Bausch lomb ear drops

Cortisporin Otic Solution

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 12/21/2018

Cortisporin Otic Solution (neomycin and polymyxin B sulfates and hydrocortisone otic solution) is a combination of two antibiotics and an anti-inflammatory corticosteroid in an ear drop used to treat outer ear infections caused by bacteria (also known as swimmer’s ear). Cortisporin Otic Solution is available in generic form. Common side effects of Cortisporin Otic Solution include:

  • temporary stinging or burning of the ear for a minute or two when applied.

Tell your doctor if you have a rare but very serious side effect of Cortisporin Otic Solution such as:

  • hearing problems (e.g., hearing loss).

The dose of Cortisporin Otic Solution for adults is four drops instilled into the affected ear 3 or 4 times daily. For infants and children, three drops are suggested. Cortisporin Otic Solution may interact with other medications. Before using this medication, tell your doctor all prescription and nonprescription/herbal products you may use. Cortisporin Otic Solution should be used only if prescribed during pregnancy. It is not known whether this medication passes into breast milk. Consult your doctor before breastfeeding.

Our Cortisporin Otic Solution (neomycin and polymyxin B sulfates and hydrocortisone otic solution, USP) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

HOW SUPPLIED:

Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution, USP is supplied in a white plastic dropper bottle in the following size:

10 mL – NDC 24208-631-10

Storage: Store between 15°-25°C (59°-77°F). Rx Only

Securely tighten cap between uses.

DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT

KEEP OUT OF REACH OF CHILDREN.

1. Jones, RN, Milazzo J, Seidlin, M. Ofloxacin Otic Solution for Treatment of Otitis Externa in Children and Adults. Arch Otolaryngol Head Neck Surg. 1997; 123; 1193-1200. 2. Leyden JJ, Kligman AM. Contact dermatitis to neomycin sulfate. JAMA 1979; 242: 276-1278. 3. Prystowsky SD, Allen AM, Smith RW, Nonomura JH, Odum RB, Akers WA. Allergic contact hypersensitivity to nickel, neomycin, ethylenediamine, and benzocaine: relationships between age, sex, history of exposure, and reactivity to standard patch tests and use tests in general population. Arch Dermatol 1979; 115:959-962.

Bausch + Lomb, a division of
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
©Bausch & Lomb Incorporated

Revised August 2016

9072105 (Folded)

9072205 (Flat)

Prod. No. 10009

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 24208-631-10

Neomycin and
Polymyxin B
Sulfates and
Hydrocortisone
Otic Solution,
USP (Sterile)

FOR USE IN EARS ONLY

Rx only

10 mL

BAUSCH + LOMB

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
neomycin sulfate, polymyxin b sulfate, hydrocortisone solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24208-631
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN 3.5 mg in 1 mL
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B 10000 in 1 mL
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL
HYDROCHLORIC ACID
POTASSIUM METABISULFITE
CUPRIC SULFATE
GLYCERIN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24208-631-10 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 10 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-631-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064053 12/29/1995

Labeler — Bausch & Lomb Incoporated (196603781)

Establishment
Name Address ID/FEI Operations
Bausch & Lomb Incoporated 079587625 MANUFACTURE (24208-631)

Revised: 08/2016 Bausch & Lomb Incoporated

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Floxin Otic

SIDE EFFECTS

Subjects with Otitis Externa

In the phase III clinical trials performed in support of once-daily dosing, 799 subjects with otitis externa and intact tympanic membranes were treated with ofloxacin otic solution. The studies, which served as the basis for approval, were 020 (pediatric, adolescents and adults), 016 (adolescents and adults) and 017 (pediatric). The following treatment-related adverse events occurred in two or more of the subjects.

An unexpected increased incidence of application site reaction was seen in studies and was similar for both ofloxacin and the active control drug (neomycin-polymyxin B sulfate-hydrocortisone). This finding is believed to be the result of specific questioning of the subjects regarding the incidence of application site reactions.

In once daily dosing studies, there were also single reports of nausea, seborrhea, transient loss of hearing, tinnitus, otitis externa, otitis media, tremor, hypertension and fungal infection.

In twice daily dosing studies, the following treatment-related adverse events were each reported in a single subject: dermatitis, eczema, erythematous rash, follicular rash, hypoaesthesia, tinnitus, dyspepsia, hot flushes, flushing and otorrhagia.

