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

Azithromycin

Azithromycin

Macrolide (PO, IV)

AtypicalQTCAPSTI

Indication

CAP β€’ pertussis β€’ chlamydia/gonorrhea combo β€’ COPD exacerbation selected β€’ traveler’s diarrhea

At a glance

INDICATIONS (CORE USE)

Atypical coverage, STIs, some CAP β€” **QT prolongation**; **drug interactions** via CYP3A/P-gp; **hearing loss** high dose prolonged.

ADULT DOSE (STANDARD)

500 mg PO daily Γ— 3d or 5d packs (indication-specific); CAP 500 mg day1 then 250 mg daily

MAX DOSE

1.5 g cumulative some STI regimens β€” single high doses distinct

Route

PO, IV

PEDIATRIC DOSE

10 mg/kg day1 max 500 mg then 5 mg/kg days 2–5 β€” verify indication

Do not miss

Must-not-miss safety points

Major warning

- QT prolongation / torsades β€” check ECG if risk factors + other QT drugs - Hepatotoxicity - Sensory hearing loss with prolonged high exposure - Resistance: pneumococcus/macrolide β€” don’t rely monotherapy severe pneumococcal pneumonia in high-resistance regions

Indications

USE IF: Atypical coverage, chlamydia, pertussis, some CAP per guideline. AVOID IF: Congenital long QT + multiple QT drugs; can use beta-lactam narrower for bacterial sinusitis in many cases.

Primary

  • Atypical pneumonia coverage component
  • Chlamydia / uncomplicated cervicitis / urethritis regimens
  • Pertussis treatment / post-exposure prophylaxis

Secondary

  • Acute COPD exacerbation macrolide benefit debate β€” local protocol
  • Traveler’s diarrhea (selected regions/resistance patterns)

Other

  • Gonorrhea: **not reliable monotherapy** β€” resistance

Dosing

STANDARD (ADULT PO)

500 mg PO day 1 β†’ 250 mg daily days 2–5 (Z-pack pattern) OR 500 mg Γ—3d β€” match indication

ADULT DOSE

Z-pack vs 3-day vs 5-day β€” match indication; IV rare severe CAP GI intolerance

PEDIATRIC DOSE

Suspension dosing by weight.

MAX DOSE

~500 mg/day typical after day 1 load; avoid stacking QT-prolonging agents

Practical Note

Food decreases absorption slightly β€” usually acceptable.

Warnings

Clinical warnings

  • C. diff
  • Infantile hypertrophic pyloric stenosis after maternal macrolide β€” discuss OB

Adverse effects

  • GI upset
  • headache
  • cholestatic hepatitis

Contraindications

  • History QT syndrome with contraindicated co-therapy

Drug interactions

  • QT drugs β€” amiodarone, haloperidol, fluoroquinolones
  • Statins β€” myopathy via CYP3A
  • Warfarin β€” INR

Special populations

Pediatrics

10 mg/kg day1 max 500 mg then 5 mg/kg days 2–5 β€” verify indication

Pregnancy

Generally considered acceptable short courses

Lactation

low risk.

Renal impairment

No adjustment oral; severe renal GFR <10 β€” some guidance extends interval for Zmax β€” check label. **CrCl scaffold (FMBM β€” titrate to FDA/SFDA label + institutional pharmacy nomogram):** - **CrCl β‰₯50** β†’ standard per agent (azithro PO often unchanged) - **CrCl 10–50** β†’ clarithro/erythro β€” check label for interval/dose; azithro usually minimal change - **CrCl <10** β†’ extend interval or reduce dose per label (Zmax / IV forms β€” **verify product**)

Hepatic impairment

Severe hepatic impairment β€” caution.

Elderly

QT risk; drug interactions.

Administration

PO with or without food; IV infusion rate per stability.

Monitoring

  • Monitor: - Long QT, low K+/Mg2+, or QT-stacking drugs β†’ **ECG** - Start / stop macrolide β†’ **med reconciliation** (CYP3A: statins, colchicine, DOACs)
  • 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):** **torsades / polymorphic VT** (QT). **Secondary:** GI upset; hearing at extreme exposure.

Immediate Actions

Stop macrolide β†’ ECG; K+/Mg2+ repletion; telemetry if symptomatic

Antidote

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

Decontamination

Recent large PO β†’ charcoal if appropriate

Escalation

Torsades / unstable VT β†’ **ICU** ACLS; magnesium per protocol; **severe renal failure with accumulation β†’ consider HD** (erythromycin more than azithro) β€” pharmacy

Clinical pearls

Common mistakes, resistance logic, and bedside traps

High-Yield Summary

Convenient **atypical + STI** macrolide. **QT + drug interaction** landmine. **Resistance** limits empiric CAP monotherapy in many regions.

Clinical pearls

Stewardship: acute bronchitis usually viral β€” no macrolide. Pertussis early treatment matters. Anti-motility in traveler’s diarrhea with caution (toxin producers). *Stewardship (all antimicrobials):* Empiric choice β†’ syndrome severity + **local antibiogram**; shortest effective course.

Stewardship & safety

  • QT checklist
  • Hepatitis rare
  • Resistance CAP

Pharmacokinetics

Long half-life allows short courses; hepatic metabolism.

Mechanism of action

50S ribosome β€” inhibits protein synthesis; long tissue half-life.

Common brand names

Saudi Arabia

Zithromax, Azithromycin

Global

Z-Pak, (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
  • Azithromycin + ondansetron + sepsis electrolytes β†’ QT storm.
  • Gonorrhea β€” use ceftriaxone-based regimens.
  • QT checklist
  • Hepatitis rare
  • Resistance CAP