Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Metronidazol – systemiskt

Klassificering: A

Preparat: Flagyl, Flagyl®, Metronidazol Actavis, Metronidazol Baxter, Metronidazole Braun

ATC kod: J01XD01, P01AB01

Sammanfattning

En systematisk reviewartikel fann att Helicobacter pylori-resistens mot metronidazol var vanligare hos kvinnor än hos män.

En liten farmakokinetikstudie visade lägre exponering och högre clearance av metronidazol hos kvinnor efter dosjustering för kroppsvikt. Dessa farmakokinetiska skillnader bedöms dock inte kliniskt betydelsefulla.
 

Additional information

Pharmacokinetics and dosing

In an open, single-dose, two-sequence, crossover randomized trial (12 men, 12 women), bioequivalence of two different formulations of metronidazole (250 mg) and sex differences in pharmacokinetics were studied. Bioequivalence analysis showed that the formulations were similar. However, differences in pharmacokinetic parameters were observed between men and women. Following dose-adjustment for body weight, AUC for metronidazole was lower (12%) and clearance was higher in women. In accordance to these findings, metronidazole half-life was shorter among women. Volume of distribution was higher in men. However, according to the authors, these findings are most likely clinically irrelevant and no dosage adjustment based on sex are not considered necessary [1].

Effects

No studies with a clinically relevant sex analysis regarding effect of metronidazole have been found.

Adverse effects

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

Reproductive health issues

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

Other information

Several studies report differences in Helicobacter pylori antibiotic resistance between men and women. A systematic review of 31 studies, published worldwide 2006-2009, found that overall, primary metronidazole resistance was more common among women than men (31.4% vs. 21.1%). Also, metronidazole resistance rate varied widely between different populations. High resistance was reported from Denmark and Korea while low resistance was observed in Sweden, the Netherlands and Japan [2].Another study based on US-data from clinical trials between 1993 and 1999 (6087 isolates, distribution male vs. female samples unknown), described higher frequency of primary metronidazole resistant Helicobacter pylori among women than men (63% vs. 35% or 34.7% vs. 22.6%, depending on test method). The authors hypothesize that this finding is due to the use of metronidazole to treat gynecologic infections. For both men and women metronidazole resistance was more common before the age of 70 [3].

Försäljning på recept

Fler kvinnor än män hämtade ut läkemedel innehållande metronidazol (ATC-kod P01AB01) på recept i Sverige år 2015, totalt 54 115 kvinnor och 25 384 män. Det motsvarar 11 respektive 5 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 20-39 år hos kvinnor och i åldersgruppen 70 år och äldre hos män. I genomsnitt var läkemedel innehållande metronidazol 2,5 gånger vanligare hos kvinnor [4].

Uppdaterat: 2019-02-26

Litteratursökningsdatum: 2015-01-28

Referenser

  1. Carcas AJ, Guerra P, Frias J, Soto A, Fernandez-Aijón A, Montuenga C et al. Gender differences in the disposition of metronidazole. Int J Clin Pharmacol Ther. 2001;39:213-8. PubMed
  2. De Francesco V, Giorgio F, Hassan C, Manes G, Vannella L, Panella C et al. Worldwide H pylori antibiotic resistance: a systematic review. J Gastrointestin Liver Dis. 2010;19:409-14. PubMed
  3. Osato MS, Reddy R, Reddy SG, Penland RL, Malaty HM, Graham DY. Pattern of primary resistance of Helicobacter pylori to metronidazole or clarithromycin in the United States. Arch Intern Med. 2001;161:1217-20. PubMed
  4. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-05.] länk

Författare: Anna Garmén, Desirée Loikas

Faktagranskat av: Mia von Euler

Godkänt av: Karin Schenck-Gustafsson