Cortisporin-TC (Page 2 of 2)

Pregnancy

Teratogenic Effects

Pregnancy Category C

There are no adequate and well controlled studies of Cortisporin® -TC Otic Suspension in pregnant women. It is not known whether Cortisporin® -TC Otic Suspension 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 Cortisporin® -TC Otic Suspension 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.

Cortisporin® -TC Otic Suspension 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 Cortisporin® -TC Otic Suspension is used by a nursing woman.

Pediatric Use

See DOSAGE AND ADMINISTRATION.

The safety and effectiveness of Cortisporin® -TC Otic Suspension in infants below one year of age have not been established. The efficacy of Cortisporin® -TC Otic Suspension 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 to Cortisporin-TC

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/.

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.

HOW SUPPLIED

Cortisporin® -TC Otic Suspension is supplied as:

NDC 42023-109-01 …………… 10 mL bottle with dropper

Each mL contains: Colistin sulfate equivalent to 3 mg of colistin base activity, Neomycin sulfate equivalent to 3.3 mg neomycin base activity, Hydrocortisone acetate 10 mg (1%), Thonzonium bromide 0.5 mg (0.05%), and Polysorbate 80 in an aqueous vehicle buffered with acetic acid and sodium acetate. Thimerosal (mercury derivative) 0.002% is added as a preservative.

A sterilized dropper-cap assembly for use on the bottle of suspension is included in the package.

Shake well before using.

Store at 20°–25°C (68°–77°F).

Rx only.

Prescribing Information as of July 2009

Manufactured by: JHP Pharmaceuticals, LLC, Rochester, MI 48307

3000828C

PRINCIPAL DISPLAY PANEL — 10 mL Label

NDC 42023-109-01

Cortisporin® -TC

(colistin sulfate–neomycin sulfate–
thonzonium bromide–hydrocortisone
acetate otic suspension)

STERILE 10mL

JHP PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL -- 10 mL Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mL Carton

NDC 42023-109-01

Cortisporin® -TC

(colistin sulfate–neomycin sulfate–
thonzonium bromide–hydrocortisone
acetate otic suspension)

NOTE – The enclosed dropper has been sterilized. If dropper
wrapper is broken or open, sterility cannot be guaranteed.

Rx Only

STERILE Shake Well Before Using.

10mL bottle with dropper

JHP PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL -- 10 mL Carton
(click image for full-size original)
CORTISPORIN-TC
colistin sulfate, neomycin sulfate, thonzonium bromide, and hydrocortisone acetate suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42023-109
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
colistin sulfate (colistin) colistin 3 mg in 1 mL
neomycin sulfate (neomycin) neomycin 3.3 mg in 1 mL
thonzonium bromide (thonzonium bromide) thonzonium bromide 0.5 mg in 1 mL
hydrocortisone acetate (hydrocortisone) hydrocortisone 10 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42023-109-01 10 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050356 11/01/2007
Labeler — JHP Pharmaceuticals LLC (804894611)

Revised: 01/2010 JHP Pharmaceuticals LLC

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