INN monograph
Cefotaxime / Sulbactum
Beta-lactam antibiotic — cephalosporin · POM
Source-linked · Updated 03 Aug 2026 · Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Professional class pharmacology (Beta-lactam antibiotic — cephalosporin)
Kenya market
Wholesale / list prices where loaded
Risk first
Contraindications
- Serious hypersensitivity to cephalosporins.
- Use extreme caution or avoid if prior anaphylaxis to penicillins (cross-reactivity lower than historically feared but not zero, especially similar side chains).
Precautions
- Allergy history.
- Superinfection / C. difficile risk.
- Adjust renally cleared agents for CrCl.
- Ceftriaxone: avoid concurrent IV calcium in neonates
- biliary sludge with prolonged use.
Point of care
Dosing
Adult
Dosing is indication-, age-, weight- and organ-function-specific for this INN. Do not use class averages for high-risk patients. Confirm the exact regimen in the current SmPC and Kenya Standard Treatment Guidelines. Typical professional workflow: (1) confirm indication, (2) check renal/hepatic function, (3) screen interactions/allergies, (4) select dose/route/duration, (5) define monitoring.
Paediatric
Paediatric dosing is weight- and age-based; use a paediatric formulary / SmPC. Do not extrapolate adult tablets without calculation.
Renal
Most require dose adjustment in renal impairment (exceptions/nuances per agent — check SmPC).
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatic
Usually low; transient LFT elevations possible.
Safety
Drug interactions
- Choose generation by indication and resistance patterns.
- Prefer narrowest effective spectrum.
- IV-to-oral switch when clinically stable.
- Align duration with guidelines (often shorter than historical practice for many infections).
Safety
Adverse effects
- GI disturbances, allergic reactions, blood dyscrasia, severe headaches, glossitis, pain at I.M injection site, pseudomembranous entero-colitis, oedema, genital tract mycosis, oliguria.
Use
Indications
- Septicaemia, meningitis in neonates and infants, peri-operative infections prophylaxis, UTI, RTI, bone, joints, skin and soft tissue infections.
- Clinical selection for Cefotaxime / Sulbactum should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC.
- Class context: Beta-lactam antibiotic — cephalosporin.
- Confirm site-specific dose, duration and monitoring before prescribing.
Pharmacology
Mode of action
Cefotaxime interferes with the synthesis of peptidoglycans, which are part of bacterial cell wall [bactericidal].
Full mechanism text
Cefotaxime interferes with the synthesis of peptidoglycans, which are part of bacterial cell wall [bactericidal]. Sulbactam is a beta-lactamase inhibitor. Cephalosporins inhibit bacterial cell-wall synthesis by binding PBPs and blocking peptidoglycan cross-linking, producing bactericidal activity against susceptible organisms. Spectrum broadens from 1st to later generations; stability to beta-lactamases varies.
ADME
Pharmacokinetics & PD
| Onset | Rapid (IV); 1–2 h oral |
|---|---|
| Duration | 6–24 hours (agent-dependent; ceftriaxone long) |
| Route | INTRAMUSCULAR, INTRAVENOUS |
| Distribution | into tissues good; CSF penetration generation- and inflammation-dependent (e.g. ceftriaxone/cefotaxime used in meningitis). Many cleared renally; ceftriaxone has dual renal/biliary |
| Elimination | — caution in neonates with hyperbilirubinaemia. |
Full PK/PD text
Oral agents have variable bioavailability; parenteral agents achieve high peak levels. Distribution into tissues good; CSF penetration generation- and inflammation-dependent (e.g. ceftriaxone/cefotaxime used in meningitis). Many cleared renally; ceftriaxone has dual renal/biliary elimination — caution in neonates with hyperbilirubinaemia.
Kenya
Brands & prices
| Brand | Company | Pack | KES |
|---|---|---|---|
| No brands linked yet. | |||
Special populations
Pregnancy & lactation
Pregnancy
Generally considered acceptable in pregnancy when indicated; prefer agents with established safety data.
Lactation
Usually compatible; monitor infant for GI effects.
Diet
Food & alcohol
- Food
- Food
Trust
Sources & disclaimer
Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Professional class pharmacology (Beta-lactam antibiotic — cephalosporin)
Clinical review date not recorded.
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.