Clinical beta

FMBM is currently in clinical beta. Content is for professional review/testing and must not replace local protocols, senior clinical judgment, or official prescribing references.

Drug Monograph

Cefepime

Cefepime

Fourth-generation cephalosporin (IV)

PseudomonasGNRGPCICUΞ²-lactam

Indication

HAP/VAP β€’ neutropenic fever (combo) β€’ complicated UTI β€’ bacteremia (susceptible)

At a glance

INDICATIONS (CORE USE)

Broad GNR including many Pseudomonas + better gram-positive than ceftazidime β€” **neurotoxicity in CKD** if maladjusted.

ADULT DOSE (STANDARD)

1–2 g IV q8–12h; febrile neutropenia often 2 g q8h

MAX DOSE

~4 g q8h in selected protocols β€” renal cap critical

Route

IV, IM

PEDIATRIC DOSE

Weight-based per pediatric reference

Do not miss

Must-not-miss safety points

Major warning

- Ξ²-lactam anaphylaxis - **Neurotoxicity (encephalopathy, seizures)** with under-dosed renal failure / accumulation - ESBL: variable institutional policy β€” carbapenem often preferred for definitive ESBL bacteremia - AmpC inducers β€” watch Enterobacter/Citrobacter treatment failures

Indications

USE IF: Broad gram-negative coverage including Pseudomonas with some strep coverage; febrile neutropenia per guideline. AVOID IF: MRSA as sole agent; unadjusted severe CKD; ESBL definitive therapy where carbapenem standard.

Primary

  • Hospital-acquired / ventilator-associated pneumonia (susceptible pathogens, often combination)
  • Febrile neutropenia with regimen per IDSA
  • Complicated UTI / pyelonephritis due to susceptible resistant GNR

Secondary

  • Bacteremia due to susceptible Pseudomonas / Enterobacterales with source control

Other

  • Meningitis only in highly selected cases β€” not first-line vs ceftriaxone-based regimens

Dosing

STANDARD (ADULT PO)

1 g IV q12h moderate; 2 g IV q8–12h severe (renal adjust)

ADULT DOSE

1 g IV q12h moderate; 2 g IV q8–12h severe; adjust aggressively for CrCl

PEDIATRIC DOSE

Per pediatric febrile neutropenia protocols.

MAX DOSE

Institution caps common β€” never exceed without renal check.

Practical Note

Extended infusion sometimes used for PK/PD β€” pharmacy.

Warnings

Clinical warnings

  • **Ξ²-lactam allergy β€” immediate** (anaphylaxis, angioedema, bronchospasm, hypotension) β†’ **avoid** this agent; use non–β-lactam alternative
  • **Ξ²-lactam allergy β€” non-severe** (maculopapular rash without systemic anaphylaxis features) β†’ **caution**; risk/benefit + allergy/ID pathway; graded challenge or test dose **only** per protocol β€” do not dismiss automatically
  • **Neurotoxicity:** encephalopathy, confusion, myoclonus, seizures β€” **higher risk with CKD, elderly, dose accumulation** (notably cefepime, carbapenems, high-dose penicillins)
  • New CNS symptoms + renal impairment on IV Ξ²-lactam β†’ **hold dose**, check levels/exposure, rule out other causes
  • C. diff
  • Drug fever
  • Platelet function β€” bleeding with severe renal failure rare

Adverse effects

  • rash
  • diarrhea
  • CNS toxicity if accumulation

Contraindications

  • Immediate cephalosporin anaphylaxis when alternative required

Drug interactions

  • Aminoglycosides
  • Diuretics β€” renal monitoring

Special populations

Pediatrics

Weight-based per pediatric reference

Pregnancy

Use when clearly needed

Lactation

generally low risk.

Renal impairment

**Mandatory** dose/interval reduction; HD dosing schedules; neurotoxicity if ignored. **CrCl scaffold (FMBM β€” titrate to FDA/SFDA label + institutional pharmacy nomogram):** - **CrCl β‰₯50** β†’ standard interval (per Adult dosing card) - **CrCl 10–50** β†’ extend interval and/or reduce dose (often q12–24h or ↓ dose β€” **product-specific**) - **CrCl <10** β†’ maximal interval extension / dose reduction; **HD: redose post-dialysis** per protocol; AKI β†’ re-estimate CrCl; **neuro signs** β†’ hold/adjust

Hepatic impairment

No routine change.

