Ciprofloxacin and fluocinolone acetonide

Generic name: Ciprofloxacin And Fluocinolone Acetonide
Drug class: Otic steroids with anti-infectives

Usage of Ciprofloxacin and fluocinolone acetonide

Ciprofloxacin and fluocinolone acetonide combination ear drops is used to treat middle ear infections (also called otitis media) in children 6 months of age and older with tympanostomy tubes.

Ciprofloxacin belongs to the class of medicines known as fluoroquinolone antibiotics. It works by killing the bacteria causing the infection. Fluocinolone acetonide is a steroid medicine that is used to relieve the redness, itching, and swelling caused by ear infections.

This medicine is available only with your doctor's prescription.

Ciprofloxacin and fluocinolone acetonide 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:

Rare

Change in hearing

ear drainage

earache or pain in the ear

fever

loss of balance

Incidence not known

Chest pain or discomfort

cold, clammy, pale skin

confusion

dizziness

fast heartbeat

hearing loss

hives or welts, itching, or skin rash

hoarseness

irregular heartbeats

irritation

joint pain, stiffness, or swelling

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of consciousness

redness of the skin

ringing or buzzing or other unexplained noise in the ears

trouble breathing or swallowing

weakness

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:

Incidence not known

Change in taste

feeling of warmth

headache

loss of taste

redness of the face, neck, arms, and occasionally, upper chest

tingling in the ears

white patches in the mouth or throat or on the tongue

white patches with diaper rash

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.

Before taking Ciprofloxacin and fluocinolone acetonide

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 Otovel® ear drops in children. However, safety and efficacy have not been established in children younger than 6 months of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Otovel® ear drops in the elderly.

Breast Feeding

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.

Interactions with Medicines

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

Desmopressin

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

Aspirin

Astemizole

Atazanavir

Avapritinib

Azimilide

Azithromycin

Bemiparin

Bendamustine

Benzhydrocodone

Betamethasone

Bosutinib

Bretylium

Brigatinib

Budesonide

Buprenorphine

Bupropion

Buserelin

Canagliflozin

Ceritinib

Chlorpromazine

Chlorpropamide

Cholera Vaccine, Live

Cilostazol

Citalopram

Clarithromycin

Clofazimine

Clomipramine

Clothiapine

Clozapine

Codeine

Colchicine

Corticotropin

Cortisone

Cosyntropin

Crizotinib

Cyclobenzaprine

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

Nadroparin

Nafarelin

Naloxegol

Nateglinide

Nilotinib

Nitisinone

Norfloxacin

Nortriptyline

Octreotide

Ofloxacin

Olanzapine

Olaparib

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

Ribociclib

Rimegepant

Rosiglitazone

Sargramostim

Saxagliptin

Selpercatinib

Selumetinib

Semaglutide

Sematilide

Sertraline

Sevoflurane

Simeprevir

Simvastatin

Siponimod

Sirolimus Protein-Bound

Sitagliptin

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Solifenacin

Somatrogon-ghla

Sonidegib

Sorafenib

Sotalol

Sparsentan

Sufentanil

Sulpiride

Sunitinib

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

Cyclosporine

Diclofenac

Dutasteride

Fosphenytoin

Itraconazole

Lanthanum Carbonate

Phenytoin

Probenecid

Rifapentine

Ropinirole

Ropivacaine

Sildenafil

Suvorexant

Interactions with Food/Tobacco/Alcohol

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

Relate drugs

How to use Ciprofloxacin and fluocinolone acetonide

Use this medicine exactly 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. To do so may increase the chance of side effects.

This medicine should come with patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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

To use the ear drops:

Wash hands thoroughly with soap and water.

Gently clean any fluid (discharge) from the outer ear using a clean cloth or tissue. Do not put a cotton swab or any other object in the ear canal.

Remove the medicine from the foil pouch. Do not open the foil pouch until you are ready to use it.

Pull apart 1 single dose vial. Hold the vial in your hands for 1 or 2 minutes to warm the medicine. Cold drops could cause you to become dizzy.

Lie down on your side with your infected ear facing up.

Twist off the vial cap to open. Drop the entire contents of one vial and pump the tragus 4 times.

Keep the ear tilted up for 1 minute.

If necessary, use another vial for the other ear and repeat the same steps.

Throw away the opened vials after use.

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 otic dosage form (ear drops):

For acute otitis media with tympanostomy tubes:

Adults and children 6 months of age and older—0.25 milliliter (1 vial) two times a day for 7 days. Each dose should be 12 hours apart.

Children younger than 6 months 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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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.

Upon opening the foil pouch, use the vials within 7 days.

Warnings

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

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, loss of consciousness, or any swelling of your hands, face, or mouth while you are using this medicine.

Call your doctor right away if you have fluid that continues to drain from your ear (otorrhea) after you have finished your treatment with this medicine.

Disclaimer

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