What is ciprodex for?

Ciprodex

Generic Name: ciprofloxacin and dexamethasone otic (SIP roe FLOX a sin and DEX a METH a sone OH tik)
Brand Names: Ciprodex

Medically reviewed by Drugs.com. Last updated on Aug 9, 2018.

  • Overview
  • Side Effects
  • Dosage
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What is Ciprodex?

Ciprodex ear drops contain ciprofloxacin and dexamethasone. Ciprofloxacin is an antibiotic that treats infections caused by bacteria.

Dexamethasone is a steroid. It reduces the actions of chemicals in the body that cause inflammation.

Ciprodex is used to treat infections inside the ear (also called otitis media), and infections of the ear canal (also called otitis externa).

Ciprodex may also be used for purposes not listed in this medication guide.

Important information

You should not use Ciprodex ear drops if you have a viral infection affecting your ear canal, including herpes or chickenpox.

Do not use this medication in the eyes or take it by mouth. Ciprodex is intended for use in the ears only. Do not touch the dropper opening to any surface, including the ears or hands. The dropper opening is sterile. If it becomes contaminated, it could cause another infection in the ear.

Notify your doctor if the condition does not improve or appears to worsen.

Before taking this medicine

You should not use Ciprodex ear drops if you are allergic to ciprofloxacin or dexamethasone, or if you have:

  • a viral infection affecting your ear canal, including herpes or chickenpox; or

  • if you are allergic to any antibiotic similar to ciprofloxacin (Cipro), such as gatifloxacin (Tequin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), or ofloxacin (Floxin).

To make sure Ciprodex is safe for you, tell your doctor if you have:

  • severe ear pain; or

  • hearing problems.

FDA pregnancy category C. It is not known whether Ciprodex will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether ciprofloxacin and dexamethasone otic passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Ciprodex should not be used on a child younger than 6 months old.

How should I use Ciprodex?

Use Ciprodex exactly as directed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Ciprodex is for use only in the ears.

Shake the medicine well just before each use.

You may warm the medicine before use by holding the bottle in your hand for 1 or 2 minutes. Using cold ear drops can cause dizziness, especially in a child who has ear tubes in place.

To use the Ciprodex ear drops:

  • Lie down or tilt your head with your ear facing upward. Open the ear canal by gently pulling your ear back, or pulling downward on the earlobe when giving this medicine to a child.

  • Hold the dropper upside down over your ear and drop the correct number of drops into the ear.

  • Stay lying down or with your head tilted for 60 seconds. You may use a small piece of cotton to plug the ear and keep the medicine from draining out.

Do not touch the Ciprodex dropper tip or place it directly in your ear. It may become contaminated. Wipe the tip with a clean tissue but do not wash with water or soap.

Use Ciprodex for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have new symptoms.

Store Ciprodex ear drops at room temperature away from moisture, heat, and light. Throw away any unused medicine after your treatment is finished.

Ciprodex dosing information

Usual Adult Dose of Ciprodex for Otitis Externa:

4 drops in the affected ear{s} twice daily for 7 days

Usual Pediatric Dose for Otitis Media:

>=6 months: 4 drops in the affected ear{s} twice daily for 7 days

Usual Pediatric Dose for Otitis Externa:

>=6 months: 4 drops in the affected ear{s} twice daily for 7 days

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

An overdose of this medicine is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

What should I avoid while using Ciprodex?

Avoid getting water in your ears while bathing or showering. Avoid swimming while you are treating an ear infection.

Avoid getting the medicine in your eyes.

Do not use other ear medications unless your doctor tells you to.

Ciprodex side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Ciprodex: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Ciprodex and call your doctor at once if you have:

  • the first sign of any skin rash, no matter how mild;

  • drainage from your ears; or

  • severe burning or other irritation after using the ear drops.

Common Ciprodex side effects may include:

  • ear itching or pain, ear discomfort or fullness;

  • unusual taste in your mouth;

  • feeling irritable;

  • rash; or

  • a buildup of debris in the ear canal.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ciprodex?

