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

Cefixime

Cefixime

Third-generation oral cephalosporin

UTIGonorrheaPOΞ²-lactam

Indication

Uncomplicated UTI β€’ pharyngitis alternative β€’ GC (check resistance) β€’ typhoid (selected regions)

At a glance

INDICATIONS (CORE USE)

Uncomplicated UTI; otitis/sinusitis (susceptible); **gonorrhea only if local resistance allows** β€” verify guideline.

ADULT DOSE (STANDARD)

400 mg PO daily or 200 mg PO q12h (indication-specific)

MAX DOSE

400 mg/day typical adult max

Route

PO

PEDIATRIC DOSE

8 mg/kg/day PO max 400 mg/day (suspension) β€” verify indication

Do not miss

Must-not-miss safety points

Major warning

- **Misuse boundary:** NOT appropriate as sole therapy for **pyelonephritis**, **bacteremia**, or **unstable systemic infection** β€” escalate route/spectrum when indicated - **MRSA:** **no reliable MRSA coverage** β€” do not use as monotherapy when MRSA in differential - Ξ²-lactam anaphylaxis - **Gonorrhea resistance** β€” ceftriaxone-based regimens often first-line; oral cefixime only where guideline-endorsed - Poor staph reliability β€” not first-line cellulitis if MRSA in differential - Renal adjustment

Indications

USE IF: Uncomplicated UTI with susceptible organisms; selected respiratory infections per guideline; GC only if public health guidance supports. AVOID IF: MRSA cellulitis; severe infection needing IV; resistant GC.

Primary

  • Uncomplicated urinary tract infection (female cystitis patterns per guideline)
  • Otitis media / pharyngitis alternatives when susceptibility expected

Secondary

  • Uncomplicated gonorrhea only where local/public health guidance permits oral therapy

Other

  • Enteric fever in some endemic settings (specialist-directed)

Dosing

STANDARD (ADULT PO)

400 mg PO once daily (many UTIs)

ADULT DOSE

400 mg PO daily or divided BID depending on indication; UTI duration per guideline (often short)

PEDIATRIC DOSE

Suspension dosing by weight β€” max 400 mg/day.

MAX DOSE

400 mg/day (adult usual ceiling)

Practical Note

Check stone patient adherence β€” single daily may improve compliance.

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
  • Oral Ξ²-lactams: **CNS toxicity uncommon** vs IV agents; still consider if massive overdose + severe CKD
  • C. diff
  • Drug-induced hemolytic anemia rare

Adverse effects

  • GI upset
  • rash
  • headache

Contraindications

  • Severe cephalosporin allergy when avoided

Drug interactions

  • Carbamazepine levels may rise β€” monitor
  • Warfarin β€” INR

Special populations

Pediatrics

8 mg/kg/day PO max 400 mg/day (suspension) β€” verify indication

Pregnancy

Generally acceptable

Lactation

low risk.

Renal impairment

CrCl <60 β†’ reduce dose/interval per label. **CrCl scaffold (FMBM β€” titrate to FDA/SFDA label + institutional pharmacy nomogram):** - **CrCl β‰₯50** β†’ usual PO regimen - **CrCl 10–50** β†’ extend interval or ↓ total daily dose per label - **CrCl <10** β†’ further reduction; align **HD** timing with absorption / redose per protocol

Hepatic impairment

No routine adjustment.

Elderly

Renal dosing; fall risk.

Administration

PO with or without food per tolerance.

Monitoring

  • Monitor: - CKD, frail elderly, or dehydration β†’ estimate CrCl β†’ adjust interval/dose per label - Institutional Ξ²-lactam allergy pathway β†’ first-dose observation if protocol mandates - Recurrent UTI β†’ culture strategy - GC: resistance surveillance
  • 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):** **anaphylaxis**; **CNS toxicity** (seizures, encephalopathy) β€” uncommon vs IV but consider **massive ingestion + severe CKD** or continued dosing in renal failure. **Secondary:** GI upset (nausea, vomiting, diarrhea).

Immediate Actions

Stop drug β†’ ABCs; seizures β†’ benzos; anaphylaxis β†’ epinephrine + ACLS

Antidote

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

Decontamination

Large recent ingestion β†’ charcoal if appropriate window, airway protected

Escalation

Refractory shock, angioedema, seizures, intractable vomiting β†’ **ED/ICU**; **severe neurotoxicity or renal failure with suspected accumulation β†’ consider hemodialysis** (agent-dependent) β€” nephrology + pharmacy

Clinical pearls

Common mistakes, resistance logic, and bedside traps

High-Yield Summary

Oral third-gen for **UTI** + selected **resp** β€” **GC oral use is public-health dependent**. Renal adjust.

Clinical pearls

Stewardship: avoid treating asymptomatic bacteriuria except pregnancy/surgery indications. De-escalation from IV ceftriaxone when safe. *Stewardship (all antimicrobials):* Empiric choice β†’ syndrome severity + **local antibiogram**; shortest effective course.

Stewardship & safety

  • GC resistance check
  • Renal dose
  • C. diff

Pharmacokinetics

PO absorption moderate; renal elimination; half-life allows q24h for some indications.

Mechanism of action

Oral third-gen cephalosporin β€” gram-negative weighted spectrum.

Common brand names

Saudi Arabia

Suprax, Cefixime

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
  • Resistance: ESBL UTIs β†’ failure.
  • Not MRSA drug.
  • GC resistance check
  • Renal dose
  • C. diff