Imipenem and Cilastatin

IMIPENEM AND CILASTATIN- imipenem anhydrous and cilastatin sodium injection, powder, for solution
WG Critical Care, LLC

1 INDICATIONS AND USAGE

1.1 Lower Respiratory Tract Infections

Imipenem and Cilastatin for Injection, USP 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 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 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 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 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 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 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 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 is not indicated in patients with meningitis because safety and efficacy have not been established.
Imipenem and Cilastatin for Injection, USP 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 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 and other antibacterial drugs, Imipenem and Cilastatin for Injection, USP 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.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Adults

For Intravenous Injection Only

The dosage of Imipenem and Cilastatin for Injection in adult patients should be based on suspected or confirmed pathogen susceptibility as shown in Table 1 below. The dosage recommendations for Imipenem and Cilastatin for Injection represent the quantity of imipenem to be administered. An equivalent amount of cilastatin is also present in the solution.
These doses should be used for patients with creatinine clearance of greater than or equal to 90 mL/min. A reduction in dose must be made for patients with creatinine clearance less than 90 mL/min as shown in Table 3 [see Dosage and Administration (2.3)].
Recommend that the maximum total daily dosage not exceed 4 g/day.
Administer 500 mg by intravenous infusion over 20 to 30 minutes.
Administer 1000 mg by intravenous infusion over 40 to 60 minutes.
In patients who develop nausea during the infusion, the rate of infusion may be slowed.
Table 1: Dosage of Imipenem and Cilastatin for Injection in Adult Patients with Creatinine Clearance Greater than or Equal to 90 mL/min
Suspected or Proven Pathogen Susceptibility Dosage of Imipenem and Cilastatin for Injection

If the infection is suspected or proven to be due to a susceptible bacterial species

500 mg every 6 hours
OR
1000 mg every 8 hours

If the infection is suspected or proven to be due to bacterial species with intermediate susceptibility [see Microbiology (12.4)]

1000 mg every 6 hours

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