It is not likely that other drugs you take orally or inject will have an effect on Ciprodex used in the ears. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Ciprodex only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2020 Cerner Multum, Inc. Version: 2.01.

Medical Disclaimer

More about Ciprodex (ciprofloxacin / dexamethasone otic)

  • Side Effects
  • During Pregnancy
  • Dosage Information
  • Compare Alternatives
  • Pricing & Coupons
  • En Español
  • 69 Reviews
  • Drug class: otic steroids with anti-infectives

Consumer resources

  • Ciprodex
  • Ciprodex (Advanced Reading)

Professional resources

  • Ciprodex (FDA)

Related treatment guides

  • Otitis Externa
  • Otitis Media

How does this medication work? What will it do for me?

This medication is a combination product that contains two medications: ciprofloxacin and dexamethasone. Ciprofloxacin is an antibiotic that belongs to the family of medications known as fluoroquinolones. It is used for the treatment of infections caused by certain bacteria. Dexamethasone belongs to a family of medications known as corticosteroids. Corticosteroids reduce inflammation.

Ciprofloxacin – dexamethasone ear drops are used to treat bacterial middle ear infections in children 6 months and older who have tubes in their ears. They are also used to treat outer ear infections in anyone 1 year and older.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are using this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each mL of otic suspension contains ciprofloxacin HCl (equivalent to ciprofloxacin base 3 mg) and dexamethasone 1 mg. Nonmedicinal ingredients: acetic acid, benzalkonium chloride 0.1 mg as preservative, boric acid, edetate disodium, hydroxyethyl cellulose, purified water, sodium acetate, sodium chloride, and tyloxapol. Sodium hydroxide and/or hydrochloric acid may be added for adjustment of pH.

How should I use this medication?

The usual dose of this medication for both middle and outer ear infections is 4 drops into the affected ear twice a day (about 12 hours apart) for 7 days. The person giving or using the medication should wash their hands with soap and water first. To avoid dizziness, warm the ear drops in the palm of your hand for 1 to 2 minutes before using. Shake the bottle well immediately before using. The simplest way to put drops in the ear is to lie down with the affected ear up. Drop the medication directly into the ear. You or your child should remain in that position for 60 seconds so the drops don’t leak out.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

Ask your doctor or pharmacist to show you the correct method of using ear drops. The procedure is different for children than for adults. The procedure also differs whether there are tubes in the ear or not. This medication is intended for use only as ear drops. Do not apply this medication to your eyes.

It is important to use this medication exactly as prescribed by your doctor. Continue using this medication for the period of time prescribed by your doctor, even if you start to feel better. Stopping the medication too early may cause the bacteria to return and be harder to treat. If there is no improvement in the infection after you have been using the medication for one week, contact your doctor.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light, and keep it out of the reach of children. After treatment has finished, safely discard any remaining drops in the dropper bottle. Do not keep any leftover medication for future use.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not use this medication if you:

  • are allergic to dexamethasone, ciprofloxacin, or any ingredients of the medication
  • are allergic to any of the medications belonging to the class of medications called quinolones (e.g., levofloxacin, moxifloxacin, ofloxacin, norfloxacin, nalidixic acid)
  • are allergic to any other corticosteroids (e.g., prednisone, hydrocortisone)
  • have viral infections of the external ear, including chicken pox and herpes simplex
  • have an ear infection caused by yeast or fungi

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who uses this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people using this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • changes in taste
  • ear debris
  • ear discomfort (feeling of fullness or plugging in the ear)
  • ear itching
  • ear pain
  • irritability
  • overgrowth of fungus, yeast, or other bacteria in the affected ear

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

  • check with your doctor as soon as possible if any of the following side effects occur:
  • discharge from the ear
  • ear swelling
  • nausea
  • peeling skin
  • vomiting

Stop using the medication and seek immediate medical attention if any of the following occur:

  • signs of allergic reaction such as skin itching, rash, redness, or swelling

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: Ciprofloxacin may cause a skin rash. If you notice skin rashes, skin blisters, itchy skin, hives, or other signs of an allergic reaction, stop using the medication and contact your doctor immediately.

