Generic Name: hydrocortisone butyrate (Topical application route)

hye-droe-KOR-ti-sone BUE-ti-rate

Commonly used brand name(s):

In the U.S.

• Locoid
• Locoid Lipocream

In Canada

• Barriere-Hc
• Cortate
• Cort-Eze
• Cortoderm Mild Ointment
• Cortoderm Regular Ointment
• Emo-Cort
• Emo-Cort Scalp Solution
• Hydrocortisone Cream
• Novo-Hydrocort
• Novo-Hydrocort Cream
• Prevex Hc
• Sarna Hc

Available Dosage Forms:

• Ointment
• Lotion
• Cream
• Solution

Therapeutic Class: Corticosteroid, Intermediate

Pharmacologic Class: Hydrocortisone

Uses For Cortoderm Regular Ointment

Hydrocortisone butyrate topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions (e.g., atopic dermatitis, seborrheic dermatitis). This medicine is a corticosteroid (cortisone-like medicine or steroid).

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

Before Using Cortoderm Regular Ointment

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 hydrocortisone butyrate topical in children 3 months of age or older. However, because of this medicine’s toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor’s instructions very carefully.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocortisone butyrate topical in the elderly.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cushing’s syndrome (adrenal gland disorder) or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or
• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

Proper Use of hydrocortisone butyrate

This section provides information on the proper use of a number of products that contain hydrocortisone butyrate. It may not be specific to Cortoderm Regular Ointment. Please read with care.

It is very important that you use this medicine only 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 cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

Do not use the topical cream or lotion on the face, groin, or underarms unless directed to do so by your doctor, and do not use these forms for more than 4 weeks.

To use:

• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.
• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

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 atopic dermatitis:
  • For topical dosage forms (cream and lotion):
    • Children 3 months to 18 years of age—Apply to the affected area of the skin two times per day.
    • Children younger than 3 months of age—Use and dose must be determined by your doctor.

• For redness, itching, and swelling of the skin:
  • For topical dosage forms (cream and ointment):
    • Adults—Apply to the affected area of the skin two or three times per day.
    • Children—Apply to the affected area of the skin two or three times per day.

• For seborrheic dermatitis:
  • For topical dosage form (solution):
    • Adults—Apply to the affected area of the skin two or three times per day.
    • Children—Apply to the affected area of the skin two or three times per day.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Cortoderm Regular Ointment

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child’s symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

Cortoderm Regular Ointment 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:

Less common

• Burning sensation of skin
• flushing or redness of skin
• itching skin
• red, scaling, or crusted skin
• scaly rash
• skin irritation
• unusually warm skin

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin
• irritation
• itching, scaling, severe redness, soreness, or swelling of the skin
• redness and scaling around the mouth
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)
• thinning, weakness, or wasting away of the skin

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:

Less common

• Acne or pimples
• lightening of normal skin color

Incidence not known

• Burning and itching of the skin with pinhead-sized red blisters
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• increased hair growth on the forehead, back, arms, and legs
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin

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.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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Generic Name: hydrocortisone, neomycin, and polymyxin B otic (HYE droe KOR ti sone, NEE oh MYE sin, POL ee MIX in B)
Brand Names: Cort-Biotic, Cortatrigen, Cortatrigen Modified, Cortisporin Otic, Cortomycin, Oti-Sone, Pediotic

What is Cortomycin (hydrocortisone, neomycin, and polymyxin B otic)?

Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Neomycin and polymyxin B are antibiotics that fight bacteria.

The combination of hydrocortisone, neomycin, and polymyxin B otic (for the ears) is used to treat ear infections caused by bacteria.

This medication will not treat a viral infection such as herpes or shingles.

Hydrocortisone, neomycin, and polymyxin B otic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Cortomycin (hydrocortisone, neomycin, and polymyxin B otic)?

You should not use this medication 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).

Before using this medication, tell your doctor if you have herpes (simplex or zoster), 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 amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), netilmicin (Netromycin), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.

Do not use this medication 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. Stop using this medication and call your doctor at once if you have skin rash, redness, swelling, itching, dryness, scaling, severe burning or stinging, or other irritation in or around the ear. Other serious side effects include new signs of infection, hearing loss, or urinating less than usual or not at all.

