Data from FDA - Curated by EPG Health - Last updated 22 December 2016

Indication(s)

INDICATIONS AND USAGE Coly-Mycin®S Otic is indicated for the treatment of superficial bacterial infections of the external auditory canal, caused by organisms susceptible to the action of the antibiotics; and for the treatment of infections of mastoidectomy and fenestration cavities, caused by organisms susceptible to the antibiotics.

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Advisory information

contraindications
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 (e.g., herpes simplex virus or varicella zoster virus).
Special warnings and precautions

PRECAUTIONS General As with any other antibiotic preparation, prolonged treatment may result in overgrowth of nonsusceptible organisms and fungi.

If the infection is not improved after one week, cultures should be repeated to verify the identity of the organism and to determine whether therapy should be changed.

Treatment should not be continued for longer than ten days.

Allergic cross-reactions may occur which could prevent the use of any or all of the aminoglycoside antibiotics for the treatment of future infections.

Information for Patients Avoid contaminating the dropper with material from the ear, fingers, or other source.

This caution is necessary if the sterility of the drops is to be preserved.

If sensitization or irritation occurs, discontinue use immediately and contact your physician.

Do not use in the eyes.

If you prefer to warm the medication before using it, do not heat the suspension above body temperature in order to avoid loss of potency.

SHAKE WELL

BEFORE USING.

Laboratory Tests Systemic effects of excessive levels of hydrocortisone may include a reduction in the number of circulating eosinophils and a decrease in urinary excretion of 17-hydroxycorticosteroids.

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal carcinogenicity studies have not been performed with colistin or neomycin, or Coly-Mycin® S Otic.

An increased incidence of chromosome aberrations in human lymphocytes has been reported following in_vitro exposure to colistin or neomycin.

Fertility studies have not been performed with neomycin, but reports from the scientific literature suggest that it may decrease spermatogenesis in rats.

No adverse effects on fertility were observed in male or female rats given intramuscular doses of colistimethate sodium, the methanesulfonate salt of colistin, up to 20 mg/kg (equivalent to 9.3 mg/kg of colistin base).

This is approximately 30 times the clinical daily dose based on body surface area, assuming 100 % absorption from the ear; however, significant systemic levels of colistin or neomycin would not be anticipated in humans when Coly-Mycin®S Otic is used as directed.

Long term studies in rodents showed no evidence of carcinogenicity attributable to oral administration of corticosteroids.

Mutagenicity studies with hydrocortisone were negative.

Studies have not been performed to evaluate the effect on fertility of topical corticosteroids.

Pregnancy Teratogenic Effects Pregnancy Category C There are no adequate and well controlled studies of Coly-Mycin®S Otic in pregnant women.

It is not known whether Coly-Mycin® S Otic can cause fetal harm when administered to a pregnant woman.

Colistimethate sodium, the methanesulfonate salt of colistin, was not teratogenic in rats or rabbits given intramuscular doses up to 20 mg/kg (equivalent to 9.3 mg/kg of colisitin base, approximately 30 times (rats) or 55 times (rabbits) the clinical daily dose based on body suface area and assuming 100 % absorption from the ear).

Increased resorptions were observed in rabbits at 20 mg/kg, but not 10 mg/kg (equivalent to 4.15 mg/kg of colistin base).

Decreased pup survival at weaning was observed in rats at 20 mg/kg, a maternally toxic dose of colistin, but not 10 mg/kg.

Colistin has not been shown to have any adverse effects on the developing embryo or fetus at doses relevant to the amount that will be delivered ototopically at the recommended clinical doses.

Although aminoglycosides can cause congenital deafness in humans if administered during pregnancy, significant systemic levels of neomycin would not be anticipated when Coly-Mycin®S Otic is used as directed.

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels.

The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

Coly-Mycin®S Otic should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers Hydrocortisone and colistin sulfate appear in human milk following oral administration of the drugs.

Since systemic absorption of these drugs may occur when they are used topically, caution should be exercised when Coly-Mycin®S Otic Suspension is used by a nursing woman.

Pediatric Use See DOSAGE AND ADMINISTRATION.

The safety and effectiveness of Coly-Mycin® S Otic in infants below one year of age have not been established.

The efficacy of Coly-Mycin® S Otic in pediatric patients one year or older in the treatment of superficial bacterial infections of the external auditory canal and for the treatment of infections of mastoidectomy and fenestration cavities has been demonstrated in a controlled clinical trial.

Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse reactions

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 populaton.

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 JHP at 1-866-923-2547 or MEDWATCH at 1-800-FDA-1088 (1-800-332-1088) or http://www.fda.gov/medwatch/.

Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION Therapy with this product should be limited to 10 days.

(See WARNINGS.)

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

When using the calibrated dropper: For adults, 5 drops of the suspension should be instilled into the affected ear 3 or 4 times daily.

For pediatric patients, 4 drops are suggested because of the smaller capacity of the ear canal.

The patient should lie with the affected ear upward and then the drops should be instilled.

This position should be maintained for 5 minutes to facilitate penetration of the drops into the ear canal.

Repeat, if necessary, for the opposite ear.

If preferred, a cotton wick may be inserted into the canal and then the cotton may be saturated with the suspension.

This wick should be kept moist by adding further solution every 4 hours.

The wick should be replaced at least once every 24 hours.

Pregnancy and lactation
Nursing Mothers Hydrocortisone and colistin sulfate appear in human milk following oral administration of the drugs. Since systemic absorption of these drugs may occur when they are used topically, caution should be exercised when Coly-Mycin®S Otic Suspension is used by a nursing woman.

More information

Category Value
Authorisation number NDA050356
Orphan designation No
Product NDC 42023-108
Date Last Revised 17-03-2016
Type HUMAN PRESCRIPTION DRUG
RXCUI 854995
Storage and handling Store at 20°–25°C (68°–77°F). Rx only.
Marketing authorisation holder Par Pharmaceutical, Inc.