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PubMed1999

Safety profile of meropenem: a review of nearly 5,000 patients treated with meropenem.

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.

Adult↗
PubMed1995

Intramuscular meropenem in the treatment of bacterial infections of the urinary and lower respiratory tracts. Italian Intramuscular Meropenem Study Group.

In three open, multicentre, prospective randomised studies, the efficacy and safety of meropenem were assessed and compared with ceftazidime (Study 1) and imipenem/cilastatin (Studies 2 and 3) in 864 patients; 417 with urinary tract infections (UTI) and 447 with community acquired lower respiratory tract infections (LRTI). All the antibiotics were administered by intramuscular injection. Clinical and bacteriological responses were assessed at the end of therapy and at follow-up (2-4 weeks for LRTI, 4-6 weeks for UTI). The clinical response rate in UTI at the end of therapy was 93-100% for meropenem 500 mg tds compared with 94-95% for ceftazidime 500 mg tds; for meropenem 500 mg bd it was 97%, significantly higher than that for imipenem/cilastatin 500 mg bd which was 90% (P = 0.03). At follow-up, the response rates were 90% for meropenem tds compared with 81-85% for ceftazidime 500 mg tds and 81% for meropenem bd compared with 78% for imipenem/cilastatin 500 mg bd. The clinical response rate in LRTI at end of therapy was 93% for meropenem 500 mg tds, compared with 92% for ceftazidime 1 g tds; for meropenem 500 mg bd the clinical response rate was 96%, compared with 91% for imipenem/cilastatin 500 mg bd (P = 0.054). At follow-up, the clinical response rates were 96%, 89%, 93% and 96%, respectively. The bacteriological response rates at 5-9 days post-therapy in UTI were 61-84% in patients treated with meropenem 500 mg tds, compared to 73-82% in patients treated with ceftazidime 500 mg tds; the rates for meropenem 500 mg bd and imipenem/cilastatin 500 mg bd were each 75%. At follow-up, the response rates were 40-72%, 57-70%, 51% and 49%, respectively. In LRTI, bacteriological response rates at the end of therapy were 91% for both meropenem 500 mg tds and ceftazidime 1 g tds, and 91% for meropenem 500 mg bd compared with 86% for imipenem/cilastatin 500 mg bd. At follow-up, the response rates were 87%, 77%, 84% and 79%, respectively. All treatments were well tolerated. In these studies, intramuscular meropenem proved to be an effective and well tolerated treatment for LRTI and UTI.

Bacterial Infections↗
PubMed1995

Safety profile of meropenem: international clinical experience based on the first 3125 patients treated with meropenem.

Data from 3125 patients (3220 patient exposures) treated with meropenem were compared with those from 2886 patients (2960 patient exposures) treated with a variety of comparator agents including cephalosporins (alone or in combination with aminoglycosides or an anti-anaerobe agent) and imipenem/cilastatin. Patients treated included those with bacterial infections of the lower respiratory tract, urinary tract and skin and soft tissues, abdominal, obstetric and gynaecological infections, meningitis, febrile episodes in neutropenic patients and paediatric patients with infections. In three studies, meropenem was administered intramuscularly; in the remainder, meropenem was given by 15-30 min iv infusion or by bolus injection over approximately 5 min. The usual dosages were 500 mg or 1 g 8 hourly in adults and 10 or 20 mg/kg 8 hourly in children. In bacterial meningitis, the meropenem dosage in adults was 2 g 8 hourly and 40 mg/kg 8 hourly in children. The overall pattern and frequency of adverse events with meropenem were similar to those of the other beta-lactam antibiotics with which it was compared. The most frequently reported adverse events were diarrhoea, rash, nausea and vomiting, thrombocytosis, eosinophilia and changes in hepatic biochemistry. Abnormal laboratory tests occurred with similar frequencies between meropenem and the comparator agents. The safety profile of meropenem was similar in adults and children, and the presence of renal impairment did not alter the safety profile of meropenem. Experience in clinical studies in 3220 patient exposures has revealed no unusual or unexpected toxicity. The possibility of administration by either iv infusion or bolus injection with a low incidence of nausea and vomiting also provides flexibility in the clinical management of patients. Moreover, the low incidence of reported seizures and good tolerability at high doses, make meropenem particularly useful for the treatment of meningitis and other indications which carry a risk of seizures, or in the treatment of serious infections where high doses of antibiotics are frequently indicated.

