Valproinsyra
Valproinsyra
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Produkter
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Absenor, Absenor Depot, Convulex, Delepsine, Depakine, Depakine Retard......
Absenor, Absenor Depot, Convulex, Delepsine, Depakine, Depakine Retard, Deprakine, Ergenyl, Ergenyl 300mg/ml Lösung, Ergenyl Retard, Ergenyl chrono, Ergenyl intravenös, Orfiril, Orfiril long, Valproinsyra Ebb, valproat-biomoATC-koder
N03AG01
N03AG01Substanser
natriumvalproat, valproinsyra
natriumvalproat, valproinsyraSammanfattning
Valproinsyra ska undvikas till flickor och kvinnor som kan tänkas bli gravida om inte villkoren i graviditetspreventionsprogrammet uppfylls. Andra behandlingsalternativ ska då övervägas. Visa hela sammanfattningen
Valproinsyra kan orsaka fosterskador och neuropsykiatrisk funktionsnedsättning hos barn som exponerats under graviditet. Av denna anledning är valproinsyra kontraindicerat under graviditet vid behandling av bipolär sjukdom. Valproinsyra är kontraindicerat under graviditet vid behandling av epilepsi om andra lämpliga behandlingsalternativ finns. För mer information, se kunskapsstödet Janusmed fosterpåverkan.
Valproinsyra kan öka risken för neuropsykiatrisk funktionsnedsättning hos barn till män som behandlats med valproinsyra under 3 månader före konception. Därför rekommenderas försiktighetsåtgärder vid behandling med valproinsyra hos män.
Kvinnor, framförallt flickor som passerat puberteten, tycks vara mer benägna till viktökning vid behandling med valproinsyra jämfört med pojkar/män. Hos kvinnor som behandlas med valproinsyra är det vanligt med störningar av hormonbalansen, som vid polycystiskt......
Background
Pharmacokinetics and dosing
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A small single dose pharmacokinetic study showed women, particularly women without contraceptive treatment, to have higher valproic acid exposure than men. The reason being that hepatic reabsorption was twice that in men (46% vs. 22%) [1]. Another study showed men to have a larger distribution volume than women even though the differences were mainly attributed to weight [2]. A study based on therapeutic drug monitoring data showed that women and patients over 65 years had lower daily dose and higher mean dose-adjusted serum concentrations of valproic acid, compared to men and younger patients. The authors suggest that women over 65 years would require 30-50% lower daily dose to achieve therapeutic serum concentrations comparable to younger men [3].
No studies with a clinically relevant sex analysis regarding the dosing of valproic acid have been found. The producer does not recommend different dosing in men and women [4, 5].
During pregnancy, total concentrations of valproic acid have been reported to fall in late pregnancy by up to 40% compared with......
Försäljning på recept
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Fler män än kvinnor hämtade ut läkemedel innehållande valproinsyra (ATC-kod N03AG01) på recept i Sverige år 2022, totalt 13 896 män och 9 415 kvinnor. Det motsvarar 2,6 respektive 1,8 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 55-59 år hos båda könen. I genomsnitt var läkemedel innehållande valproinsyra 1,6 gånger vanligare hos män [17].
Referenser
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Ibarra M, Vázquez M, Fagiolino P, Derendorf H. Sex related differences on valproic acid pharmacokinetics after oral single dose. J Pharmacokinet Pharmacodyn. 2013;40:479-86.
Park HM, Kang SS, Lee YB, Shin DJ, Kim ON, Lee SB et al. Population pharmacokinetics of intravenous valproic acid in Korean patients. J Clin Pharm Ther. 2002;27:419-25.
Smith RL, Haslemo T, Refsum H, Molden E. Impact of age, gender and CYP2C9/2C19 genotypes on dose-adjusted steady-state serum concentrations of valproic acid-a large-scale study based on naturalistic therapeutic drug monitoring data. Eur J Clin Pharmacol. 2016;72(9):1099-104.
Absenor (valproic acid). Summary of Product Characteristics. Swedish Medical Products Agency; 2018.
Ergenyl (valproic acid). Summary of Product Characteristics. Swedish Medical Products Agency; 2018.
Tomson T, Landmark CJ, Battino D. Antiepileptic drug treatment in pregnancy: changes in drug disposition and their clinical implications. Epilepsia. 2013;54:405-14.
Verrotti A, D'Egidio C, Mohn A, Coppola G, Chiarelli F. Weight gain following treatment with valproic acid: pathogenetic mechanisms and clinical implications. Obes Rev. 2011;12:e32-43.
Noai M, Soraoka H, Kajiwara A, Tanamachi Y, Oniki K, Nakagawa K et al. Cytochrome P450 2C19 polymorphisms and valproic acid-induced weight gain. Acta Neurol Scand. 2016;133(3):216-23.
Yamamoto Y, Takahashi Y, Imai K, Mishima N, Yazawa R, Inoue K et al. Risk factors for hyperammonemia in pediatric patients with epilepsy. Epilepsia. 2013;54(6):983-9.
Yamamoto Y, Takahashi Y, Suzuki E, Mishima N, Inoue K, Itoh K et al. Risk factors for hyperammonemia associated with valproic acid therapy in adult epilepsy patients. Epilepsy Res. 2012;101(3):202-9.
