Ciprofloxacin Otic Solution, 0.2%
Generic Name: ciprofloxacin otic solution, 0.2%
Brand Names:
Ciprofloxacin Otic Solution, 0.2%
11 DESCRIPTION Ciprofloxacin otic solution, 0.2% contains the synthetic antimicrobial agent ciprofloxacin hydrochloride. Ciprofloxacin otic solution, 0.2% is a sterile, preservative-free solution for otic use. Each single-dose container of ciprofloxacin otic solution, 0.2% delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin. The inactive ingredients are povidone, glycerin, and water for injection. Sodium hydroxide and/or lactic acid may be added to adjust pH.
Overview
11 DESCRIPTION Ciprofloxacin otic solution, 0.2% contains the synthetic antimicrobial agent ciprofloxacin hydrochloride. Ciprofloxacin otic solution, 0.2% is a sterile, preservative-free solution for otic use. Each single-dose container of ciprofloxacin otic solution, 0.2% delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin. The inactive ingredients are povidone, glycerin, and water for injection. Sodium hydroxide and/or lactic acid may be added to adjust pH.
Uses
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 )
Dosage
2 DOSAGE AND ADMINISTRATION The contents of one single-dose container (deliverable volume: 0.25 mL) should be instilled into the affected ear twice daily (approximately 12 hours apart) for 7 days. Wash hands before use. The solution should be warmed, by holding the container in the hands for at least 1 minute, to minimize the dizziness that may result from the instillation of a cold solution into the ear canal. The patient should lie with the affected ear upward and then the solution should be instilled. This position should be maintained for at least 1 minute to facilitate penetration of the drops into the ear. Repeat, if necessary, for the opposite ear. Discard unused portion.
Side Effects
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.
Warnings
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. 4 CONTRAINDICATIONS Ciprofloxacin otic solution, 0.2% is contraindicated in persons with a history of hypersensitivity to ciprofloxacin. History of hypersensitivity to ciprofloxacin. ( 4 )
Pregnancy
8.1 Pregnancy Pregnancy Category C. Reproduction studies have been performed in rats and mice using oral doses of up to 100 mg/kg and intravenous (IV) doses up to 30 mg/kg and have revealed no evidence of harm to the fetus as a result of ciprofloxacin. In rabbits, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Ciprofloxacin otic solution, 0.2% is a clear, colorless, sterile, preservative-free solution. Ciprofloxacin otic solution, 0.2% is supplied as a 0.2% otic solution in a low-density polyethylene (LDPE) single-dose container.
Frequently Asked Questions
What is Ciprofloxacin Otic Solution, 0.2% used for?▼
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 )
What are the side effects of Ciprofloxacin Otic Solution, 0.2%?▼
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.
Can I take Ciprofloxacin Otic Solution, 0.2% during pregnancy?▼
8.1 Pregnancy Pregnancy Category C. Reproduction studies have been performed in rats and mice using oral doses of up to 100 mg/kg and intravenous (IV) doses up to 30 mg/kg and have revealed no evidence of harm to the fetus as a result of ciprofloxacin. In rabbits, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose.
What are the important warnings for Ciprofloxacin Otic Solution, 0.2%?▼
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. 4 CONTRAINDICATIONS Ciprofloxacin otic solution, 0.2% is contraindicated in persons with a history of hypersensitivity to ciprofloxacin. History of hypersensitivity to ciprofloxacin. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.