Imipenem cilastatin indications and usage

Imipenem Cilastatin
PRIMAXIN® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
Compatibility, Reconstitution, and Stability
Directions For Use
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

Indications and Usage

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, Enterobacterspecies, Escherichia coli,Haemophilus influenzae, Haemophilus parainfluenzae1, Klebsiella species, Serratia marcescens

• Urinary tract infections (complicated and uncomplicated). [[Enterococcus faecalis]], Staphylococcus aureus (penicillinase-producing strains)1, Enterobacter species,Enterobacter, Klebsiella species, Morganella morganii1, Proteus vulgaris1, Providencia rettgeri1, Pseudomonas aeruginosa

• Intra-abdominal infections. Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains)1, Staphylococcus epidermidis, Citrobacter species,Enterobacter species, Enterobacter, Klebsiella species, Morganella morganii1, Proteus species, Pseudomonas aeruginosa, Bifidobacterium species,Clostridium species, Eubacterium species, Peptococcus species, Peptostreptococcus species, Propionibacterium species1, Bacteroides species includingB. fragilis, Fusobacterium species

• Gynecologic infections. Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains)1, Staphylococcus epidermidis, Streptococcus agalactiae(Group B streptococci), Enterobacter species1, Enterobacter, Gardnerella vaginalis, Klebsiella species1, Proteus species, Bifidobacterium species1,Peptococcus species1, Peptostreptococcus species, Propionibacterium species1, Bacteroides species including B. fragilis1

• Bacterial septicemia. Enterococcus faecalis, Staphylococcus aureus (penicillinase-producing strains), Enterobacter species, Enterobacter, Klebsiella species,Pseudomonas aeruginosa, Serratia species1, Bacteroides species including B. fragilis1

• 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, Acinetobacterspecies, Citrobacter species, Enterobacter species, Enterobacter, Klebsiella species, Morganella morganii, Proteus vulgaris, Providencia rettgeri1,Pseudomonas aeruginosa, Serratia species, Peptococcus species, Peptostreptococcus species, Bacteroides species including B. fragilis, Fusobacterium species1

• 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 byPseudomonas 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.

References

Adapted from the FDA Package Insert.