Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Neomycin occasionally causes skin sensitization.
Ototoxicity (see WARNINGS section) and nephrotoxicity have also been reported.
Adverse reactions have occurred with topical use of antibiotic combinations.
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.
In another study the incidence was found to be approximately 1%.
The following local adverse events 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.
For medical advice about adverse reactions contact your medical professional.
To report SUSPECTED ADVERSE REACTIONS, contact Endo at 1-800-462-3636 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
WARNINGS Neomycin can induce permanent sensorineural hearing loss due to cochlear damage, mainly destruction of hair cells in the organ of Corti.
The risk is greater with prolonged use.
Therapy should be limited to 10 consecutive days (See PRECAUTIONS-General ).
Patients being treated with eardrops containing neomycin should be under close clinical observation.
Cortisporin ® TC Otic should be used cautiously in any patient with a perforated tympanic membrane.
Like all medications, Cortisporin Tc can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: