Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 3/27/2023

Drug Summary

What Is Cetraxal?

Cetraxal (ciprofloxacin) Otic Solution 0.2% is an antibiotic used to treat ear infections that affect the outer ear canal. This type of ear infection is sometimes called "swimmer's ear."

What Are Side Effects of Cetraxal?

Cetraxal may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • skin rash (no matter how mild), and
  • new ear drainage with severe itching

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Cetraxal Otic Solution include headache, or discomfort, pain, irritation, or itching in the ear. Seek medical attention if you have side effects of a severe allergic reaction to Cetraxal Otic Solution including:

  • hives
  • difficulty breathing, or
  • swelling of your face, lips, tongue, or throat

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Cetraxal

The dose of Cetraxal is to instill the contents of one single use container (0.25 mL) into the affected ear twice daily (approximately 12 hours apart) for 7 days.

What Drugs, Substances, or Supplements Interact with Cetraxal?

Cetraxal may interact with other drugs. Tell your doctor all medications and supplements you use.

Cetraxal During Pregnancy or Breastfeeding

During pregnancy, Cetraxal should be used only if prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Cetraxal (ciprofloxacin) Otic Solution 0.2% Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

Drug Description


CETRAXAL (ciprofloxacin otic solution) 0.2% contains the synthetic antimicrobial agent ciprofloxacin hydrochloride. CETRAXAL (ciprofloxacin otic solution) is a sterile, preservative-free solution for otic use. Each single use container of CETRAXAL 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 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3•HCl•H2O, and molecular weight is 385.82.

The chemical structure of ciprofloxacin hydrochloride is:

 CETRAXAL (ciprofloxacin) Structural Formula Illustration

Side Effects & Drug Interactions


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 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.


No Information Provided

Warnings & Precautions


Included as part of the "PRECAUTIONS" Section


Otic Use Only

CETRAXAL is for otic use only. It should not be used for injection, for inhalation or for topical ophthalmic use.


CETRAXAL should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.

Growth Of Resistant Organisms With Prolonged Use

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.

Lack Of Clinical Response

If the infection is not improved after one week of therapy, cultures may help guide further treatment.

Use In Specific Populations


Pregnancy Category C

Reproduction studies have been performed in rats and mice using oral doses of up to 100 mg/kg and intravenous (IV) doses up to 30 mg/kg and have revealed no evidence of harm to the fetus as a result of ciprofloxacin. In rabbits, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose. After intravenous administration of doses up to 20 mg/kg, no maternal toxicity was produced in the rabbit, and no embryotoxicity or teratogenicity was observed.

Animal reproduction studies have not been conducted with CETRAXAL. No adequate and well-controlled studies have been performed in pregnant women. Caution should be exercised when CETRAXAL is used by a pregnant woman.

Nursing Mothers

Ciprofloxacin is excreted in human milk with systemic use. It is not known whether ciprofloxacin is excreted in human milk following otic use. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and effectiveness of CETRAXAL in infants below one year of age have not been established. The efficacy of CETRAXAL in treating otitis externa in pediatric patients one year or older has been demonstrated in controlled clinical trials (see Clinical Studies).

There is no evidence that the otic administration of quinolones has any effect on weight bearing joints, even though systemic administration of some quinolones has been shown to cause arthropathy in immature animals.

Geriatric Use

No overall differences in safety and effectiveness have been observed between elderly and younger

Overdose & Contraindications


No Information Provided


CETRAXAL is contraindicated in persons with a history of hypersensitivity to ciprofloxacin.

Clinical Pharmacology


Mechanism Of Action

Ciprofloxacin is a fluoroquinolone antimicrobial (see CLINICAL PHARMACOLOGY, Microbiology).


The plasma concentrations of ciprofloxacin were not measured following administration of 0.25 mL CETRAXAL (total dose: 0.5 mg ciprofloxacin). However, the maximum plasma concentration of ciprofloxacin is anticipated to be less than 5 ng/mL.


The bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase, which is needed for the synthesis of bacterial DNA.

Bacterial resistance to quinolones can develop through chromosomally- or plasmid-mediated mechanisms.

The mechanism of action of fluoroquinolones, including ciprofloxacin, is different from that of macrolides. Therefore, ciprofloxacin may be active against pathogens that are resistant to these antibiotics, and these antibiotics may be active against pathogens that are resistant to ciprofloxacin. In vitro studies demonstrated cross-resistance between ciprofloxacin and some fluoroquinolones.

Ciprofloxacin has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections of acute otitis externa as described in Section INDICATIONS AND USAGE.

Staphylococcus aureus
Pseudomonas aeruginosa.

Clinical Studies

In a randomized, multi-center, evaluator-blinded study of patients with acute otitis externa, patients were treated with either CETRAXAL twice daily or neomycin and polymyxin B sulfates and hydrocortisone otic solution (PNH) three times daily for 7 days.

In the per protocol population, clinical cure was achieved at the end of a 7-day treatment in 70% (173/247) for the CETRAXAL treated group versus 60% (147/243) for the control treated group.

Medication Guide


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.

Wash your hands before use - Illustration

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.

Warm the container in your hands for at least one minute  - Illustration

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.

Lie with the affected ear upward and then instill the contents of one container into the ear - Illustration

Repeat, if necessary, for the opposite ear.

Discard used container.

Store unused containers in pouch to protect from light.


Patients should be advised to immediately discontinue CETRAXAL at the first appearance of a skin rash or any other sign of hypersensitivity [see WARNINGS AND PRECAUTIONS].

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