What is Cetraxal?
Cetraxal is a newly approved eardrop formulation of ciprofloxacin. It is a sterile 0.2% solution that contains no preservatives.
Ciprofloxacin is an antibiotic in the fluoroquinolone family, which are associated with rare but severe side effects. Systemic forms (oral and intravenous administration) carry a “black box warning” for tendinitis leading to permanent joint damage. Cetraxal has an advantage over these forms because the eardrop form does not spread systemically, making it far less dangerous.
In clinical studies, 70% of patients were cured of their condition after treatment with Cetraxal—but the same was true for 60% of patients treated by placebo. Therefore, it is probably most useful for patients with stubborn infections that show no signs of clearing up without it. Doctors may decide to prescribe the drug even for new infections, if they fear that non-treatment could lead to complications. If you have concerns after being prescribed, talk to your health care provider about risks, benefits, and other options.
Indications: External Ear Infections
Cetraxal is approved for treatment of acute otitis externa caused by bacterial infection. Otitis externa affects the ear canal and outer ear and is sometimes called “swimmer’s ear,” although it has other causes. This condition is distinct from otitis media, or middle ear infection. The main symptom is pain in the ear with inflammation in the ear canal.
Otitis externa can be caused by fungi or by non-infectious skin conditions such as eczema. Cetraxal is not effective in these cases. The FDA specifies that Cetraxal is only for infections of Staphylococcus aureas or Pseudomonas aeruginosa bacteria.
How to Use Cetraxal
Cetraxal should be added directly to the affected ear about every 12 hours (twice a day) for seven days. It is packaged in single-use containers, each containing 0.25 mL of solution. The entire contents of one of these containers should be squeezed into the ear canal with each dose. All 14 doses should be taken even if the infection seems to clear up.
Adding cold liquids into the ear canal can cause dizziness because the balance system is located inside the ears. To avoid dizziness, the solution should be warmed up by holding it in a (washed) hand for a minute or two. It should never be warmed using any electrical applicance, only by body heat.
The patient should lie on his or her side with the affected ear up. The solution should be squeezed into the ear canal, and the patient should not sit up for at least one minute, to keep the medicine from leaking out.
Warnings and Side Effects
Since it is only for otic (ear) use, Cetraxal is much safer than most formulations of ciproflocaxin. The most common side effects, each occurring in 2-3% of patients, were ear pain, ear itching, headache, and secondary fungal infection.
Tell your health care provider about all medications and herbal supplements you are taking. Ciprofloxacin is known to interact not only with certain drugs, but with some herbal supplements as well, so be sure to mention any natural ear infection treatments or home remedies you have tried.
If you do not take the entire course of medication, resistant bacteria can develop. Antibiotics misuse can even lead to superbugs resistant to multiple drugs. Once you start Cetraxal, take it exactly as prescribed unless your health care provider tells you otherwise.
FDA labels for Cetraxal and generic ciprofloxacin