Bacterial Infections↗
PubMed1995

Equivalent efficacies of meropenem and ceftazidime as empirical monotherapy of febrile neutropenic patients. The Meropenem Study Group of Leuven, London and Nijmegen.

The efficacies of meropenem, a novel carbapenem, and ceftazidime, as empirical therapy of febrile neutropenic patients, were compared in a prospective, randomized clinical trial. One hundred and twelve adult patients were given meropenem 1 g tds iv for 153 episodes of fever, while 109 patients received ceftazidime 2 g tds iv for 151 episodes. All patients survived the first 3 days of therapy and, by the end of the treatment courses, 67 (44%) episodes had responded to meropenem, compared with 62 (41%) to ceftazidime. Eighty (53%) episodes initially treated with ceftazidime and 63 (41%) episodes treated with meropenem were considered to have failed treatment because it was thought necessary to administer additional antibacterial agents; however, modifications were made twice as often because of fever that persisted beyond 2-3 days than because of obvious causes of failure such as persistent infection. Three patients in the ceftazidime group and five in the meropenem group died. Meropenem was well tolerated, with no reports of nausea or toxicity to the central nervous system. Although ceftazidime was shown in the present study to be as effective as meropenem, the broader spectrum of activity of meropenem against Gram-positive cocci suggests that it might be more appropriate as empirical therapy of febrile neutropenic patients who are at high risk of acquiring infections caused by these bacteria.

Adolescent↗
PubMed1995

A randomised comparison of meropenem with cefotaxime or ceftriaxone for the treatment of bacterial meningitis in adults. Meropenem Meningitis Study Group.

Third-generation cephalosporins are presently the agents of choice for the empirical antimicrobial therapy of bacterial meningitis. However, a number of factors associated with these agents, namely the development of resistance by pneumococci, limited activity against some Enterobacteriaceae and Pseudomonas spp., and the possible adverse effects of their bacteriolytic mode of action, indicate that newer classes of antimicrobial agents be evaluated for the treatment of bacterial meningitis. Meropenem is a carbapenem antibiotic which is highly active against the major bacterial pathogens causing meningitis, and penetrates well into the cerebrospinal fluid. Two prospective randomised studies in 56 adult bacterial meningitis patients have compared meropenem 40 mg/kg 8-hourly, up to a maximum of 6 g/day (n = 28) with cephalosporin treatment, i.e. cefotaxime (n = 17) or ceftriaxone (n = 11). Patients were assessed by neurological examination, Glasgow Coma Score and Herson-Todd score. Clinical cure was observed in all 23 evaluable patients treated with meropenem (100%) and with 17 of the 22 evaluable cephalosporin-treated patients (77%). All pre-treatment isolates were eradicated except one isolate of Staphylococcus aureus in a cefotaxime-treated patient. Neurological sequelae were noted in three meropenem and four cephalosporin-treated patients. No patients in either treatment group experienced seizures after the start of therapy. This was despite the fact that a patient in each group had experienced seizures before therapy, several had underlying CNS disorders, and that doses of 6 g/day of meropenem were given. Hearing impairment was recorded in 11 meropenem and nine cephalosporin treated patients. Three patients in the meropenem group and one in the cephalosporin group died during treatment for reasons unrelated to study therapy. Overall, the results of this study indicate that meropenem is an effective and well-tolerated antibiotic for the treatment of bacterial meningitis in adults.

Adult↗
PubMed1996

Intravenous meropenem versus imipenem/cilastatin in the treatment of serious bacterial infections in hospitalized patients. Meropenem Serious Infection Study Group.

Meropenem was compared with imipenem/cilastatin for the treatment of serious bacterial infections in a randomized, prospective multicentre study. Both study drugs were given intravenously 1 g every 8 h and no other antimicrobial agents were permitted concomitantly. Of the 204 patients enrolled, the treatment of 177 was evaluable for clinical efficacy and 115 for bacteriological efficacy. In the clinically evaluable treatment population, 75 (83%) of the 90 patients in the meropenem group and 78 (90%) of the 87 in the imipenem/cilastatin group had a single site of infection whereas the remainder had two or more sites of infection. Infections of the lower respiratory tract and peritoneal cavity predominated accounting for 95 and 75 cases respectively. Other infections included skin and soft tissue infections, complicated urinary tract infections, bacteraemia and a case of meningitis treated with meropenem and one of mediastinitis treated with imipenem/cilastatin. One hundred and nineteen (67%) patients were in an intensive care unit, 105 (59%) were receiving assisted ventilation and 93 (53%) of the patients had failed previous antibiotic therapy. One hundred and ten organisms were identified as pathogens in the meropenem group and 109 in the imipenem/cilastatin group. Overall, treatment with meropenem was clinically successful in 68 (76%) of 90 cases and imipenem/cilastatin in 67 (77%) of 87 cases and the corresponding eradication rates of bacteria were 85 of 110 (77%) and 90 of 109 (83%) respectively. Superinfections due to resistant bacteria occurred in two patients treated with meropenem and three cases given imipenem/cilastatin. No statistically significant differences in the clinical or bacteriological outcome were observed between the treatment groups for any of the infection sites analysed. Both drugs were well tolerated with adverse events considered to be related to therapy being recorded for 10 (9%) of 106 patients treated with meropenem and 12 (12%) of 98 of those who had been given imipenem/cilastatin. Empirical monotherapy with meropenem was therefore as effective and as well tolerated as that with imipenem/cilastatin for the treatment of serious bacterial infections.

Adolescent↗
PubMed1999

Prospective, randomized, investigator-blinded study of the efficacy and safety of meropenem vs. cefotaxime therapy in bacterial meningitis in children. Meropenem Meningitis Study Group.

OBJECTIVES: To compare the efficacy and safety of meropenem with cefotaxime for the treatment of infants and children with bacterial meningitis. METHODS: Infants and children with strongly suspected or documented bacterial meningitis were randomly assigned in a prospective multicenter study to receive either meropenem or cefotaxime. Patients were assessed at the end of therapy and at 5 to 7 weeks and 5 to 7 months after the end of treatment for the presence of neurologic and sensory neural sequelae. RESULTS: A total of 258 children were randomized to either treatment group. A further 8 patients with suspected pneumococcal meningitis were treated with meropenem without randomization. Of the randomized patients 154 were fully evaluable, 79 in the meropenem group and 75 in the cefotaxime group. At the end of treatment there were no significant differences in clinical outcome between the two treatment groups. Clinical cure with or without sequelae was achieved in 97 and 96% of the meropenem- and cefotaxime-treated patients, respectively. At the end of treatment and at 5 to 7 weeks, 46 and 54% of meropenem patients were cured with no sequelae, respectively. Corresponding results for cefotaxime patients were 56 and 58%. All pathogens were eradicated. In total 37 patients had seizures during treatment, 15 (12%) in the meropenem and 22 (17%) in the cefotaxime group. None of the seizures was considered to be drug-related. CONCLUSIONS: This trial shows that meropenem is suitable therapy for bacterial meningitis in infants and children and that it offers an efficacy and safety profile similar to that of cefotaxime.

Cefotaxime↗
PubMed1998

Meropenem compared with ceftazidime in the empiric treatment of acute severe infections in hospitalized children. Italian Pediatric Meropenem Study Group.