Elderly

Assume reduced CrCl β€” verify dosing.

Administration

IV infusion.

Monitoring

  • Monitor: - ICU or CKD β†’ **creatinine daily** β†’ underdosing in AKI vs accumulation / **neurotoxicity** if not adjusted - New confusion / myoclonus / seizures + renal impairment on IV Ξ²-lactam β†’ **hold dose** β†’ evaluate encephalopathy - Serious GNR infection β†’ extended-infusion / pharmacy optimization per protocol - Renal function daily in ICU - Any altered mental status in CKD patient on cefepime β†’ hold dose, consider neurotoxicity
  • Recheck: - No clinical improvement at 48–72h β†’ reassess diagnosis, resistance, source control, and drug interactions - If targets not met after reassessment of dose, organ function, and interactions β†’ escalate per protocol (DO NOT continue blindly)

Overdose / toxicity

Clinical Picture

**Life-threatening (first):** **CNS toxicity** β€” seizures, encephalopathy, agitation, myoclonus, coma (**↑ CKD, elderly, accumulation**; cefepime, carbapenems, high-dose penicillins). **Allergic:** anaphylaxis / angioedema (separate pathway). **Secondary:** nausea/vomiting/diarrhea mainly with acute massive **oral** co-ingestion or local infusion reaction.

Immediate Actions

Stop Ξ²-lactam β†’ ABCs β†’ **seizure precautions**; benzos if seizures; check renal function / dose vs CrCl; anaphylaxis β†’ epinephrine + ACLS

Antidote

No specific antidote; treat complications (e.g. anaphylaxis β†’ epinephrine per ACLS)

Decontamination

Stop infusion; recent large PO load β†’ charcoal if protected airway + early presentation

Escalation

Status epilepticus, coma, refractory seizures β†’ **ICU**; **severe CNS toxicity or AKI with accumulation β†’ consider hemodialysis** for dialyzable agents β€” nephrology + pharmacy; persistent anaphylaxis β†’ ICU

Clinical pearls

Common mistakes, resistance logic, and bedside traps

High-Yield Summary

Broad ICU cephalosporin β€” **renally cleared** β†’ **seizures if not adjusted**. Pseudomonas + some G+. ESBL: know hospital policy.

Clinical pearls

De-escalation to narrower beta-lactam when cultures return. Febrile neutropenia: follow time-to-antibiotic and protocol end points. *Stewardship (all antimicrobials):* Empiric choice β†’ syndrome severity + **local antibiogram**; shortest effective course.

Stewardship & safety

  • Renal dose non-negotiable
  • AMS encephalopathy differential
  • ESBL caution

Pharmacokinetics

Renal elimination; penetrates CSF better than many cephs at treatment doses.

Mechanism of action

Fourth-gen cephalosporin β€” zwitterionic penetration + broad PBP affinity.

Common brand names

Saudi Arabia

Maxipime, Cefepime

Global

(placeholder β€” verify local formulary)

Common trade names are curated examples only β€” formulations and availability vary. Verify the exact product name with your local pharmacy and national regulator before prescribing or dispensing.

Country practice notes

  • Empiric choice β†’ tie to syndrome, severity, and local antibiogram β€” not habit.
  • IV β†’ PO step-down when oral bioavailability and susceptibility allow.
  • Do not use antibiotics for uncomplicated viral illness β€” stewardship.

References

Saudi Arabia

  • SFDA (Saudi Food & Drug Authority)
  • Saudi National Formulary / MOH (where available)

International

  • WHO Model List of Essential Medicines (verify current edition)
  • US FDA or EU EMA product information (when national SmPC is unavailable)
  • Sanford Guide
  • IDSA / ESCMID (indication-specific)
  • Local antimicrobial stewardship / hospital formulary
  • FDA / SFDA / regional product labeling
  • Sanford Guide
  • IDSA / ESCMID (indication-specific)
  • Local antimicrobial stewardship / hospital formulary
  • FDA / SFDA / regional product labeling

Do not miss

  • Uncomplicated viral URI/bronchitis β†’ antibiotics rarely indicated
  • Narrow or stop when susceptibilities + clinical stability allow
  • Cefepime encephalopathy in dialysis/AKI.
  • Not MRSA monotherapy.
  • Renal dose non-negotiable
  • AMS encephalopathy differential
  • ESBL caution