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.

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.

 
 

For the treatment of Otitis Externa… CETRAXAL is the first Food and Drug Administration (FDA) Ciprofloxacin single agent prescription ototopical antibiotic approved for the treatment of acute otitis externa in adults and children 1 year and older in the United States. CETRAXAL individual dosing vials make it easy for accurate dosing. CETRAXAL is preservative free, which minimizes the risk of ototoxicity.

IMPORTANT SAFETY INFORMATION
CETRAXAL® is for otic use only. It should not be used for injection, for inhalation or for topical ophthalmic use.  CETRAXAL® is contraindicated in persons with a history of hypersensitivity to ciprofloxacin.  CETRAXAL® should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. As with other anti-infectives, use of CETRAXAL® may result in overgrowth of nonsusceptible organisms, including yeast and fungi.  If super-infection occurs, discontinue use and institute alternative therapy.  If the infection is not improved after one week of therapy, cultures may help guide further treatment. In a randomized, active-controlled clinical trial, approximately 300 patients with clinical signs and symptoms of otitis externa were treated with CETRAXAL®. 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.

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® is a registered trademark of Laboratorios Salvat, S.A