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.
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