Preparat: Imipenem/Cilastatin Actavis, Imipenem/Cilastatin Fresenius Kabi, Imipenem/Cilastatin Pfizer, Tienam®
ATC kod: J01DH51
Substanser: imipenem, imipenemmonohydrat
Det saknas kontrollerade studier om skillnader mellan könen avseende effekt hos vuxna. En studie på barn med febril neutropeni visade ingen könsskillnad i effekt av imipenem/cilastatin.
Vår bedömning är att de beskrivna skillnaderna inte motiverar olika dosering eller behandling hos kvinnor och män.
No studies with a clinically relevant sex analysis regarding imipenem pharmacokinetics in healthy volunteers have been found. In a study of imipenem in burn patients (25 men, 12 women), sex was tested as a covariate but did not influence clearance .
During pregnancy, plasma clearance of imipenem was found to be 2.2 times faster but renal clearance was unchanged (adjusted for body weight). The volume of distribution was 3.3 times higher and AUC was reduced with 44%. Half-life was unchanged. The authors suggests that dose adjustment may be necessary when treating pregnant women with serious infections .
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 IV 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 imipenem-cilastatin (80% and 88%, respectively) . A randomized study compared imipenem-cilastatin (60 mg/kg/day) and piperacillin-tazobactam (360 mg/kg/day) for treatment of febrile neutropenia in children with malignant diseases (41 boys, 22 girls). The authors reported that treatment success was not correlated with the patient’s sex or primary disease . Resistance patterns for pathogens often differ between populations and ages. A Spanish study (73914 isolates from women, 29978 isolates from men) found higher percentages of imipenem resistance in E. coliisolate from men in the age group 0-54 years. In patients 55 years and older, the percentage of resistance were similar in men and women . In a Turkish retrospective case-control study investigating risk factors for nosocomial imipenem-resistant Acinetobacter baumanniiinfections (83 men, 40 women), univariate analysis showed that that female sex was a significant risk factor . Male sex was identified as a risk factor (OR 8.01, 95%CI 1.7-38.5) associated with hospital-acquired pneumonia caused by imipenem-resistant Pseudomonas aeruginosain a Brazilian retrospective case-control study (202 men, 140 women).
No studies with a clinically relevant sex analysis regarding adverse effects of imipenem have been found.
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Läkemedel innehållande kombination av imipenem och enzymhämmare (ATC-kod J01DH51) används huvudsakligen på sjukhus och därför saknas könsspecifika användningsdata .
Faktagranskat av: Mia von Euler
Godkänt av: Karin Schenck-Gustafsson