Powder for preparing solution for infusion
Trade name: Cilapenem, powder for preparing solution for infusion.
International non- proprietary name: Imipenem / Cilastain.
Description: white to yellow powder.
Composition: each bottle/ vial contains: imipenem (as imipenem monohydrate)-250 mg or 500 mg and cilastain (as cilastain sodium salt) – 250 mg or 500 mg (as the mixture of imipenem and cilastain sodium salt)*.
*the mixture of imipenem and cilastain sodium salt contains sodium bicarbonate.
Pharmacotherapeutic group: Beta- lactam antibiotics.
Carbapenem + renal dehydropeptidase inhibitor.
ATC code: J01DH51.
Indications for use:
Intravenous Cilapenem is indicated for treatment of severe infections caused by sensitive strains of the indicated microorganisms in the conditions listed below:
► lower respiratory tract infections caused by Staphylococcus aureus (penicillinase – producing strains), Acinetobacter app., Enterobacter spp., Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella spp., Serratia marcescens;
► urinary tract infections (complicated and uncomplicated) caused by Enterococcus faecalis, Staphylococcus aureus (penicillinase- producing strains), Enterobacter spp., Escherichia coli, Klebsiella spp., Morganella morganii, Proteus vulgaris, Providencia rettgeri, Pseudomonas aeruginosa;
► intraabdominal infections caused by Enterococcus faecalis, Staphylococcus aureus (penicillinase- producing strains), Staphylococcus epidermidis, Citrobacter spp., Enterobacter spp., Escherichia coli, Klebsiella spp., Morganella morganii, Proteus spp., Pseudomonas aeruginosa, Bifidobacterium spp., Clostridium spp., Eubacterium spp., peptococcus spp., Peptostreptococcus spp., Propionibacterium spp., Bacteroides spp., including B. fragilis, Fusobacterium spp.;
► gynecological infections caused by Enterococcus faecalis; Staphylococcus aureus (penicillinase – producing strains), Staphylococcus epidermidis, Escherichia coli; Streptococcus agalactiae (Group B streptococci), Enterobacter spp., Escherichia coli, Gardnerella vaginalis, Klebsiella spp., Proteus spp., Bifidobacterium spp., Peptococcus spp., Peptostreptococcus spp., Propionibacterium spp., Bacteroides spp., including B. fragilis;
► bacterial sepsis caused by Enterococcus faecalis; Staphylococcus aureus (penicillinase- producing strains), Enterobacter spp., Escherichia coli, Klebsiella spp., Serratia spp., Bacteroides spp., including B.fragilis, Pseudomonas aeruginosa;
► bones and joints infections caused by Enterococcus faecalis; Staphylococcus aureus (penicillinase- producing strains), Staphylococcus epidermidis, Enterobacter spp., Pseudomonas aeruginosa;
► skin and its structures infections caused by Enterococcus faecalis; Staphylococcus aureus (penicillinase- producing strains), Staphylococcus epidermidis, Acinetobacter spp., Citrobacter spp., Enterobacter spp., Escherichia coli, Klebsiella spp., Morganella morganii, Proteus vulgaris, Providencia rettgeri, Pseudomonas aeruginosa, Serratia spp., Peptococcus spp., Peptostreptococcus spp., Bacteroides spp., including B. fragilis, Fusobacterium spp.;
► infectious endocarditis caused by Staphylococcus aureus (penicillinase- producing strains);
► polymicrobial infections, including the cases when Streptococcus pneumoniae (pneumonia, septicemia), Streptococcus pneumoniae (pneumonia, septicemia), Streptococcus pyogenes (skin and its structures) or Staphylococcus aureus, non- penicillinase – producing strain is one of the causative agents, Nevertheless, as a rule monobacterial infections caused by these bacteria are corrected by narrow spectrum antibiotics, such as penicillin G.
Cilapenem is not indicated for patients with meningitis, since the safety and efficacy were not established.
Although a clinical improvement is observed in patients with mucoviscidosis, chronic pulmonary diseases and lower respiratory tract infections caused by Pseudomonas aeruginosa, eradication of the causative agent may not be always achieved along with other beta- lactam antibiotics, some Pseudomonas aeruginosa strains rather quickly can become resistant during treatment with Cilapenem. In treatment of infections caused by Pseudomonas aeruginosa periodical sensitivity testing should be performed.
Infections resistant to other antibiotics (for example, cephalosporins, penicillin, aminoglycosides) respond to the treatment with Cilapenem.
In order to reduce the growth of drug- resistant bacteria and to maintain the efficacy of Cilapenem and other antibacterial agents, Cilapenem should be used only for treatment or prevention of infections with proven or suspected sensitive microorganism. When the information about the culture and sensitivity is available, the conditions for selection or change of antibacterial therapy should be considered. If there is no such information, local epidemiological ad sensitivity data may contribute to empiric choice of therapy.