Overgrowth of organisms: As with other antibiotics, treatment with this medication may allow normal fungus, yeast, or types of bacteria not killed by the antibiotic to overgrow, causing unwanted infections. If the infection is not improved after one week of therapy, contact your doctor.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication may pass into breast milk. If you are a breast-feeding mother and are using ciprofloxacin – dexamethasone, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established for children under 6 months old.

What other drugs could interact with this medication?

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. In many cases, interactions are intended or are managed by close monitoring. Speak to your doctor about how any drug interactions are being managed or should be managed.

All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Ciprodex

Ciprodex Side Effects

Generic Name: ciprofloxacin / dexamethasone otic

Medically reviewed by Drugs.com. Last updated on Feb 8, 2019.

  • Overview
  • Side Effects
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  • Professional
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Note: This document contains side effect information about ciprofloxacin / dexamethasone otic. Some of the dosage forms listed on this page may not apply to the brand name Ciprodex.

For the Consumer

Applies to ciprofloxacin/dexamethasone otic: otic suspension

Along with its needed effects, ciprofloxacin/dexamethasone otic 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 while taking ciprofloxacin / dexamethasone otic:

Incidence not known

  • Cough
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives, itching, or skin rash
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • tightness in the chest
  • unusual tiredness or weakness

Some side effects of ciprofloxacin / dexamethasone otic 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

  • Ear discomfort
  • ear pain
  • itching skin on the ear

Rare

  • Bitter, sour, or unusual taste in the mouth
  • ear congestion
  • ear debris
  • ear residue
  • redness of the skin
  • superimposed ear infection (second ear infection)

For Healthcare Professionals

Applies to ciprofloxacin / dexamethasone otic: otic suspension

General

The most commonly reported side effects in patients with tympanostomy tubes and acute otitis media were ear pain, discomfort, and dysgeusia/tasting medicine.

The most commonly reported side effect in patients with acute otitis externa was ear pruritus.

Other

Common (1% to 10%): Ear discomfort, ear pain, ear pruritus

Uncommon (0.1% to 1%): Otorrhea, fatigue, ear congestion, candidiasis/fungal ear infection, crying, superimposed ear infection, device/tympanostomy tube blockage/occlusion, ear precipitate/residue/debris/medication residue present

Rare (0.01% to 0.1%): Hypoacusis, tinnitus

Frequency not reported: decreased hearing, ear disorder

Postmarketing reports: Auricular swelling

Nervous system

Uncommon (0.1% to 1%): Taste perversion/dysgeusia, paresthesia/tingling in ears

Rare (0.01% to 0.1%): Dizziness, headache

Dermatologic

Uncommon (0.1% to 1%): Erythema, flushing

Rare (0.01% to 0.1%): Rash erythematous

Postmarketing reports: Skin exfoliation

Gastrointestinal

Uncommon (0.1% to 1%): Vomiting

Frequency not reported: Oral moniliasis

Psychiatric

Uncommon (0.1% to 1%): Irritability

Hypersensitivity

Postmarketing reports: Hypersensitivity

1. “Product Information. Ciprodex (ciprofloxacin-dexamethasone otic).” Alcon Laboratories Inc, Fort Worth, TX.

2. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer

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
  • Amisulpride
  • Artemether
  • Bepridil
  • Cisapride
  • Desmopressin
  • Dronedarone
  • Eliglustat
  • Flibanserin
  • Mesoridazine
  • Pimozide
  • Piperaquine
  • Praziquantel
  • Rilpivirine
  • Rotavirus Vaccine, Live
  • 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
  • Aceclofenac
  • Acemetacin
  • Acetohexamide
  • Aldesleukin
  • Alfentanil
  • Alfuzosin
  • Alogliptin
  • Alosetron
  • Amiodarone
  • Amitriptyline
  • Amoxapine
  • Amtolmetin Guacil
  • Anagrelide
  • Apomorphine
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Artemether
  • Asenapine
  • Astemizole
  • Azimilide
  • Azithromycin
  • Balofloxacin
  • Bemiparin
  • Bendamustine
  • Benfluorex
  • Benzhydrocodone
  • Besifloxacin
  • Betamethasone
  • Boceprevir
  • Bosutinib
  • Bretylium
  • Brigatinib
  • Bromfenac
  • Budesonide
  • Bufexamac
  • Buprenorphine
  • Bupropion
  • Buserelin
  • Canagliflozin
  • Celecoxib
  • Ceritinib
  • Chlorpromazine
  • Chlorpropamide
  • Cholera Vaccine, Live
  • Choline Salicylate
  • Cilostazol
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clofazimine
  • Clomipramine
  • Clonixin
  • Clozapine
  • Cobicistat
  • Codeine
  • Conivaptan
  • Corticotropin
  • Cortisone
  • Cosyntropin
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Daclatasvir
  • Dapagliflozin
  • Darunavir
  • Dasatinib
  • Deflazacort
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Desogestrel
  • Deutetrabenazine
  • Dexamethasone
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Dienogest
  • Diflunisal
  • Dihydrocodeine
  • Dipyrone
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Dronedarone
  • Droperidol
  • Drospirenone
  • Droxicam
  • Duloxetine
  • Efavirenz
  • Eltrombopag
  • Elvitegravir
  • Encorafenib
  • Enoxacin
  • Entrectinib
  • Enzalutamide
  • Erlotinib
  • Ertugliflozin
  • Erythromycin
  • Escitalopram
  • Estradiol
  • Ethinyl Estradiol
  • Ethynodiol
  • Etodolac
  • Etofenamate
  • Etonogestrel
  • Etoricoxib
  • Etravirine
  • Exenatide
  • Felbinac
  • Fenoprofen
  • Fentanyl
  • Fepradinol
  • Feprazone
  • Fingolimod
  • Flecainide
  • Fleroxacin
  • Floctafenine
  • Fluconazole
  • Fludrocortisone
  • Flufenamic Acid
  • Flumequine
  • Fluocortolone
  • Fluoxetine
  • Flurbiprofen
  • Fosamprenavir
  • Foscarnet
  • Gatifloxacin
  • Gemifloxacin
  • Gestodene
  • Glasdegib
  • Gliclazide
  • Glimepiride
  • Glipizide
  • Gliquidone
  • Glyburide
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Hemin
  • Histrelin
  • Hydrocodone
  • Hydrocortisone
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibrutinib
  • Ibuprofen
  • Ibutilide
  • Ifosfamide
  • Iloperidone
  • Imipramine
  • Indomethacin
  • Inotuzumab Ozogamicin
  • Insulin
  • Insulin Aspart, Recombinant
  • Insulin Bovine
  • Insulin Degludec
  • Insulin Detemir
  • Insulin Glargine, Recombinant
  • Insulin Glulisine
  • Insulin Lispro, Recombinant
  • Ivacaftor
  • Ivosidenib
  • Ixabepilone
  • Ketoconazole
  • Ketoprofen
  • Ketorolac
  • Lapatinib
  • Lefamulin
  • Lenvatinib
  • Leuprolide
  • Levofloxacin
  • Levonorgestrel
  • Linagliptin
  • Liraglutide