In a multicenter, randomized, open comparison of meropenem to ceftazidime as empiric treatment of severe acute infections, 185 children (1 mo-15 years old, mean 65.4 mo) were enrolled. Meropenem (20 mg/kg t.i.d. i.v.) was given to 98 and ceftazidime (10-30 mg/kg t.i.d. i.v.) to 87 children, generally for 5 to 10 days (mean: 6.9 for meropenem and 7.5 for ceftazidime). Clinical response was evaluated at the beginning and at the end of therapy and 4 weeks later (follow-up). Clinical response was deemed satisfactory at the end of therapy in 96.7% of the patients treated with meropenem and in 95.3% of those who received ceftazidime without any statistically significant difference. One relapse occurred in a meropenem-treated patient at the follow-up clinical assessment. The baseline infecting organism was eradicated or presumed eradicated at the end of therapy in 14/16 patients treated with meropenem and in 14/15 treated with ceftazidime. The incidence of drug-related adverse events (mostly a slight increase in liver enzymes) was 9.2% in the meropenem group and 4.6% in the ceftazidime group. Our data show that meropenem is as effective as ceftazidime in the empiric treatment of severe infections in infants and children.

Adolescent↗
PubMed1995

Randomized comparison of meropenem with cefotaxime for treatment of bacterial meningitis. Meropenem Meningitis Study Group.

Broad-spectrum cephalosporins are drugs of choice for the treatment of meningitis in communities which can afford them. The emergence of cephalosporin-resistant pneumococci demands the clinical trial of alternate agents. Carbapenems are active against the bacteria causing meningitis, but the use of imipenem-cilastatin was frustrated by drug-associated seizures. The safety and efficacy of meropenem, a new carbapenem, were compared to those of cefotaxime in a prospective randomized trial of 190 children with bacterial meningitis. Seizures occurred within 24 h before antibiotic therapy in 16 of 98 patients (16%) randomized to receive meropenem and in 6 of 92 patients (7%) randomized to receive cefotaxime. In patients without seizures before therapy, seizures occurred during therapy in 5 of 82 patients (6%) receiving meropenem and in 1 of 86 patients (1%) receiving cefotaxime (95% confidence interval: -0.7%, 10.6%). None were thought to be drug related. Twenty-four meropenem-treated patients (24%) and 11 cefotaxime-treated patients (12%) had neurological abnormalities before therapy. In patients without pretherapy neurological abnormalities, these abnormalities were present after treatment in 4 of 74 meropenem-treated patients (5%) and in 2 of 81 cefotaxime-treated patients (2%) (95% confidence interval: -3.2%, 9.1%). Of 75 meropenem-treated and 64 cefotaxime-treated patients with pretherapy positive cerebrospinal-fluid cultures, 68 and 59, respectively, had repeat lumbar punctures. Bacterial eradication was found to be 100% in both groups. Our data suggest that meropenem may be a carbapenem agent that is well tolerated and effective in the treatment of bacterial meningitis.

Adolescent↗
PubMed1995

Empirical monotherapy with meropenem in serious bacterial infections. Meropenem Study Group.

A multicentre, open, randomised, parallel group study was carried out to assess the efficacy and safety of meropenem monotherapy versus the combination of ceftazidime plus amikacin in the treatment of serious bacterial infections. Adult, hospitalised patients (n = 237) were included if they had infections at one or more of the following sites: lower respiratory tract (89 community-acquired; 84 hospital-acquired), urinary tract (59 complicated; 3 uncomplicated), skin and skin structures (n = 8), or septicaemia (n = 29). Patients were randomised to receive either iv meropenem (1 g every 8 h) as monotherapy or iv ceftazidime (2 g every 8 h) plus iv amikacin (15 mg/kg/day in two or three divided doses). Meropenem had comparable clinical efficacy to ceftazidime plus amikacin in: community-acquired lower respiratory tract infection (LRTI) (40/43, 93% vs 31/39, 79% cured or improved); hospital-acquired LRTI (30/37, 81% vs 23/32, 72%); septicaemia (10/12, 83% vs 16/17, 94%) and complicated urinary tract infection (UTI) (13/15, 87% vs 25/25, 100%). A similar proportion of patients in each treatment group experienced adverse events, the most frequent being transient elevations in serum transaminases. Seven patients in the meropenem group and eight patients in the ceftazidime plus amikacin group died during the study period from reasons unrelated to study medication, and seven patients (five meropenem, two ceftazidime plus amikacin) were withdrawn due to adverse events. Empirical monotherapy with meropenem is as well tolerated and as effective as the combination of ceftazidime plus amikacin in the treatment of serious infections.

Adolescent↗
PubMed1997

Empiric treatment of hospital-acquired lower respiratory tract infections with meropenem or ceftazidime with tobramycin: a randomized study. Meropenem Lower Respiratory Infection Group.

OBJECTIVE: To evaluate the efficacy and tolerability of intravenous empiric treatment with meropenem compared with ceftazidime-tobramycin in patients with hospital-acquired lower respiratory tract infections. DESIGN: Prospective, nonblind, randomized trial. SETTING: Multicenter trial conducted at 22 centers. PATIENTS: Two hundred eleven patients were enrolled and 121 were evaluable for the analysis of both clinical and bacteriologic efficacy. INTERVENTIONS: One hundred four patients were randomized to receive intravenous meropenem (1000 mg) every 8 hrs and 107 patients were randomized to receive intravenous ceftazidime (2000 mg) plus tobramycin (1 mg/kg) every 8 hrs. Sixty-three meropenem-treated patients and 58 ceftazidime-tobramycin-treated patients were eligible for the analysis of clinical and bacteriologic efficacy. In the ceftazidime-tobramycin group, 32 (55%) evaluable patients received more than six doses of tobramycin, 24 (41%) received six doses or fewer, and two (3%) did not receive any tobramycin. MEASUREMENTS AND MAIN RESULTS: The analysis of efficacy was based on the clinical and bacteriologic responses at the end of treatment. Satisfactory clinical responses occurred in 56 (89%) of 63 of the meropenem-treated patients and in 42 (72%) of 58 of the ceftazidime-tobramycin-treated patients (p = .04). Corresponding bacteriologic response rates were 89% and 67%, respectively (p = .006). The frequency and profile of drug-related adverse events was similar across treatment groups. Seizures were reported in three meropenem-treated patients, but these seizures were considered by the investigator to be unrelated to treatment. CONCLUSIONS: Meropenem is well tolerated and more efficacious than the combination of ceftazidime and tobramycin for the initial empiric treatment of hospital-acquired bacterial pneumonia.

Adolescent↗
PubMed1995

Meropenem versus imipenem/cilastatin in intra-abdominal infections requiring surgery. Meropenem Study Group.

In a multicentre, open, randomised study, the efficacy and tolerability of intravenous meropenem (1 g every 8 h, infusion or bolus) was compared with that of intravenous imipenem/cilastatin (1 g every 8 h, infusion) in 232 hospitalised patients with moderate to severe intra-abdominal infections. At the end of therapy, a satisfactory clinical response (cure or improvement) was seen in 79/82 (96%) evaluable meropenem patients and 83/88 (94%) imipenem/cilastatin patients; this was still seen at follow-up (57/63; 90% and 58/66; 88%, respectively). A satisfactory bacteriological response (elimination or presumed elimination) was seen in 69/82 (84%) meropenem patients and 71/88 (81%) imipenem/cilastatin patients at the end of therapy and in 52/62 (84%) and 55/70 (79%), respectively, at follow-up. There was a high level of clinical cure or improvement (95% for both treatment groups) in the 120 patients (60 in each group) who had polymicrobial infections. A similar incidence of adverse events was seen in each group: 45/116 patients in the meropenem group (72 events) and 42/116 patients in the imipenem/cilastatin group (65 events); the adverse event profiles were also similar, with injection site inflammation and elevated transaminases the most frequent in both groups. The results of this study indicate that monotherapy with meropenem was as effective and as well tolerated as the combination of imipenem/cilastatin in the treatment of moderate to severe intra-abdominal infections.

Abdomen↗
PubMed1995

Safety and efficacy of meropenem in hospitalised children: randomised comparison with cefotaxime, alone and combined with metronidazole or amikacin. Meropenem Paediatric Study Group.

In this multicentre, randomised study of 170 children hospitalised with bacterial infections, meropenem (10 to 20 mg/kg every 8 h) was found to be as effective and as well tolerated as cefotaxime (100 to 150 mg/kg/day), with or without amikacin or metronidazole. Most drug-related adverse events were mild and self-limiting. Neither regimen was associated with seizures. The overall incidence of clinically significant laboratory changes was similar in the two treatment groups. Satisfactory clinical responses were obtained in 94/96 (98%) patients treated with meropenem monotherapy and 43/46 (93%) children treated with cefotaxime regimens, while satisfactory bacteriological responses were obtained in 25/28 (89%) and 9/10 (90%) patients, respectively. Meropenem monotherapy appears to be a well-tolerated and effective drug for paediatric infections.

Amikacin↗
PubMed1999

Comparison of meropenem with amikacin plus ceftazidime in the empirical treatment of febrile neutropenia: a prospective randomised multicentre trial in patients without previous prophylactic antibiotics. Meropenem Study Group of Turkey.

Eighty three patients with neutropenia and cancer were randomised to receive either 1 g meropenem tds or amikacin 15 mg/kg single dose daily plus ceftazidime 2 g tds. No prophylactic antibiotics were allowed before entry to the trial. Seventy seven patients were available for analysis. Infection was microbiologically or clinically documented in 53 episodes (69%). The overall success rate without adjustment was 49% in monotherapy, 37.5% in the combination group. These rates were increased to 65% and 56%, respectively when secondary infection episodes requiring a different class of chemotherapy were taken into account. Median duration for defervescence was 3 days in successfully treated patients in both groups. Only minor reversible side effects were noted in both treatment arms. Meropenem monotherapy seemed as effective and safe as amikacin plus ceftazidime for the empirical treatment of neutropenic cancer patients with fever.

Adult↗
PubMed2006

Efficacy and safety of meropenem plus tobramycin followed by meropenem plus vancomycin for treating peritonitis in patients on continuous ambulatory peritoneal dialysis.

Peritonitis is a serious complication in patients on peritoneal dialysis. We examined the efficacy of MTV therapy [first 7 days: meropenem 0.5 g intravenously (IV) twice daily, plus tobramycin 15 mg intraperitoneally (IP) in every dialysis bag; next 7 days: meropenem 0.5 g IV twice daily, plus vancomycin 8 mg/kg IP in every bag after a 1-g loading dose] on peritonitis in patients undergoing continuous ambulatory peritoneal dialysis (CAPD), comparing it with the treatment previously recommended by the International Society for Peritoneal Dialysis (combination of first-generation cephalosporins and aminoglycosides). We treated 36 CAPD peritonitis episodes with MTV therapy. Outcome measures were primary response rate at day 14 and relapse rate within 28 days after the start of antibiotic therapy. The primary response rate was 34/36 (94.4%). No patients treated with MTV therapy required catheter removal. We observed no serious side effects in these patients. We conclude that MTV therapy may be an even better choice of treatment for peritonitis in patients on CAPD than was the previous empirical treatment (combination of first-generation cephalosporin and aminoglycosides).

Anti-Bacterial Agents↗
PubMed1992

[Pharmacokinetic and clinical studies with meropenem in the pediatric field. Pediatric Study Group of Meropenem].