What should I discuss with my health care provider before using Cortomycin (hydrocortisone, neomycin, and polymyxin B otic)?

You should not use this medication 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).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• herpes (simplex or zoster);

• 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 amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), netilmicin (Netromycin), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).

FDA pregnancy category C. It is not known whether hydrocortisone, neomycin, and polymyxin B otic ear drops are harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Hydrocortisone and colistin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication in a child younger than 2 years old.

How should I use Cortomycin (hydrocortisone, neomycin, and polymyxin B otic)?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

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

Shake the ear drops well just before you measure a dose.

This medication is usually given as 4 to 5 drops into the affected ear every 6 to 8 hours. Children may need to use fewer drops. Follow your doctor’s instructions about how much medication you should use and how often.

Do not use this medication 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.

To use the ear drops, first remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. If giving this medicine to a child, pull down on the earlobe to open the ear canal. Hold the dropper upside down over the ear canal and drop the correct number of drops into the ear.

Do not place the dropper tip into your ear or allow the tip to touch any surface. It may become contaminated.

After using the ear drops, stay lying down or with your head tilted for at least 5 minutes.

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 the ear and keep it moist by adding more of the medication every 4 to 8 hours. Replace the cotton at least every 24 hours. Follow your doctor’s instructions about the use of cotton with this medication.

Wipe the ear dropper tip with a clean tissue. Do not wash the tip with water or soap.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

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.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include hearing problems, or urinating less than usual.

What should I avoid while using Cortomycin (hydrocortisone, neomycin, and polymyxin B otic)?

Avoid getting this medication in your eyes. If this does happen, rinse with water.

Cortomycin (hydrocortisone, neomycin, and polymyxin B otic) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• skin rash, redness, swelling, itching, dryness, scaling, or other irritation in or around the ear;

• severe burning, stinging, or other irritation when using the medication;

• new signs of infection;

• hearing loss; or

• urinating less than usual or not at all.

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 Cortomycin (hydrocortisone, neomycin, and polymyxin B otic)?

It is not likely that other drugs you take orally or inject will have an effect on hydrocortisone, neomycin, and polymyxin B used in the ears. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone, neomycin, and polymyxin B otic.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.03. Revision Date: 11/19/2009 2:59:51 PM.

Generic Name: Hydrocortisone/Neomycin/Polymyxin B (HYE-droe-KOR-ti-sone/NEE-oh-MYE-sin/POL-ee-MIX-in)
Brand Name: Examples include Cortisporin and Cortomycin

Cortomycin Suspension is used for:

Treating infections of the ear caused by certain bacteria. It may also be used for other conditions as determined by your doctor.

Cortomycin Suspension is a combination of 2 antibiotics and a corticosteroid. The antibiotics work by slowing the growth of, or killing, sensitive bacteria. The corticosteroid reduces inflammation.

Do NOT use Cortomycin Suspension if:

• you are allergic to any ingredient in Cortomycin Suspension, to other aminoglycosides (eg, gentamicin), or to other corticosteroids (eg, prednisone)
• you have a viral infection of the ear (eg, herpes simplex, chickenpox, shingles)
• you have a perforated ear drum

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cortomycin Suspension:

Some medical conditions may interact with Cortomycin Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have asthma

Some MEDICINES MAY INTERACT with Cortomycin Suspension. Because little, if any, of Cortomycin Suspension is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Cortomycin Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cortomycin Suspension:

Use Cortomycin Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Cortomycin Suspension is only for the ear. Do not get it in your eyes, nose, or mouth. If you get Cortomycin Suspension in your eyes, rinse immediately with cool tap water.
• Wash your hands before and after using Cortomycin Suspension.
• Wash and dry the outer ear with a sterile cotton applicator.
• Shake well before each use.
• Lie down or tilt your head so that the affected ear faces up. For adults, gently pull the earlobe up and back to straighten the ear canal. For children, gently pull the earlobe down and back to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for several minutes so the medicine can run to the bottom of the ear canal. A clean cotton plug may be gently inserted into the ear canal to prevent medicine from leaking out. To prevent germs from getting into your medicine, do not touch the applicator to any surface, including the ear. Keep the container tightly closed.
• To clear up your infection completely, use Cortomycin Suspension for the full course of treatment. Keep using it even if you feel better in a few days.
• If you miss a dose of Cortomycin Suspension, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Cortomycin Suspension.