Subjects with Acute Otitis Media with Tympanostomy Tubes (AOM TT) and Subjects with Chronic Suppurative Otitis Media (CSOM) with Perforated Tympanic Membranes

In phase III clinical trials which formed the basis for approval, the following treatment-related adverse events occurred in 1% or more of the 656 subjects with non-intact tympanic membranes in AOM TT or CSOM treated twice-daily with ofloxacin otic solution:

Adverse Event Incidence
(N=656)
Taste Perversion 7%
Earache 1%
Pruritus 1%
Paraesthesia 1%
Rash 1%
Dizziness 1%

Post-Marketing Adverse Events

Cases of uncommon transient neuropsychiatric disturbances have been included in spontaneous post-marketing reports. A causal relationship with ofloxacin otic solution 0.3% is unknown.

Read the entire FDA prescribing information for Floxin Otic (Ofloxacin Otic Solution)

Ciprodex

The following serious adverse reactions are described elsewhere in the labeling:

  • Hypersensitivity Reactions
  • Potential for Microbial Overgrowth with Prolonged Use

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In Phases II and III clinical trials, a total of 937 patients were treated with CIPRODEX. This included 400 patients with acute otitis media with tympanostomy tubes and 537 patients with acute otitis externa. The reported adverse reactions are listed below:

Acute Otitis Media In Pediatric Patients With Tympanostomy Tubes

The following adverse reactions occurred in 0.5% or more of the patients with non-intact tympanic membranes.

The following adverse reactions were each reported in a single patient: tympanostomy tube blockage; ear pruritus; tinnitus; oral moniliasis; crying; dizziness; and erythema.

Acute Otitis Externa

The following adverse reactions occurred in 0.4% or more of the patients with intact tympanic Membranes

The following adverse reactions were each reported in a single patient: ear discomfort; decreased hearing; and ear disorder (tingling).

Postmarketing Experience

The following adverse reactions have been identified during post approval use of CIPRODEX. Because these reactions are reported voluntarily from a population of unknown size it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include: auricular swelling, headache, hypersensitivity, otorrhea, skin exfoliation, rash erythematous, and vomiting.

Read the entire FDA prescribing information for Ciprodex (Ciprofloxacin and Dexamethasone )

Chloromycetin Ear Drops

Generic Name: chloramphenicol
Product Name: Chloromycetin Ear Drops

Indication: What Chloromycetin Ear Drops is used for

Chloromycetin Ear Drops are used to treat bacterial infections of the ear.

Chloromycetin belongs to a group of medicines called antibiotics. It works by stopping the growth of bacteria causing your infection.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is not addictive.

It is available only with a doctor’s prescription.

Action: How Chloromycetin Ear Drops works

Chloramphenicol is a broad spectrum antibiotic originally isolated from Streptomyces venezuelae. It is primarily bacteriostatic and acts by inhibition of protein synthesis by interfering with the transfer of activated amino acids from soluble RNA to ribosomes.

Each 1 mL contains 5 milligrams of chloramphenicol as the active ingredient. It also contains borax, boric acid, phenylmercuric nitrate, and purified water.

Chloromycetin Ear Drops do not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Dose advice: How to use Chloromycetin Ear Drops

Before you use it

When you must not use it

Do not use Chloromycetin Ear Drops if you have an allergy to:

  • Chloramphenicol;
  • Any of the ingredients listed here;
  • Any other similar medicines.

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

Chloromycetin Ear Drops should not be used if you have a burst eardrum.

Do not give Chloromycetin to babies or children, unless your doctor tells you to.

Do not use Chloromycetin Ear Drops after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start using this medicine, talk to your doctor.

Before you start to use it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had anaemia, bleeding or other blood problems.

Tell your doctor if you are pregnant, plan to become pregnant or are breastfeeding.

Your doctor will discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you start using Chloromycetin Ear Drops.

Taking or using other medicines

Tell your doctor or pharmacist if you are taking or using any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop. Chloromycetin Ear Drops and some other medicines may interfere with each other. These include other ear drops.

These medicines may be affected by Chloromycetin or may affect how well it works. You may need different amounts of your medicines, or you may need to use different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while using Chloromycetin.

How to use Chloromycetin Ear Drops

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained here.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How much to use

The dose of Chloromycetin may be different for different people. Your doctor or pharmacist will tell you the right amount to use.

The usual dose is four drops placed into the infected ear four times a day.

How to use them

Thoroughly clean your ear canal and dry it with a cotton applicator before using Chloromycetin Ear Drops.

You may warm Chloromycetin Ear Drops to body temperature, but no higher, by holding the bottle in your hand for a few minutes.

Lie down or tilt your head so the infected ear is facing upwards. Place the required number of drops into the ear canal. Keep the ear facing up for about 5 minutes to allow the medicine to coat the ear canal. For young children who cannot stay still for 5 minutes, try to keep the ear facing up for 1 to 2 minutes.

To keep the medicine as germ-free as possible do not touch the dropper to any surface (including the ear). Close the container tightly after use.

How long to use them

Continue using Chloromycetin Ear Drops for as long as your doctor tells you. If you stop using this medicine too soon your symptoms may return.

If you forget to use them

If it is almost time for your next dose (less than 2 hours), skip the dose you missed and instill your next dose when you are meant to. Otherwise, instill a dose as soon as you remember, and then go back to using your medicine as you would normally.

Do not use a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist. If you have trouble remembering to use your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Australian Poisons Information Centre (telephone 13 11 26), or the New Zealand National Poisons Information Centre (telephone 0800 Poison or 0800 764 766) or go to Accident and Emergency at the nearest hospital if you think an infant or young child may have accidentally swallowed Chloromycetin Ear Drops. Do this even if there are no signs of discomfort or poisoning. The child may need urgent medical attention.

Contact your doctor or the Australian Poisons Information Centre (telephone 13 11 26), or the New Zealand National Poisons Information Centre (telephone 0800 POISON or 0800 764 766) if you or another adult accidentally swallows Chloromycetin Ear Drops. It is a good idea to do this even if there are no signs of discomfort or poisoning.

While you are using Chloromycetin Ear Drops

Things you must do

Use Chloromycetin Ear Drops exactly as your doctor has told you.

If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.

Stop using Chloromycetin Ear Drops and tell your doctor if irritation occurs or you experience an allergic reaction.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Chloromycetin Ear Drops.

Tell any other doctors, dentists, and pharmacists who treat you that you are using Chloromycetin.

Keep all of your doctor appointments so that your progress can be checked

Things you must not do

Do not use Chloromycetin Ear Drops for longer than your doctor has prescribed.

Do not use Chloromycetin Ear Drops to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop using your medicine or lower the dosage without checking with your doctor. If you do not complete the full course prescribed by your doctor, the infection may not be completely cured. The bacteria may grow again and your symptoms may return.

Things to be careful of

Be careful driving or operating machinery until you know how Chloromycetin Ear Drops affect you. This medicine generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, Chloromycetin may cause tiredness in some people. If you are affected, do not drive, operate machinery or do anything else that could be dangerous.

After using Chloromycetin Ear Drops

Storage

Keep your Ear Drops in the bottle until it is time to use them. If you take the Ear Drops out of the bottle they may not keep well.

Keep unopened bottles in the refrigerator, where the temperature stays between 2 degrees C and 8 degrees C. After opening, keep Chloromycetin Ear Drops in a cool dry place where the temperature stays below 25 degrees C. Protect from light.

Discard unused Ear Drops within one month.

Do not store Chloromycetin Ear Drops or any other medicine in the bathroom or near a sink. Do not leave it on a windowsill or in the car. Heat and dampness can destroy some medicines. Keep Chloromycetin Ear Drops where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using Chloromycetin or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Chloromycetin Ear Drops should be discarded within one month after opening.

Schedule of Chloromycetin Ear Drops

Chloromycetin Ear Drops is a Schedule 4 (Prescription Only Medicine).

Side effects of Chloromycetin Ear Drops

Tell your doctor or pharmacist as soon as possible if you do not feel well during or after using Chloromycetin Ear Drops. Chloromycetin helps most people with ear infections, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Do not be alarmed by the following lists of side effects. You may not experience any of them. Tell your doctor or pharmacist if you notice any of the following and it worries you:

  • Temporary itching or burning.

Tell your doctor as soon as possible if you notice any of the following:

  • Worsening of your condition;
  • Skin rash, itching or swelling;
  • Fever;
  • Unusual tiredness, weakness, bleeding or bruising more easily than normal.

The above list includes serious side effects, which may require medical attention.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • Allergic reactions including fever, rash, swelling of the face, lips, mouth or sore throat that may cause difficulty in swallowing or breathing, shortness of breath, swelling of the hands, feet or ankles.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

Other side effects not listed above may also occur in some people. Tell your doctor or pharmacist if you notice anything that is making you feel unwell during or after treatment with Chloromycetin.

For further information talk to your doctor.

