Drug products: Cefotaxim AB Unimedic Vial Mate, Cefotaxim Copyfarm, Cefotaxim Eberth, Cefotaxim MIP, Cefotaxim Navamedic, Cefotaxim Sandoz, Cefotaxim Stragen, Cefotaxim Teva, Cefotaxima SALA, Cefotaxime Sodium for Injection, BP, Claforan®
ATC code: J01DD01
Substances: cefotaxime, cefotaxime sodium
In gonorrhea, the antibacterial effect of cefotaxime has been shown to be similar in men and women.
In our opinion, the present evidence does not motivate differentiation in dosing or treatment between men and women.
A study in elderly patients (15 men, 15 women) found no sex differences in cefotaxime pharmacokinetics but rather an age-effect with slower elimination of cefotaxime in patients over 80 years of age . Another study compared cefotaxime in obese individuals compared to normal-weight individuals (6 men and 6 women in each group). Concentrations of the active metabolite desacetylcefotaxime were ~70% higher in women than in men, in both normal and obese individuals. However, clearance was higher in men than in women only in obese individuals . Contrary to this, no sex differences in disposition of cefotaxime or desacetylcefotaxime were observed in patients (13 men, 11 women) with end-stage renal disease (<15 ml/min) after receiving a single i.v. 1 g cefotaxime dose .Since pharmacokinetic studies show varying results and effect seems to be similar in men and women treated with the same dose we do not at present find dose adjustment to be motivated. No studies with a clinically relevant sex analysis regarding the dosing of cefotaxim have been found.
A randomized study evaluated the antibacterial effect of a single IM injection of 1 g cefotaxime against N. gonorrhoeae(86 men, 56 women). The gonococcal culture became negative after treatment to a similar degree in both women and men . Another study in patients with uncomplicated gonorrhea treated with cefotaxime 1 g IM, observed no differences in cure rate between heterosexual men, homosexual men and women . Also a lower single IM dose of cefotaxime, 500 mg, has been shown to be similarly effective in men and women with uncomplicated gonorrhea .In some settings urine cultures to identify pathogens and resistance pattern cannot always be obtained and therapy of urinary tract infections then has to be empirical. A Brazilian study analyzed urine isolates to identify suitable empirical therapy options for cystitis and urinary tract infections in relation to patient’s sex and age (1098 men, 8700 women). Drug classes analyzed was ampicillin, nitrofurantoin, fluoroquinolones (ciprofloxacin and levofloxacin), trimethoprim-sulfamethoxazole, gentamicin, and ceftriazone/cefotaxime, Women exhibited higher susceptibility values for all drug classes studied than men. For women in any age group, only nitrofurantoin and gentamicin provided adequate activity for empirical therapy (> 80% susceptibility). For men in any age group, only gentamicin was suitable for empirical therapy. In women aged over 60 years, few suitable empirical treatment options were identified .
No studies with a clinically relevant sex analysis regarding adverse effects of cefotaxime have been found.
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2016-02-24
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson