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DrugindexOnline2nd edition
All about: Ofloxacin

Class: Antibiotic, Fluoroquinolone
Trade Names:
Floxin Otic
- Solution, otic 3 mg/mL
Trade Names:
Ocuflox
- Solution, ophthalmic 3 mg/mL
Trade Names:
Ofloxacin
- Tablets 200 mg
- Tablets 300 mg
- Tablets 400 mg
Mechanism of Action
Pharmacology
Interferes with microbial DNA synthesis.
Pharmacokinetics
Absorption
C max is 2.7 to 4 mcg/mL. T max is 1 to 2 h (oral).
Distribution
Widely distributed to body tissues and fluids. 32% protein bound. Bioavailability is 98%.
Metabolism
Pyridobenzoxazine ring appears to decrease the extent of parent compound metabolism.
Elimination
The t ½ is 4 to 5 hr (oral). Less than 5% is eliminated by the kidneys as desmethyl or N-oxide metabolites; 4% to 8% by feces.
Special Populations
Renal Function ImpairmentCl is reduced in patients with Ccr less than 50 mL/min. Dosage adjustment is necessary.
ElderlyLonger plasma t ½ is approximately 6.4 to 7.4 h.
Indications and Usage
Treatment of acute bacterial exacerbations of chronic bronchitis, community acquired pneumonia, uncomplicated skin and skin structure infections, acute uncomplicated urethral and cervical gonorrhea, nongonococcal urethritis, cervicitis, acute pelvic inflammatory disease, uncomplicated cystitis, complicated UTI, prostatitis caused by Escherichia coli .
OphthalmicTreatment of conjunctivitis and corneal ulcer infections caused by susceptible organisms.
OticTreatment of otitis externa, chronic suppurative otitis media in patients with perforated tympanic membranes, and acute otitis media in children with tympanostomy tubes.
Contraindications
Standard considerations.
OphthalmicEpithelial herpes simplex keratitis; vaccinia; varicella; fungal disease of ocular structure; mycobacterial infections of the eye.
Dosage and Administration
Acute Otitis Media in Children with Tympanostomy TubesChildren 1 to 12 yr of age
Otic 5 gtt (0.25 mL, 0.75 mg ofloxacin) instilled into affected ear twice daily for 10 days.
Acute Pelvic Inflammatory DiseaseAdults
PO 400 mg every 12 h for 10 to 14 days.
Acute Uncomplicated Urethral and Cervical GonorrheaAdults
PO 400 mg as single dose.
Bacterial ConjunctivitisAdults and Children 1 yr of age or older
Ophthalmic Days 1 and 2 instill 1 to 2 gtt every 2 to 4 h in affected eye(s). Days 3 through 7 instill 1 to 2 gtt 4 times daily.
Bacterial Corneal UlcerAdults and Children 1 yr of age or older
Ophthalmic Days 1 and 2 instill 1 to 2 gtt into affected eye every 30 min while awake, awaken at approximately 4 to 6 h after retiring and instill 1 to 2 gtt; days 3 through 7 to 9 instill 1 to 2 gtt every h while awake; days 7 to 9 instill 1 to 2 gtt 4 times daily.
Cervicitis/UrethritisAdults
PO 300 mg every 12 h for 7 days.
Chronic Bronchitis, Community-Acquired Pneumonia, Uncomplicated Skin and Skin Structure InfectionsAdults
PO 400 mg every 12 h for 10 days.
Chronic Suppurative Otitis Media with Perforated Tympanic MembranesAdults and children 12 yr of age and older
Otic 10 gtt (0.5 mL, 1.5 mg ofloxacin) instilled into affected ear twice daily for 10 days.
Complicated UTIAdults
PO 200 mg every 12 h for 10 days.
EpididymitisAdults
PO 300 mg twice daily for 10 days.
Otitis ExternaAdults and children 12 yr of age and older
Otic 10 gtt (0.5 mL, 1.5 mg ofloxacin) instilled into affected ear twice daily for 10 days.
Children 1 to 12 yr of ageOtic 5 gtt (0.25 mL, 0.75 mg ofloxacin) instilled into affected ear twice daily for 10 days.
ProstatitisAdults
PO 300 mg every 12 h for 6 wk.
Uncomplicated Cystitis Caused by E. Coli or Klebsiella PneumoniaeAdults
PO 200 mg every 12 h for 3 days.
Uncomplicated Cystitis Caused by Other PathogensAdults
PO 200 mg every 12 h for 7 days.
Storage/Stability
Store at 59° to 86°F. Protect from light.
Drug Interactions
Antacids, didanosine, iron salts, sucralfate, zinc saltsMay decrease oral absorption of ofloxacin.
Antineoplastic agentsSerum ofloxacin levels may be decreased.
NSAIDsCoadministration with ofloxacin may increase risk of CNS stimulation and seizures.
ProcainamidePlasma levels of procainamide may be elevated, increasing the risk of toxicity.
TheophyllineDecreased Cl and increased plasma levels of theophylline may result in toxicity.
Laboratory Test Interactions
None well documented.
Adverse Reactions
Cardiovascular
Chest pain.
CNS
Dizziness, vertigo (1%, otic); headache; dizziness; fatigue; lethargy; drowsiness; insomnia; nervousness.
Dermatologic
Pruritus, rash (4%, otic); rash, pruritus.
EENT
Tearing, dryness, eye pain, visual disturbances, transient burning, itching, stinging, inflammation, facial edema (ophthalmic); earache (otic).
GI
Taste perversion (7%, otic); diarrhea; nausea; vomiting; abdominal pain or discomfort; dry or painful mouth; flatulence; dysgeusia.
Genitourinary
Vaginal discharge; genital pruritus.
Hematologic
Eosinophilia; lymphocytopenia.
Hepatic
Increased ALT, AST.
Miscellaneous
Application site reaction (3%), paresthesia (otic); vaginitis; fever; decreased appetite. Ophthalmic use may possibly cause same adverse reactions seen with systemic use because of absorption.
Precautions
Pregnancy
Category C .
Lactation
Excreted in breast milk.
Children
Safety and efficacy not established in children younger than 1 yr of age. Safety and efficacy not established in children younger than 18 yr of age (otic).
Hypersensitivity
Serious and occasionally fatal reactions (eg, anaphylactic) have occurred, some after the first dose.
Renal Function
Reduced Ccr may occur; decrease dose accordingly.
Superinfection
May result in bacterial or fungal overgrowth of nonsusceptible microorganisms.
Photosensitivity
Moderate to severe reactions may occur; avoid excessive sunlight and ultraviolet light.
Convulsions/Toxic psychosis
CNS stimulation can occur; use drug with caution in patients with known or suspected CNS disorders.
Pseudomembranous colitis
Consider possibility in patients who develop diarrhea.
Syphilis
Not effective for treating syphilis.
Tendonitis
Inflammation and rupture of tendons have been associated with the use of fluoroquinolone antibiotics.
Overdosage
Symptoms
Nausea, dizziness, crystalluria, facial swelling and numbness, vomiting, drowsiness, hot and cold flushes.
Patient Information
- Instruct patient to avoid taking antacids, sucralfate, vitamins with iron or minerals within 2 h before or 2 h after dose.
- Advise diabetic patient to discontinue and notify health care provider if a hypoglycemic reaction occurs.
- Encourage patient to drink fluids liberally.
- Caution patient to avoid exposure to sunlight, and to use sunscreen or wear protective clothing to avoid photosensitivity reaction.
- Advise patient to notify health care provider of signs of superinfection.
- Caution patient to report the following symptoms to health care provider: seizures, nausea, rash, itching, diarrhea, shortness of breath, dizziness, headache.
- Instruct patient to complete full course of therapy, even if symptoms have resolved.
- Instruct patient to stop treatment and inform health care provider if experiencing pain, inflammation, or rupture of tendon, and to rest or refrain from exercise until diagnosis of tendonitis or tendon rupture is excluded.
- Ophthalmic
- Demonstrate and observe correct technique for instillation of ophthalmic drops.
- Advise patient using ophthalmic solution to discontinue medication and notify health care provider of rash or allergic reaction.
- Otic
- Caution patient to avoid contaminating the applicator tip with material from fingers or other sources.
- Instruct patient to warm the solution by holding the bottle in the hand for 1 or 2 min to avoid dizziness, which may result from the instillation of cold solution.
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