Drug Facts
Composition & Profile
Identifiers & Packaging
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. Each single-dose container delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin; 14 single-dose containers are packaged in a foil overwrap pouch in a carton (NDC 69543-457-14). Store at 15°C to 25°C (59°F to 77°F). Discard used containers. Store unused containers in pouch to protect from light.; PRINCIPAL DISPLAY PANEL - 0.25 mL Carton NDC 69543-457-14 Sterile Preservative-Free Ciprofloxacin Otic Solution, 0.2% Ingredients: Each 0.25 mL contains ciprofloxacin hydrochloride equivalent to 0.50 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. See accompanying package insert for usual dosage information. Containers not for individual sale. Discard used containers. Store at 15°C to 25°C (59° to 77° F). Store unused containers in pouch to protect from light. Manufactured for: Virtus Pharmaceuticals, LLC Manhasset, NY 11030 Manufactured by: Holopack Verpackungstechnik GmbH Sulzbach-Laufen, Germany 74429 Origin Germany Rev 01/2024 Rx Only VIRTUS ® PHARMACEUTICALS Principal Display Panel - 0.25 mL Carton
- 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. Each single-dose container delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin; 14 single-dose containers are packaged in a foil overwrap pouch in a carton (NDC 69543-457-14). Store at 15°C to 25°C (59°F to 77°F). Discard used containers. Store unused containers in pouch to protect from light.
- PRINCIPAL DISPLAY PANEL - 0.25 mL Carton NDC 69543-457-14 Sterile Preservative-Free Ciprofloxacin Otic Solution, 0.2% Ingredients: Each 0.25 mL contains ciprofloxacin hydrochloride equivalent to 0.50 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. See accompanying package insert for usual dosage information. Containers not for individual sale. Discard used containers. Store at 15°C to 25°C (59° to 77° F). Store unused containers in pouch to protect from light. Manufactured for: Virtus Pharmaceuticals, LLC Manhasset, NY 11030 Manufactured by: Holopack Verpackungstechnik GmbH Sulzbach-Laufen, Germany 74429 Origin Germany Rev 01/2024 Rx Only VIRTUS ® PHARMACEUTICALS Principal Display Panel - 0.25 mL Carton
Overview
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. Ciprofloxacin, a fluroquinolone is available as the monohydrochloride, monohydrate salt of 1cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C 17 H 18 FN 3 O 3 •HCl•H 2 O, and molecular weight is 385.82. The chemical structure of ciprofloxacin hydrochloride is: Chemical Structure
Indications & 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 & 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. Contents of one single-dose container should be instilled into the affected ear twice daily (approximately 12 hours apart) for 7 days. ( 2 )
Warnings & 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.
Contraindications
Ciprofloxacin otic solution, 0.2% is contraindicated in persons with a history of hypersensitivity to ciprofloxacin. History of hypersensitivity to ciprofloxacin. ( 4 )
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 .
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