Tobramycin Dosage

Drug Detail:Tobramycin (inhalation) (Tobramycin (inhalation) [ toe-bra-my-sin ])

Drug Class: Aminoglycosides Inhaled anti-infectives

Usual Adult Dose for Bacteremia

Serious infections: 1 mg/kg IM or IV infusion (over 20 to 60 minutes) every 8 hours

Duration of therapy: 7 to 10 days

Life-threatening infections:

Initial dose: Up to 5 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maintenance dose: 3 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maximum dose: 5 mg/kg/day
Duration of therapy: 7 to 10 days

Comments:

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.
This drug is not routinely indicated in the initial treatment of uncomplicated urinary tract infections UNLESS the organism is resistant to other less toxic antibacterial agents.
Empiric treatment may begin prior to obtaining susceptibility results.

Uses:

Serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use
Treatment of septicemia caused by Pseudomonas aeruginosa, Klebsiella species, and Escherichia coli
Treatment of serious lower respiratory tract infections caused by P aeruginosa, Klebsiella species, Enterobacter species, Serratia species, E coli, and Staphylococcus aureus (penicillinase and non-penicillinase-producing strains)
Treatment of serious skin, bone, and skin structure infections caused by P aeruginosa, Proteus species, E coli, Klebsiella species, Enterobacter species, S aureus
Treatment of complicated and recurrent urinary tract infections caused by P aeruginosa, Proteus species (indole-positive/-negative), E coli, Klebsiella species, Enterobacter species, Serratia species, S aureus, Providencia species, and Citrobacter species

Infectious Diseases Society of America (IDSA) Recommendations:
5 to 7 mg/kg IV every 24 hours PLUS cefepime, imipenem, meropenem, OR piperacillin/tazobactam

Comment: The susceptibility of strains varies.

Use: Treatment of catheter-related infections caused by P aeruginosa

Usual Adult Dose for Osteomyelitis

Serious infections: 1 mg/kg IM or IV infusion (over 20 to 60 minutes) every 8 hours

Duration of therapy: 7 to 10 days

Life-threatening infections:

Initial dose: Up to 5 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maintenance dose: 3 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maximum dose: 5 mg/kg/day
Duration of therapy: 7 to 10 days

Comments:

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.
This drug is not routinely indicated in the initial treatment of uncomplicated urinary tract infections UNLESS the organism is resistant to other less toxic antibacterial agents.
Empiric treatment may begin prior to obtaining susceptibility results.

Uses:

Serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use
Treatment of septicemia caused by Pseudomonas aeruginosa, Klebsiella species, and Escherichia coli
Treatment of serious lower respiratory tract infections caused by P aeruginosa, Klebsiella species, Enterobacter species, Serratia species, E coli, and Staphylococcus aureus (penicillinase and non-penicillinase-producing strains)
Treatment of serious skin, bone, and skin structure infections caused by P aeruginosa, Proteus species, E coli, Klebsiella species, Enterobacter species, S aureus
Treatment of complicated and recurrent urinary tract infections caused by P aeruginosa, Proteus species (indole-positive/-negative), E coli, Klebsiella species, Enterobacter species, Serratia species, S aureus, Providencia species, and Citrobacter species

Usual Adult Dose for Pneumonia

Serious infections: 1 mg/kg IM or IV infusion (over 20 to 60 minutes) every 8 hours

Duration of therapy: 7 to 10 days

Life-threatening infections:

Initial dose: Up to 5 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maintenance dose: 3 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maximum dose: 5 mg/kg/day
Duration of therapy: 7 to 10 days

Comments:

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.
This drug is not routinely indicated in the initial treatment of uncomplicated urinary tract infections UNLESS the organism is resistant to other less toxic antibacterial agents.
Empiric treatment may begin prior to obtaining susceptibility results.

Uses:

Serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use
Treatment of septicemia caused by Pseudomonas aeruginosa, Klebsiella species, and Escherichia coli
Treatment of serious lower respiratory tract infections caused by P aeruginosa, Klebsiella species, Enterobacter species, Serratia species, E coli, and Staphylococcus aureus (penicillinase and non-penicillinase-producing strains)
Treatment of serious skin, bone, and skin structure infections caused by P aeruginosa, Proteus species, E coli, Klebsiella species, Enterobacter species, S aureus
Treatment of complicated and recurrent urinary tract infections caused by P aeruginosa, Proteus species (indole-positive/-negative), E coli, Klebsiella species, Enterobacter species, Serratia species, S aureus, Providencia species, and Citrobacter species

Usual Adult Dose for Pyelonephritis

Serious infections: 1 mg/kg IM or IV infusion (over 20 to 60 minutes) every 8 hours

Duration of therapy: 7 to 10 days

Life-threatening infections:

Initial dose: Up to 5 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maintenance dose: 3 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maximum dose: 5 mg/kg/day
Duration of therapy: 7 to 10 days

Comments:

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.
This drug is not routinely indicated in the initial treatment of uncomplicated urinary tract infections UNLESS the organism is resistant to other less toxic antibacterial agents.
Empiric treatment may begin prior to obtaining susceptibility results.

Uses:

Serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use
Treatment of septicemia caused by Pseudomonas aeruginosa, Klebsiella species, and Escherichia coli
Treatment of serious lower respiratory tract infections caused by P aeruginosa, Klebsiella species, Enterobacter species, Serratia species, E coli, and Staphylococcus aureus (penicillinase and non-penicillinase-producing strains)
Treatment of serious skin, bone, and skin structure infections caused by P aeruginosa, Proteus species, E coli, Klebsiella species, Enterobacter species, S aureus
Treatment of complicated and recurrent urinary tract infections caused by P aeruginosa, Proteus species (indole-positive/-negative), E coli, Klebsiella species, Enterobacter species, Serratia species, S aureus, Providencia species, and Citrobacter species

Usual Adult Dose for Skin or Soft Tissue Infection

Serious infections: 1 mg/kg IM or IV infusion (over 20 to 60 minutes) every 8 hours

Duration of therapy: 7 to 10 days

Life-threatening infections:

Initial dose: Up to 5 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maintenance dose: 3 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maximum dose: 5 mg/kg/day
Duration of therapy: 7 to 10 days

Comments:

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.
This drug is not routinely indicated in the initial treatment of uncomplicated urinary tract infections UNLESS the organism is resistant to other less toxic antibacterial agents.
Empiric treatment may begin prior to obtaining susceptibility results.

