Ofloxacin

FLOXIN

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Pronunciation: oe-FLOX-a-sin

Ofloxacin ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Ofloxacin ballicule

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.

Ofloxacin molecular structure (skeletal formula) — Molecular structure: Ofloxacin

Ofloxacin prescription history

Animated chart of estimated U.S. prescriptions per year, Quinolone antibacterials (1964–2026). Ofloxacin enters in 1991 (estimated).

FDA-approved for

bacterial conjunctivitis and otitis externa
various systemic bacterial infections

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.

FDA label

Read the full label on DailyMed ↗

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 dosing	Population	Start	Max
Acute bacterial exacerbation of chronic bronchitis	Adult	400 mg BID ×10 days	800 mg/day
Community-acquired pneumonia	Adult	400 mg BID ×10 days	800 mg/day
Uncomplicated skin/skin structure infection	Adult	400 mg BID ×10 days	800 mg/day
Acute uncomplicated urethral/cervical gonorrhea	Adult	400 mg single dose	400 mg
Nongonococcal cervicitis/urethritis (C. trachomatis)	Adult	300 mg BID ×7 days	600 mg/day
Mixed urethral/cervical infection (C. trachomatis + N. gonorrhoeae)	Adult	300 mg BID ×7 days	600 mg/day
Acute pelvic inflammatory disease	Adult	400 mg BID ×10–14 days	800 mg/day
Uncomplicated cystitis (E. coli / K. pneumoniae)	Adult	200 mg BID ×3 days	400 mg/day
Uncomplicated cystitis (other approved pathogens)	Adult	200 mg BID ×7 days	400 mg/day
Complicated UTI	Adult	200 mg BID ×10 days	400 mg/day
Prostatitis (E. coli)	Adult	300 mg BID ×6 weeks	600 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

Reserve use for patients with no alternative options (per boxed warning) for ABECB and uncomplicated cystitis
Discontinue immediately if tendon, neuropathic, or CNS reactions occur

Available strengths

tab 200, 300, 400 mg
drops 0.3 %
sol 3 mg/mL

Contraindications

History of hypersensitivity to ofloxacin or any quinolone antimicrobial

Cautions

Tendinitis/tendon rupture; peripheral neuropathy; CNS effects
Avoid in known myasthenia gravis (may worsen weakness)
QT prolongation, hypersensitivity, C. difficile, photosensitivity, dysglycemia

Adverse reactions

Nausea, insomnia, headache
Dizziness, diarrhea, vomiting
Rash, pruritus
Vaginitis, external genital pruritus
Dysgeusia

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

Lactation Undefined

Cost

Ofloxacin (FLOXIN)

Strength		#/mo	CostPlus
200 mg	tab	60 BID	not offered
300 mg	tab	60 BID	not offered
400 mg	tab	60 BID	not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Ofloxacin is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry2002

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Self-check

Can ofloxacin otic drops be used with a perforated tympanic membrane?
Yes.
What neuromuscular disease can systemic ofloxacin worsen?
Myasthenia gravis.