OFLOXACIN(o-flox'a-cin)Floxin, Floxin Otic, OcufloxClassifications: antiinfective; antibiotic, quinolonePrototype: CiprofloxacinPregnancy Category: C

Availability200 mg, 300 mg, 400 mg tablets; 200 mg, 400 mg injection; 0.3% ophthalmic solution; 0.3% otic solution

ActionsA fluoroquinolone antibiotic with a broad spectrum of activity against gram-positive and gram-negative aerobic and anaerobic bacteria. Inhibits DNA gyrase, an enzyme necessary for bacterial DNA replication and some aspects of its transcription, repair, recombination, and transposition.

Therapeutic EffectsMost effective against gram-negative organisms including Citrobacter diversus, C. freundii, Enterobacter cloacae, E. aerogenes, Escherichia coli, Klebsiella species, Morganella morganii, Proteus species, Salmonella species, Shigella species, and Yersinia enterocolitica. More potent against Serratia species than is norfloxacin, and it is equipotent against Providencia species; less active against Pseudomonas aeruginosa but more potent against Xanthomonas maltophilia than is ciprofloxacin.

UsesChlamydia trachomatis infection, uncomplicated gonorrhea, prostatitis, respiratory tract infections, skin and skin structure infections, urinary tract infections due to susceptible bacteria, superficial ocular infections, pelvic inflammatory disease. Otic: otitis externa, otitis media with perforated tympanic membranes.

Unlabeled UsesEENT infections, Helicobacter pylori infections, Salmonella gastroenteritis.

Contraindications

Hypersensitivity to ofloxacin or other quinolone antibacterial agents; tendon pain; sunlight (UV) exposure; viral infection; pregnancy (category C); lactation.

Cautious UseRenal disease; patients with a history of epilepsy, psychosis, or increased intracranial pressure, cerebrovascular disease, CNS disorders such as seizures, epilepsy, myasthenia gravis; GI disease, colitis, dehydration; syphilis. Safety and effectiveness in children and adolescents <18 y (except for otic preparation) are not established.

Route & Dosage

Uncomplicated GonorrheaAdult: PO 400 mg for 1 dose

Urinary Tract, Respiratory Tract, and Skin and Skin Structure InfectionsAdult: PO 200–400 mg q12h times 7–10 d IV 400 mg q12h times 7 d

ProstatitisAdult: PO 300 mg b.i.d. times 6 wk IV 300 mg q12h times 10 d, then switch to PO for 6 wk

Superficial Ocular InfectionsAdult: Ophthalmic Instill 1–2 drops q2–4h for first 2d, then q.i.d. for up to 5 additional d

Otitis Media with PerforationAdult: Otic 10 drops (0.5 mL) q12h for 14 dChild: Otic 1 y, 5 drops (0.25 mL) q12h for 14 d

Otitis ExternaAdult: Otic 10 drops (0.5 mL) q12h for 7 dChild: Otic 6 mo–13 y, 5 drops (0.25 mL) q12h for 7 d

AdministrationOral

Do not give with meals. Avoid administering mineral supplements or vitamins with iron or zinc within 2 h

of drug. Do not give antacids with magnesium, aluminum, or sucralfate within 4 h before

or 2 h after drug.

Instillation

Do NOT allow tip of dropper for ocular preparation to contact any surface.

Intravenous

PREPARE: Intermittent: Withdraw the required dose from a 10 mL (40 mg/mL) or 20 mL (20 mg/mL) vial and add to 100 mL D5W, NS, D5/NS or other compatible solution. Final concentration may range from 0.4 mg/mL to 4 mg/mL.  

ADMINISTER: Intermittent: Give a single dose over at least 60 min. Avoid rapid infusion.  

INCOMPATIBILITIES Y-site: Amphotericin B cholesteryl sulfate complex, cefepime, doxorubicin liposome.

Adverse Effects ( 1%)CNS: Headache, dizziness, insomnia, hallucinations. GI: Nausea, vomiting, diarrhea, GI discomfort. Urogenital: Pruritus, pain, irritation, burning, vaginitis, vaginal discharge, dysmenorrhea, menorrhagia, dysuria, urinary frequency. Skin: Pruritus, rash.

Diagnostic Test InterferenceMay cause false positive on opiate screening tests.

InteractionsDrug: Ofloxacin absorption decreased when it is administered with magnesium- or aluminum-containing antacids. Other cations, including calcium, iron, and zinc, also appear to interfere with ofloxacin absorption.

PharmacokineticsAbsorption: 90%–98% absorbed from GI tract. Peak: 1–2 h. Distribution: Distributes to most tissues; 50% crosses into CSF with inflamed meninges; 20%–32% protein bound; crosses placenta; distributed into breast milk. Metabolism: Slightly metabolized in liver. Elimination: 72%–98% excreted in urine within 48 h. Half-Life: 5–7.5 h.

NURSING IMPLICATIONSAssessment & Drug Effects

Lab tests: Do C&S tests prior to initial dose. Treatment may be implemented pending results.

Determine history of hypersensitivity reactions to quinolones or other drugs before therapy is started.

Withhold ofloxacin and notify physician at first sign of a skin rash or other allergic reaction.

Monitor for seizures, especially in patients with known or suspected CNS disorders. Discontinue ofloxacin and notify physician immediately if seizure occurs.

Assess for signs and symptoms of superinfection (see Appendix F).

Patient & Family Education

Drink fluids liberally unless contraindicated. Be aware that dizziness or light-headedness may occur; use appropriate caution. Avoid excessive sunlight or artificial ultraviolet light because of the possibility of

phototoxicity. Do not breast feed while taking this drug.

Common adverse effects in italic, life-threatening effects underlined: generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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