Clinical medicine profile
Roxithromycin
Macrolide antibiotic
- Route
- ORAL / IV (agent-dependent)
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
Safety essentials
The information most likely to change a prescribing or dispensing decision.
Contraindications
- Hypersensitivity to macrolides.
- Clarithromycin/erythromycin: concomitant strong CYP3A4 substrates with narrow therapeutic index where interaction is labelled contraindicated (e.g. certain ergot alkaloids, some statins — check SmPC).
- History of cholestatic jaundice/hepatic dysfunction with prior macrolide.
Precautions
- QT prolongation risk — caution with other QT drugs, electrolyte disturbance, cardiac disease.
- Hepatic impairment.
- Superinfection.
- Myasthenia gravis may worsen.
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
Adults: 150mg BD or 300mg OD. Chil- dren: 2-5years; 5mg/kg BD. Taken on an empty stomach.
See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.
Usually less critical than beta-lactams; still review SmPC for severe impairment.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatotoxicity recognised (especially erythromycin estolate historically); monitor if prolonged therapy or prior liver disease.
Use, effects & interactions
Indications
- E.N.T infections [mild to moderate], skin and soft tissues infections, gut infections.
- Clinical selection for Roxithromycin should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC.
- Class context: Macrolide antibiotic.
- Confirm site-specific dose, duration and monitoring before prescribing.
Adverse effects
- GI cramps, nausea, diarrhoea (erythromycin more prokinetic).
- Taste disturbance (clarithromycin).
- Serious: QT prolongation, hepatotoxicity, C. difficile, severe skin reactions (rare).
Drug interactions
Open multi-drug checker ↗- First-line for many atypical pneumonias and selected STIs.
- Review drug–drug interactions before clarithromycin.
- Resistance rising in streptococci/pneumococci in many regions — know local data.
Mechanism & disposition
Binds to 50s sub-unit of the bacterial ribosome and inhibits bacterial protein synthesis by preventing attachment of aminoacyl transfer RNA to its acceptor site on the ribosome.
Read complete mechanism
Binds to 50s sub-unit of the bacterial ribosome and inhibits bacterial protein synthesis by preventing attachment of aminoacyl transfer RNA to its acceptor site on the ribosome. This prevents peptide bond formation by peptidyl transferase.
2–3 hours
12–24 h+ (azithromycin long tissue half-life)
ORAL / IV (agent-dependent)
and long terminal
(CYP3A4) with important interaction potential. Biliary
important for some agents.
Pregnancy, lactation & diet
Often used when indicated (e.g. azithromycin in some STIs/pregnancy protocols); confirm local guidance.
Usually compatible with monitoring; check agent-specific advice.
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.