Cetraxal

eneric Name: ciprofloxacin otic solution
Date of Approval: May 1, 2009
Company: Laboratorios Salvat

Treatment for: Acute Otitis Externa

FDA Approves Cetraxal

The United States Food and Drug Administation has approved Cetraxal (ciprofloxacin otic solution) 0.2% for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aerugenosa or Staphylococcus aureus.

Highlights of Cetraxal Prescribing Information

Indications and Usage

Cetraxal is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus.

Dosage and Administration

Contents of one single use container should be instilled into the affected ear twice daily (approximately 12 hours apart) for 7 days.

Dosage Forms and Strengths

Cetraxal is a sterile, preservative-free otic solution of ciprofloxacin hydrochloride equivalent to 0.2 % ciprofloxacin (0.5 mg in 0.25 mL) in each single use container.

Contraindications

History of hypersensitivity to ciprofloxacin.

Warnings and Precautions

• Cetraxal is for otic use only.
• Hypersensitivity: discontinue at the first appearance of a skin rash or any other sign of hypersensitivity.
• Use of Cetraxal may result in overgrowth of nonsusceptible organisms.

Adverse Reactions

The most common adverse reactions reported in 2-3% of patients treated with Cetraxal were application site pain, ear pruritis, fungal ear superinfection, and headache.

To report SUSPECTED ADVERSE REACTIONS, contact WraSer Pharmaceuticals at 1-888-252-3901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Cetraxal Patient Counseling Information

Directions for Use

Patients should be advised that Cetraxal is for otic use only. It is not for ophthalmic or inhalation use. It is not for injection.

Cetraxal should be given 2 times each day (about 12 hours apart) in each infected ear.

Cetraxal should be used for as long as it is prescribed, even if the symptoms improve. The patient should be advised to follow these directions while on Cetraxal:

• Wash their hands before use.
• Warm the container in their hands for at least one minute prior to use to minimize dizziness that may result from the instillation of a cold solution into the ear canal. Twist off and discard top of container.
• Lie with the affected ear upward and then instill the contents of one container into the ear. Maintain this position for at least one minute to facilitate penetration of the drops into the ear.
  • Repeat, if necessary, for the opposite ear.
  • Discard used container.
  • Store unused containers in pouch to protect from light.

Hypersensitivity

Patients should be advised to immediately discontinue Cetraxal at the first appearance of a skin rash or any other sign of hypersensitivity.