Cortisporin Otic

This section provides information on the proper use of a number of products that contain neomycin, polymyxin b, and hydrocortisone. It may not be specific to Cortisporin. Please read with care.

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:

• Lie down or tilt the 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 medicine 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 have inserted a gauze or cotton wick into 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 in 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 (ear drops) dosage forms:
  • For ear canal infection:
    • Adults—Use four drops in the ear three or four times a day.
    • Children—Use three drops in the ear three or four times a day.
  • For mastoid cavity infection:
    • Adults—Use four to ten drops in the ear every six to eight hours.
    • Children—Use four or five drops in the ear every six to eight 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.

You should not use this medicine if you are allergic to hydrocortisone, neomycin, or polymyxin B, or if you have:

• a ruptured ear drum; or

• an ear infection caused by chickenpox, or herpes infection (simplex or zoster).

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

• chickenpox or small pox;

• any ear infection that causes blistering;

• asthma or sulfite allergy; or

• if you are allergic to an antibiotic similar to neomycin, such as kanamycin, paromomycin, streptomycin, or gentamicin.

FDA pregnancy category C. It is not known whether hydrocortisone, neomycin, and polymyxin B otic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Hydrocortisone can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not use this medicine in a child younger than 2 years old.

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.

It is not likely that other drugs you take orally or inject will have an effect on hydrocortisone, neomycin, and polymyxin B otic 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.

This medication may temporarily sting or burn your ear for a minute or two when applied. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if this rare but very serious side effect occurs: hearing problems (e.g., hearing loss).

Use of this medication for prolonged or repeated periods may result in a new fungal ear infection. Do not use it for longer than prescribed. Contact your doctor if you notice new or worsening symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), redness of the ears, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. This medicine may be harmful if swallowed.

Notes

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in those cases.

It is important to keep the infected ear(s) clean and dry. Try not to get the infected ear(s) wet when bathing. Avoid swimming unless your doctor tells you otherwise.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.

More frequent side effects include: idiopathic edema, pruritus, skin rash, erythema, and local irritation. See below for a comprehensive list of adverse effects.

Applies to hydrocortisone / neomycin / polymyxin b otic: otic solution, otic suspension

Hypersensitivity

Rare (less than 0.1%): Application site hypersensitivity[Ref]

Dermatologic

Rare (less than 0.1%): Local exfoliative dermatitis, skin atrophy, telangiectasia , stria, exacerbation of underlying skin conditions (including eczema)
Frequency not reported: Folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, miliaria[Ref]

General

The most commonly reported side effect was hypersensitivity.[Ref]

Nervous system

Frequency not reported: Ototoxicity[Ref]

Immunologic

Frequency not reported: Secondary infection[Ref]

Local

Rare (less than 0.1%): Application site reaction including pain, irritation, edema, burning sensation, rash
Frequency not reported: Itching, dryness, stinging[Ref]

Renal

Frequency not reported: Nephrotoxicity[Ref]

Some side effects of Cortisporin Otic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.