CORTISPORIN® OTIC SOLUTION Contraindications (neomycin and polymyxin B sulfates, hydrocortisone) | Pfizer Medical Information - US

CONTRAINDICATIONS

This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

This product should not be used if the external auditory canal disorder is suspected or known to be due to cutaneous viral infection (for example, herpes simplex virus or varicella zoster virus).

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INDICATIONS AND USAGE

For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics.

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DOSAGE AND ADMINISTRATION

Therapy with this product should be limited to 10 consecutive days.

The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator.

For adults, four...

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CONTRAINDICATIONS

This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

This product should not be used if the external auditory canal disorder is suspected or...

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WARNINGS

Neomycin can induce permanent sensorineural hearing loss due to cochlear damage, mainly destruction of hair cells in the organ of Corti. The risk of ototoxicity is greater with prolonged use; therefore, duration of...

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ADVERSE REACTIONS

Neomycin occasionally causes skin sensitization. Ototoxicity and nephrotoxicity have also been reported (see WARNINGS). Adverse reactions have occurred with topical use of antibiotic...

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DESCRIPTION

CORTISPORIN Otic Solution (neomycin and polymyxin B sulfates and hydrocortisone otic solution, USP) is a sterile antibacterial and anti-inflammatory solution for otic use. Each mL contains: neomycin sulfate...

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CLINICAL PHARMACOLOGY

Corticoids suppress the inflammatory response to a variety of agents and they may delay healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial...

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REFERENCES

1.: Jones, RN, Milazzo J, Seidlin, M. Ofloxacin Otic Solution for Treatment of Otitis Externa in Children and Adults. Arch Otolaryngol Head Neck Surg. 1997; 123: 1193–1200.
2.: Leyden JJ, Kligman AM....

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HOW SUPPLIED

Bottle of 10 mL with sterilized dropper (NDC 61570-034-10).

Store at 15° to 25°C (59° to 77°F)....

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PRODUCT OVERVIEW:

CORTISPORIN SOLUTION

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Report Adverse Event

Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.