  1. Chloromycetin Ear Drops Consumer Medicine Information (CMI). West Ryde, NSW: Pfizer Australia Pty Ltd. March 2005.
  2. Chloromycetin Ear Drops Product Information (PI). West Ryde, NSW: Pfizer Australia Pty Ltd. March 2014.

Hydrocortisone / Neomycin / Polymyxin B Otic Dosage

Medically reviewed by Drugs.com. Last updated on Nov 25, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

Applies to the following strengths: 1%-0.35%-10000 units/mL

Usual Adult Dose for:

  • Otitis Externa

Usual Pediatric Dose for:

  • Otitis Externa

Additional dosage information:

  • Renal Dose Adjustments
  • Liver Dose Adjustments
  • Precautions
  • Dialysis
  • Other Comments

Usual Adult Dose for Otitis Externa

4 drops instilled into the affected ear 3 or 4 times per day

-Therapy with this product should be limited to 10 consecutive days.
-The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator.
Use: Treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Safety and efficacy have not been established in patients younger than 2 years.
Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Shake well before using.
-Do not use if imprinted neckband is not intact.
-The patient should lie with the affected ear upward and then the drops should be instilled. This position should be maintained for 5 minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.
-If preferred, a cotton wick may be inserted into the canal and then the cotton may be saturated with the solution. This wick should be kept moist by adding further solution every 4 hours. The wick should be replaced at least once every 24 hours.
Patient advice:
-This drug is for administration into the ear only.
Storage requirements:
-Securely tighten cap between uses.

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

Medical Disclaimer

More about hydrocortisone / neomycin / polymyxin b otic

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  • Otitis Media
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Hydrocortisone/Neomycin/Polymyxin B Otic

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Before using this medication, clean and dry your ear canal with sterile cotton.

Shake the ear drops well just before each use.

To use the 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 at least 5 minutes. You may use a small piece of cotton to plug the ear and keep the medicine from draining out.
  • Do not touch the 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.

As an alternative to dropping the medicine into your ear, you may insert a small piece of cotton into the ear canal and then drop the medicine directly onto the cotton to soak it. Leave the cotton in your ear for at least 24 hours, and keep it moist by adding a few drops of the medicine to the cotton every 4 hours. Replace the cotton at least every 24 hours. Follow your doctor’s instructions about the use of cotton with this medication.

Call your doctor if your symptoms do not improve, or if they get worse while using hydrocortisone, neomycin, and polymyxin B otic.

Use this medicine 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.

Do not use hydrocortisone, neomycin, and polymyxin B otic for longer than 10 days in a row unless your doctor tells you to. Long-term use of neomycin may cause damage to your hearing.

Store at room temperature away from moisture and heat.

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.

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

Copyright 1996-2020 Cerner Multum, Inc.

Latest Update: 11/9/2018, Version: 2.05

Neomycin, polymyxin b, and hydrocortisone (Otic route)

Proper Use of This Medicine:

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 be used only in the ear. Do not put it into 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.

You may warm the ear drops to body temperature (37 C or 98.6 F), but no higher, by holding the bottle in your hand for a few minutes before using the medicine. If the medicine gets too warm, it may break down and not work at all.

To use the ear drops:

  • Wash hands thoroughly with soap and water.
  • Shake the bottle well before using it.
  • Lie down or tilt your head so that the infected ear faces up. Gently pull the earlobe up and back for adults (down and back for children) to straighten the ear canal.
  • Drop the prescribed number of drops into the ear canal. Keep the ear facing up for about 5 minutes to allow the medicine to coat the ear canal. (For young children and other patients who cannot stay still for 5 minutes, try to keep the ear facing up for at least 1 or 2 minutes.)
  • Your doctor may insert a gauze or cotton wick inside your ear and may want you to keep the wick moistened with this medicine. Your doctor also may have other directions for you, such as how long you should keep the wick inside your ear or when you should return to your doctor to have the wick replaced. If you have any questions about this, check with your doctor.
  • To keep the medicine as germ-free as possible, do not touch the dropper to any surface (including the ear). Also, keep the container tightly closed.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your symptoms have disappeared. 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 otic dosage form (ear drops):
    • For ear canal infection:
      • Adults4 drops into the affected ear 3 or 4 times a day.
      • Children3 drops into the ear 3 or 4 times a day.
    • For mastoid cavity infection:
      • Adults4 to 10 drops in the ear every 6 to 8 hours.
      • Children4 or 5 drops in the ear every 6 to 8 hours.

Missed dose

If you miss a dose of this medicine, apply 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.

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.

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