Cortisporin Otic Solution
"The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear "...
Cortisporin Otic Solution
Cortisporin Otic Solution Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Cortisporin Otic Solution (neomycin and polymyxin B sulfates and hydrocortisone otic solution, USP) is a combination of two antibiotics and an anti-inflammatory corticosteroid in an ear drop used to treat outer ear infections caused by bacteria (also known as swimmer's ear). Cortisporin Otic Solution is available in generic form. Common side effects of Cortisporin Otic Solution include temporary stinging or burning of the ear for a minute or two when applied.
The dose of Cortisporin Otic Solution for adults is four drops instilled into the affected ear 3 or 4 times daily. For infants and children, three drops are suggested. Cortisporin Otic Solution may interact with other medications. Before using this medication, tell your doctor all prescription and nonprescription/herbal products you may use. Cortisporin Otic Solution should be used only if prescribed during pregnancy. It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding.
Our Cortisporin Otic Solution (neomycin and polymyxin B sulfates and hydrocortisone otic solution, USP) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
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 immediately 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.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Cortisporin Otic Solution (Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Cortisporin Otic Solution FDA Prescribing Information: Side Effects
Neomycin occasionally causes skin sensitization. Ototoxicity and nephrotoxicity have also been reported (see WARNINGS). Adverse reactions have occurred with topical use of antibiotic combinations including neomycin and polymyxin B. Exact incidence figures are not available since no denominator of treated patients is available. The reaction occurring most often is allergic sensitization. In one clinical study, using a 20% neomycin patch, neomycin-induced allergic skin reactions occurred in two of 2,175 (0.09%) individuals in the general population.2 In another study, the incidence was found to be approximately 1%.3
The following local adverse reactions have been reported with topical corticosteroids, especially under occlusive dressings: 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. Stinging and burning have been reported when this product has gained access to the middle ear.
Read the entire FDA prescribing information for Cortisporin Otic Solution (Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution)
Additional Cortisporin Otic Solution Information
Cortisporin Otic Solution - User Reviews
Cortisporin Otic Solution User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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