meropenem and Nausea

Meropenem is a parenteral carbapenem that has been used clinically since 1994. Since the first review of its safety profile in 1995, the patient database has increased substantially. This new safety analysis includes data from 46 clinical trials in hospitalized patients with serious bacterial infections. The additional data comprise patients with lower respiratory tract and intra-abdominal infections, septicaemia and meningitis, and cancer patients with febrile neutropenia, and represents a group of more severely ill patients compared with the earlier review. In total, 4872 patients with 5026 meropenem treatment exposures were compared with 4642 patients treated with comparator agents (4752 exposures). Meropenem was administered most often by intravenous injection at 1g or 500 mg every 8 h. Meropenem-related adverse events most frequently reported were diarrhoea (2.3%), rash (1.4%), nausea/vomiting (1.4%) and injection site inflammation (1.1%). The most commonly reported meropenem-related laboratory adverse events were thrombocytosis (1.6%) and increased hepatic enzymes (1.5-4.3%). In meropenem-treated patients with meningitis, the incidence of seizures was low and none were drug related. In patients with infections other than meningitis, the incidence of seizures considered by the investigators to be related to meropenem was 0.08%. In general, the safety profile of meropenem was similar to that of the comparator agents. Withdrawals and deaths were similarly infrequent in the meropenem, cephalosporin and imipenem-cilastatin groups. Increased doses of meropenem were not associated with an increased incidence of adverse events. Meropenem was well tolerated in all patients, including children and patients with neutropenia. This new analysis supports the previous findings that meropenem has a favourable and acceptable safety profile.

Topics: Adult; Anti-Bacterial Agents; Cephalosporins; Child; Child, Preschool; Clindamycin; Diarrhea; Drug Eruptions; Humans; Imipenem; Meningitis; Meropenem; Nausea; Seizures; Thienamycins; Thrombocytosis

The purpose of this article is to review the safety and tolerance of two carbapenems (imipenem/cilastatin and meropenem) in order to establish their possible use in different clinical settings. The tolerance and safety profile of both carbapemens in intravenous and intramuscular formulation is good. With imipenem/cilastatin, nausea and vomiting can constitute a practical problem requiring prolonged times of perfusion and high dilutions. The possibility of administering meropenem in intravenous infusion or bolus injection with lower volumes of fluid, without increasing the incidence of these adverse reactions, may have practical advantages in special situations. The possible neurotoxicity of the imipenem/cilastatin presents limitations of the use in high risk circumstances such as meningitis, previous alterations of CNS, renal insufficiency and concomitant administration of other drugs with neurotoxic profiles and when high doses of administration are needed. The meropenem, by the contrary, can be used in patients with infections of the CNS and other risk factors, at high doses, without increased risk of seizures.

Topics: Animals; Cilastatin; Drug Interactions; Epilepsy; Humans; Imipenem; Injections, Intramuscular; Kidney; Meropenem; Nausea; Opportunistic Infections; Thienamycins; Vomiting

Cystic fibrosis patients (children and young adults) with Pseudomonas spp. chest infections were treated with meropenem or ceftazidime. This study was the first to investigate the use of meropenem in cystic fibrosis. Meropenem was well tolerated with only transient elevations of serum transaminases. No patient experienced nausea and vomiting, even when meropenem was administered as a bolus injection. This allowed home therapy to be used. Meropenem appeared to be at least as active as ceftazidime even at the low doses used. Patients showed a greater improvement in respiratory function on meropenem than ceftazidime. Only one patient (out of 60 courses) failed to respond to meropenem (98% success rate) compared with two failures out of 21 episodes with ceftazidime (90% success rate). There was little emergence of resistance to meropenem even though some patients were treated up to eight times over a 2 year period.

Topics: Adolescent; Adult; Carbapenems; Ceftazidime; Cephalosporins; Child, Preschool; Cystic Fibrosis; Drug Tolerance; Humans; Liver; Meropenem; Microbial Sensitivity Tests; Nausea; Pseudomonas Infections; Spirometry; Sputum; Thienamycins; Transaminases; Treatment Outcome; Vomiting