Uses:

Serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use
Treatment of septicemia caused by Pseudomonas aeruginosa, Klebsiella species, and Escherichia coli
Treatment of serious lower respiratory tract infections caused by P aeruginosa, Klebsiella species, Enterobacter species, Serratia species, E coli, and Staphylococcus aureus (penicillinase and non-penicillinase-producing strains)
Treatment of serious skin, bone, and skin structure infections caused by P aeruginosa, Proteus species, E coli, Klebsiella species, Enterobacter species, S aureus
Treatment of complicated and recurrent urinary tract infections caused by P aeruginosa, Proteus species (indole-positive/-negative), E coli, Klebsiella species, Enterobacter species, Serratia species, S aureus, Providencia species, and Citrobacter species

Usual Adult Dose for Bacterial Infection

Serious infections: 1 mg/kg IM or IV infusion (over 20 to 60 minutes) every 8 hours

Duration of therapy: 7 to 10 days

Life-threatening infections:

Initial dose: Up to 5 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maintenance dose: 3 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maximum dose: 5 mg/kg/day
Duration of therapy: 7 to 10 days

Comments:

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.
This drug is not routinely indicated in the initial treatment of uncomplicated urinary tract infections UNLESS the organism is resistant to other less toxic antibacterial agents.
Empiric treatment may begin prior to obtaining susceptibility results.

Uses:

Serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use
Treatment of septicemia caused by Pseudomonas aeruginosa, Klebsiella species, and Escherichia coli
Treatment of serious lower respiratory tract infections caused by P aeruginosa, Klebsiella species, Enterobacter species, Serratia species, E coli, and Staphylococcus aureus (penicillinase and non-penicillinase-producing strains)
Treatment of serious skin, bone, and skin structure infections caused by P aeruginosa, Proteus species, E coli, Klebsiella species, Enterobacter species, S aureus
Treatment of complicated and recurrent urinary tract infections caused by P aeruginosa, Proteus species (indole-positive/-negative), E coli, Klebsiella species, Enterobacter species, Serratia species, S aureus, Providencia species, and Citrobacter species

Usual Adult Dose for Urinary Tract Infection

Serious infections: 1 mg/kg IM or IV infusion (over 20 to 60 minutes) every 8 hours

Duration of therapy: 7 to 10 days

Life-threatening infections:

Initial dose: Up to 5 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maintenance dose: 3 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maximum dose: 5 mg/kg/day
Duration of therapy: 7 to 10 days

Comments:

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.
This drug is not routinely indicated in the initial treatment of uncomplicated urinary tract infections UNLESS the organism is resistant to other less toxic antibacterial agents.
Empiric treatment may begin prior to obtaining susceptibility results.

Uses:

Serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use
Treatment of septicemia caused by Pseudomonas aeruginosa, Klebsiella species, and Escherichia coli
Treatment of serious lower respiratory tract infections caused by P aeruginosa, Klebsiella species, Enterobacter species, Serratia species, E coli, and Staphylococcus aureus (penicillinase and non-penicillinase-producing strains)
Treatment of serious skin, bone, and skin structure infections caused by P aeruginosa, Proteus species, E coli, Klebsiella species, Enterobacter species, S aureus
Treatment of complicated and recurrent urinary tract infections caused by P aeruginosa, Proteus species (indole-positive/-negative), E coli, Klebsiella species, Enterobacter species, Serratia species, S aureus, Providencia species, and Citrobacter species

Usual Adult Dose for Sepsis

Serious infections: 1 mg/kg IM or IV infusion (over 20 to 60 minutes) every 8 hours

Duration of therapy: 7 to 10 days

Life-threatening infections:

Initial dose: Up to 5 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maintenance dose: 3 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maximum dose: 5 mg/kg/day
Duration of therapy: 7 to 10 days

Comments:

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.
This drug is not routinely indicated in the initial treatment of uncomplicated urinary tract infections UNLESS the organism is resistant to other less toxic antibacterial agents.
Empiric treatment may begin prior to obtaining susceptibility results.

Uses:

Serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use
Treatment of septicemia caused by Pseudomonas aeruginosa, Klebsiella species, and Escherichia coli
Treatment of serious lower respiratory tract infections caused by P aeruginosa, Klebsiella species, Enterobacter species, Serratia species, E coli, and Staphylococcus aureus (penicillinase and non-penicillinase-producing strains)
Treatment of serious skin, bone, and skin structure infections caused by P aeruginosa, Proteus species, E coli, Klebsiella species, Enterobacter species, S aureus
Treatment of complicated and recurrent urinary tract infections caused by P aeruginosa, Proteus species (indole-positive/-negative), E coli, Klebsiella species, Enterobacter species, Serratia species, S aureus, Providencia species, and Citrobacter species

Usual Adult Dose for Pneumonia with Cystic Fibrosis

INHALATION:
Inhalation capsules: 112 mg (4 capsules) inhaled via Podhaler (R) 2 times a day
Inhalation solution: 300 mg inhaled via nebulizer 2 times a day
Duration of therapy: 28 days

PARENTERAL:
Serious infections: 1 mg/kg IM or IV infusion (over 20 to 60 minutes) every 8 hours

Duration of therapy: 7 to 10 days

Life-threatening infections:

Initial dose: Up to 5 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maintenance dose: 3 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maximum dose: 5 mg/kg/day
Duration of therapy: 7 to 10 days

Comments:

Safety and efficacy of the inhalation solution have not been demonstrated in patients with a predicted forced expiratory volume in 1 second (FEV1) of 25% or less OR greater than 75% at screening, or those colonized with Burkholderia cepacia.
Doses should be given as close to 12 hours apart as possible; doses should not be given less than 6 hours apart.
Parenteral formulations should be limited to short-term use.
After 28 days of treatment with an inhalation formulation, patients should stop treatment for 28 days before restarting treatment for additional 28-day on/28-day off cycles.
Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.
In patients with cystic fibrosis, altered pharmacokinetics may result in reduced serum levels of aminoglycosides; measurement of serum levels is recommended as the basis for dose adjustments.
In patients with severe cystic fibrosis, an initial dosing regimen of 10 mg/kg/day in 4 equally divided doses is suggested by the manufacturer.
The serum levels should be measured directly during therapy due to wide interpatient variability.

Uses:

Management of cystic fibrosis in patients with P aeruginosa infections
Serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use
Treatment of serious lower respiratory tract infections caused by P aeruginosa, Klebsiella species, Enterobacter species, Serratia species, E coli, and S aureus (penicillinase and non-penicillinase-producing strains)

Usual Adult Dose for Cystic Fibrosis

Duration of therapy: 7 to 10 days

Life-threatening infections:

Initial dose: Up to 5 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maintenance dose: 3 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maximum dose: 5 mg/kg/day
Duration of therapy: 7 to 10 days

Comments:

Safety and efficacy of the inhalation solution have not been demonstrated in patients with a predicted forced expiratory volume in 1 second (FEV1) of 25% or less OR greater than 75% at screening, or those colonized with Burkholderia cepacia.
Doses should be given as close to 12 hours apart as possible; doses should not be given less than 6 hours apart.
Parenteral formulations should be limited to short-term use.
After 28 days of treatment with an inhalation formulation, patients should stop treatment for 28 days before restarting treatment for additional 28-day on/28-day off cycles.
Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.
In patients with cystic fibrosis, altered pharmacokinetics may result in reduced serum levels of aminoglycosides; measurement of serum levels is recommended as the basis for dose adjustments.
In patients with severe cystic fibrosis, an initial dosing regimen of 10 mg/kg/day in 4 equally divided doses is suggested by the manufacturer.
The serum levels should be measured directly during therapy due to wide interpatient variability.

Uses:

Management of cystic fibrosis in patients with P aeruginosa infections
Serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use
Treatment of serious lower respiratory tract infections caused by P aeruginosa, Klebsiella species, Enterobacter species, Serratia species, E coli, and S aureus (penicillinase and non-penicillinase-producing strains)

Usual Adult Dose for Meningitis

Serious infections: 1 mg/kg IV or IM every 8 hours

Life-threatening infections: Up to 5 mg/kg/day may be administered IV or IM in 3 or 4 equal doses; however, the dosage should be reduced to 3 mg/kg/day as soon as clinically indicated.

Comments:

To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.
Some experts recommend a loading dose of 2 mg/kg.
Parenteral therapy should be continued for at least 1 week after the patient becomes afebrile and cerebrospinal fluid (CSF) normalizes.

IDSA recommendations:
Parenteral: 5 mg/kg/day IV or IM in 3 divided doses

Intraventricular: 5 to 20 mg intraventricularly (preservative-free formulation) per day; subsequent doses should be based on the CSF concentration

Duration of therapy:
Neisseria meningitidis: 7 days
Haemophilus influenzae: 7 days
Streptococcus pneumoniae: 10 to 14 days
Streptococcus agalactiae: 14 to 21 days
Aerobic gram-negative bacilli: 21 days
Listeria monocytogenes: 21 days or longer

Comments:

These guidelines are not standardized and the duration of therapy should be individualized based on the patient's clinical response.
IV antimicrobial therapy is recommended for the duration of therapy to ensure that adequate CSF levels are attained.

Usual Adult Dose for CNS Infection

To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.
Some experts recommend a loading dose of 2 mg/kg.
Parenteral therapy should be continued for at least 1 week after the patient becomes afebrile and cerebrospinal fluid (CSF) normalizes.

These guidelines are not standardized and the duration of therapy should be individualized based on the patient's clinical response.
IV antimicrobial therapy is recommended for the duration of therapy to ensure that adequate CSF levels are attained.

Usual Adult Dose for Shunt Infection

To prevent increased toxicity due to excessive blood levels, dosage should not exceed 5 mg/kg/day unless serum levels are monitored.
Some experts recommend a loading dose of 2 mg/kg.
Parenteral therapy should be continued for at least 1 week after the patient becomes afebrile and cerebrospinal fluid (CSF) normalizes.

These guidelines are not standardized and the duration of therapy should be individualized based on the patient's clinical response.
IV antimicrobial therapy is recommended for the duration of therapy to ensure that adequate CSF levels are attained.

Usual Adult Dose for Intraabdominal Infection

PARENTERAL:
Serious infections: 1 mg/kg IM or IV infusion (over 20 to 60 minutes) every 8 hours

Duration of therapy: 7 to 10 days

Life-threatening infections:

Initial dose: Up to 5 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maintenance dose: 3 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maximum dose: 5 mg/kg/day
Duration of therapy: 7 to 10 days

Comments:

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.

Use: Treatment of serious intraabdominal infections caused by E coli, Klebsiella species, and Enterobacter species

Surgical Infection Society (SIS) and IDSA Recommendations:
Initial dose: 5 to 7 mg/kg IV every 24 hours

Duration of therapy: Up to 4 to 7 days

Comments:

This drug should be used in combination with a carbapenem and piperacillin-tazobactam in healthcare-associated infections.
Maintenance doses should be based on adjusted body weight and serum drug concentrations.

Use: Empiric combination treatment of complicated healthcare-associated intraabdominal infections caused by extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae or P aeruginosa greater than 20% resistant to ceftazidime

Usual Adult Dose for Peritonitis

PARENTERAL:
Serious infections: 1 mg/kg IM or IV infusion (over 20 to 60 minutes) every 8 hours

Duration of therapy: 7 to 10 days

Life-threatening infections:

Initial dose: Up to 5 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maintenance dose: 3 mg/kg IM or IV infusion (over 20 to 60 minutes), given in equally divided doses 3 to 4 times a day
Maximum dose: 5 mg/kg/day
Duration of therapy: 7 to 10 days

Comments:

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.

Use: Treatment of peritonitis caused by E coli, Klebsiella species, and Enterobacter species

International Society for Peritoneal Dialysis (ISPD) Recommendations:
Intermittent (1 exchange daily): 0.6 mg/kg intraperitoneally once a day

Continuous (all exchanges):

Loading dose: 8 mg/L
Maintenance dose: 4 mg/L

Comments:

Intermittent dosing is recommended, and should be allowed to dwell for at least 6 hours.
Prolonged courses of treatment should be avoided.

Use: Treatment of peritonitis

Usual Adult Dose for Endocarditis

American Heart Association (AHA) and IDSA Recommendations:
Gram-negative enteric bacilli: 3 to 5 mg/kg IV per day (or gentamicin or amikacin) PLUS ceftazidime, cefepime, cefotaxime, ceftriaxone, OR piperacillin/tazobactam

Duration of therapy: At least 6 weeks

Haemophilus species, Aggregatibacter species, Cardiobacterium hominis, Eikenella corrodens, and Kingella species (HACEK group): 3 to 5 mg/kg IV per day (or gentamicin or amikacin) PLUS ampicillin

Duration of therapy: At least 6 weeks

Uses:

Recommended antibiotic treatment (with ceftazidime, cefepime, cefotaxime, or ceftriaxone) for the treatment of infective endocarditis (IE) caused by gram-negative enteric bacilli
Alternative antibiotic treatment (with piperacillin/tazobactam) for the treatment of IE caused by gram-negative enteric bacilli
Alternative antibiotic treatment (with ampicillin) for the treatment of IE caused by HACEK group organisms

Usual Pediatric Dose for Bacteremia

PARENTERAL:
Premature and full-term neonates 1 week of age or less: Up to 4 mg/kg IM or IV infusion (over 20 to 60 minutes) every 12 hours
Pediatric patients greater than 1 week of age: 2 to 2.5 mg/kg IM or IV infusion (over 20 to 60 minutes) every 8 hours OR 1.5 to 1.89 mg/kg IM or IV infusion (over 20 to 60 minutes) every 6 hours
Duration of therapy: 7 to 10 days

Comments:

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.
This drug is not routinely indicated in the initial treatment of uncomplicated urinary tract infections UNLESS the organism is resistant to other less toxic antibacterial agents.
Empiric treatment may begin prior to obtaining susceptibility results.

Uses:

Serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use
Treatment of septicemia caused by P aeruginosa, Klebsiella species, and E coli
Treatment of serious lower respiratory tract infections caused by P aeruginosa, Klebsiella species, Enterobacter species, Serratia species, E coli, and S aureus (penicillinase and non-penicillinase-producing strains)
Treatment of serious skin, bone, and skin structure infections caused by P aeruginosa, Proteus species, E coli, Klebsiella species, Enterobacter species, S aureus
Treatment of complicated and recurrent urinary tract infections caused by P aeruginosa, Proteus species (indole-positive/-negative), E coli, Klebsiella species, Enterobacter species, Serratia species, S aureus, Providencia species, and Citrobacter species

American Academy of Pediatrics (AAP) Recommendations:
Severe Infections:
Gestational age less than 30 weeks, postnatal age 14 days or less: 5 mg/kg IM or IV every 48 hours
Gestational age less than 30 weeks, postnatal age 14 to 28 days: 5 mg/kg IM or IV every 36 hours
Gestational age 30 to 34 weeks, postnatal age 14 days or less: 5 mg/kg IM or IV every 36 hours
Gestational age 30 to 34 weeks, postnatal age 14 to 28 days: 5 mg/kg IM or IV every 24 hours
Gestational age 35 weeks or greater, postnatal age 7 days or less: 4 mg/kg IM or IV every 24 hours
Gestational age 35 weeks or greater, postnatal age 7 to 28 days: 5 mg/kg IM or IV every 24 hours
Greater than 28 days: 6 to 7.5 mg IM or IV in 3 to 4 doses OR 5 to 7.5 mg IM or IV once a day

Comments:

Serum concentrations should guide ongoing treatment.
Higher doses may be used in patients with cystic fibrosis.

IDSA Recommendations:
Preterm neonates less than 1000 grams: 3.5 mg/kg IV every 24 hours
Neonates 0 to 4 weeks and less than 1200 grams: 2.5 mg/kg IV every 18 hours
Neonates postnatal age 7 days or less AND 1200 to 2000 grams: 2.5 mg/kg IV every 12 hours
Neonates postnatal age 7 days or less AND greater than 2000 grams: 2.5 mg/kg IV every 12 hours
Infants and children less than 5 years: 2.5 mg/kg IV every 8 hours
Children 5 years and older: 2 to 2.5 mg/kg every 8 hours

Comments:

The susceptibility of strains varies.
Some children (e.g., those with cystic fibrosis, major burns, febrile neutropenia) may require more frequent dosing (e.g., every 6 hours) or higher doses.

Use: Treatment of catheter-related infections caused by P aeruginosa

Usual Pediatric Dose for Osteomyelitis

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.
This drug is not routinely indicated in the initial treatment of uncomplicated urinary tract infections UNLESS the organism is resistant to other less toxic antibacterial agents.
Empiric treatment may begin prior to obtaining susceptibility results.

Uses:

Serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use
Treatment of septicemia caused by P aeruginosa, Klebsiella species, and E coli
Treatment of serious lower respiratory tract infections caused by P aeruginosa, Klebsiella species, Enterobacter species, Serratia species, E coli, and S aureus (penicillinase and non-penicillinase-producing strains)
Treatment of serious skin, bone, and skin structure infections caused by P aeruginosa, Proteus species, E coli, Klebsiella species, Enterobacter species, S aureus
Treatment of complicated and recurrent urinary tract infections caused by P aeruginosa, Proteus species (indole-positive/-negative), E coli, Klebsiella species, Enterobacter species, Serratia species, S aureus, Providencia species, and Citrobacter species

Serum concentrations should guide ongoing treatment.
Higher doses may be used in patients with cystic fibrosis.

The susceptibility of strains varies.
Some children (e.g., those with cystic fibrosis, major burns, febrile neutropenia) may require more frequent dosing (e.g., every 6 hours) or higher doses.

Use: Treatment of catheter-related infections caused by P aeruginosa

Usual Pediatric Dose for Pneumonia

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.
This drug is not routinely indicated in the initial treatment of uncomplicated urinary tract infections UNLESS the organism is resistant to other less toxic antibacterial agents.
Empiric treatment may begin prior to obtaining susceptibility results.

Uses:

Serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use
Treatment of septicemia caused by P aeruginosa, Klebsiella species, and E coli
Treatment of serious lower respiratory tract infections caused by P aeruginosa, Klebsiella species, Enterobacter species, Serratia species, E coli, and S aureus (penicillinase and non-penicillinase-producing strains)
Treatment of serious skin, bone, and skin structure infections caused by P aeruginosa, Proteus species, E coli, Klebsiella species, Enterobacter species, S aureus
Treatment of complicated and recurrent urinary tract infections caused by P aeruginosa, Proteus species (indole-positive/-negative), E coli, Klebsiella species, Enterobacter species, Serratia species, S aureus, Providencia species, and Citrobacter species

Serum concentrations should guide ongoing treatment.
Higher doses may be used in patients with cystic fibrosis.

The susceptibility of strains varies.
Some children (e.g., those with cystic fibrosis, major burns, febrile neutropenia) may require more frequent dosing (e.g., every 6 hours) or higher doses.

Use: Treatment of catheter-related infections caused by P aeruginosa

Usual Pediatric Dose for Pyelonephritis

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.
This drug is not routinely indicated in the initial treatment of uncomplicated urinary tract infections UNLESS the organism is resistant to other less toxic antibacterial agents.
Empiric treatment may begin prior to obtaining susceptibility results.

Uses:

Serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use
Treatment of septicemia caused by P aeruginosa, Klebsiella species, and E coli
Treatment of serious lower respiratory tract infections caused by P aeruginosa, Klebsiella species, Enterobacter species, Serratia species, E coli, and S aureus (penicillinase and non-penicillinase-producing strains)
Treatment of serious skin, bone, and skin structure infections caused by P aeruginosa, Proteus species, E coli, Klebsiella species, Enterobacter species, S aureus
Treatment of complicated and recurrent urinary tract infections caused by P aeruginosa, Proteus species (indole-positive/-negative), E coli, Klebsiella species, Enterobacter species, Serratia species, S aureus, Providencia species, and Citrobacter species

Serum concentrations should guide ongoing treatment.
Higher doses may be used in patients with cystic fibrosis.

The susceptibility of strains varies.
Some children (e.g., those with cystic fibrosis, major burns, febrile neutropenia) may require more frequent dosing (e.g., every 6 hours) or higher doses.

Use: Treatment of catheter-related infections caused by P aeruginosa

Usual Pediatric Dose for Skin or Soft Tissue Infection

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.
This drug is not routinely indicated in the initial treatment of uncomplicated urinary tract infections UNLESS the organism is resistant to other less toxic antibacterial agents.
Empiric treatment may begin prior to obtaining susceptibility results.

Uses:

Serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use
Treatment of septicemia caused by P aeruginosa, Klebsiella species, and E coli
Treatment of serious lower respiratory tract infections caused by P aeruginosa, Klebsiella species, Enterobacter species, Serratia species, E coli, and S aureus (penicillinase and non-penicillinase-producing strains)
Treatment of serious skin, bone, and skin structure infections caused by P aeruginosa, Proteus species, E coli, Klebsiella species, Enterobacter species, S aureus
Treatment of complicated and recurrent urinary tract infections caused by P aeruginosa, Proteus species (indole-positive/-negative), E coli, Klebsiella species, Enterobacter species, Serratia species, S aureus, Providencia species, and Citrobacter species

Serum concentrations should guide ongoing treatment.
Higher doses may be used in patients with cystic fibrosis.

The susceptibility of strains varies.
Some children (e.g., those with cystic fibrosis, major burns, febrile neutropenia) may require more frequent dosing (e.g., every 6 hours) or higher doses.

Use: Treatment of catheter-related infections caused by P aeruginosa

Usual Pediatric Dose for Bacterial Infection

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.
This drug is not routinely indicated in the initial treatment of uncomplicated urinary tract infections UNLESS the organism is resistant to other less toxic antibacterial agents.
Empiric treatment may begin prior to obtaining susceptibility results.

Uses:

Serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use
Treatment of septicemia caused by P aeruginosa, Klebsiella species, and E coli
Treatment of serious lower respiratory tract infections caused by P aeruginosa, Klebsiella species, Enterobacter species, Serratia species, E coli, and S aureus (penicillinase and non-penicillinase-producing strains)
Treatment of serious skin, bone, and skin structure infections caused by P aeruginosa, Proteus species, E coli, Klebsiella species, Enterobacter species, S aureus
Treatment of complicated and recurrent urinary tract infections caused by P aeruginosa, Proteus species (indole-positive/-negative), E coli, Klebsiella species, Enterobacter species, Serratia species, S aureus, Providencia species, and Citrobacter species

Serum concentrations should guide ongoing treatment.
Higher doses may be used in patients with cystic fibrosis.

The susceptibility of strains varies.
Some children (e.g., those with cystic fibrosis, major burns, febrile neutropenia) may require more frequent dosing (e.g., every 6 hours) or higher doses.

Use: Treatment of catheter-related infections caused by P aeruginosa

Usual Pediatric Dose for Urinary Tract Infection

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.
This drug is not routinely indicated in the initial treatment of uncomplicated urinary tract infections UNLESS the organism is resistant to other less toxic antibacterial agents.
Empiric treatment may begin prior to obtaining susceptibility results.

Uses:

Serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use
Treatment of septicemia caused by P aeruginosa, Klebsiella species, and E coli
Treatment of serious lower respiratory tract infections caused by P aeruginosa, Klebsiella species, Enterobacter species, Serratia species, E coli, and S aureus (penicillinase and non-penicillinase-producing strains)
Treatment of serious skin, bone, and skin structure infections caused by P aeruginosa, Proteus species, E coli, Klebsiella species, Enterobacter species, S aureus
Treatment of complicated and recurrent urinary tract infections caused by P aeruginosa, Proteus species (indole-positive/-negative), E coli, Klebsiella species, Enterobacter species, Serratia species, S aureus, Providencia species, and Citrobacter species

Serum concentrations should guide ongoing treatment.
Higher doses may be used in patients with cystic fibrosis.

The susceptibility of strains varies.
Some children (e.g., those with cystic fibrosis, major burns, febrile neutropenia) may require more frequent dosing (e.g., every 6 hours) or higher doses.

Use: Treatment of catheter-related infections caused by P aeruginosa

Usual Pediatric Dose for Sepsis

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.
This drug is not routinely indicated in the initial treatment of uncomplicated urinary tract infections UNLESS the organism is resistant to other less toxic antibacterial agents.
Empiric treatment may begin prior to obtaining susceptibility results.

Uses:

Serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use
Treatment of septicemia caused by P aeruginosa, Klebsiella species, and E coli
Treatment of serious lower respiratory tract infections caused by P aeruginosa, Klebsiella species, Enterobacter species, Serratia species, E coli, and S aureus (penicillinase and non-penicillinase-producing strains)
Treatment of serious skin, bone, and skin structure infections caused by P aeruginosa, Proteus species, E coli, Klebsiella species, Enterobacter species, S aureus
Treatment of complicated and recurrent urinary tract infections caused by P aeruginosa, Proteus species (indole-positive/-negative), E coli, Klebsiella species, Enterobacter species, Serratia species, S aureus, Providencia species, and Citrobacter species

Serum concentrations should guide ongoing treatment.
Higher doses may be used in patients with cystic fibrosis.

The susceptibility of strains varies.
Some children (e.g., those with cystic fibrosis, major burns, febrile neutropenia) may require more frequent dosing (e.g., every 6 hours) or higher doses.

Use: Treatment of catheter-related infections caused by P aeruginosa

Usual Pediatric Dose for Burns - External

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.
This drug is not routinely indicated in the initial treatment of uncomplicated urinary tract infections UNLESS the organism is resistant to other less toxic antibacterial agents.
Empiric treatment may begin prior to obtaining susceptibility results.

Uses:

Serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use
Treatment of septicemia caused by P aeruginosa, Klebsiella species, and E coli
Treatment of serious lower respiratory tract infections caused by P aeruginosa, Klebsiella species, Enterobacter species, Serratia species, E coli, and S aureus (penicillinase and non-penicillinase-producing strains)
Treatment of serious skin, bone, and skin structure infections caused by P aeruginosa, Proteus species, E coli, Klebsiella species, Enterobacter species, S aureus
Treatment of complicated and recurrent urinary tract infections caused by P aeruginosa, Proteus species (indole-positive/-negative), E coli, Klebsiella species, Enterobacter species, Serratia species, S aureus, Providencia species, and Citrobacter species

Serum concentrations should guide ongoing treatment.
Higher doses may be used in patients with cystic fibrosis.

The susceptibility of strains varies.
Some children (e.g., those with cystic fibrosis, major burns, febrile neutropenia) may require more frequent dosing (e.g., every 6 hours) or higher doses.

Use: Treatment of catheter-related infections caused by P aeruginosa

Usual Pediatric Dose for Pneumonia with Cystic Fibrosis

INHALATION:
6 years and older:
Inhalation capsules: 112 mg (4 capsules) inhaled via Podhaler (R) 2 times a day
Inhalation solution: 300 mg inhaled via nebulizer 2 times a day
Duration of therapy: 28 days

PARENTERAL:
Premature and full-term neonates 1 week of age or less: Up to 4 mg/kg IM or IV infusion (over 20 to 60 minutes) every 12 hours
Pediatric patients greater than 1 week of age: 2 to 2.5 mg/kg IM or IV infusion (over 20 to 60 minutes) every 8 hours OR 1.5 to 1.89 mg/kg IM or IV infusion (over 20 to 60 minutes) every 6 hours
Duration of therapy: 7 to 10 days

Comments:

Safety and efficacy of the inhalation solution have not been demonstrated in patients with a predicted FEV1 of 25% or less OR greater than 75% at screening, or those colonized with B cepacia.
Doses should be given as close to 12 hours apart as possible; doses should not be given less than 6 hours apart.
Parenteral formulations should be limited to short-term use.
After 28 days of treatment with an inhalation formulation, patients should stop treatment for 28 days before restarting treatment for additional 28-day on/28-day off cycles.
In patients with cystic fibrosis, altered pharmacokinetics may result in reduced serum levels of aminoglycosides; measurement of serum levels is recommended as the basis for dose adjustments.
In patients with severe cystic fibrosis, an initial dosing regimen of 10 mg/kg/day in 4 equally divided doses is suggested by the manufacturer.
The serum levels should be measured directly during therapy due to wide interpatient variability.

Uses:

Management of cystic fibrosis in patients with P aeruginosa infections
Serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use
Treatment of serious lower respiratory tract infections caused by P aeruginosa, Klebsiella species, Enterobacter species, Serratia species, E coli, and S aureus (penicillinase and non-penicillinase-producing strains)

Usual Pediatric Dose for Cystic Fibrosis

Safety and efficacy of the inhalation solution have not been demonstrated in patients with a predicted FEV1 of 25% or less OR greater than 75% at screening, or those colonized with B cepacia.
Doses should be given as close to 12 hours apart as possible; doses should not be given less than 6 hours apart.
Parenteral formulations should be limited to short-term use.
After 28 days of treatment with an inhalation formulation, patients should stop treatment for 28 days before restarting treatment for additional 28-day on/28-day off cycles.
In patients with cystic fibrosis, altered pharmacokinetics may result in reduced serum levels of aminoglycosides; measurement of serum levels is recommended as the basis for dose adjustments.
In patients with severe cystic fibrosis, an initial dosing regimen of 10 mg/kg/day in 4 equally divided doses is suggested by the manufacturer.
The serum levels should be measured directly during therapy due to wide interpatient variability.

Uses:

Management of cystic fibrosis in patients with P aeruginosa infections
Serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgement indicate its use
Treatment of serious lower respiratory tract infections caused by P aeruginosa, Klebsiella species, Enterobacter species, Serratia species, E coli, and S aureus (penicillinase and non-penicillinase-producing strains)

Usual Pediatric Dose for Meningitis

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.

Use: Treatment of serious central nervous system (CNS) infections (e.g., meningitis) caused by susceptible organisms

IDSA, AAN, AANS, and NCS Recommendations:
Bacterial Meningitis:
IV:
Neonates 0 to 7 days: 5 mg/kg IV per day, given in divided doses every 12 hours
Neonates 8 to 28 days, infants, and children: 7.5 mg/kg IV per day, given in divided doses every 8 hours

Intraventricular: 5 to 20 mg intraventricularly once a day

Healthcare-Associated Ventriculitis and Meningitis:
Infants and children:
IV: 7.5 mg/kg IV per day, given in divided doses every 8 hours
Intraventricular: 5 to 20 mg intraventricularly once a day

Duration of therapy:

N meningitis or H influenzae: 7 days
Coagulase-negative Staphylococcus or P acnes with no/minimal CSF pleocytosis, normal CSF glucose, few symptoms/systemic features: 10 days
Coagulase-negative staphylococcus or P acnes with significant CSF pleocytosis, S aureus or gram-negative bacilli with/without significant CSF pleocytosis, CSF hypoglycorrhachia, or symptoms/systemic features: 10 to 14 days
S pneumoniae: 10 to 14 days
S agalactiae: 14 to 21 days
Aerobic gram-negative bacilli: 21 days
L monocytogenes: At least 21 days
Repeatedly positive CSF cultures on appropriate antimicrobial treatment: Continue treatment for 10 to 14 days after the last positive culture

Comments:

The intraventricular drain should be clamped for approximately 15 to 60 minutes to allow the drug to equilibrate.
Neonate duration of therapy is 2 weeks beyond the first sterile CSF culture OR at least 3 weeks, whichever is longer.

