Indication

ImbacTM IV 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 (penicillinaseproducing 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 (penicillinaseproducing 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: ImbacTM IV 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.


Dosage & Administration

Pediatric Patients For pediatric patients <3 months of age (weighing >1.5 kg), the following dosage schedule is recommended for non-CNS infections:

  • <1 wk of age: 25 mg/kg every 12 hrs
  • 1-4 wks of age: 25 mg/kg every 8 hrs
  • 4 wks-3 mos. of age: 25 mg/kg every 6 hrs.
  • For pediatric patients >3 months : The recommended dose for non-CNS infections is 15-25 mg/kg/dose administered every six hours.

Based on studies in adults, the maximum daily dose for treatment of infections with fully susceptible organisms is 2.0 g per day, and of infections with moderately susceptible organisms (primarily some strains of P. aeruginosa) is 4.0 g/day. Higher doses (up to 90 mg/kg/day in older children) have been used in patients with cystic fibrosis. Doses less than or equal to 500 mg should be given by intravenous infusion over 15 to 30 minutes. Doses greater than 500 mg should be given by intravenous infusion over 40 to 60 minutes. Adults INTRAVENOUS DOSAGE SCHEDULE FOR ADULTS WITH NORMAL RENAL FUNCTION AND BODY WEIGHT>70 kg

Type or Severity of Infection A
Fully suspectible organisms including
gram-positive and gram negative aerobes
and anaerobes
B
Moderately suspectible organisms,
primarily some strains of P.aeruginosa
Mid 250 mg q 6 h
(Total Daily Dose = 1.0 g)
500 mg q 6 h
(Total Daily Dose = 2.0 g)
Moderate 500 mg q 8 h
(Total Daily Dose = 1.5 g)
or
500 mg q 6 h
(Total Daily Dose = 2.0 g)
500 mg q 6 h
(Total Daily Dose = 2.0 g)
or
1 g q 6 h
(Total Daily Dose = 3.0 g)
Severe,life threating only 500 mg q 6 h
(Total Daily Dose = 2.0 g)
1 g q 8 h
(Total Daily Dose = 3.0 g)
or
1 g q 6 h
(Total Daily Dose = 4.0 g)
Uncomplicated urinary tract infection 250 mg q 6 h
(Total Daily Dose = 1.0 g)
250 mg q 6 h
(Total Daily Dose = 1.0 g)
Complicated urinary tract infection 500 mg q 6 h
(Total Daily Dose = 2.0 g)
500 mg q 6 h
(Total Daily Dose = 2.0 g)

Each 125 mg, 250 mg, or 500 mg dose should be given by intravenous administration over 20 to 30 minutes. Each 750 mg or 1000 mg dose should be infused over 40 to 60 minutes. In patients who develop nausea during the infusion, the rate of infusion may be slowed. Dosage adjustment in renal impairment:

  • [CRCL >71]: No changes.
  • [41 -70 ]: Max 37.5 mg/kg/day or 3 g/day. (Range: 9.4 - 37.5mg/kg/day) divided q6-8h.
  • [21-40]: Max 25 mg/kg/day or 2 g/day. (Range: 6.25 - 25 mg/kg/day) divided q6-12h.
  • [6-20 ]: Max 12.5 mg/kg/day (max dose 1 g/day). Range: 6.25 - 12.5 mg/kg/day) divided q12h. (Usual: 250mg q12h)

Dialysis Hemodialysis: 125 - 500 mg q12h. (Max 12.5 mg/kg/day). Give dose after dialysis. Peritonial Dialysis: 125 - 250 mg q12h


Precautions

CNS adverse experiences such as confusional states, myoclonic activity, and seizures have been reported during treatment with Imipenem-Cilastatin, especially when recommended dosages were exceeded. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including Imipenem/Cilastatin Sodium, and may range in severity from mild to life threatening. Use in Pregnancy: Pregnancy category C. Imipenem should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus. Use in Lactation: It is not known whether Imipenem/Cilastatin Sodium is excreted in human milk.


Product Details


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