Important safety information:

• Cortomycin Suspension only works against bacteria; it does not treat fungal or viral infections.
• Be sure to use Cortomycin Suspension for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Long-term or repeated use of Cortomycin Suspension may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• If your symptoms do not get better within 7 days or if they get worse, check with your doctor.
• Do NOT take more than the recommended dose or use for longer than 7 days without checking with your doctor.
• Do not use Cortomycin Suspension for other ear conditions at a later time.
• Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.
• Tell your doctor or dentist that you take Cortomycin Suspension before you receive any medical or dental care, emergency care, or surgery.
• Cortomycin Suspension should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cortomycin Suspension while you are pregnant. It is not known if Cortomycin Suspension is found in breast milk after topical use. If you are or will be breast-feeding while you use Cortomycin Suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Cortomycin Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild, temporary burning or stinging.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; changes in hearing; decreased urination; dry, scaly, or peeling skin at the application site; continued burning or stinging; excessive hair growth; inflamed hair follicles; inflammation around the mouth; loss of hearing; muscle weakness; pain, redness, itching, irritation, or swelling not present when you began using Cortomycin Suspension; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately.

Proper storage of Cortomycin Suspension:

Store Cortomycin Suspension between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Keep the container tightly closed. Keep Cortomycin Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Cortomycin Suspension, please talk with your doctor, pharmacist, or other health care provider.
• Cortomycin Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Cortomycin Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: cortisone (KOR ti sone)
Brand Names: Cortone Acetate

What is Cortone Acetate (cortisone)?

Cortisone is in a class of drugs called steroids. Cortisone prevents the release of substances in the body that cause inflammation.

Cortisone is used to treat many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.

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

What is the most important information I should know about Cortone Acetate (cortisone)?

You should not use this medication if you are allergic to cortisone, or if you have a fungal infection anywhere in your body.

Before taking cortisone, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.

Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.

Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a “live” vaccine while you are taking cortisone. Vaccines may not work as well while you are taking a steroid.

Do not stop using cortisone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency.

What should I discuss with my healthcare provider before taking Cortone Acetate (cortisone)?

You should not use this medication if you are allergic to cortisone, or if you have a fungal infection anywhere in your body.

Steroid medication can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking this medication, tell your doctor about any illness or infection you have had within the past several weeks.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take cortisone:

• liver disease (such as cirrhosis);

• kidney disease;

• a thyroid disorder;

• diabetes;

• a history of malaria;

• tuberculosis;

• osteoporosis;

• a muscle disorder such as myasthenia gravis;

• glaucoma or cataracts;

• herpes infection of the eyes;

• stomach ulcers, ulcerative colitis, or diverticulitis;

• depression or mental illness;

• congestive heart failure; or

• high blood pressure

FDA pregnancy category C. It is not known whether cortisone is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Cortisone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Steroids can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

How should I take Cortone Acetate (cortisone)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Your steroid medication needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using cortisone.

Do not stop using cortisone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking steroid medication. Store cortisone at room temperature away from moisture and heat.

What happens if I miss a dose?

If you miss a dose or forget to take your medicine, contact your doctor or pharmacist for instructions.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

A single large dose of cortisone is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while taking Cortone Acetate (cortisone)?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a “live” vaccine while you are being treated with cortisone. Vaccines may not work as well while you are taking a steroid.

Avoid drinking alcohol while you are taking cortisone.

Cortone Acetate (cortisone) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• problems with your vision;

• swelling, rapid weight gain, feeling short of breath;

• severe depression, unusual thoughts or behavior, seizure (convulsions);

• bloody or tarry stools, coughing up blood;

• pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

• sleep problems (insomnia), mood changes;

• acne, dry skin, thinning skin, bruising or discoloration;

• slow wound healing;

• increased sweating;

• headache, dizziness, spinning sensation;

• nausea, stomach pain, bloating; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

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 Cortone Acetate (cortisone)?

