Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Gabapentin

Klassificering: B

Preparat: Gabapentin, Gabapentin 1A Farma, Gabapentin 2care4, Gabapentin Accord, Gabapentin Actavis, Gabapentin Alternova, Gabapentin Aurobindo, Gabapentin Ebb, Gabapentin HEXAL, Gabapentin Nycomed, Gabapentin Orifarm, Gabapentin Orion, Gabapentin Pfizer, Gabapentin Ranbaxy, Gabapentin Sandoz, Gabapentin STADA®, Gabapentin Takeda, Gabapentin Teva, Neurontin, Neurontin®

ATC kod: N03AX12

Substanser: gabapentin

Sammanfattning

Det finns inga uppgifter om könsskillnader i effektivitet hos gabapentin vare sig vad gäller anfallsförebyggande eller smärtlindrande effekt, men uppskattningar av respons från kliniska prövningar tyder inte på några större könsskillnader.

Det finns motstridig information om inverkan av kön på farmakokinetiken för gabapentin. De skillnader som observerats anses inte vara kliniskt relevanta.
 
Kunskapsunderlaget avseende skillnader mellan kvinnor och män är begränsat och motiverar inte olika dosering eller behandling.

Additional information

Pharmacokinetics and dosing

It appears that the pharmacokinetic parameters for men and women are similar [1]. One small clinical trial evaluated the effect of sex on the pharmacokinetics of gabapentin in 18 men and 18 women. Following a single 400 mg oral dose gabapentin, Cmax was the only pharmacokinetic parameter that was significantly different between healthy men and women. Cmax was about 25% higher for women than for men, probably due to a smaller volume of distribution in women, as a result of their smaller size. The difference in Cmax values is not considered to be clinically important. The mean value of the apparent volume of distribution was about 17% higher for men than the mean value for women, although it was not statistically significant between sexes. The relations with age for apparent oral clearance and renal clearance were not significantly different in men and women. There was a significant interaction between age and sex for the apparent elimination rate constant, in that there was a significant decline with increasing age for women and no significant relation with age for men. There was a difference in relation between apparent elimination rate constant and age for men and women, but since the relation between the apparent oral clearance and age was similar for men and women, the difference may be due to a sex-related difference in the relation between volume of distribution and age [2]. No sex differentiation in dosing has been recommended by the manufacturer [3].

Effects

No formal analysis on the effect of sex on response to gabapentin in epilepsy has been performed, but estimates of response derived from clinical trials (398 men, 307 women) indicate no important sex differences [1].

Adverse effects

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

Reproductive health issues

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

Försäljning på recept

Fler kvinnor än män hämtade ut läkemedel innehållande gabapentin (ATC-kod N03AX12) på recept i Sverige år 2015, totalt 34 997 kvinnor och 23 821 män. Det motsvarar 7,2 respektive 4,9 personer per tusen invånare. Andelen som hämtat ut läkemedel ökade med stigande ålder hos båda könen. I genomsnitt var läkemedel innehållande gabapentin 1,4 gånger vanligare hos kvinnor [4].

Uppdaterat: 2019-02-26

Litteratursökningsdatum: 2013-03-12

Referenser

  1. Gabapentin. DailyMed [www]. US National Library of Medicine. [updated 2012-05-01, cited 2013-03-12]. webplats
  2. Boyd RA, Türck D, Abel RB, Sedman AJ, Bockbrader HN. Effects of age and gender on single-dose pharmacokinetics of gabapentin. Epilepsia. 1999;40:474-9. PubMed
  3. Neurontin (gabapentin). Summary of Product Characteristics. Medical Products Agency - Sweden; 2016.
  4. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-29] länk

Författare: Linnéa Karlsson Lind, Desirée Loikas

Faktagranskat av: Expertrådet för neurologiska sjukdomar, Ellen Vinge, Lars Lööf

Godkänt av: Mia von Euler