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|Cortatrigen Modified Ear Drops Otic

NEOMYCIN, POLYMYXIN B, AND HYDROCORTISONE (Otic)

Some commonly used brand names are:

In the U.S.—

• AK-Spore HC Otic
• Antibiotic Ear
• Cortatrigen Ear
• Cortatrigen Modified Ear Drops
• Cort-Biotic
• Cortisporin
• Cortomycin
• Drotic
• Ear-Eze
• LazerSporin-C
• Masporin Otic
• Octicair
• Octigen
• Otic-Care
• Otic-Care Ear
• Otimar
• Otisan
• Otocidin
• Otocort
• Pediotic
• UAD Otic

In Canada—

• Cortisporin

Generic name product may be available in the U.S.

Category

• Antibacterial-corticosteroid, otic

Description

Neomycin, polymyxin B, and hydrocortisone (nee-oh-MYE-sin, pol-i-MIX-in bee, and hye-droe-KOR-ti-sone) is a combination antibiotic and cortisone-like medicine. It is used to treat infections of the ear canal and to help provide relief from redness, irritation, and discomfort of certain ear problems.

Neomycin, polymyxin B, and hydrocortisone preparation is available only with your doctor"s prescription, in the following dosage forms:

• Otic
• Solution (U.S. and Canada)
• Suspension (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For neomycin, polymyxin B, and hydrocortisone otic preparations, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or to any related antibiotic, such as amikacin (e.g., Amikin), colistimethate (e.g., Coly-Mycin M), colistin (e.g., Coly-Mycin S), gentamicin (e.g., Garamycin), kanamycin (e.g., Kantrex), neomycin by mouth or by injection (e.g., Mycifradin), netilmicin (e.g., Netromycin), paromomycin (e.g., Humatin), polymyxin B by injection (e.g., Aerosporin), streptomycin, or tobramycin (e.g., Nebcin). Also tell your health care professional if you are allergic to any other substances, such as preservatives or dyes.

Pregnancy—Neomycin, polymyxin B, and hydrocortisone otic preparations have not been studied in pregnant women. However, studies in animals have shown that topical corticosteroids (such as hydrocortisone) cause birth defects. Before using this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Neomycin, polymyxin B, and hydrocortisone otic preparations have not been reported to cause problems in nursing babies.

Children—Although there is no specific information comparing use of otic neomycin, polymyxin B, and hydrocortisone preparation in children with use in other age groups, this preparation is not expected to cause different side effects or problems in children than it does in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of otic neomycin, polymyxin B, and hydrocortisone preparation in the elderly with use in other age groups, this preparation is not expected to cause different side effects or problems in older people than it does in younger adults.

Other 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. Tell your health care professional if you are using any other otic (for the ear) prescription or nonprescription (over-the-counter [OTC] medicine).

Other medical problems—The presence of other medical problems may affect the use of neomycin, polymyxin B, and hydrocortisone otic preparations. Make sure you tell your doctor if you have any other medical problems, especially:

• Any other ear infection or condition (including punctured eardrum)—Use of neomycin, polymyxin B, and hydrocortisone otic preparations may make the condition worse

Proper Use of This Medicine

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 neomycin, polymyxin B, and hydrocortisone otic preparation 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 neomycin, polymyxin B, and hydrocortisone otic preparation. If your dose is different, do not change it unless your doctor tells you to do so.

• 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—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If your symptoms do not improve within 1 week, or if they become worse, check with your doctor.

Do not use this medicine for more than 10 days unless otherwise directed by your doctor.

Side Effects of This Medicine

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:

More common

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

Revised: 06/02/1995

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