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Pharmacologic class: Fluoroquinolone
Therapeutic class: Anti-infective
Pregnancy risk category C
FDA Box Warning
• Fluoroquinolones for systemic use are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in patients usually over age 60, with concomitant use of corticosteroids, and in kidney, heart, and lung transplant recipients.
• Drug may exacerbate muscle weakness in patients with myasthenia gravis. Avoid use in patients with known history of myasthenia gravis.
Inhibits bacterial DNA synthesis by inhibiting DNA gyrase in susceptible bacteria
Ophthalmic solution: 3 mg/ml (0.3%)
Otic solution: 0.3%
Tablets: 200 mg, 300 mg, 400 mg
Indications and dosages
➣ Prostatitis caused by Escherichia coli
Adults: 300 mg P.O. q 12 hours for 6 weeks
➣ Complicated urinary tract infections caused by E. coli, Klebsiella pneumoniae, or Proteus mirabilis
Adults: 200 mg P.O. q 12 hours for 10 days
➣ Uncomplicated cystitis caused by E. coli or K. pneumoniae
Adults: 200 mg P.O. q 12 hours for 3 days
➣ Acute uncomplicated urethral and cervical gonorrhea
Adults: 400 mg P.O. as a single dose
➣ Nongonococcal cervicitis or urethritis caused by Chlamydia trachomatis; mixed infections of cervix or urethra caused by C. trachomatis or Neisseria gonorrhoeae
Adults: 300 mg P.O. q 12 hours for 7 days
➣ Acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia, and uncomplicated skin and skin-structure infections caused by susceptible organisms
Adults: 400 mg P.O. q 12 hours for 10 days
➣ Acute pelvic inflammatory disease
Adults: 400 mg P.O. q 12 hours for 10 to 14 days
➣ Bacterial conjunctivitis
Adults and children ages 1 and older: One to two drops of ophthalmic solution in affected eye q 2 to 4 hours on days 1 and 2; then one to two drops q.i.d. on days 3 through 7
➣ Corneal ulcers
Adults: One to two drops of ophthalmic solution in affected eye q 30 minutes while awake on days 1 and 2, then one to two drops q hour while awake on days 3 to 7, then one to two drops q.i.d. while awake on days 7 to 9
➣ Otitis externa
Adults and children ages 13 and older: 10 drops of otic solution into affected ear daily for 7 days
➣Chronic suppurative otitis media with perforated tympanic membrane
Adults and children ages 12 and older: 10 drops of otic solution into affected ear b.i.d. for 14 days
• Renal impairment
• Severe hepatic impairment
• Hypersensitivity to drug or other fluoroquinolones
Use cautiously in:
• underlying CNS disease, renal impairment, cirrhosis, bradycardia, acute myocardial ischemia
• known history of myasthenia gravis (avoid use)
• history of tendinitis or tendon rupture with fluoroquinolone use
• dialysis patients
• elderly patients
• pregnant or breastfeeding patients (safety not established except in postex-posure inhalation or cutaneous anthrax).
• children younger than age 18 (except in postexposure inhalation or cutaneous anthrax and in ophthalmic and otic use).
• Don't give zinc- or iron-containing drugs within 2 hours of ofloxacin.
CNS: dizziness, drowsiness, headache, light-headedness, insomnia, acute psychoses, agitation, confusion, tremors, hallucinations, increased intracranial pressure, seizures
CV: chest pain, vasodilation
GI: nausea, diarrhea, constipation, abdominal pain, pseudomembranous colitis
GU: interstitial cystitis, vaginitis
Hematologic: eosinophilia, leukopenia
Musculoskeletal: tendinitis, tendon rupture, joint pain, back pain
Skin: rash, photosensitivity, phototoxicity, Stevens-Johnson syndrome
Other: altered taste, superinfection, myasthenia gravis exacerbation
Drug-drug. Amiodarone, bepridil, disopyramide, erythromycin, pentamidine, phenothiazines, pimozide, procainamide, quinidine, sotalol, tricyclic antidepressants: increased risk of serious adverse cardiovascular reactions
Antacids, bismuth subsalicylate, iron or zinc salts, sucralfate: decreased ofloxacin absorption
Corticosteroids: increased risk of tendon rupture
Probenecid: decreased renal elimination of ofloxacin
Theophylline: increased theophylline blood level and possible toxicity
Warfarin: increased warfarin effects
Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase, platelets: increased levels
Hemoglobin, hematocrit: decreased values
Drug-food. Milk or yogurt (consumed alone), tube feedings: impaired drug absorption
Drug-herbs. Fennel: decreased drug absorption
Dong quai, St. John's wort: phototoxicity
Drug-behaviors. Sun exposure: phototoxicity
• Assess patient for signs and symptoms of superinfection.
• Inspect for rash. Check for signs and symptoms of hypersensitivity reaction.
☞ Watch for fever with diarrhea; diarrhea containing pus; or severe, persistent diarrhea; and tendinitis or tendon rupture.
• Evaluate neurologic status closely.
• Encourage patient to maintain fluid intake of at least 1,500 ml daily to prevent crystalluria.
• Inform patient being treated for gonorrhea that partners must be treated.
☞ Tell patient to immediately report fever and diarrhea, especially if stool contains blood, pus, mucus. Caution him not to treat diarrhea without consulting prescriber.
☞ Instruct patient to stop taking drug and immediately report rash or tendon pain or inflammation.
• Instruct patient not to take iron- or zinc-containing drugs or antacids within 2 hours of ofloxacin.
• Teach patient ways to counteract photosensitivity, such as by wearing sunglasses and avoiding excessive exposure to bright light.
• Teach patient how to use eye or ear drops. Caution him not to touch dropper tip to any surface (including eye or ear).
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, herbs, and behaviors mentioned above.