Drug products: Penomax, Penomax®, Selexid®
ATC code: J01CA08
Substances: pivmecillinam, pivmecillinam hydrochloride
Published controlled studies on differences between men and women regarding efficacy, safety and pharmacokinetics of pivmecillinam are lacking.
Pivmecillinam is also known as amdinocillin pivoxilin English literature. Pivmecillinam is a prodrug to mecillinam.
No studies with a clinically relevant sex analysis regarding the pharmacokinetics or dosing of pivmecillinam have been found. In pregnant women, half-life after oral administration of 200 mg pivmecillinam has shown to be similar compared to non-pregnant women [1, 2]. After parenteral administration of 200 mg pivmecillinam, half-life was longer during early and late pregnancy as compared with non-pregnant. Parenteral administration of pivmecillinam is not available in Sweden. [1, 2].
No differences in effects between men and women have been shown but the data is limited. In an open multicentre study, patients with acute uncomplicated cystitis received 200 mg pivmecillinam three times daily for 5 days (10 men, 101 women). There was no significant difference in treatment effect between men and women .
Resistance patterns for pathogens often differ between populations. In a Portuguese retrospective analysis of urinary samples (120 691 (78 %) from women and 34 898 (22 %) from men) pivmecillinam resistance was more common in male urinary samples positive for E. coli, P. mirabilis, Klebsiella spp, P. vulgaris, Enterobacter spp,and Providencia spp .
Among reported cases of oesophageal complications of pivmecillinam treatment in Sweden during 1978-1987, 76% were women. Of all prescriptions of pivmecillinam during this period, 78-85 % were prescribed to women .
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2016-02-01
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson