Composition :

Each vial of the injection powder contains Meropenem with Sodium Carbonate equivalent to Meropenem 1 g

Pharmacology :

Meropenem is a carbapenem antibiotic for parenteral use, relatively stable against human dehydropeptidase – 1 (DHP – 1), therefore no addition of DHP inhibitors – 1. Meropenem bactericidal effect is by inhibiting bacterial cell wall synthesis. With its ability to penetrate bacterial cell walls, Meropenem has a high degree of stability against all serine-lactamases and has a strong affinity for Penicilline Binding Protein (PBP’s). They explain the potential bactericidal effects and wide spectrum of Meropenem against aerobic and anaerobic bacteria. Minimum Bacterisidal Concentration (MBC) is generally the same as Minimum Inhibitory Concentration (MIC). At 76% bacterial test the MBC ratio: MIC is < 2.

Meropenem is stable on sensitivity tests using routine methods. In the in – vitro test, Meropenem showed a synergistic effect with other antibiotics. Meropenem also exhibits post-antibiotic effects (post antibiotic effect) through in-vitro and in-vivo tests.

Recommended a Meropenem sensitivity criteria based on pharmacokinetic data and correlations between clinical and microbiological outcomes with diameter of the inhibition zone and minimum inhibitory levels of infectious organisms are as follow:

CATEGORY	MEASURING METHODS
	Inhibit zone diameter ( mm )	Breakpoints KHM ( mg/L )
Sensitive Intermediate Resistant	≥ 14 12 – 13 ≤ 11	≤ 4 8 ≥ 16

The antibacterial spectrum Meropenem (in-vitro) includes most of the gram-positive bacteria, gram-negative bacteria and aerobic and anaerobic strains that are clinically significant, as follow :

Aerob gram – positive :

Bacillus spp., Corynebacterium diphtheriae, Enterococcus liquefaciens, Enterococcus avium, Listeria monocytogenes, Lactobacillus spp., Nocardia asteroides, Staphylococcus aureus ( penicillinase negative and positive ), Staphylococci coagulase – negative; including among others Staphylococcus epidermis, Staphylococcus saprophyticus, Staphylococcus capitis, Staphylococcus cohnii, Staphylococcus xylosus, Staphylococcus warneri, Staphylococcus hominis, Staphylococcus simulans, Staphylococcus intermedius, Staphylococcus sciuri, Staphylococcus lugdunensis, Streptococcus pneumoniae ( sensitif dan resisten terhadap penisilin ), Streptococcus agalactiae, Streptococcus pyogenes, Streptococcus equi, Streptococcus bovis, Streptococcus mitis, Streptococcus mitior, Streptococcus milleri, Streptococcus sangius, Streptococcus viridans, Streptococcus salivarius, Streptococcus morbillorum, Streptococcus Group G, Streptococcus Group F, Rhodococcus equi

Aerob gram – negative :

Achromobacter xylosoxidans, Acinetobacter anitratus, Acinetobacter lwoffii, Acinetobacter baumannii, Aeromonas hydrophilia, Aeromonas sorbria, Aeromonas caviae, Alcaligenes faecalis, Bordetella bronchiseptica, Brucella melitensis, Campylobacter coli, Campylobacter jejuni, Citrobacter freundii, Citrobacter diversus, Citrobacter koseri, Citrobacter amalonaticus, Enterobacter aerogenes, Enterobacter ( Pantoea ) agglomerans, Enterobacter cloacae, Enterobacter sakazakii, Escherichia coli, Escherichia hermannii, Gardnerella vaginalis, Haemophilus influenzae ( included ß – lactamase positive strains and strains that are resistant to ampicillin ), Haemophilus parainfluenzae, Haemophilus ducreyi, Helicobacter pylori, Neisseria meningitidis, Neisseria gonorrhoeae (including ß – lactamase positive strains, strains resistant to penicillin, and strains resistant to spectinomycin ), Hafnia alvei, Klebsiella pneumoniae, Klebsiella aerogenes, Klebsiella ozaenae, Klebsiella oxytoca, Moraxella ( Branhamella ) catarrhalis, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Proteus penneri, Providencia rettgeri, Providencia stuartii, Providencia alcalifaciens, Pasteurella multocida, Plesiomonas shigelloides, Pseudomonas aeruginosa, Pseudomonas putida, Pseudomonas alcaligenes, Burkholderia ( Pseudomonas ) cepacia, Pseudomonas fluorescens, Pseudomonas stutzeri, Pseudomonas pseudomallei, Pseudomonas acidovorans, Salmonella spp. included Salmonella enteritidis/typhi, Serratia marcescens, Serratia liquefaciens, Serratia rubidaea, Shigella sonnei, Shigella flexnen, Shigella boydii, Shigella dysenteriae, Vibrio cholerae, Vibrio parahaemolyticus, Vibrio vulnificus, Yersinia enterocolitica

Anaerob bacteria :

