Generic: CIPROFLOXACIN OTIC SOLUTION, 0.2%
Fluoroquinolone Antibacterial [EPC]
1 INDICATIONS AND USAGE Ciprofloxacin otic solution, 0.2% is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus . Ciprofloxacin otic solution, 0.2% is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus . ( 1 )
5 WARNINGS AND PRECAUTIONS Ciprofloxacin otic solution, 0.2% is for otic use only. ( 5.1 ) Hypersensitivity: discontinue at the first appearance of a skin rash or any other sign of hypersensitivity. ( 5.2 ) Use of ciprofloxacin otic solution, 0.2% may result in overgrowth of nonsusceptible organisms. ( 5.3 ) 5.1 Otic Use Only Ciprofloxacin otic solution, 0.2% is for otic use only. It should not be used for injection, for inhalation or for topical ophthalmic use. 5.2 Hypersensitivity Ciprofloxaci...
5 WARNINGS AND PRECAUTIONS Ciprofloxacin otic solution, 0.2% is for otic use only. ( 5.1 ) Hypersensitivity: discontinue at the first appearance of a skin rash or any other sign of hypersensitivity. ( 5.2 ) Use of ciprofloxacin otic solution, 0.2% may result in overgrowth of nonsusceptible organisms. ( 5.3 ) 5.1 Otic Use Only Ciprofloxacin otic solution, 0.2% is for otic use only. It should not be used for injection, for inhalation or for topical ophthalmic use. 5.2 Hypersensitivity Ciprofloxacin otic solution, 0.2% should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. 5.3 Growth of Resistant Organisms with Prolonged Use As with other anti-infectives, use of ciprofloxacin otic solution, 0.2% may result in overgrowth of nonsusceptible organisms, including yeast and fungi. If super-infection occurs, discontinue use and institute alternative therapy. 5.4 Lack of Clinical Response If the infection is not improved after one week of therapy, cultures may help guide further treatment.
6 ADVERSE REACTIONS Because clinical studies are conducted under widely varying conditions, adverse drug reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. In a randomized, active-controlled clinical trial, approximately 300 patients with clinical signs and symptoms of otitis externa were treated with ciprofloxacin otic solution, 0.2%. The most frequent...
6 ADVERSE REACTIONS Because clinical studies are conducted under widely varying conditions, adverse drug reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. In a randomized, active-controlled clinical trial, approximately 300 patients with clinical signs and symptoms of otitis externa were treated with ciprofloxacin otic solution, 0.2%. The most frequently reported adverse reactions were application site pain, ear pruritus, fungal ear superinfection, and headache, each reported in approximately 2-3% of patients. The most common adverse reactions reported in 2-3% of patients treated with ciprofloxacin otic solution, 0.2% were application site pain, ear pruritus, fungal ear superinfection and headache. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Virtus Pharmaceuticals, LLC at 1-888-848-3593 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare provider before making any decisions about your medications. Data sourced from openFDA.