  • Lofexidine
  • Lomefloxacin
  • Lopinavir
  • Lornoxicam
  • Loxoprofen
  • Lumefantrine
  • Lumiracoxib
  • Lurasidone
  • Macimorelin
  • Meclofenamate
  • Mefenamic Acid
  • Mefloquine
  • Meloxicam
  • Meperidine
  • Mestranol
  • Metformin
  • Methadone
  • Methylprednisolone
  • Metronidazole
  • Midazolam
  • Mifepristone
  • Miglitol
  • Moricizine
  • Morniflumate
  • Moxifloxacin
  • Mycophenolate Mofetil
  • Nabumetone
  • Nadifloxacin
  • Nadroparin
  • Nafarelin
  • Naloxegol
  • Naproxen
  • Nateglinide
  • Nepafenac
  • Neratinib
  • Nevirapine
  • Nifedipine
  • Niflumic Acid
  • Nilotinib
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Nimodipine
  • Norethindrone
  • Norfloxacin
  • Norgestimate
  • Norgestrel
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Olaparib
  • Ondansetron
  • Osimertinib
  • Oxaprozin
  • Oxycodone
  • Oxyphenbutazone
  • Paliperidone
  • Panobinostat
  • Parecoxib
  • Pasireotide
  • Pazopanib
  • Pazufloxacin
  • Pefloxacin
  • Pentazocine
  • Phenylbutazone
  • Piketoprofen
  • Pimavanserin
  • Pioglitazone
  • Piperaquine
  • Pirfenidone
  • Piroxicam
  • Pitolisant
  • Pomalidomide
  • Posaconazole
  • Pramlintide
  • Pranoprofen
  • Prednisolone
  • Prednisone
  • Procainamide
  • Prochlorperazine
  • Proglumetacin
  • Promethazine
  • Propafenone
  • Propyphenazone
  • Proquazone
  • Protriptyline
  • Prulifloxacin
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Rasagiline
  • Repaglinide
  • Ribociclib
  • Ritonavir
  • Rofecoxib
  • Rosiglitazone
  • Rufloxacin
  • Salicylic Acid
  • Salsalate
  • Saquinavir
  • Sargramostim
  • Saxagliptin
  • Sematilide
  • Sertraline
  • Sevoflurane
  • Simeprevir
  • Simvastatin
  • Siponimod
  • Sitagliptin
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Sodium Salicylate
  • Solifenacin
  • Sonidegib
  • Sorafenib
  • Sotalol
  • Sparfloxacin
  • Sufentanil
  • Sulindac
  • Sulpiride
  • Sunitinib
  • Tacrolimus
  • Tasimelteon
  • Tedisamil
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Tenoxicam
  • Tetrabenazine
  • Tezacaftor
  • Thalidomide
  • Theophylline
  • Tiaprofenic Acid
  • Ticagrelor
  • Tolazamide
  • Tolbutamide
  • Tolfenamic Acid
  • Tolmetin
  • Tolvaptan
  • Toremifene
  • Tosufloxacin
  • Tramadol
  • Trazodone
  • Triamcinolone
  • Triclabendazole
  • Trifluoperazine
  • Trimipramine
  • Triptorelin
  • Ulipristal
  • Valdecoxib
  • Vandetanib
  • Vardenafil
  • Velpatasvir
  • Vemurafenib
  • Venetoclax
  • Vildagliptin
  • Vincristine Sulfate Liposome
  • Vinflunine
  • Voriconazole
  • Vortioxetine
  • Voxilaprevir
  • Warfarin
  • 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
  • Alcuronium
  • Aminoglutethimide
  • Aminolevulinic Acid
  • Aprepitant
  • Aspirin
  • Atracurium
  • Auranofin
  • Caspofungin
  • Chloroquine
  • Cyclosporine
  • Diclofenac
  • Dutasteride
  • Fluindione
  • Fosaprepitant
  • Fosnetupitant
  • Fosphenytoin
  • Gallamine
  • Hexafluorenium
  • Itraconazole
  • Lanthanum Carbonate
  • Licorice
  • Metocurine
  • Netupitant
  • Olanzapine
  • Ospemifene
  • Pancuronium
  • Phenobarbital
  • Phenytoin
  • Probenecid
  • Rifampin
  • Rifapentine
  • Ropinirole
  • Ropivacaine
  • Saiboku-To
  • Sildenafil
  • Vecuronium
  • Warfarin

