Gemifloxacin
FACTIVE
What it isOral broad-spectrum fluoroquinolone antibiotic that inhibits bacterial DNA gyrase and topoisomerase IV.
Why this oneUsed for community-acquired pneumonia and acute bacterial exacerbations of chronic bronchitis, with strong activity against respiratory pathogens including S. pneumoniae.
What limits itCarries the fluoroquinolone class risks of tendon rupture, peripheral neuropathy, CNS effects and QT prolongation, and a maculopapular rash is notably common with courses beyond 7 days.
FDA label
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| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Acute bacterial exacerbation of chronic bronchitis (reserve for patients with no alternative options) | Adults | 320 mg QD x 5 days | 320 mg QD; do not exceed recommended dose/duration | |
| Community-acquired pneumonia (mild-moderate) due to S. pneumoniae, H. influenzae, M. pneumoniae, or C. pneumoniae | Adults | 320 mg QD x 5 days | 320 mg QD; do not exceed recommended dose/duration | |
| Community-acquired pneumonia (mild-moderate) due to known/suspected MDRSP, K. pneumoniae, or M. catarrhalis | Adults | 320 mg QD x 7 days | 320 mg QD; do not exceed recommended dose/duration |
Renal CrCl >40 mL/min: no adjustment. CrCl <=40 mL/min (incl. hemodialysis or CAPD): 160 mg q24h
Hepatic No adjustment needed
Instructions
- With or without food; swallow whole with a liberal amount of liquid
- Choice of 5- vs 7-day CAP regimen guided by initial sputum culture
Contraindications
- History of hypersensitivity to any fluoroquinolone antibiotic (class cross-reactivity)
Cautions
- Tendinitis and tendon rupture (class; disabling, potentially irreversible) - discontinue immediately if symptoms
- Peripheral neuropathy - discontinue immediately if symptoms
- CNS effects - discontinue immediately if symptoms
- Myasthenia gravis exacerbation - avoid with known history of MG
- Rash (3.5% vs 1.1% comparator; led to discontinuation in 0.8%)
Adverse reactions
- Diarrhea 5.0%, headache 4.2%, nausea 3.7%, rash 3.5%, abdominal pain 2.2%, dizziness 1.7%, vomiting 1.6%
- <1%: transaminase/CPK elevations, urticaria, photosensitivity/phototoxicity, insomnia, taste perversion
Pregnancy Undefined
Lactation Undefined
⚠ BOXED WARNINGS
- Tendinitis and tendon rupture
- Peripheral neuropathy
- CNS effects
- Myasthenia gravis exacerbation
Principal riskBoxed warning: fluoroquinolone class risks of disabling tendinitis/tendon rupture, peripheral neuropathy, CNS effects, and exacerbation of myasthenia gravis.
Classes and tags
Clinical profile
Mechanism of action: Gemifloxacin ballicule