Actinomyces odontolyticus, Actinomyces meyeri, Bacteroides – Prevotella – Porphyromonas spp., Bacteroides fragilis, Bacteroides vulgatus, Bacteroides variabilis, Bacteroides pneumosintes, Bacteroides coagulans, Bacteroides uniformis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides eggerthii, Bacteroides capsillosis, Prevotella buccalis, Prevotella corporis, Bacteroides gracilis, Prevotella melaninogenica, Prevotella intermedia, Prevotella bivia, Prevotella splanchnicus, Prevotella oralis, Prevotella disiens, Prevotella rumenicola, Bacteroides ureolyticus, Prevotella oris, Prevotella buccae, Prevotella denticola, Bacteroides levii, Porphyromonas asaccharolytica, Bifidobacterium spp., Bilophila wadsworthia, Clostridium perfringens, Clostridium bifermentans, Clostridium ramosum, Clostridium sporogenes, Clostridium cadaveris, Clostridium sordellii, Clostridium butyricum, Clostridium clostridiiformis, Clostridium innocuum, Clostridium subterminate, Clostridium tertium, Eubacterium lentum, Eubacterium aerofaciens, Fusobacterium mortiferum, Fusobacterium necrophorum, Fusobacterium nucleatum, Fusobacterium varium, Mobiluncus curtisii, Mobiluncus mulieris, Peptostreptococcus anaerobius, Peptostreptococcus micros, Peptostreptococcus saccharolyticus, Peptococcus saccharolyticus, Peptostreptococcus saccharolyticus, Peptostreptococcus asaccharolyticus, Peptostreptococcus magnus, Peptostreptococcus prevotii, Propionibacterium acnes, Propionibacterium avidum, Propionibacterium granulosum, Stenotrophomonas maltopphilia, Enterococcus faecium and methicyllin-resistant staphylococci were also found to be resistant to Meropenem.

 

Indication:

Meropenem IV is indicated for adults and children with either single or multiple infectious diseases that are sensitive to Meropenem:

• Pneumonia and nosocomial pneumonia.
• Urinary tract infection (UTI).
• Intra – abdominal infection.
• Gynecological infections, including endometritis.
• Skin and skin structure infection.
• Empirical treatment, in adult patients suspected of having an infection with symptoms of febrile neutropenia, is used as a single therapy or a combination with antiviral or antifungal. Meropenem has been shown to be effective as a single therapy as well as a combination with other antimicrobials in the treatment of polymicrobial infections. There is no evidence in children with primary/secondary immunodeficiency.

 

Dosage :

Adult :

Dosage and duration are determined by type, severity and condition of the patient.

Recommended doses are:

• Pneumonia, urinary tract infection/UTI, gynecological infections (eg, endometritis), skin and skin structure infection: 500 mg IV every 8 hours.
• Nosocomial pneumonia, peritonitis, patients suspected of infection with symptoms of neutropenia, septicemia: 1 g IV every 8 hours.
• Meningitis: 2 g IV every 8 hours.

Like other antibiotics, Meropenem is recommended as a single antibiotic therapy for patients diagnosed or suspected of having a lower respiratory tract infection caused by Pseudomonas aeruginosa with a critical condition. Regular sensitivity tests are recommended for the treatment of infectious diseases caused by Pseudomonas aeruginosa.

 

Adults in adult patients with impaired renal function :

The dose should be reduced in patients with creatin clearance <51 ml / min, ie :

 

Creatinine Release ( ml/minute )	Dosage (based on unit dose 500 mg, 1 g, 2g)	Frequency
26 – 50 10 – 25 < 10	1 dose units ½ dose unit ½ dose unit	Every 12 hours Every 12 hours Every 24 hours

Meropenem will be cleansed by hemodialysis, therefore, if it will use Meropenem in patients who will or are undergoing hemodialysis is recommended to adjust the dose (according to the severity of the infection) to achieve expected plasma levels. There is no data or experience in patients with peritoneal dialysis.

 

Use in adult patients with liver insufficiency :

No dose adjustment required.

 

Usage in elderly patients :

In elderly patients with normal renal function (creatinine clearance > 50 ml/minutes) no dose adjustment is required.

 

Usage in children (3 months – 12 years old) :

Recommended dose 10 – 20 mg / kg body weight every 8 hours (depending on the type and severity of infection, the sensitivity of infectious bacteria, and the condition of the patient). Children with body weight > 50 kg can use an adult dose. In children with meningitis, a recommended dose of 40 mg/ kg body weight every 8 hours. There is no data or experience of Meropenem use in children with kidney disease.

 

Solution Preparation :

For Intravenous Bolus Use :

Enter 20 ml of aqua pro injection into vial containing Meropenem 1 g powder, then shake. The formed solution will be clear until pale yellow. After Meropenem powder is reconstituted with 20 ml aqua pro injection, it can be stored for 2 hours at a temperature of 15 – 25⁰C or up to 12 hours at a temperature of 6 – 9⁰C.

For Intravenous Infusion :

After Meropenem powder is reconstituted with 20 ml of aqua pro injection can be directly mixed with the appropriate infusion fluid.

 

Presentation and Registration Number :

MEREM^® Box, 1 vial @ 1 g; DKL1008015344A1

 

ON MEDICAL PRESCRIPTION ONLY

 

Categorised in:

This post was written by admin