Cortisporin (Neomycin, Polymyxin B, and Hydrocortisone (Topical))

• If you have an allergy to neomycin, polymyxin B, hydrocortisone, or any other part of Cortisporin (neomycin, polymyxin B, and hydrocortisone (topical)).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Fungal, TB (tuberculosis), or viral infection of the skin.
• If you have a ruptured eardrum.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Cortisporin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use as you have been told, even if your signs get better.
• To gain the most benefit, do not miss doses.
• Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
• Do not take Cortisporin by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.
• Do not put on the face, underarms, or the groin area unless told to do so by the doctor.
• Do not use coverings (bandages, dressings, make-up) unless told to do so by the doctor.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Skin changes (pimples, stretch marks, slow healing, hair growth).
• Pain.
• Swelling.
• Very bad skin irritation.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Skin irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to hydrocortisone / neomycin / polymyxin b topical: topical cream

Dermatologic

Dermatologic side effects associated with the use of topical corticosteroids have included burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. These reactions are more likely with the use of occlusive dressings or with long-term use.[Ref]

Hypersensitivity

Hypersensitivity reactions have been associated with the anti-infective component of this drug and are manifested by itching and swelling. Neomycin is known to cause contact sensitivity with an estimated incidence of 0.09% to 1%.[Ref]

Nervous system

Nervous system side effects have included ototoxicity associated with the use of neomycin.[Ref]

Renal

Renal side effects have included nephrotoxicity associated with the use of neomycin.[Ref]

Some side effects of hydrocortisone / neomycin / polymyxin b topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Hydrocortisone/neomycin/polymyxin B topical has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity from topically administered corticosteroids. There are no controlled data in human pregnancy. This drug is only recommended during pregnancy when benefit outweighs risk.