PATIENT INFORMATION

CIPRODEX
(CI-PRO-DEX)
(ciprofloxacin and dexamethasone) otic suspension

What is CIPRODEX?

CIPRODEX is a prescription medicine used in the ear only (otic use) that contains 2 medicines, a quinolone antibiotic medicine called ciprofloxacin and a corticosteroid medicine called dexamethasone. CIPRODEX is used in adults and children 6 months of age or older to treat certain types of infections caused by certain germs called bacteria. These bacterial infections include:

  • middle ear infection (known as acute otitis media) in people who have a tube in their eardrum known as a tympanostomy to prevent having too much fluid in the middle ear
  • outer ear canal infection (known as acute otitis externa)

It is not known if CIPRODEX is safe and effective in children under 6 months of age.

Who should not use CIPRODEX?

Do not use CIPRODEX if you:

  • are allergic to ciprofloxin, quinolones, or any of the ingredients in CIPRODEX. See the end of this Patient Information leaflet for a complete list of ingredients in CIPRODEX.
  • have an outer ear canal infection caused by certain viruses including the herpes simplex virus
  • have an ear infection caused by a fungus

What should I tell my doctor before using CIPRODEX?

Before using CIPRODEX, tell your doctor about all of your medical conditions , including if you:

  • are pregnant or plan to become pregnant. It is not known if CIPRODEX will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. CIPRODEX can pass into your breast milk and may harm your baby. You and your doctor should decide if you will use CIPRODEX or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use CIPRODEX?

  • Read the detailed Instructions for Use that come with CIPRODEX.
  • Use CIPRODEX exactly as your doctor tells you to.
  • CIPRODEX is for us e in the ear only (otic use). Do not inject CIPRODEX or use CIPRODEX in the eye.
  • Apply 4 drops of CIPRODEX into the affected ear 2 times a day for 7 days.
  • Do not stop using CIPRODEX unless your doctor tells you to, even if your symptoms improve.

If your symptoms do not improve after 7 days of treatment with CIPRODEX, call your doctor.

  • Call your doctor right away if:
    • you have fluid that continues to drain from your ear (otorrhea) after you have finished your treatment with CIPRODEX
    • you have fluid that drains from your ear 2 or more times within 6 months after you stop treatment with CIPRODEX

What are the possible side effects of CIPRODEX?

CIPRODEX may cause serious side effects, including:

  • allergic reactions . Stop using CIPRODEX and call your doctor if you have any of the following signs or symptoms of an allergic reaction:
    • hives (urticaria)
    • swelling of your face, lips, mouth, or tongue
    • rash
    • itching
    • trouble breathing
    • dizziness, fast heartbeat, or pounding in your chest

The most common side effects of CIPRODEX include:

  • ear discomfort
  • ear pain
  • ear itching (pruritus)

These are not all the possible side effects of CIPRODEX. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store CIPRODEX?

  • Store CIPRODEX at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not freeze CIPRODEX.
  • Keep CIPRODEX out of light.

Keep CIPRODEX and all medicines out of the reach of children.

General information about the safe and effective use of CIPRODEX.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use CIPRODEX for a condition for which it was not prescribed. Do not give CIPRODEX to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about CIPRODEX that is written for health professionals.

What are the ingredients in CIPRODEX?

Active ingredients : ciprofloxacin hydrochloride, dexamethasone, and benzalkonium chloride as a preservative

Inactive ingredients : boric acid, sodium chloride, hydroxyethyl cellulose, tyloxapol, acetic acid, sodium acetate, edetate disodium, and purified water. Sodium hydroxide or hydrochloric acid may be added for adjustment of pH

Instructions for Use

CIPRODEX
(CI-PRO-DEX)
(ciprofloxacin and dexamethas one) otic suspension

Read this Instructions for Use that comes with CIPRODEX before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.

