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Cloxacillin

Classification: B

Drug products: Cloxacillin AB Unimedic Vial Mate, Cloxacillin Stragen, Ekvacillin®

ATC code: J01CF02

Substances: cloxacillin, cloxacillin sodium

Summary

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.

Additional information

Pharmacokinetics and dosing

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 [1].

Effects

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 [2].

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 [3] but did not prevent meningitis [4]. Male sex was among risk factors for infection and meningitis.

Adverse effects

No studies with an analysis of clinically relevant sex differences regarding adverse effects of cloxacillin have been found.

Reproductive health issues

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

Updated: 2019-02-26

Date of litterature search: 2016-10-17

References

  1. Vinge E, Nergelius G, Nilsson LG, Lidgren L. Pharmacokinetics of cloxacillin in patients undergoing hip or knee replacement. Eur J Clin Pharmacol. 1997;52:407-11. PubMed
  2. Søndenaa K, Diab R, Nesvik I, Gullaksen FP, Kristiansen RM, Saebø A et al. Influence of failure of primary wound healing on subsequent recurrence of pilonidal sinus combined prospective study and randomised controlled trial. Eur J Surg. 2002;168:614-8. PubMed
  3. Korinek AM, Golmard JL, Elcheick A, Bismuth R, van Effenterre R, Coriat P et al. Risk factors for neurosurgical site infections after craniotomy: a critical reappraisal of antibiotic prophylaxis on 4,578 patients. Br J Neurosurg. 2005;19:155-62. PubMed
  4. Korinek AM, Baugnon T, Golmard JL, van Effenterre R, Coriat P, Puybasset L. Risk factors for adult nosocomial meningitis after craniotomy: role of antibiotic prophylaxis. Neurosurgery. 2006;59:126-33; discussion 126-33. PubMed
  5. Concise. Stockholm: eHälsomyndigheten. 2015 [cited 2016-10-20.] länk

Authors: Linnéa Karlsson Lind

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson