Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

1. Cetraxal

Descriptions

Ciprofloxacin ear solution or suspension is used to treat otitis externa. Otitis externa, also known as swimmer's ear, is an infection of the outer ear canal caused by bacteria. The ear canal and outer part of the ear may be swollen, red, and painful.

Ciprofloxacin belongs to the class of medicines known as fluoroquinolone antibiotics. It works by killing the bacteria or preventing their growth.

Cetraxal® is available only with your doctor's prescription.

Otiprio® ear suspension is to be given by or under the direct supervision of your doctor.

This product is available in the following dosage forms:

• Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ciprofloxacin ear solution or suspension in children. However, safety and efficacy have not been established in infants younger than 1 year of age for Cetraxal® ear solution and in infants younger than 6 months of age for Otiprio® ear suspension.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ciprofloxacin ear solution or suspension in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Agomelatine
• Bepridil
• Cisapride
• Dronedarone
• Eliglustat
• Fezolinetant
• Flibanserin
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Tizanidine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acalabrutinib
• Acarbose
• Acecainide
• Adagrasib
• Albiglutide
• Alfentanil
• Alfuzosin
• Alogliptin
• Alosetron
• Alprazolam
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Anagrelide
• Apomorphine
• Aprepitant
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asenapine
• Astemizole
• Atazanavir
• Avapritinib
• Azimilide
• Azithromycin
• Bendamustine
• Benzhydrocodone
• Betamethasone
• Bosutinib
• Bretylium
• Brigatinib
• Budesonide
• Buprenorphine
• Bupropion
• Buserelin
• Canagliflozin
• Capivasertib
• Carbamazepine
• Ceritinib
• Chlorpromazine
• Chlorpropamide
• Cholera Vaccine, Live
• Cilostazol
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Codeine
• Colchicine
• Corticotropin
• Cortisone
• Cosyntropin
• Crizotinib
• Cyclobenzaprine
• Cyclosporine
• Dabrafenib
• Dapagliflozin
• Daridorexant
• Dasatinib
• Deflazacort
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexamethasone
• Dexmedetomidine
• Dihydrocodeine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Dulaglutide
• Duloxetine
• Efavirenz
• Elacestrant
• Elexacaftor
• Empagliflozin
• Encorafenib
• Entrectinib
• Erlotinib
• Ertugliflozin
• Erythromycin
• Escitalopram
• Etrasimod
• Exenatide
• Fenfluramine
• Fentanyl
• Fexinidazole
• Finerenone
• Fingolimod
• Flecainide
• Fluconazole
• Fludrocortisone
• Fluocortolone
• Fluoxetine
• Formoterol
• Fosaprepitant
• Foscarnet
• Fostemsavir
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Glimepiride
• Glipizide
• Glyburide
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydrocodone
• Hydrocortisone
• Hydroxychloroquine
• Hydroxyzine
• Ibrutinib
• Ibutilide
• Ifosfamide
• Iloperidone
• Imipramine
• Infigratinib
• Inotuzumab Ozogamicin
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Ivacaftor
• Ivosidenib
• Ketoconazole
• Lapatinib
• Larotrectinib
• Lefamulin
• Leflunomide
• Lemborexant
• Lenvatinib
• Leuprolide
• Levofloxacin
• Linagliptin
• Liraglutide
• Lixisenatide
• Lofexidine
• Lopinavir
• Lumateperone
• Lumefantrine
• Lurasidone
• Lurbinectedin
• Macimorelin
• Magnesium Sulfate
• Mavacamten
• Mefloquine
• Meperidine
• Metformin
• Methadone
• Methotrexate
• Methylprednisolone
• Metronidazole
• Midazolam
• Mifepristone
• Miglitol
• Mirtazapine
• Mitapivat
• Mobocertinib
• Moricizine
• Moxifloxacin
• Mycophenolate Mofetil
• Nafarelin
• Naloxegol
• Nateglinide
• Nilotinib
• Nirogacestat
• Nitisinone
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Olaparib
• Oliceridine
• Omaveloxolone
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxycodone
• Ozanimod
• Pacritinib
• Paliperidone
• Palovarotene
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pemigatinib
• Pentazocine
• Pexidartinib
• Phenobarbital
• Pimavanserin
• Pioglitazone
• Pirfenidone
• Pitolisant
• Pomalidomide
• Ponesimod
• Porfimer
• Posaconazole
• Pralsetinib
• Pramlintide
• Prednisolone
• Prednisone
• Primidone
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Rasagiline
• Relugolix
• Repaglinide
• Repotrectinib
• Ribociclib
• Rimegepant
• Roflumilast
• Rosiglitazone
• Saxagliptin
• Selpercatinib
• Selumetinib
• Semaglutide
• Sematilide
• Sertraline
• Sevoflurane
• Simeprevir
• Simvastatin
• Siponimod
• Sirolimus Protein-Bound
• Sitagliptin
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sonidegib
• Sorafenib
• Sotalol
• Sparsentan
• Sufentanil
• Sulpiride
• Sunitinib
• Suvorexant
• Tacrolimus
• Tasimelteon
• Tazemetostat
• Tedisamil
• Telavancin
• Telithromycin
• Teriflunomide
• Tetrabenazine
• Tezacaftor
• Theophylline
• Tolazamide
• Tolbutamide
• Tolvaptan
• Toremifene
• Tramadol
• Trazodone
• Triamcinolone
• Triclabendazole
• Trifluoperazine
• Trimipramine
• Triptorelin
• Ubrogepant
• Vandetanib
• Vardenafil
• Vemurafenib
• Venetoclax
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voglibose
• Voriconazole
• Warfarin
• Zanubrutinib
• Zolpidem
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Aminolevulinic Acid
• Amlodipine
• Chloroquine
• Diclofenac
• Dutasteride
• Fosphenytoin
• Itraconazole
• Lanthanum Carbonate
• Phenytoin
• Probenecid
• Rifapentine
• Ropinirole
• Ropivacaine
• Sildenafil

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine

Proper Use

A doctor or other healthcare professional will give your child the Otiprio® ear suspension. It is to be given through a needle into your child's middle ear.

Use Cetraxal® ear solution only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

The solution comes in small containers that are only used one time. Throw the empty container away after putting the medicine into your ear(s).

This medicine should be used only inside the ear. Do not put it in the eyes or nose, and do not take it by mouth. If this medicine is swallowed by accident or gets into your eyes, call your doctor right away.

It is important that the infected ear remain clean and dry. When bathing, avoid getting the infected ear wet. Avoid swimming unless your doctor has instructed you otherwise.

To use the ear drops:

• Wash your hands thoroughly with soap and water.
• Hold the solution container in your hands for at least 1 minute to warm the solution. Putting a cold solution in your ear could cause you to become dizzy.
• Twist the top of the container off and throw it away.
• Lie down on your side with the infected ear facing up.
• Put all of the solution from the container in the infected ear. You should remain on your side for at least 1 minute.
• Throw the empty container away.
• Repeat the above steps if both ears are infected.

Keep using this medicine for the full treatment time, even if you or your child feel better after the first few doses. The infection may not clear up if you stop using the medicine too soon. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ear drops:
  • For ear infections:
    • Adults and children older than 1 year of age—Use the contents of one container in the affected ear(s) 2 times a day for 7 days.
    • Children younger than 1 year of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

Your doctor will check your or your child's progress closely while you are receiving Otiprio®. Your doctor will also check your or your child's progress at regular visits while you are using Cetraxal®. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to use or receive it.

If you or your child feel that your symptoms have not improved after 7 days, or if they have become worse, check with your doctor.

Call your doctor right away at the first sign of a skin rash or any other allergic reaction.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

1. Burning, itching, redness, skin rash, swelling, or soreness at the application site
2. changes in hearing
3. ear drainage
4. earache or pain in the ear
5. fever

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

1. Headache

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Portions of this document last updated: April 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/ciprofloxacin-otic-route/precautions/drg-20073040