Drug products: Meronem, Meronem®, Meropenem Bradex, Meropenem FarmaPlus, Meropenem Fresenius Kabi, Meropenem Hexal, Meropenem Mylan, Meropenem Panpharma, Meropenem Pfizer, Meropenem Sandoz, Meropenem STADA, Meropenem SUN, Meropenem-Rotexmedica
ATC code: J01DH02
Substances: meropenem, meropenem trihydrate
Studies have shown that the response to meropenem is similar in men and women.
In our opinion, the described differences do not motivate differentiated dosing or treatment in men and women.
A population pharmacokinetic model of meropenem in Japanese adult patients with febrile neutropenia has been developed with patient data from an open-label Phase 3 clinical study (64 men, 34 women). Patients received meropenem 1 g every 8 h for 7-14 days. The volume of distribution was higher in men (13.8 vs. 10.7 L). However, Cmax, Tmax and plasma concentration levels were similar in men and women, despite renal function .
In a randomized double-blind trial conducted by the manufacturer, adult patients (in total 1037) with complicated skin and skin structure infections received 500 mg meropenem i.v. every 8 h or 500 mg imipenem-cilastatin IV every 8 h. Percent of patients with satisfactory clinical response at the follow-up visit were similar in men and women receiving meropenem (88% and 84%, respectively) .
Meropenem (1 g every 8 h) were compared to doripenem (500 mg every 8 h) in a phase 3, randomized, double-blind study including hospitalized adult patients (200 men, 119 women) with complicated intra-abdominal infections. The clinical cure rates were similar in men and women receiving meropenem (85.1% and 85.5%, respectively) . The clinical and bacteriological responses to ceftazidime (1 g every 8 h) versus meropenem (0.5 g every 8 h) were assessed in hospitalized patients (257 men, 152 women) with community-acquired pneumonia, according to risk factors. The responses were similar in men and women in both treatment groups .
No studies with a clinically relevant sex analysis regarding adverse effects of meropenem have been found.
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2016-08-17
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson