Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Gabapentin

Klassificering: B

Preparat: Gabapentin, Gabapentin 1A Farma, Gabapentin 2care4, Gabapentin Accord, Gabapentin Actavis, Gabapentin Aurobindo, Gabapentin Ebb, Gabapentin EQL, Gabapentin HEXAL, Gabapentin Nycomed, Gabapentin Orifarm, Gabapentin Orion, Gabapentin Pfizer, Gabapentin Ranbaxy, Gabapentin Rivopharm, Gabapentin Sandoz, Gabapentin Takeda, Gabapentin Teva, Nelakap, 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.

Additional information

Pharmacokinetics and dosing

Population data analyses indicate that the pharmacokinetic parameters for men and women are similar [1, 2]. One small clinical trial evaluated the effect of patient’s sex on the pharmacokinetics of gabapentin (18 men, 18 women). Following a single 400 mg oral dose gabapentin, 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 generally smaller size. However, the sex difference in Cmax values is not considered to be clinically important. The apparent elimination rate constant declined with increasing age for women but did not reach significance in relation with age for men. Since the relation between the apparent oral clearance and age was similar for men and women, the sex difference in relation between apparent elimination rate constant and age may be due to a sex-related difference in the relation between volume of distribution and age [3]. No sex differentiation in dosing has been recommended by the pharmaceutical company [4]. Individual dose-titration is recommended for all indications in both men and women.

Effects

No published studies with a clinically relevant sex analysis regarding the effects of gabapentin in epilepsy or neuropathic pain have been found. Estimates of response to gabapentin in epilepsy derived from clinical trials (398 men, 307 women) indicate no appearant sex differences [1].

Adverse effects

According to the pharmaceutical company, adverse effects were more common in men than in women [2], but studies with a clinically relevant sex analysis regarding adverse effects of gabapentin have not been published.

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 2019, totalt 55 865 kvinnor och 37 877 män. Det motsvarar 11,0 respektive 7,4 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 [5].

Uppdaterat: 2020-03-19

Litteratursökningsdatum: 2019-08-28

Referenser

  1. Neurontin (gabapentin). DailyMed [www]. US National Library of Medicine. [updated 2019-07-01, cited 2019-08-28]. webplats
  2. US Food and Drug Administration. Medical Review - Neurontin (gabapentin). Drugs@FDA [www]. [updated 2000-10-12, cited 2019-08-28]. länk
  3. 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
  4. Neurontin (gabapentin). Summary of Product Characteristics. Swedish Medical Products Agency [updated 2019-07-08, cited 2019-08-28].
  5. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2019 [cited 2020-03-10.] länk

Författare: Linnéa Karlsson Lind

Faktagranskat av: Mia von Euler, Carl-Olav Stiller

Godkänt av: Karin Schenck-Gustafsson