1 INDICATIONS AND USAGE
Imipenem and Cilastatin for Injection, USP for intravenous use is a combination of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria:
Lower respiratory tract infections. (
1.1)
Urinary tract infections. (
1.2)
Intra-abdominal infections. (
1.3)
Gynecologic infections. (
1.4)
Bacterial septicemia. (
1.5)
Bone and joint infections. (
1.6)
Skin and skin structure infections. (
1.7)
Endocarditis. (
1.8)
Limitations of Use:
Imipenem and Cilastatin for Injection, USP (I.V.) is not indicated in patients with meningitis because safety and efficacy have not been established (
1.9).
Imipenem and Cilastatin for Injection, USP (I.V.) is not recommended in pediatric patients with CNS infections because of the risk of seizures (
1.9).
Imipenem and Cilastatin for Injection, USP (I.V.) is not recommended in pediatric patients weighing less than 30 kg with impaired renal function (
1.9).
Usage:
To reduce the development of drug resistant bacteria and maintain the effectiveness of Imipenem and Cilastatin for Injection, USP (I.V.) and other antibacterial drugs, Imipenem and Cilastatin for Injection, USP (I.V.) should be used only to treat infections that are proven or strongly suspected to be caused by bacteria (
1.10).
1.1 Lower Respiratory Tract Infections
Imipenem and Cilastatin for Injection, USP (I.V.) for intravenous use is indicated for the treatment of lower respiratory tract infections caused by susceptible strains of
Staphylococcus aureus (penicillinase-producing isolates),
Acinetobacter species,
Enterobacter species,
Escherichia coli,
Haemophilus influenzae,
Haemophilus parainfluenzae,
Klebsiella species,
Serratia marcescens.
1.2 Urinary Tract Infections (complicated and uncomplicated)
Imipenem and Cilastatin for Injection, USP (I.V.) is indicated for the treatment of urinary tract infections (complicated and uncomplicated) caused by susceptible strains of
Enterococcus faecalis,
Staphylococcus aureus (penicillinase-producing isolates),
Enterobacter species,
Escherichia coli,
Klebsiella species,
Morganella morganii,
Proteus vulgaris,
Providencia rettgeri,
Pseudomonas aeruginosa.
1.3 Intra-Abdominal Infections
Imipenem and Cilastatin for Injection, USP (I.V.) is indicated for the treatment of intra-abdominal infections caused by susceptible strains of
Enterococcus faecalis,
Staphylococcus aureus (penicillinase-producing isolates),
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.
1.4 Gynecologic Infections
Imipenem and Cilastatin for Injection, USP (I.V.) is indicated for the treatment of gynecologic infections caused by susceptible strains of
Enterococcus faecalis,
Staphylococcus aureus (penicillinase-producing isolates),
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.
1.5 Bacterial Septicemia
Imipenem and Cilastatin for Injection, USP (I.V.) is indicated for the treatment of bacterial septicemia caused by susceptible strains of
Enterococcus faecalis,
Staphylococcus aureus (penicillinase-producing isolates),
Enterobacter species,
Escherichia coli,
Klebsiella species,
Pseudomonas aeruginosa,
Serratia species,
Bacteroides species including
B. fragilis.
1.6 Bone and Joint Infections
Imipenem and Cilastatin for Injection, USP (I.V.) is indicated for the treatment of bone and joint infections caused by susceptible strains of
Enterococcus faecalis,
Staphylococcus aureus (penicillinase-producing isolates),
Staphylococcus epidermidis,
Enterobacter species,
Pseudomonas aeruginosa.
1.7 Skin and Skin Structure Infections
Imipenem and Cilastatin for Injection, USP (I.V.) is indicated for the treatment of skin and skin structure infections caused by susceptible strains of
Enterococcus faecalis,
Staphylococcus aureus (penicillinase-producing isolates),
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.
1.8 Endocarditis
Imipenem and Cilastatin for Injection, USP (I.V.) is indicated for the treatment of endocarditis caused by susceptible strains of
Staphylococcus aureus (penicillinase-producing isolates).
1.9 Limitations of Use
Imipenem and Cilastatin for Injection, USP (I.V.) is not indicated in patients with meningitis because safety and efficacy have not been established.
Imipenem and Cilastatin for Injection, USP (I.V.) is not recommended in pediatric patients with CNS infections because of the risk of seizures
[see Dosage and Administration (
2.2), Warnings and Precautions (
5.2), and Use in Specific Populations (
8.4)]
.
Imipenem and Cilastatin for Injection, USP (I.V.) is not recommended in pediatric patients less than 30 kg with impaired renal function, as no data are available
[see Use in Specific Populations (
8.4), and Dosage and Administration (
2.2)]
.
Periodic assessment of organ system functions, including renal, hepatic and hematopoietic, is advisable during prolonged therapy.
1.10 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Imipenem and Cilastatin for Injection, USP (I.V.) and other antibacterial drugs, Imipenem and Cilastatin for Injection, USP (I.V.) should be used only to treat 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.