DrugindexOnline^{2nd edition}

Pronouncation: (koe-LISS-tin SULL-fate/NEE-oh-MY-sin SULL-fate/thahn-ZOE-nee-uhm BROE-mide/HIGH-droe-core-tih-sone ASS-uh-TATE)
Class: Steroid and antibiotic combination

Trade Names:
Coly-Mycin S Otic
- Suspension 1% hydrocortisone, 4.71 mg neomycin sulfate (equiv. to 3.3 mg neomycin base), 3 mg colistin (as sulfate), and 0.05% thonzonium bromide/mL

Trade Names:
Cortisporin-TC Otic
- Suspension 1% hydrocortisone, 3.3 mg neomycin sulfate, 3 mg colistin (as sulfate), and 0.5 mg thonzonium bromide

Mechanism of Action

Pharmacology

Colistin

Bactericidal agent against most gram-negative organisms, particularly, Pseudomonas aeruginosa .

Neomycin

Inhibits protein synthesis by binding to ribosomal RNA, causing bacterial genetic code misreading.

Thonzonium

Surface-active agent that promotes tissue contact by dispersion and penetration of the cellular debris and exudates.

Hydrocortisone

Depresses formation, release, and activity of endogenous mediators of inflammation as well as modifying body's immune response.

Indications and Usage

Treatment of superficial bacterial infections of the external auditory canal caused by susceptible organisms; treatment of infection of mastoidectomy and fenestration cavities caused by susceptible organisms.

Contraindications

Sensitivity to any component of the product; external auditory canal disorder caused by cutaneous viral infections (eg, herpes simplex virus, varicella zoster virus).

Dosage and Administration

Adults

Otic Thoroughly clean external auditory canal and dry with sterile cotton applicator. Using the calibrated dropper, instill 5 drops of the suspension into affected ear 3 or 4 times daily.

Children

Otic Thoroughly clean external auditory canal and dry with sterile cotton applicator. Using the calibrated dropper, instill 4 drops of the suspension into affected ear 3 or 4 times daily. Alternatively, a cotton wick may be inserted into the canal and then saturated with the suspension. The wick may be kept moist by adding additional solution every 4 h. Replace wick at least once every 24 h.

General Advice

• For otic use only. Not for oral, nasal, or ocular use.
• Hold bottle in hand for 1 to 2 min to warm suspension.
• Shake well immediately before using.
• Do not touch ear with dropper.
• Do not rinse dropper after use.

Storage/Stability

Store at controlled room temperature (59° to 86°F).

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Dermatologic

Cutaneous sensitization (particularly neomycin).

Precautions

Monitor Improvement Monitor patient for improvement of symptoms of infection. Sensitivity Monitor patient for sensitization or irritation and report to health care provider if noted.

Superinfection

Prolonged use may result in bacterial or fungal overgrowth of nonsusceptible microorganisms.

Bacterial resistance

Bacterial resistance to components of the product may develop.

Cross allergy

Allergic cross-sensitivity may occur, which could prevent future use of the following antibiotics: kanamycin, paromomycin, streptomycin, and possibly gentamicin.

Perforated eardrum/Chronic otitis media

Use with caution because of possibility of neomycin-induced ototoxicity.

Patient Information

• Remind patient, family, or caregiver that medication is for use in the ear only.
• Teach patient proper technique for instilling ear drops: wash hands; thoroughly clean external ear canal and dry with sterile cotton applicator. Warm solution by holding bottle in hand for 1 to 2 min; shake well. Tilt head to side or lie on side with affected ear upward; instill prescribed number of drops and maintain position for 5 min to allow drops to penetrate ear canal. Repeat, if necessary, for the opposite ear. Do not allow dropper to touch ear; replace dropper.
• If preferred, a cotton wick may be placed in the ear canal and then saturated with suspension every 4 h. Instruct patient to replace wick at least once every 24 h.
• Advise patient, family, or caregiver to use only supplied dropper and to not rinse dropper after use.
• Advise patient, family, or caregiver to notify health care provider if symptoms do not improve or if irritation, inflammation, or itching of ear canal is noted.