/or adverse events is lacking [18]. A meta-analysis evaluated NSAID use and the risk of Parkinson’s disease. Pooled risk ratios of Parkinson’s disease were similar in men and women using NSAID (men 0.79 (95%CI 0.69, 0.92); women 0.72 (95%CI 0.45, 1.15)) [19]. The relationship between use of aspirin or ibuprofen and reduced risk of colorectal polyp prevalence was analysed in a cross-sectional study (19 756 men, 18 640 women). Dose-dependent risk reductions were seen in men using aspirin and ibuprofen > 2 times/day. Protective effects in women were only found among those with BMI <25 and a regular use of aspirin or ibuprofen [20]. # Reproductive health issues Studies on animal models shows that non-selective NSAIDs (diclofenac, ibuprofen, ketoprofen, ketorolac, naproxen) can affect implantation and ovulation and small clinical studies report that non-selective NSAIDS may cause decreased fertility in some women. However, the effect is reversible after treatment discontinuation [6, 21-24]. Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
Försäljning på recept

Läkemedel innehållande ibuprofen (ATC-koder M01AE01, M02AA13, C01EB16) köps huvudsakligen receptfritt och därför saknas könsspecifika användningsdata [25].
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. Greenblatt DJ, Abernethy DR, Matlis R, Harmatz JS, Shader RI. Absorption and disposition of ibuprofen in the elderly. Arthritis Rheum. 1984;27:1066-9.
  6. Ipren (ibuprofen). Summary of Products Characteristics. Swedish Medical Products Agency (MPA) [updated 2021-02-17, cited 2021-12-13].
  7. Averbuch M, Katzper M. A search for sex differences in response to analgesia. Arch Intern Med. 2000;160:3424-8.
  8. Ryan JL, Jureidini B, Hodges JS, Baisden M, Swift JQ, Bowles WR. Gender differences in analgesia for endodontic pain. J Endod. 2008;34:552-6.
  9. Lewis DW, Kellstein D, Dahl G, Burke B, Frank LM, Toor S et al. Children's ibuprofen suspension for the acute treatment of pediatric migraine. Headache. 2002;42:780-6.
  10. Butcher BE, Carmody JJ. Sex differences in analgesic response to ibuprofen are influenced by expectancy: a randomized, crossover, balanced placebo-designed study. Eur J Pain. 2012;16:1005-13.
  11. Walker JS, Carmody JJ. Experimental pain in healthy human subjects: gender differences in nociception and in response to ibuprofen. Anesth Analg. 1998;86:1257-62.
  12. Moore N, Charlesworth A, Van Ganse E, LeParc JM, Jones JK, Wall R et al. Risk factors for adverse events in analgesic drug users: results from the PAIN study. Pharmacoepidemiol Drug Saf. 2003;12:601-10.
  13. Castellsague J, Holick CN, Hoffman CC, Gimeno V, Stang MR, Perez-Gutthann S. Risk of upper gastrointestinal complications associated with cyclooxygenase-2 selective and nonselective nonsteroidal antiinflammatory drugs. Pharmacotherapy. 2009;29:1397-407.
  14. García Rodríguez LA, Williams R, Derby LE, Dean AD, Jick H. Acute liver injury associated with nonsteroidal anti-inflammatory drugs and the role of risk factors. Arch Intern Med. 1994;154:311-6.
  15. Lacroix I, Lapeyre-Mestre M, Bagheri H, Pathak A, Montastruc JL, Club de Reflexion des cabinets de Groupe de Gastro-Enterologie (CREGG) et al. Nonsteroidal anti-inflammatory drug-induced liver injury: a case-control study in primary care. Fundam Clin Pharmacol. 2004;18:201-6.
  16. Leise MD, Poterucha JJ, Talwalkar JA. Drug-induced liver injury. Mayo Clin Proc. 2014;89:95-106.
  17. Nissen SE, Yeomans ND, Solomon DH, Lüscher TF, Libby P, Husni ME et al. Cardiovascular Safety of Celecoxib, Naproxen, or Ibuprofen for Arthritis. N Engl J Med. 2016;375(26):2519-29.
  18. Solomon DH, Shao M, Wolski K, Nissen S, Husni ME, Paynter N. Derivation and Validation of a Major Toxicity Risk Score Among Nonsteroidal Antiinflammatory Drug Users Based on Data From a Randomized Controlled Trial. Arthritis Rheumatol. 2019;71(8):1225-1231.
  19. Samii A, Etminan M, Wiens MO, Jafari S. NSAID use and the risk of Parkinson's disease: systematic review and meta-analysis of observational studies. Drugs Aging. 2009;26:769-79.
  20. Johnson CC, Hayes RB, Schoen RE, Gunter MJ, Huang WY, PLCO Trial Team. Non-steroidal anti-inflammatory drug use and colorectal polyps in the Prostate, Lung, Colorectal, And Ovarian Cancer Screening Trial. Am J Gastroenterol. 2010;105:2646-55.
  21. Salman S, Sherif B, and Al-Zohyri A. OP0131 Effects of Some Non Steroidal Anti-Inflammatory Drugs on Ovulation in Women with Mild Musculoskeletal Pain. Annals of the Rheumatic Diseases. 2015;74(suppl 2):117-118.
  22. Stone S, Khamashta MA, Nelson-Piercy C. Nonsteroidal anti-inflammatory drugs and reversible female infertility: is there a link?. Drug Saf. 2002;25:545-51.
  23. Uhler ML, Hsu JW, Fisher SG, Zinaman MJ. The effect of nonsteroidal anti-inflammatory drugs on ovulation: a prospective, randomized clinical trial. Fertil Steril. 2001;76(5):957-61.
  24. Matyas RA, Mumford SL, Schliep KC, Ahrens KA, Sjaarda LA, Perkins NJ et al. Effects of over-the-counter analgesic use on reproductive hormones and ovulation in healthy, premenopausal women. Hum Reprod. 2015;30(7):1714-23.
  25. Conise (INSIKT). Kalmar: eHälsomyndigheten. 2018 [cited 2021-11-18.]
Uppdaterat

Litteratursökningsdatum 12/13/2021

Litteratursökningsdatum 12/13/2021
Se även