Ciprofloxacin Otic Solution, 0.2%

Preservative Free is an Excellent Choice to reduce the risk of Ototoxicity and Ear Canal Irritation
Preservative-Free
14 Ampules (0.25 mL)
Ciprofloxacin Otic Solution 0.2% 3D Carton
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NOW AVAILABLE FROM ALEMBIC THERAPEUTICS

Targeted Otic Antimicrobial Therapy

Key Clinical Value Proposition

Preservative Free is an Excellent Choice to reduce the risk of Ototoxicity and Ear Canal Irritation.

Convenient Dosing 1 single-dose container instilled twice daily for 7 days.
Pure Preservative-Free Sterile single-dose LDPE ampules prevent contamination.
Proven Antimicrobial Active against P. aeruginosa & S. aureus.
NDC 62332-168-25 14 individual ampules (0.25 mL each) in protective pouch.
Download Package Insert (PDF) View Safety Information (ISI) Medical Inquiries

Indication & Usage

Ciprofloxacin Otic Solution, 0.2% is a quinolone antimicrobial indicated for the treatment of acute otitis externa (swimmer's ear) due to susceptible isolates of:

  • Pseudomonas aeruginosa
  • Staphylococcus aureus
Bactericidal action results from interference with bacterial DNA gyrase.

Dosing & Administration

Supplied in preservative-free single-dose containers to support convenient and hygienic administration:

Standard Dosage: Instill the contents of one single-dose container into the affected ear twice daily (approximately 12 hours apart) for 7 days.
  • Warm container in hands for 1 minute before use.
  • Maintain ear upward position for at least 1 minute.
  • Discard each single-dose container after use.

Contraindications & Warnings

Strict Contraindication: Should not be used by patients with a history of hypersensitivity to ciprofloxacin or any member of the quinolone class.
  • Otic Use Only: Never for ophthalmic, injection, or inhalation use.
  • Superinfections: Prolonged use may result in fungal overgrowth.
  • Discontinue immediately at the first sign of skin rash or allergic reaction.

Patient Counseling Information & Directions for Use

Step-by-Step Guide
1
Wash Hands Thoroughly

Wash your hands with soap and water prior to handling the single-dose ampule.

2
Warm the Ampule in Hands

Hold and warm the container in your hands for at least 1 minute to avoid dizziness caused by cold drops.

3
Twist Off the Cap

Twist off and discard the top tab of the single-dose container immediately prior to instillation.

4
Instill Solution into Affected Ear

Lie on your side with the affected ear facing upward. Instill the complete deliverable contents (0.25 mL) into the ear canal.

5
Maintain Position for 1 Minute

Remain in this position for at least 1 full minute to ensure the drops penetrate completely into the ear canal.

6
Discard Used Container

Discard the empty ampule immediately. Repeat for the other ear if prescribed. Store remaining unopened containers in foil pouch.

Packaging & Product Specifications

Brand / Product Name Ciprofloxacin Otic Solution
Active Ingredient Ciprofloxacin hydrochloride (equivalent to 0.2% ciprofloxacin; 0.5 mg in 0.25 mL)
Strength & Concentration 0.2% (w/v)
Dosage Form Sterile, Preservative-Free Otic Solution
Package Size & Configuration 14 Individual Single-Dose Ampules (each containing 0.25 mL deliverable volume) packaged in a protective foil overwrap pouch inside a unit carton.
National Drug Code (NDC) 62332-168-25
Storage Conditions Store at 15°C to 25°C (59°F to 77°F). Discard used containers. Store unused containers in pouch to protect from light.
Container Material Low-Density Polyethylene (LDPE) Single-Dose Ampules
Inactive Ingredients Povidone, glycerin, water for injection. Sodium hydroxide and/or lactic acid may be added to adjust pH.
Distributor & Marketing Alembic Therapeutics LLC • 550 Hills Drive, Suite 110, Bedminster, NJ 07921, USA

Important Safety Information (ISI)

Ciprofloxacin Otic Solution, 0.2% • Prescribing Reference
View Full Prescribing Information
INDICATION AND USAGE

Ciprofloxacin Otic Solution, 0.2% is a quinolone antimicrobial indicated for the local treatment of acute otitis externa (swimmer's ear) caused by susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus.

CONTRAINDICATIONS

Hypersensitivity: Ciprofloxacin Otic Solution, 0.2% is strictly contraindicated in patients with a known history of hypersensitivity to ciprofloxacin or any other member of the quinolone class of antimicrobial agents.

WARNINGS AND PRECAUTIONS
  • Otic Use Only: This medication is exclusively for otic (ear) administration. It is not formulated for, and must never be used for, injection, inhalation, or topical ophthalmic (eye) use.
  • Hypersensitivity Reactions: The solution must be immediately discontinued at the first appearance of a skin rash or any other sign of a systemic hypersensitivity reaction.
  • Growth of Resistant Organisms: Prolonged use of this anti-infective may result in the overgrowth of nonsusceptible organisms, including fungal or yeast infections. If a superinfection manifests, the medication should be discontinued, and an alternate treatment strategy should be initiated.
  • Lack of Clinical Response: If the ear infection shows no improvement after one week of continuous therapy, diagnostic cultures should be obtained to guide further clinical treatment decisions.
ADVERSE REACTIONS (SIDE EFFECTS)

In randomized clinical trials, the most commonly reported adverse events occurred in approximately 2% to 3% of patients. These local adverse reactions include:

Application Site Pain
Ear Pruritus (Itching)
Fungal Ear Superinfection
Headache
USE IN SPECIFIC POPULATIONS

Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Caution should be exercised when administered to a pregnant woman.

Nursing Mothers: It is not known whether ciprofloxacin is excreted in human milk following otic administration. A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: The safety and effectiveness of ciprofloxacin otic solution, 0.2% in pediatric patients 1 year of age and older have been established in controlled clinical trials. Safety and effectiveness in pediatric patients below 1 year have not been established.

Medical Inquiries & Adverse Event Reporting

To report SUSPECTED ADVERSE REACTIONS or side effects, contact Alembic Therapeutics LLC at 1-866-210-9797 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Report Adverse Event Online