Clinical medicine profile
Cefoperazone / Sulbactam
Therapeutic agent (verify pharmacological class)
- Route
- See product SmPC
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
This profile needs source confirmation
Some sections contain general class guidance rather than medicine-specific evidence. Confirm prescribing decisions against the current SmPC and Kenya STG/EML.
Safety essentials
The information most likely to change a prescribing or dispensing decision.
Contraindications
- [From component Sulbactam] CONTRAINDICATIONS The use of ampicillin and sulbactam for injection is contraindicated in individuals with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to ampicillin, sulbactam or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins).
- Ampicillin and sulbactam for injection is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with ampicillin and sulbactam for injection.
Precautions
- Potential for colonisation and superinfection with resistant organisms.
- Changes in bowel flora may be more marked than with cefotaxime because of the greater biliary excretion of cefoperazone
- diarrhoea may occur more often.
- Cefoperazone contains an N-methylthiotetrazole side-chain, a structure associated with hypoprothrombinaemia.
- Hypoprothrombinaemia has been reported in patients treated with cefoperazone and has rarely been associated with bleeding episodes.
- Prothrombin time should be monitored in patients at risk of hypoprothrombinaemia and vitamin K used if necessary.
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
Usual dose is 2 to 4g daily in 2 divided doses. In severe infections, up to 12g daily in 2 to 4 divided doses may be given
See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.
Review renal impairment dosing; many agents need CrCl/eGFR adjustment.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Review hepatic impairment dosing; monitor LFTs if agent is hepatically cleared or hepatotoxic.
Use, effects & interactions
Indications
- Susceptible infections, especially those due to pseudomonas species.
- Clinical selection for Cefoperazone / Sulbactam should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC.
- Class context: Therapeutic agent (verify pharmacological class).
- Confirm site-specific dose, duration and monitoring before prescribing.
Adverse effects
- Diarrhoea and rarely antibiotic-associated colitis, nausea and vomiting, abdominal discomfort, headache
- allergic reactions including rashes, pruritus, urticaria, serum sickness-like reactions with rashes, fever and arthralgia, and anaphylaxis
- Stevens-Johnson syndrome, toxic epidermal necrolysis reported
- disturbances in liver enzymes, transient hepatitis and cholestatic jaundice
- other side-effects reported include eosinophilia and blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
- reversible interstitial nephritis, hyperactivity, nervousness, sleep disturbances, hallucinations, confusion, hypertonia, and dizziness.
Drug interactions
Open multi-drug checker ↗- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Cefoperazone / Sulbactam, Sulbactam.
- Confirm combination SmPC for exact dosing.
Mechanism & disposition
Cefoperazone interferes with the synthesis of peptidoglycans, which are part of bacterial cell wall [bactericidal].
Read complete mechanism
Cefoperazone interferes with the synthesis of peptidoglycans, which are part of bacterial cell wall [bactericidal]. Sulbactam is a beta-lactamase inhibitor. Mechanism is agent-specific. At receptor, enzyme, ion channel, transporter or microbial target level, the drug alters a physiological or pathological pathway to produce its therapeutic effect. Confirm precise molecular mechanism in current SmPC / pharmacology reference for this INN before high-stakes decisions.
Product-specific
Product-specific
See product SmPC
are product-specific. Consider food effects, protein binding, hepatic CYP/UGT
when adjusting for organ impairment, age and drug interactions. Verify parameters in the current SmPC.
Pregnancy, lactation & diet
[From component Sulbactam] Pregnancy: Reproduction studies have been performed in mice, rats, and rabbits at doses up to ten (10) times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to ampicillin and sulbactam for injection. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed (see PRECAUTIONS-Drug/ Laboratory Test Interactions section).
[From component Sulbactam] Nursing Mothers: Low concentrations of ampicillin and sulbactam are excreted in the milk; therefore, caution should be exercised when ampicillin and sulbactam for injection is administered to a nursing woman.
Brands & loaded prices
| Brand | Manufacturer | Pack | Observed price |
|---|---|---|---|
| No reviewed brand listings are linked yet. | |||
Sources & review state
Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.