Pharmacokinetic and clinical evaluations in pediatrics were made on meropenem (SM-7338, MEPM), a new parenteral dehydropeptidase-1 stable carbapenem used without any inhibitors, at 33 medical institutions. The results are summarized as follows. 1. Pharmacokinetic studies. MEPM at a dose of 10, 20, or 40 mg/kg was administered to 53 children by 30-minute drip infusion. Peak plasma concentrations (Cmax's) and plasma half-lives (T1/2's) of these doses were 28.5, 47.2 and 130.0 micrograms/ml, and 0.80, 0.93 and 0.94 hours, respectively. A clear dose response was observed in Cmax's and T1/2 values were quite similar to those observed in adults. In the first 6 hours after administration, 54.4 to 68.1% of the administered drug was recovered in urine. The cerebrospinal fluid (CSF) levels of MEPM in patients with purulent meningitis were 0.13 microgram/ml at a dose of 6 mg/kg, and 0.64 to 4.22 micrograms/ml at a dose of 29 to 44 mg/kg within day 4 of onset. The penetration rate of MEPM showed an intermediate value among those for other cephalosporin antibiotics. 2. Clinical study. Clinical efficacies of MEPM were evaluated in 389 cases. The most common doses used were 10 to 20 mg/kg/once, 2 to 3 times a day. The maximum dose was 173 mg/kg/day q.i.d. MEPM gave "excellent" or "good" responses in 242 (97.6%) out of 248 cases in which causative organisms were documented and in 134 (95.0%) out of 141 cases in which causative organisms were not identified. Clinical efficacy rates were 100% in 11 patients with purulent meningitis, 85.7% in 7 with septicemia, 98.8% in 173 with pneumonia, and 100% in 65 with UTI. Bacteriologically, 260 strains (96.7%) out of 269 strains were eradicated by MEPM treatment. Eradication rates were 89.2% for Staphylococcus aureus (37 strains) and 100% for Streptococcus pneumoniae (35 strains). The overall eradication rate for Gram-positive bacteria was 94.6%. Among Gram-negative bacteria, 98.3% out of 172 strains were eradicated. The eradication rate of Haemophilus influenzae (73 strains) was 98.6% and Pseudomonas aeruginosa (11 strains) was 90.9%, and all of Branhamella catarrhalis (15 strains), Escherichia coli (42 strains), and Klebsiella pneumoniae (6 strains) were eradicated. Out of 84 cases for which previous antibiotic therapies of 3 days or longer were not successful, MEPM gave "excellent" or "good" responses in 77 cases (91.7%) and excellent bacteriological responses (95.7%).(ABSTRACT TRUNCATED AT 400 WORDS)

Bacterial Infections↗
PubMed2000

Meropenem: a review of its use in patients in intensive care.

UNLABELLED: Meropenem is a carbapenem antibacterial agent that has antimicrobial activity against gram-negative, gram-positive and anaerobic micro-organisms. In vitro studies involving isolates from patients in intensive care units (ICUs) indicate that meropenem is more active against most gram-negative pathogens than other comparators (including imipenem), although, compared with imipenem, meropenem is less active against most gram-positive organisms. Resistance to meropenem is uncommon in most bacteria. Treatment with meropenem as initial empirical monotherapy was effective in a range of serious infections in adult and paediatric ICU patients. Meropenem monotherapy was as effective as imipenem/cilastatin in 4 comparative trials in terms of satisfactory clinical and bacteriological responses. Meropenem monotherapy was significantly more effective than ceftazidime-based combination treatments in 2 trials in patients with nosocomial lower respiratory tract infections (LRTIs) in terms of both clinical and bacteriological responses. Meropenem was also more active than ceftazidime-based treatments against both gram-positive and gram-negative organisms. However, 2 studies in patients with a range of serious infections found no significant differences between meropenem and cephalosporin-based treatments in terms of clinical or bacteriological response. Meropenem was also as effective as cephalosporin-based treatments in comparative trials in children with serious infections. Meropenem is well tolerated as either a bolus or an infusion, and clinical trials have shown similar incidences of adverse events to those observed with cephalosporin-based treatments. It is well tolerated by the CNS, with seizures reported infrequently, and can therefore be used at high doses and in patients with meningitis. The incidence of drug-related nausea and vomiting is low and, in contrast to imipenem/cilastatin, does not increase with dose or speed of administration. CONCLUSIONS: Meropenem is a well tolerated broad spectrum antibacterial agent that, when used as initial empirical monotherapy, is as effective as imipenem/cilastatin in the treatment of a range of serious infections (including nosocomial) in adults and children in ICUs. Compared with cephalosporin-based combination treatments, meropenem monotherapy may be more effective in the treatment of nosocomial LRTIs and can be used as monotherapy. Meropenem has an important role in the empirical treatment of serious infections in adults and children in ICUs.

Adult↗