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

Clarithromycin

Clarithromycin

Macrolide (PO, IV)

H pyloriAtypicalCYP3A

Indication

H. pylori β€’ CAP atypical β€’ NTM β€’ sinusitis selected

At a glance

INDICATIONS (CORE USE)

H. pylori triple/quad therapy; atypical coverage; **strong CYP3A inhibitor** β†’ statins, colchicine, DOAC interactions.

ADULT DOSE (STANDARD)

500 mg PO BID; XL 1 g daily (formulation dependent); H. pylori regimens 500 mg BID

MAX DOSE

1 g/day XL vs 1 g/day divided immediate per product

Route

PO, IV

PEDIATRIC DOSE

7.5 mg/kg PO BID max 500 mg BID

Do not miss

Must-not-miss safety points

Major warning

- QT prolongation - **CYP3A interactions** β€” colchicine contraindicated with clarithromycin in many renal scenarios; simvastatin contraindicated - Hepatotoxicity - Macrolide resistance S. pneumoniae in some regions

Indications

USE IF: H. pylori regimen, atypical coverage when azithro not chosen, NTM specialist. AVOID IF: On simvastatin/colchicine without hold; long QT risk.

Primary

  • Helicobacter pylori eradication regimens (with PPI + amoxicillin/metronidazole etc.)
  • Community-acquired pneumonia atypical coverage component

Secondary

  • Acute bacterial sinusitis / otitis selected (often amox-clav preferred first-line)
  • NTM therapy (specialist)

Other

  • Mycobacterium avium prophylaxis HIV historical β€” check current guidelines

Dosing

STANDARD (ADULT PO)

500 mg PO q12h Γ— 7–14d (infection) OR 500 mg BID Γ— 14d (H. pylori component)

ADULT DOSE

500 mg PO BID 7–14d infections; H. pylori 14d triple therapy common

PEDIATRIC DOSE

Suspension per mg/kg.

MAX DOSE

Follow formulation max daily.

Practical Note

XL vs immediate release not interchangeable mg-for-mg schedule.

Warnings

Clinical warnings

  • Sensorineural hearing loss high dose prolonged

Adverse effects

  • metallic taste
  • nausea
  • diarrhea
  • headache

Contraindications

  • History QT with forbidden co-drugs
  • Concomitant simvastatin (many labels)
  • Colchicine in renal/hepatic impairment combinations

Drug interactions

  • CYP3A substrates β€” calcineurin inhibitors, DOACs, benzodiazepines
  • Theophylline levels

Special populations

Pediatrics

7.5 mg/kg PO BID max 500 mg BID

Pregnancy

Animal data β€” human use if benefit

Lactation

excreted β€” caution.

Renal impairment

CrCl <30 β†’ reduce dose / extend interval per label for tablet **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€” contraindicated IV; PO caution.

Elderly

QT + renal dosing + polypharmacy.

Administration

PO with food reduces GI upset; IV infusion rate per monograph.

Monitoring

  • Monitor: - Long QT, low K+/Mg2+, or QT-stacking drugs β†’ **ECG** - Start / stop macrolide β†’ **med reconciliation** (CYP3A: statins, colchicine, DOACs) - INR if warfarin - CK if statin unavoidable - QT if multiple contributors
  • 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

**H. pylori** staple. **CYP3A sledgehammer** β€” simvastatin/colchicine nightmares. QT like other macrolides.

Clinical pearls

Stewardship: CAP β€” prefer beta-lactam backbone in many guidelines. NTM: always specialist + TDM sometimes. *Stewardship (all antimicrobials):* Empiric choice β†’ syndrome severity + **local antibiogram**; shortest effective course.

Stewardship & safety

  • Med interaction check
  • Renal CRCL <30
  • QT

Pharmacokinetics

Hepatic metabolism; CYP3A4 substrate/inhibitor; penetrates intracellular pathogens.

Mechanism of action

50S macrolide β€” bacteriostatic.

Common brand names

Saudi Arabia

Klacid, Biaxin

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
  • Patient on DOAC + clarithromycin β†’ bleeding or levels chaos.
  • Renal dose XL tablet adjustments.
  • Med interaction check
  • Renal CRCL <30
  • QT