Tseng YL, Huang CR, Lin CH, Lu YT, Lu CH, Chen NC et al. Risk factors of hyperammonemia in patients with epilepsy under valproic acid therapy. Medicine (Baltimore). 2014;93(11):e66.
Läkemedelsverket. Valproat: Nya användningsbegränsningar; implementering av graviditetspreventionsprogrammet. Läkemedelsverket [www]. [cited 2018-09-28].
Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines: PRAC recommends precautionary measures. European Medicines Agency (EMA) [www]. [updated 2024-01-12, cited 2024-01-19].
Verrotti A, D'Egidio C, Mohn A, Coppola G, Parisi P, Chiarelli F. Antiepileptic drugs, sex hormones, and PCOS. Epilepsia. 2011;52:199-211.
Isojärvi JI, Löfgren E, Juntunen KS, Pakarinen AJ, Päivänsalo M, Rautakorpi I et al. Effect of epilepsy and antiepileptic drugs on male reproductive health. Neurology. 2004;62:247-53.
Ocek L, Tarhan H, Uludağ FI, Sarıteke A, Köse C, Colak A et al. Evaluation of sex hormones and sperm parameters in male epileptic patients. Acta Neurol Scand. 2018;137(4):409-416.
Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2022 [cited 2023-03-02.]
- Ibarra M, Vázquez M, Fagiolino P, Derendorf H. Sex related differences on valproic acid pharmacokinetics after oral single dose. J Pharmacokinet Pharmacodyn. 2013;40:479-86.
- Park HM, Kang SS, Lee YB, Shin DJ, Kim ON, Lee SB et al. Population pharmacokinetics of intravenous valproic acid in Korean patients. J Clin Pharm Ther. 2002;27:419-25.
- Smith RL, Haslemo T, Refsum H, Molden E. Impact of age, gender and CYP2C9/2C19 genotypes on dose-adjusted steady-state serum concentrations of valproic acid-a large-scale study based on naturalistic therapeutic drug monitoring data. Eur J Clin Pharmacol. 2016;72(9):1099-104.
- Absenor (valproic acid). Summary of Product Characteristics. Swedish Medical Products Agency; 2018.
- Ergenyl (valproic acid). Summary of Product Characteristics. Swedish Medical Products Agency; 2018.
- Tomson T, Landmark CJ, Battino D. Antiepileptic drug treatment in pregnancy: changes in drug disposition and their clinical implications. Epilepsia. 2013;54:405-14.
- Verrotti A, D'Egidio C, Mohn A, Coppola G, Chiarelli F. Weight gain following treatment with valproic acid: pathogenetic mechanisms and clinical implications. Obes Rev. 2011;12:e32-43.
- Noai M, Soraoka H, Kajiwara A, Tanamachi Y, Oniki K, Nakagawa K et al. Cytochrome P450 2C19 polymorphisms and valproic acid-induced weight gain. Acta Neurol Scand. 2016;133(3):216-23.
- Yamamoto Y, Takahashi Y, Imai K, Mishima N, Yazawa R, Inoue K et al. Risk factors for hyperammonemia in pediatric patients with epilepsy. Epilepsia. 2013;54(6):983-9.
- Yamamoto Y, Takahashi Y, Suzuki E, Mishima N, Inoue K, Itoh K et al. Risk factors for hyperammonemia associated with valproic acid therapy in adult epilepsy patients. Epilepsy Res. 2012;101(3):202-9.
- Tseng YL, Huang CR, Lin CH, Lu YT, Lu CH, Chen NC et al. Risk factors of hyperammonemia in patients with epilepsy under valproic acid therapy. Medicine (Baltimore). 2014;93(11):e66.
- Läkemedelsverket. Valproat: Nya användningsbegränsningar; implementering av graviditetspreventionsprogrammet. Läkemedelsverket [www]. [cited 2018-09-28].
- Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines: PRAC recommends precautionary measures. European Medicines Agency (EMA) [www]. [updated 2024-01-12, cited 2024-01-19].
- Verrotti A, D'Egidio C, Mohn A, Coppola G, Parisi P, Chiarelli F. Antiepileptic drugs, sex hormones, and PCOS. Epilepsia. 2011;52:199-211.
- Isojärvi JI, Löfgren E, Juntunen KS, Pakarinen AJ, Päivänsalo M, Rautakorpi I et al. Effect of epilepsy and antiepileptic drugs on male reproductive health. Neurology. 2004;62:247-53.
- Ocek L, Tarhan H, Uludağ FI, Sarıteke A, Köse C, Colak A et al. Evaluation of sex hormones and sperm parameters in male epileptic patients. Acta Neurol Scand. 2018;137(4):409-416.
- Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2022 [cited 2023-03-02.]
Uppdaterat
Litteratursökningsdatum: 1/19/2024
Litteratursökningsdatum: 1/19/2024Läs mer
Valproatinnehållande läkemedel: nya åtgärder avseende den potentiella risken för neuropsykiatrisk funktionsnedsättning hos barn vars pappor behandlats med valproat inom tre månader före befruktningen