There are many other medicines that can interact with steroids. Below is only a partial list of these medicines:

• aspirin (taken on a daily basis or at high doses);

• a diuretic (water pill);

• a blood thinner such as warfarin (Coumadin);

• cyclosporine (Gengraf, Neoral, Sandimmune);

• insulin or diabetes medications you take by mouth;

• ketoconazole (Nizoral);

• rifampin (Rifadin, Rifater, Rifamate, Rimactane); or

• seizure medications such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).

This list is not complete and there may be other drugs that can interact with cortisone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about cortisone.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 5.01. Revision Date: 06/24/2009 3:07:30 PM.

Generic Name: Cosyntropin (koe-sin-TROE-pin)
Brand Name: Cortrosyn

Cortrosyn is used for:

Helping doctors diagnose adrenal gland problems (eg, Addison disease, insufficiency due to steroid use, tumors). It may also be used to treat long-term medical conditions that produce swelling that may respond to corticosteroids.

Cortrosyn is a man-made (synthetic) portion of the natural hormone corticotropin (ACTH). It works by stimulating the adrenal cortex to produce and secrete adrenocortical hormones.

Do NOT use Cortrosyn if:

• you are allergic to any ingredient in Cortrosyn

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cortrosyn:

Some medical conditions may interact with Cortrosyn. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have kidney disease

Some MEDICINES MAY INTERACT with Cortrosyn. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Carbamazepine because the effectiveness of Cortrosyn may be decreased
• Itraconazole because the actions and side effects of Cortrosyn may be increased
• Live vaccines or ritodrine because the actions and side effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cortrosyn may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cortrosyn:

Use Cortrosyn as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Cortrosyn is usually administered as an injection at your doctor’s office, hospital, or clinic. If you are using Cortrosyn at home, carefully follow the injection procedures taught to you by your health care provider.
• If Cortrosyn contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Cortrosyn, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Cortrosyn.

Important safety information:

• Cortrosyn may cause dizziness or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Cortrosyn. Using Cortrosyn alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Cortrosyn during pregnancy. It is unknown if Cortrosyn is excreted in breast milk. If you are or will be breast-feeding while you are using Cortrosyn, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Cortrosyn:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Redness or swelling at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; dizziness; headache; irregular heartbeat; severe swelling.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Cortrosyn:

Store Cortrosyn at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Use the contents of the vial promptly after opening. Discard any unused medicine. Keep Cortrosyn out of the reach of children and away from pets.

General information:

• If you have any questions about Cortrosyn, please talk with your doctor, pharmacist, or other health care provider.
• Cortrosyn is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Cortrosyn. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: hydrocortisone, neomycin, and polymyxin B otic (HYE droe KOR ti sone, NEE oh MYE sin, POL ee MIX in B)
Brand Names: Cort-Biotic, Cortatrigen, Cortatrigen Modified, Cortisporin Otic, Cortomycin, Oti-Sone, Pediotic

What is Cortisporin Otic (hydrocortisone, neomycin, and polymyxin B otic)?

Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Neomycin and polymyxin B are antibiotics that fight bacteria.

The combination of hydrocortisone, neomycin, and polymyxin B otic (for the ears) is used to treat ear infections caused by bacteria.

This medication will not treat a viral infection such as herpes or shingles.

Hydrocortisone, neomycin, and polymyxin B otic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Cortisporin Otic (hydrocortisone, neomycin, and polymyxin B otic)?

You should not use this medication 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).

Before using this medication, tell your doctor if you have herpes (simplex or zoster), 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 amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), netilmicin (Netromycin), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.

Do not use this medication 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. Stop using this medication and call your doctor at once if you have skin rash, redness, swelling, itching, dryness, scaling, severe burning or stinging, or other irritation in or around the ear. Other serious side effects include new signs of infection, hearing loss, or urinating less than usual or not at all.

What should I discuss with my health care provider before using Cortisporin Otic (hydrocortisone, neomycin, and polymyxin B otic)?

You should not use this medication 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).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• herpes (simplex or zoster);

• 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 amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), netilmicin (Netromycin), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).

FDA pregnancy category C. It is not known whether hydrocortisone, neomycin, and polymyxin B otic ear drops are harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Hydrocortisone and colistin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication in a child younger than 2 years old.

How should I use Cortisporin Otic (hydrocortisone, neomycin, and polymyxin B otic)?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

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

Shake the ear drops well just before you measure a dose.

This medication is usually given as 4 to 5 drops into the affected ear every 6 to 8 hours. Children may need to use fewer drops. Follow your doctor’s instructions about how much medication you should use and how often.

Do not use this medication 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.

To use the ear drops, first remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. If giving this medicine to a child, pull down on the earlobe to open the ear canal. Hold the dropper upside down over the ear canal and drop the correct number of drops into the ear.

Do not place the dropper tip into your ear or allow the tip to touch any surface. It may become contaminated.

After using the ear drops, stay lying down or with your head tilted for at least 5 minutes.

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 the ear and keep it moist by adding more of the medication every 4 to 8 hours. Replace the cotton at least every 24 hours. Follow your doctor’s instructions about the use of cotton with this medication.

Wipe the ear dropper tip with a clean tissue. Do not wash the tip with water or soap.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

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.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include hearing problems, or urinating less than usual.

What should I avoid while using Cortisporin Otic (hydrocortisone, neomycin, and polymyxin B otic)?

Avoid getting this medication in your eyes. If this does happen, rinse with water.

Cortisporin Otic (hydrocortisone, neomycin, and polymyxin B otic) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• skin rash, redness, swelling, itching, dryness, scaling, or other irritation in or around the ear;

• severe burning, stinging, or other irritation when using the medication;

• new signs of infection;

• hearing loss; or

• urinating less than usual or not at all.

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 Cortisporin Otic (hydrocortisone, neomycin, and polymyxin B otic)?

It is not likely that other drugs you take orally or inject will have an effect on hydrocortisone, neomycin, and polymyxin B used in the ears. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone, neomycin, and polymyxin B otic.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.03. Revision Date: 11/19/2009 2:59:51 PM.

Generic Name: colistin, neomycin, thonzonium, and hydrocortisone (Otic route)

koe-LIS-tin SUL-fate, nee-oh-MYE-sin SUL-fate, hye-droe-KOR-ti-sone AS-e-tate, thon-ZOE-nee-um BROE-mide

Commonly used brand name(s):

In the U.S.

• Coly-Mycin S
• Cortisporin TC

In Canada

• Coly-Mycin

Available Dosage Forms:

• Suspension

Therapeutic Class: Anti-Infective/Anti-Inflammatory Combination

Pharmacologic Class: Hydrocortisone

Chemical Class: Neomycin

Uses For Cortisporin TC

Colistin, neomycin, and hydrocortisone combination contains two antibiotics and a cortisone-like medicine. It is used in the ear to treat infections of the ear canal and to help provide relief from redness, irritation, and discomfort of certain ear problems.

Colistin, neomycin, and hydrocortisone combination is available only with your doctor’s prescription.

Before Using Cortisporin TC

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

Although there is no specific information comparing use of colistin, neomycin, and hydrocortisone combination in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

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 colistin, neomycin, and hydrocortisone combination in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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

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.

• Rotavirus Vaccine, Live

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.

• Alcuronium
• Aldesleukin
• Atracurium
• Bupropion
• Cidofovir
• Cisatracurium
• Decamethonium
• Doxacurium
• Ethacrynic Acid
• Fazadinium
• Furosemide
• Gallamine
• Hexafluorenium
• Metocurine
• Mivacurium
• Pancuronium
• Pipecuronium
• Quetiapine
• Rapacuronium
• Rocuronium
• Tacrolimus
• Tubocurarine
• Vecuronium

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.

• Alatrofloxacin
• Alcuronium
• Atracurium
• Balofloxacin
• Bumetanide
• Cinoxacin
• Ciprofloxacin
• Clinafloxacin
• Colestipol
• Enoxacin
• Fleroxacin
• Flumequine
• Gallamine
• Gemifloxacin
• Grepafloxacin
• Hexafluorenium
• Itraconazole
• Levofloxacin
• Licorice
• Lomefloxacin
• Metocurine
• Moxifloxacin
• Norfloxacin
• Ofloxacin
• Pefloxacin
• Primidone
• Prulifloxacin
• Rifapentine
• Rosoxacin
• Rufloxacin
• Saiboku-To
• Sparfloxacin
• Temafloxacin
• Tosufloxacin
• Trovafloxacin Mesylate

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Other ear infection or problem, including punctured eardrum—Use of colistin, neomycin, and hydrocortisone combination may make the condition worse or may increase the chance of side effects

• Herpes simplex—Use of hydrocortisone may make the condition worse

Proper Use of colistin, neomycin, thonzonium, and hydrocortisone

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

Before applying this medicine, thoroughly clean the ear canal and dry it with a sterile cotton applicator.

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 applying. If this medicine gets too warm, it may break down and not work properly.

To apply this medicine:

• 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.

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

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return. 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 suspension (ear drops) dosage form:
  • For infections of the ear canal:
    • Adults—Use four drops in the ear every six to eight hours.
    • Children—Use up to three 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.

Precautions While Using Cortisporin TC

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

Cortisporin TC 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:

More common

• Itching, skin rash, redness, swelling, or other sign of irritation not present before use of this medicine

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.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Generic Name: colistin, hydrocortisone, neomycin, and thonzonium (otic) (koe LIS tin, HYE droe KOR ti sone, NEE oh MYE sin, thon ZOE nee um)
Brand Names: Coly Mycin S, Coly-Mycin S, Cortisporin-TC

What is colistin, hydrocortisone, neomycin, and thonzonium?

Colistin and neomycin are antibiotics that fight bacteria.

Hydrocortisone is in a class of drugs called steroids. Hydrocortisone prevents the release of substances in the body that cause inflammation.

Thonzonium is a wetting agent.

The combination of colistin, hydrocortisone, neomycin, and thonzonium otic (for the ears) is used to treat ear infections caused by bacteria.

This medication will not treat a viral infection such as herpes or shingles.

Colistin, hydrocortisone, neomycin, and thonzonium otic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about colistin, hydrocortisone, neomycin, and thonzonium?

You should not use colistin, hydrocortisone, neomycin, and thonzonium if you are allergic to any of the drugs contained in this combination, or if you have a ruptured ear drum..

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.

Do not use this medication 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. Stop using this medication and call your doctor at once if you have a skin rash, redness, swelling, itching, dryness, or scaling.

What should I discuss with my health care provider before using colistin, hydrocortisone, neomycin, and thonzonium?

You should not use colistin, hydrocortisone, neomycin, and thonzonium if you are allergic to any of the drugs contained in this combination, or if you have a ruptured ear drum.. FDA pregnancy category C. It is not known whether colistin, hydrocortisone, neomycin, and thonzonium ear drops are harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Hydrocortisone and colistin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use colistin, hydrocortisone, neomycin, and thonzonium?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

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

Shake the ear drops well just before you measure a dose.

The usual dose of this medication is 5 drops into the affected ear every 6 to 8 hours. If you are using this medicine on a child, use only 4 drops per affected ear.

Do not use this medication 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.

To use the ear drops, first remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. If giving this medicine to a child, pull down on the earlobe to open the ear canal. Hold the dropper upside down over the ear canal and drop the correct number of drops into the ear.

Do not place the dropper tip into your ear, or allow the tip to touch any surface. It may become contaminated.

After using the ear drops, stay lying down or with your head tilted for at least 5 minutes.

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 the ear and keep it moist by adding more of the medication every 4 hours. Replace the cotton at least every 24 hours. Follow your doctor’s instructions about the use of cotton with this medication.

Wipe the ear dropper tip with a clean tissue. Do not wash the tip with water or soap.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

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.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include hearing problems, or urinating less than usual.

What should I avoid while using colistin, hydrocortisone, neomycin, and thonzonium?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using this medication.

Colistin, hydrocortisone, neomycin, and thonzonium side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• skin rash, redness, swelling, itching, dryness, or scaling;

• hearing loss; or

• urinating less than usual or not at all.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect colistin, hydrocortisone, neomycin, and thonzonium?

There may be other drugs that can interact with colistin, hydrocortisone, neomycin, and thonzonium. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about colistin, hydrocortisone, neomycin, and thonzonium otic.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.03. Revision Date: 4/12/2009 4:42:53 PM.

Generic Name: Colistin/Hydrocortisone/Neomycin/Thonzonium (koe-LIS-tin/hye-droe-KOR-ti-sone/nee-oh-MYE-sin/thon-ZOE-nee-um)
Brand Name: Cortisporin-TC

Cortisporin-TC Suspension is used for:

Treating infections of the ear caused by certain bacteria. It may also be used for other conditions as determined by your doctor.

Cortisporin-TC Suspension is a combination of 2 antibiotics and a corticosteroid. The antibiotics work by killing sensitive bacteria. The corticosteroid reduces inflammation.

Do NOT use Cortisporin-TC Suspension if:

• you are allergic to any ingredient in Cortisporin-TC Suspension, to other aminoglycosides (eg, gentamicin), or to other corticosteroids (eg, prednisone)
• you have a viral infection of the ear (eg, herpes simplex, chickenpox, shingles)
• you have a perforated ear drum

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cortisporin-TC Suspension:

Some medical conditions may interact with Cortisporin-TC Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have the blood disease porphyria

Some MEDICINES MAY INTERACT with Cortisporin-TC Suspension. Because little, if any, of Cortisporin-TC Suspension is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Cortisporin-TC Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cortisporin-TC Suspension:

Use Cortisporin-TC Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Cortisporin-TC Suspension is only for the ear. Do not get it in your eyes, nose, or, mouth. If you get Cortisporin-TC Suspension in your eyes, rinse immediately with cool tap water.
• Wash your hands before and after using Cortisporin-TC Suspension.
• Wash and dry the outer ear with a sterile cotton applicator.
• Shake well before each use.
• Before using, hold the ear drop container in your hand for 1 or 2 minutes to avoid dizziness that may result from putting cold drops into the ear. Do not heat Cortisporin-TC Suspension by any other method because it could decrease its effectiveness.
• Lie down or tilt your head so that the affected ear faces up. For adults, gently pull the earlobe up and back to straighten the ear canal. For children, gently pull the earlobe down and back to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for several minutes so the medicine can run to the bottom of the ear canal. A clean cotton plug may be gently inserted into the ear canal to prevent medicine from leaking out.
• To prevent germs from contaminating your medicine, do not touch the applicator to any surface, including the ear. Keep the container tightly closed.
• To clear up your infection completely, use Cortisporin-TC Suspension for the full course of treatment. Keep using it even if you feel better in a few days.
• If you miss a dose of Cortisporin-TC Suspension, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Cortisporin-TC Suspension.

Important safety information:

• Cortisporin-TC Suspension is only works against bacteria; it does not treat fungal or viral infections.
• Be sure to use Cortisporin-TC Suspension for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Long-term or repeated use of Cortisporin-TC Suspension may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• Do NOT take more than the recommended dose or use for longer than 10 days without checking with your doctor.
• Do not use Cortisporin-TC Suspension for other ear conditions at a later time.
• Tell your doctor or dentist that you take Cortisporin-TC Suspension before you receive any medical or dental care, emergency care, or surgery.
• PREGNANCY and BREAST-FEEDING: It is not known if Cortisporin-TC Suspension causes harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cortisporin-TC Suspension while you are pregnant. It is not known if Cortisporin-TC Suspension is found in breast milk after topical use. If you are or will be breast-feeding while you are using Cortisporin-TC Suspension, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Cortisporin-TC Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild, temporary burning or stinging.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; changes in hearing; decreased urination; dry, scaly, or peeling skin at the application site; continued burning or stinging; excessive hair growth; inflamed hair follicles; inflammation around the mouth; loss of hearing; pain, redness, itching, irritation, or swelling not present when you began using Cortisporin-TC Suspension; thinning, softening, or discoloration of the skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Cortisporin-TC Suspension:

Store Cortisporin-TC Suspension between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep the container tightly closed. Keep Cortisporin-TC Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Cortisporin-TC Suspension, please talk with your doctor, pharmacist, or other health care provider.
• Cortisporin-TC Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Cortisporin-TC Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.