PRIMAXIN I.V. SUMMARY
PRIMAXIN I.V. (Imipenem and Cilastatin for Injection) is a sterile formulation of imipenem (a thienamycin antibiotic) and cilastatin sodium (the inhibitor of the renal dipeptidase, dehydropeptidase I), with sodium bicarbonate added as a buffer. PRIMAXIN I.V. is a potent broad spectrum antibacterial agent for intravenous administration.
PRIMAXIN I.V. is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
- Lower respiratory tract infections. Staphylococcus aureus
(penicillinase-producing strains), Acinetobacter
species,
Enterobacter
species,
Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae *, Klebsiella
species,
Serratia marcescens
- Urinary tract infections (complicated and uncomplicated). Enterococcus faecalis, Staphylococcus aureus
(penicillinase-producing strains) *,
Enterobacter
species,
Escherichia coli, Klebsiella
species,
Morganella morganii *, Proteus vulgaris *, Providencia rettgeri *, Pseudomonas aeruginosa
- Intra-abdominal infections. Enterococcus faecalis, Staphylococcus aureus
(penicillinase-producing strains) *,
Staphylococcus epidermidis, Citrobacter
species,
Enterobacter
species,
Escherichia coli, Klebsiella
species,
Morganella morganii *, Proteus
species,
Pseudomonas aeruginosa, Bifidobacterium
species,
Clostridium
species,
Eubacterium
species,
Peptococcus
species,
Peptostreptococcus
species,
Propionibacterium
species
*,
Bacteroides
species including
B. fragilis, Fusobacterium
species
- Gynecologic infections. Enterococcus faecalis, Staphylococcus aureus
(penicillinase-producing strains) *,
Staphylococcus epidermidis, Streptococcus agalactiae
(Group B streptococci),
Enterobacter
species*,
Escherichia coli, Gardnerella vaginalis, Klebsiella
species
*,
Proteus
species,
Bifidobacterium
species
*,
Peptococcus
species
*,
Peptostreptococcus
species,
Propionibacterium
species
*,
Bacteroides
species including
B. fragilis *
- Bacterial septicemia. Enterococcus faecalis, Staphylococcus aureus
(penicillinase-producing strains), Enterobacter
species,
Escherichia coli, Klebsiella
species,
Pseudomonas aeruginosa, Serratia
species
*, Bacteroides
species including
B. fragilis *
- Bone and joint infections. Enterococcus faecalis, Staphylococcus aureus
(penicillinase-producing strains), Staphylococcus epidermidis, Enterobacter
species,
Pseudomonas aeruginosa
- Skin and skin structure infections. Enterococcus faecalis, Staphylococcus aureus
(penicillinase-producing strains), Staphylococcus epidermidis, Acinetobacter
species,
Citrobacter
species,
Enterobacter
species,
Escherichia coli, Klebsiella
species,
Morganella morganii, Proteus vulgaris, Providencia rettgeri *, Pseudomonas aeruginosa, Serratia
species,
Peptococcus
species,
Peptostreptococcus
species,
Bacteroides
species including
B. fragilis, Fusobacterium
species
*
- Endocarditis. Staphylococcus aureus
(penicillinase-producing strains)
- Polymicrobic infections. PRIMAXIN I.V. is indicated for polymicrobic infections including those in which
S. pneumoniae
(pneumonia, septicemia),
S. pyogenes
(skin and skin structure), or nonpenicillinase-producing
S. aureus
is one of the causative organisms. However, monobacterial infections due to these organisms are usually treated with narrower spectrum antibiotics, such as penicillin G.
PRIMAXIN I.V. is not indicated in patients with meningitis because safety and efficacy have not been established.
For Pediatric Use information, See PRECAUTIONS, Pediatric Use, and DOSAGE AND ADMINISTRATION sections.
Because of its broad spectrum of bactericidal activity against gram-positive and gram-negative aerobic and anaerobic bacteria, PRIMAXIN I.V. is useful for the treatment of mixed infections and as presumptive therapy prior to the identification of the causative organisms.
Although clinical improvement has been observed in patients with cystic fibrosis, chronic pulmonary disease, and lower respiratory tract infections caused by
Pseudomonas aeruginosa,
bacterial eradication may not necessarily be achieved.
As with other beta-lactam antibiotics, some strains of
Pseudomonas aeruginosa
may develop resistance fairly rapidly during treatment with PRIMAXIN I.V. During therapy of
Pseudomonas aeruginosa
infections, periodic susceptibility testing should be done when clinically appropriate.
Infections resistant to other antibiotics, for example, cephalosporins, penicillin, and aminoglycosides, have been shown to respond to treatment with PRIMAXIN I.V.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of PRIMAXIN I.V. and other antibacterial drugs, PRIMAXIN I.V. should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
*Efficacy for this organism in this organ system was studied in fewer than 10 infections.
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