Drug products: Cloxacillin, Cloxacillin AB Unimedic Vial Mate, Cloxacillin Stragen, Ekvacillin®
ATC code: J01CF02
Substances: cloxacillin, cloxacillin sodium
Published placebo-controlled clinical studies on differences between men and women regarding efficacy and safety of cloxacillin are lacking. Pharmacokinetic studies have not shown any differences between men and women.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
The only pharmacokinetic study with a clinically relevant sex difference analysis found was in patients undergoing hip or knee replacement. Men and women (14 and 24, respectively) received the same dose, cloxacillin 1 g i.v., but if corrected for body surface area, women received a 15% higher dose than men. When adjusted for body surface area, no differences in pharmacokinetic parameters were observed .
No studies with an analysis of clinically relevant sex differences of the effect of cloxacillin have been found, except in comparison with other antibacterial agents.
The influence of antibiotics on the incidence of recurrence of pilonidal sinus was evaluated in a prospective study and a subsequent randomized multicenter study (137 men, 60 women). Patients in the prospective group received cloxacillin 2 g i.v. before operation and 300 mg after followed by 600 mg daily for 6 days. Patients in the other group were randomized to either cefoxitin 2 g i.v. before operation or no prophylaxis. The authors report that neither the patients’ sex nor which antibiotic treatment used predicted recurrence .
The benefit of antibiotic prophylaxis in preventing infections after craniotomy has been evaluated based on surveillance data of infections after craniotomy (one including 4 878 men and women, the other study 3134 men, 3109 women) [3,4]. In both studies, patients received cloxacillin or amoxicillin-clavulanate. Results showed that antibiotic prophylaxis decreased infections rates  but did not prevent meningitis . Male sex was among risk factors for infection and meningitis.
No studies with an analysis of clinically relevant sex differences regarding adverse effects of cloxacillin have been found.
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2016-10-17
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson