Sulbactam Dosing in Pediatric Patients
For pediatric patients 1 year of age or older, the FDA-approved dose of ampicillin-sulbactam is 300 mg/kg/day (representing 200 mg/kg/day ampicillin plus 100 mg/kg/day sulbactam) administered intravenously in equally divided doses every 6 hours, with a maximum sulbactam dose not exceeding 4 grams per day. 1
Standard Dosing Regimen
The recommended dose is 300 mg/kg/day of the ampicillin-sulbactam combination (2:1 ratio), which translates to 200 mg/kg/day ampicillin and 100 mg/kg/day sulbactam, divided into doses given every 6 hours via IV infusion 1
Pediatric patients weighing 40 kg or more should receive adult dosing recommendations, with total sulbactam not exceeding 4 grams daily 1
The course of IV therapy should not routinely exceed 14 days, and most children transition to oral antimicrobials following initial IV treatment 1
Administration Guidelines
Each dose should be administered as a slow IV infusion over 15-30 minutes when diluted in 50-100 mL of compatible diluent 1
The safety and efficacy of intramuscular administration in pediatric patients have not been established 1
Specific Clinical Applications
Endocarditis
- For pediatric endocarditis, the American Heart Association recommends 300 mg/kg/day IV divided into 4-6 equally divided doses for 4-6 weeks 2
Intra-abdominal Infections
- For complicated intra-abdominal infections, 200 mg/kg/day of ampicillin-sulbactam given every 6 hours is recommended 2
Omphalitis in Neonates
- The American Academy of Pediatrics recommends ampicillin-sulbactam 200 mg/kg/day IV divided every 6 hours for neonatal omphalitis 3
Pharmacokinetic Considerations
Pharmacokinetic studies demonstrate that ampicillin and sulbactam achieve mean peak concentrations of 177-200 mcg/mL and 82-102 mcg/mL respectively in pediatric patients aged 1-12 years 4
The mean half-life is approximately 0.77 hours for ampicillin and 0.81 hours for sulbactam, comparable to adult values 4
Age does not significantly affect the pharmacokinetics of either drug in children 1-12 years old 4
Dosing for Severe or Resistant Infections
For empiric therapy of community-acquired pneumonia where MIC90 values are high (≥2 mcg/mL), the maximum FDA-approved dosage of 75 mg/kg four times daily may provide better coverage than lower doses 5
This higher dosing achieves the pharmacodynamic target of 50% fT>MIC against common respiratory pathogens including Streptococcus pneumoniae and Haemophilus influenzae 5
Renal Impairment Adjustments
- In pediatric patients with renal impairment, dosing frequency should be reduced based on creatinine clearance, similar to adult recommendations 1:
- CrCl ≥30 mL/min: Every 6-8 hours
- CrCl 15-29 mL/min: Every 12 hours
- CrCl 5-14 mL/min: Every 24 hours
Common Pitfalls to Avoid
Do not use intramuscular administration in pediatric patients, as safety and efficacy have not been established 1
Avoid underdosing in severe infections—the standard 300 mg/kg/day may be insufficient for pneumonia caused by organisms with higher MICs, where 75 mg/kg four times daily is preferred 5
Do not exceed 4 grams per day of the sulbactam component, even in patients weighing >40 kg 1
Ensure proper dilution and infusion time (15-30 minutes) to minimize adverse reactions 1
Safety Profile
Ampicillin-sulbactam is well tolerated in pediatric patients, with cure rates of 98.7% reported in clinical studies 6
Adverse reactions are uncommon, with rash being the most frequently reported side effect, rarely requiring discontinuation 6
The combination demonstrates lower nephrotoxicity compared to polymyxin-based therapies when treating resistant organisms 7