Use: Treatment of healthcare-associated ventriculitis and meningitis

Usual Pediatric Dose for Shunt Infection

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.

N meningitis or H influenzae: 7 days
Coagulase-negative Staphylococcus or P acnes with no/minimal CSF pleocytosis, normal CSF glucose, few symptoms/systemic features: 10 days
Coagulase-negative staphylococcus or P acnes with significant CSF pleocytosis, S aureus or gram-negative bacilli with/without significant CSF pleocytosis, CSF hypoglycorrhachia, or symptoms/systemic features: 10 to 14 days
S pneumoniae: 10 to 14 days
S agalactiae: 14 to 21 days
Aerobic gram-negative bacilli: 21 days
L monocytogenes: At least 21 days
Repeatedly positive CSF cultures on appropriate antimicrobial treatment: Continue treatment for 10 to 14 days after the last positive culture

Comments:

The intraventricular drain should be clamped for approximately 15 to 60 minutes to allow the drug to equilibrate.
Neonate duration of therapy is 2 weeks beyond the first sterile CSF culture OR at least 3 weeks, whichever is longer.

Use: Treatment of healthcare-associated ventriculitis and meningitis

Usual Pediatric Dose for Intraabdominal Infection

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.

Use: Treatment of serious intraabdominal infections caused by E coli, Klebsiella species, and Enterobacter species

SIS and IDSA Recommendations:
Initial dose: 3 to 7.5 mg/kg IV, given in divided doses every 8 to 24 hours

Duration of therapy: Up to 4 to 7 days

Comments:

This drug may be used in combination with metronidazole or clindamycin with/without ampicillin in community-acquired infections.
This drug should be used in combination with a carbapenem and piperacillin-tazobactam in healthcare-associated infections.
Maintenance doses should be based on adjusted body weight and serum drug concentrations.

Uses:

Empiric combination treatment of extra-biliary complicated intraabdominal community-acquired infection
Empiric combination treatment of complicated healthcare-associated intraabdominal infections caused by ESBL-producing Enterobacteriaceae or P aeruginosa greater than 20% resistant to ceftazidime
Alternative treatment in patients with severe reactions to beta-lactam antibiotics
Adjunctive treatment of necrotizing enterocolitis in neonates

Usual Pediatric Dose for Peritonitis

Maintenance doses should be used as soon as clinically indicated.
Doses exceeding 5 mg/kg/day should be avoided unless serum levels are closely monitored for toxicity.

Use: Treatment of peritonitis caused by E coli, Klebsiella species, and Enterobacter species

ISPD Recommendations:
Continuous peritoneal dialysis:

Loading dose: 8 mg/L
Maintenance dose: 4 mg/L

Intermittent peritoneal dialysis:

Anuric patients: 0.6 mg/kg intraperitoneally once a day
Non-anuric patients: 0.75 mg/kg intraperitoneally once a day

Comments:

Continuous: Loading doses should be allowed to dwell for at least 3 to 6 hours.
Intermittent: Doses should be administered via the long-dwell (unless otherwise specified) and be allowed to dwell for at least 6 hours.
Prolonged courses of treatment should be avoided.

Use: Treatment of peritonitis

Usual Pediatric Dose for Endocarditis

AHA and IDSA Recommendations:
Children:
Gram-negative enteric bacilli endocarditis: 3 to 6 mg/kg IV per day, given in divided doses every 8 hours (or gentamicin or amikacin) PLUS ceftazidime, cefepime, cefotaxime, ceftriaxone, OR piperacillin/tazobactam

Duration of therapy: At least 6 weeks

HACEK group endocarditis: 3 to 6 mg/kg IV per day, given in divided doses every 8 hours (or gentamycin or amikacin) PLUS ampicillin

Duration of therapy: At least 6 weeks

Uses:

Recommended antibiotic treatment (with ceftazidime, cefepime, cefotaxime, or ceftriaxone) for the treatment of IE caused by gram-negative enteric bacilli
Alternative antibiotic treatment (with piperacillin/tazobactam) for the treatment of IE caused by gram-negative enteric bacilli
Alternative antibiotic treatment (with ampicillin) for the treatment of IE caused by HACEK group organisms

Renal Dose Adjustments

INHALATION:
Inhalation capsules:

Patients with known/suspected renal dysfunction: Use with caution.
Nephrotoxicity occurring during treatment: Discontinue treatment until serum concentrations fall below 2 mcg/mL.

Inhalation solution:

Nephrotoxicity occurring during treatment: Patients should be managed as medically appropriate; discontinuation of treatment should be considered.

PARENTERAL:

Prolonged intervals (serum creatinine known): Administer the recommended single dose (e.g., 1 mg/kg IM or IV) at the dosage interval (in hours) determined by multiplying the serum creatinine by 6.
Reduced dose (patients with known serum creatinine levels or those with CrCl less than 70 mL/min):
Administer a loading dose of 1 mg/kg IM or IV).
Maintenance dose given IM or IV every 8 hours: (recommended dose [in mg] divided by the serum creatinine level).

Liver Dose Adjustments

INHALATION: No adjustment recommended.
PARENTERAL: Data not available

Dose Adjustments

Therapeutic drug monitoring/range:

Trough levels: Less than 2 mcg/mL
Therapeutic levels: 4 to 6 mcg/mL
Peak levels: 12 mcg/mL

AAP Recommendations:

Trough levels: Less than 2 mg/L
Peak levels: 6 to 12 mg/L

INHALATION:
Inhalation capsules:
Use in patients after organ transplantation: Data not available

Hearing loss and/or ototoxicity:

Hearing loss or tinnitus occurring during treatment: Patients should undergo audiological assessment.
Ototoxicity occurring during treatment: Discontinue treatment until serum concentrations fall below 2 mcg/mL.

