AMPICILLIN 1g / SULBACTAM 0.5g, powder, vial
Valid Article
AMPICILLIN / SULBACTAM
Full Name
Synonym: Unasyn®
- Not in the WHO list of Essential Medicines 2025
Therapeutic Action
Anti-infective for systemic use
Combination of a penicillin-derived antibiotic (ampicillin) with a beta-lactamanase inhibitor (sulbactam).
Active against certain Gram-positive cocci, Gram-negative bacteria, and anaerobes. Sulbactam is particularly active against Acinetobacter baumannii.
Indications
In MSF, ampicillin/sulbactam is indicated in the treatment of infections caused by Acinetobacter baumanii and other Acinetobacter spp:
- severe infections due to Carbapenem-Resistant Acinetobacter Baumanii (CRAB), as a second drug to be associated in polymyxin- or tigecycline-based regimen.
- second-line (for non-CNS infections) and third-line treatment (for CNS infections) of infections caused by Acinetobacter baumanni or spp (non-CRAB).
Instructions for use
Must be given as deep IM, slow IV injection or IV infusion:
- IM route: reconstitute the powder vial with 3.2 ml of water for injection (or with 0.5% lidocaine to reduce pain during injection).
- IV route: reconstitute the powder vial with 3.2 ml of water for injection or 0.9% NaCl.
The reconstituted solution contains 250mg/ml ampicillin and 125 mg/ml sulbactam.
- IV infusion: dilute the reconstituted solution (see IV route above) in water for injection or 0.9% NaCl to a final volume of 50 ml. The resulting dilution contains 20mg/ml ampicillin and 10mg/ml sulbactam.
The diluted solution must be clear and free of visible particles.
Dosage should be determined by susceptibility of the causative organisms, severity and site of infection, and the condition of the patient.
The antibiotic treatment will be started only once culture and antibiotic susceptibility testing (AST) results are available (for empiric use in hospital outbreak settings, discuss with specialist).
Only to be used in health settings where validated microbiology laboratory is available to confirm antimicrobial susceptibility.
Precautions for Use
In children, administer only by IV route.
Contraindicated in patients with previous history of:
- severe immediate hypersensitivity reaction (anaphylaxis) to another beta lactam agent (e.g. cephalosporin, carbapenem)
- cholestatic jaunice/hepatic dysfunction associated with ampicillin sulbactam.
Use with caution in breastfeeding (ampicillin/sulbactam is excreted in breast milk).
Storage
- Below 25°C
- After reconstitution, use the solution immediately.