Important information about CIPRODEX:

  • Use CIPRODEX exactly as your doctor tells you to use it.
  • CIPRODEX is for use in the ear only (otic use). Do not inject CIPRODEX or use CIPRODEX in the eye.
  • Shake CIPRODEX well before each use.
  • Do not touch your ear, fingers or other surfaces with the tip of the CIPRODEX bottle. You may get bacteria on the tip of the bottle that can cause you to get another infection.

How should I use CIPRODEX?

Step 1. Wash your hands with soap and water.

Figure A

Step 2. Warm the bottle of CIPRODEX by rolling the bottle between your hands for 1 to 2 minutes (See Figure A). Shake the bottle of CIPRODEX well.

Step 3. Remove the CIPRODEX cap. Put the cap in a clean and dry area. Do not let the tip of the bottle touch your ear, fingers or other surfaces.

Figure B

Step 4. Lie down on your side so that the affected ear faces upward (See Figure B).

Figure C

Step 5. Hold the bottle of CIPRODEX between your thumb and index finger (See Figure C). Place the tip of the bottle close to your ear. Be careful not to touch your fingers or ear with the tip of the bottle.

Step 6. Gently squeeze the bottle and let 4 drops of CIPRODEX fall into the affected ear. If a drop misses your ear, follow the instructions in Step 5 again.

Step 7. Stay on your side with the affected ear facing upward (See Figure B)

It is important that you follow the instructions below for your specific ear infection, to allow CIPRODEX to enter the affected part of your ear.

Step 8.

If you use CIPRODEX to treat a middle ear infection and you have a tube in your eardrum known as a tympanos tomy:

  • Gently press the part of the ear known as the tragus (See Figure D) 5 times using a pumping motion (See Figure D). This will allow the drops of CIPRODEX to enter your middle ear.
  • Remain on your side with the affected ear facing upward (See Figure B) for 1 minute.

Figure D

If you use CIPRODEX to treat an outer ear canal infection:

  • Gently pull the outer ear lobe upward and backward (See Figure E). This will allow the drops of CIPRODEX to enter your ear canal.
  • Remain on your side with the affected ear facing upward (See Figure B) for 1 minute.

Figure E

Step 9. If your doctor has told you to use CIPRODEX in both ears, repeat steps 5-8 for your other ear.

Step 10. Put the cap back on the bottle and close it tightly.

Step 11. After you have used all of your CIPRODEX doses, there may be some CIPRODEX left in the bottle. Throw the bottle away.

How should I store CIPRODEX?

  • Store CIPRODEX at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not freeze CIPRODEX.
  • Keep CIPRODEX out of light.

Keep CIPRODEX and all medicines out of the reach of children.

If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for more information about CIPRODEX that is written for health professionals.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

PATIENT INFORMATION

CIPRODEX® (CI-PRO-DEX)

(ciprofloxacin 0.3% and dexamethasone 0.1%)

Sterile Otic Suspension

IMPORTANT PATIENT INFORMATION AND INSTRUCTIONS. READ BEFORE USE.

What is CIPRODEX® Otic?

CIPRODEX® Otic is an antibiotic/steroid combination product in a sterile suspension used to treat:

• Middle Ear Infection with Drainage Through a Tube in Children 6 months and older: A middle ear infection is a bacterial infection behind the eardrum. People with a tube in the eardrum may notice drainage from the ear canal.\

• Outer Ear Canal Infection in Patients 6 months and older: An outer ear canal infection, also known as “Swimmer’s Ear”, is a bacterial infection of the outer ear canal. The ear canal and the outer part of the ear may swell, turn red, and be painful. Also, a fluid discharge may appear in the ear canal.

Who should NOT use CIPRODEX® Otic?

• Do not use this product if allergic to ciprofloxacin or to other quinolone antibiotics.

• Do not use this product if allergic to dexamethasone or to other steroids.

• Do not give this product to pediatric patients who are less than 6 months old.

How often should CIPRODEX® Otic be given?

