Ampicillin sulbactam dosage and administration

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Ampicillin/Sulbactam
UNASYN® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Clinical Studies
Dosage and Administration
Compatibility, Reconstitution, and Stability
Directions For Use
How Supplied
Other Size Packages Available
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Dosage and Administration

The pharmacy bulk package is for preparation of solutions for IV infusion only. ampicillin/sulbactam should be administered by slow intravenous injection over at least 10–15 minutes or can also be delivered in greater dilutions with 50–100 mL of a compatible diluent as an intravenous infusion over 15–30 minutes.

Adult

The recommended adult dosage of ampicillin/sulbactam is 1.5 g (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) to 3 g (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) every six hours. This 1.5 to 3 g range represents the total of ampicillin content plus the sulbactam content of ampicillin/sulbactam, and corresponds to a range of 1 g ampicillin/0.5 g sulbactam to 2 g ampicillin/1 g sulbactam. The total dose of sulbactam should not exceed 4 grams per day.

Pediatric Patients 1 Year of Age or Older

The recommended daily dose of ampicillin/sulbactam in pediatric patients is 300 mg per kg of body weight administered via intravenous infusion in equally divided doses every 6 hours. This 300 mg/kg/day dosage represents the total ampicillin content plus the sulbactam content of ampicillin/sulbactam, and corresponds to 200 mg ampicillin/ 100 mg sulbactam per kg per day. The safety and efficacy of ampicillin/sulbactam administered via intramuscular injection in pediatric patients have not been established. Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations, and the total dose of sulbactam should not exceed 4 grams per day. The course of intravenous therapy should not routinely exceed 14 days. In clinical trials, most children received a course of oral antimicrobials following initial treatment with intravenous ampicillin/sulbactam.

Impaired Renal Function

In patients with impairment of renal function the elimination kinetics of ampicillin and sulbactam are similarly affected, hence the ratio of one to the other will remain constant whatever the renal function. The dose of ampicillin/sulbactam in such patients should be administered less frequently in accordance with the usual practice for ampicillin and according to the following recommendations:

Ampicillin/Sulbactam Dosage Guide for Patients With Renal Impairment
Creatinine Clearance (mL/min/1.73m2) Half-Life (Hours) Recommended Dosage
≥30 1 1.5–3.0 g q6h-q8h
15–29 5 1.5–3.0 g q12h
5–14 9 1.5–3.0 g q24h

When only serum creatinine is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

Males: weight (kg) × (140 – age) / 72 × serum creatinine
Females: 0.85 × above value[1]

References

  1. "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050608s040lbl.pdf" (PDF). External link in |title= (help)

Adapted from the FDA Package Insert.