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Ofloxacin

FLOXIN

What it isDNA-gyrase-inhibiting fluoroquinolone; mainly topical treatment of bacterial conjunctivitis and otitis externa.

Why this oneOtic drops are safe with a perforated tympanic membrane and deliver high local exposure without systemic treatment.

What limits itSystemic use can cause tendon rupture, neuropathy and CNS effects and can worsen myasthenia gravis; topical overuse selects resistance.

FDA-approved for

FDA label

BOXED WARNING Fluoroquinolone class: disabling/irreversible tendinitis & tendon rupture, peripheral neuropathy, CNS effects; may exacerbate myasthenia gravis. Reserve for infections with no alternative options for ABECB and uncomplicated cystitis.
FDA dosingPopulationStartTargetMax
Acute bacterial exacerbation of chronic bronchitisAdult400 mg BID ×10 days800 mg/day
Community-acquired pneumoniaAdult400 mg BID ×10 days800 mg/day
Uncomplicated skin/skin structure infectionAdult400 mg BID ×10 days800 mg/day
Acute uncomplicated urethral/cervical gonorrheaAdult400 mg single dose400 mg
Nongonococcal cervicitis/urethritis (C. trachomatis)Adult300 mg BID ×7 days600 mg/day
Mixed urethral/cervical infection (C. trachomatis + N. gonorrhoeae)Adult300 mg BID ×7 days600 mg/day
Acute pelvic inflammatory diseaseAdult400 mg BID ×10–14 days800 mg/day
Uncomplicated cystitis (E. coli / K. pneumoniae)Adult200 mg BID ×3 days400 mg/day
Uncomplicated cystitis (other approved pathogens)Adult200 mg BID ×7 days400 mg/day
Complicated UTIAdult200 mg BID ×10 days400 mg/day
Prostatitis (E. coli)Adult300 mg BID ×6 weeks600 mg/day

Renal After a normal initial dose: CrCl 20–50 mL/min give usual unit dose q24h; CrCl <20 mL/min give ½ usual unit dose q24h

Hepatic Severe hepatic impairment (cirrhosis): do not exceed 400 mg/day

Instructions

Contraindications

Cautions

Adverse reactions

Pregnancy Category C; use only if potential benefit justifies risk to fetus.

Lactation Undefined

⚠ BOXED WARNINGS

Cost, est. cash$5–$150/month

Generic entry2002

Classes and tags

Clinical profile

Therapeutic safety burden2 / 4
Overdose danger2 / 4
Weight-gain liability0 / 4
Sedation liability0 / 4
QT / Torsades2 / 4
Direct muscarinic antagonism0 / 4
Embryofetal risk1 / 4

Legacy pregnancy categoryC

Defining liabilityTendon/aortic injury, dysglycemia and CNS effects; QT or CYP1A2 risk varies by agent.

Mechanism of action: Ofloxacin ballicule

Ofloxacin ballicule: receptor binding, kinetics and half-life diagram

Open Ofloxacin in the interactive console ↗