Inhalation solution:
Ototoxicity occurring during treatment: Patients should be managed as medically appropriate; discontinuation of treatment should be considered.

PARENTERAL:
Obese patients: Use lean body weight and add 40% of the excess as the weight to calculate the dose (in mg/kg).

Allergic reactions occurring during treatment: Discontinue treatment and appropriate therapy should be instituted.

Precautions

US BOXED WARNINGS:
TOXICITY:

Patients treated with parenteral formulations and other aminoglycosides should be under close clinical observation, because these drugs have an inherent potential for causing ototoxicity and nephrotoxicity.

NEPHROTOXICITY:

Rarely, nephrotoxicity may not become apparent until the first few days after cessation of therapy.
Other factors that may increase patient risk are advanced age and dehydration.
Aminoglycoside-induced nephrotoxicity usually is reversible.

NEUROTOXICITY:

Neurotoxicity, manifested by both auditory and vestibular ototoxicity, can occur. The auditory changes are irreversible, and are usually bilateral, and may be partial or total.
Eighth-nerve impairment and nephrotoxicity may develop, primarily in patients having pre-existing renal damage and in those with normal renal function to whom aminoglycosides are administered for longer periods or in higher doses than those recommended.
Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching, and convulsions.
The risk of aminoglycoside-induced hearing loss increases with the degree of exposure to either high peak or high trough serum concentrations.
Patients who develop cochlear damage may not have symptoms during therapy to warn them of eighth-nerve toxicity, and partial or total irreversible bilateral deafness may continue to develop after the drug has been discontinued.

MONITORING:

Renal and eighth-nerve function should be closely monitored in patients with known/suspected renal impairment and also in those whose renal function is initially normal but who develop signs of renal dysfunction during therapy.
Peak and trough serum concentrations of aminoglycosides should be monitored periodically during therapy to assure adequate levels and to avoid potentially toxic levels.
Prolonged serum concentrations above 12 mcg/mL should be avoided.
Rising trough levels (above 2 mcg/mL) may indicate tissue accumulation. Such accumulation, excessive peak concentrations, advanced age, and cumulative dose may contribute to ototoxicity and nephrotoxicity.
Urine should be examined for decreased specific gravity and increased excretion of protein, cells, and casts.
Blood urea nitrogen, serum creatinine, and creatinine clearance should be measures periodically.
When feasible, it is recommended that serial audiograms be obtained in patients old enough to be tested, particularly high-risk patients.
Evidence of impairment of renal, vestibular, or auditory function requires discontinuation of the drug or dosage adjustment.
This drug should be used with caution in premature and neonatal infants because of their renal immaturity and the resulting prolongation of serum half-life of the drug.

CONCOMITANT USE:

Concurrent and sequential use of other neurotoxic and/or nephrotoxic antibiotics, particularly other aminoglycosides (e.g., amikacin, gentamicin, kanamycin, neomycin, paromomycin, and streptomycin), cephaloridine, cisplatin, colistin, polymyxin, vancomycin, and viomycin, should be avoided.
Aminoglycosides should not be given concurrently with potent diuretics, such as ethacrynic acid and furosemide.
Some diuretics themselves cause ototoxicity, and IV administered diuretics enhance aminoglycoside concentrations in serum and tissue.

PREGNANCY:

Aminoglycosides can cause fetal harm when administered to pregnant women.

NARROW THERAPEUTIC INDEX:

This drug should be considered a narrow therapeutic index (NTI) drug as small differences in dose or blood concentrations may lead to serious therapeutic failures or adverse drug reactions.

Recommendations:

Generic substitution should be done cautiously, if at all, as current bioequivalence standards are generally insufficient for NTI drugs.
Additional and/or more frequent monitoring should be done to ensure receipt of an effective dose while avoiding unnecessary toxicities.

CONTRAINDICATIONS:

Hypersensitivity to the active component, other aminoglycosides, or any of the ingredients
Patients with a history of serious toxic reactions to aminoglycosides (parenteral formulations)

Safety and efficacy of inhalation formulations have not been established in patients younger than 6 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

Patients receiving multiple medications and/or chest physiotherapy concurrently should take this drug last.
Inhalation capsules: The manufacturer product information should be consulted.
Inhalation/nebulizer solution: Administer using a hand-held nebulizer and compressor over approximately 15 minutes while sitting or standing upright and breathing normally through the mouthpiece of the nebulizer. Patients should continue treatment until there is no longer any mist being produced.

Storage requirements:

Inhalation capsules: Protect from moisture by removing from original packaging immediately before use. Discard each Podhaler (R) device after 7 days of use.
Inhalation/nebulizer solution: Protect from light and refrigerate at 2 to 8 C; opened and unopened pouches may be stored at up to 25C for up to 28 days.

Reconstitution/preparation techniques:

Inhalation/nebulizer solution: The solution should not be diluted or mixed with dornase alfa or other agents in the nebulizer.

IV compatibility:

This drug should not be administered with other drugs.

General:

Limitation of inhalation/nebulizer solution use: Subcutaneous, IV and/or intrathecal administration should be avoided.

Limitation of inhalation formulations: Safety and efficacy have not been established in patients colonized with Burkholderia cepacia.

Serum concentrations should be measured via venipuncture, as finger prick blood sampling may produce falsely high serum concentrations due to contamination of the fingers by this drug.

Monitoring:

General: Peak and trough levels
Genitourinary: Urine function tests (e.g., cells, casts, protein excretion) at the discretion of the treating healthcare provider
Metabolic: Serum calcium, magnesium, sodium, and urea levels
Nervous system: Vestibular function monitoring, especially during longer courses of treatment
Other: Auditory function monitoring, especially during longer courses of treatment
Renal: Regular serum creatinine levels (at least weekly), creatinine clearance, and/or blood urea nitrogen levels but may be more frequent in patients who are unstable and/or with renal dysfunction

Patient advice:

Inform patients that this drug may cause dizziness and/or vertigo, and they should avoid driving or operating machinery if these side effects occur.
Patients should be told to report any unusual or severe side effects, including signs/symptoms of Clostridium difficile-associated diarrhea, ototoxicity, and nephrotoxicity.
Patients should be directed to take the full course of treatment, even if they feel better.
Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.
Patients should be instructed to avoid swallowing inhalation capsules.

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