CIPRODEX® Otic ear drops should be given 2 times each day (about 12 hours apart, for example, 8 AM and 8 PM) in each infected ear unless the doctor has instructed otherwise. The best times to use the ear drops are in the morning and at night. It is very important to use the ear drops for as long as the doctor has instructed, even if the symptoms improve. If CIPRODEX® Otic ear drops are not used for as long as the doctor has instructed, the infection may return.

What if a dose is missed?

If a dose of CIPRODEX® Otic is missed, it should be given as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not use a double dose unless the doctor has instructed you to do so. If the infection is not improved after one week, you should consult your doctor. If you have two or more episodes of drainage within six months, it is recommended you see your doctor for further evaluation.

What activities should be avoided while using CIPRODEX® Otic?

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

What are the possible side effects of CIPRODEX® Otic?

During the testing of CIPRODEX® Otic for middle ear infections, the most common side effect related to CIPRODEX® Otic was ear discomfort that occurred in up to 3 out of 100 patients. Other common side effects were: ear pain; ear precipitate (residue); irritability; and abnormal taste. During the testing of CIPRODEX® Otic for ear canal infections, the most common side effect related to CIPRODEX® Otic was itching of the ear that occurred in 1 to 2 out of 100 patients. Other common side effects were: ear debris; ear infection in the treated ear; ear congestion; ear pain; and rash.

If any of these side effects persist, call the doctor.

If an allergic reaction to CIPRODEX® Otic occurs, stop using the product and contact your doctor.

DO NOT TAKE BY MOUTH

If CIPRODEX® Otic is accidentally swallowed or overdose occurs, call the doctor immediately. This medicine is available only with a doctor’s prescription. Use only as directed. Do not use this medicine if outdated. If you wish to learn more about CIPRODEX® Otic, call your doctor or pharmacist.

HOW SUPPLIED

CIPRODEX® Otic is supplied as follows: 7.5 mL fill in a DROP-TAINER® system. The DROP-TAINER® system consists of a natural polyethylene bottle and natural plug, with a white polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package.

NDC 21695-969-75, 7.5 mL fill

Storage:

Store at controlled room temperature, 15°C to 30°C (59°F to 86°F). Avoid freezing. Protect from light.

U.S. Patent Nos. 6,284,804; 6,359,016

Licensed to Alcon, Inc. by Bayer Schering Pharma AG.

CIPRODEX is a registered trademark of Bayer AG, licensed to Alcon, Inc by Bayer AG.

Rx Only

©2003, 2004, 2008, 2009 Alcon, Inc.

Relabeled by: Rebel Distributors Corp

Thousand Oaks, CA 91320

How should CIPRODEX® Otic be given?

1. Wash hands

The person giving CIPRODEX® Otic should wash his/her hands with soap and water.

2. Warm & shake bottle

Hold the bottle of CIPRODEX® Otic in the hand for one or two minutes to warm the suspension, then shake well.

3. Add drops

The person receiving CIPRODEX® Otic should lie on his/her side with the infected ear up.

Patients should have 4 drops of CIPRODEX® Otic put into the infected ear. The tip of the bottle should not touch the fingers, or the ear, or any other surfaces.

BE SURE TO FOLLOW INSTRUCTIONS BELOW FOR THE PATIENT’S SPECIFIC EAR INFECTION.

4. For Patients with Middle Ear Infection with Tubes:

While the person receiving CIPRODEX® Otic lies on his/her side, the person giving the drops should gently press the tragus (see diagram) 5 times in a pumping motion. This will allow the drops to pass through the tube in the eardrum and into the middle ear.

5. For Patients with Outer Ear Infection (“Swimmer’s Ear”):

While the person receiving the drops lies on his/her side, the person giving the drops should gently pull the outer ear lobe upward and backward. This will allow the ear drops to flow down into the ear canal.

6. Stay on side

The person who received the ear drops should remain on his/her side for at least 60 seconds.

Repeat Steps 2-5 for the other ear if both ears are infected.

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