Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 30 April 2018

Indication(s)

INDICATIONS AND USAGE For the treatment of corticosteroid-responsive dermatoses with secondary infection. It has not been demonstrated that this steroid-antibiotic combination provides greater benefit than the steroid component alone after 7 days of treatment. (See WARNINGS.)

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Advisory information

contraindications
CONTRAINDICATIONS Not for use in the eyes or in the external ear canal if the eardrum is perforated. This product is contraindicated in tuberculous, fungal, or viral (for example, herpes simplex or varicella zoster) lesions of the skin. This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.
Special warnings and precautions
PRECAUTIONS General As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Treatment should not be continued for longer than 7 days. If the infection is not improved after 1 week, cultures and susceptibility tests should be repeated to verify the identity of the organism and to determine whether therapy should be changed. Allergic cross-reactions may occur which could prevent the use of any or all of the aminoglycoside antibiotics for the treatment of future infections. Use of steroids on infected areas should be supervised with care as anti-inflammatory steroids may encourage spread of infections. If this occurs, steroid therapy should be stopped and appropriate antibacterial drugs used. Generalized dermatological conditions may require systemic corticosteroid therapy. Signs and symptoms of exogenous hyperadrenocorticism can occur with the use of topical corticosteroids, including adrenal suppression. Systemic absorption of topically applied steroids will be increased if extensive body surface areas are treated or if occlusive dressings are used. Under these circumstances, suitable precautions should be taken when long-term use is anticipated. Information for Patients If redness, irritation, swelling, or pain persists or increases, discontinue use and notify physician. Do not use in the eyes. 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 and Mutagenesis and Impairment of Fertility Long-term studies in animals (rats, rabbits, mice) showed no evidence of carcinogenicity attributable to oral administration of corticosteroids. Pregnancy Teratogenic Effects Corticosteroids have been shown to be teratogenic in rabbits when applied topically at concentrations of 0.5% on days 6 to 18 of gestation and in mice when applied topically at a concentration of 15% on days 10 to 13 of gestation. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers Hydrocortisone appears in human milk following oral administration of the drug. Since systemic absorption of hydrocortisone may occur when applied topically, caution should be exercised when CORTISPORIN Ointment is used by a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Sufficient percutaneous absorption of hydrocortisone can occur in infants and children during prolonged use to cause cessation of growth, as well as other signs and symptoms of hyperadrenocorticism. Geriatric Use Clinical studies of Cortisporin Ointment did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients.
Adverse reactions
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 combinations including neomycin, bacitracin, and polymyxin B. 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.1 In another study, the incidence was found to be approximately 1%.2 The following local adverse reactions 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. When steroid preparations are used for long periods of time in intertriginous areas or over extensive body areas, with or without occlusive non-permeable dressings, striae may occur; also there exists the possibility of systemic side effects when steroid preparations are used over large areas or for a long period of time.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION Therapy with this product should be limited to 7 days. A thin film is applied 2 to 4 times daily to the affected area.
Pregnancy and lactation
Nursing Mothers Hydrocortisone appears in human milk following oral administration of the drug. Since systemic absorption of hydrocortisone may occur when applied topically, caution should be exercised when CORTISPORIN Ointment is used by a nursing woman.

More information

Category Value
Authorisation number NDA050168
Agency product number 89Y4M234ES
Orphan designation No
Product NDC 61570-031
Date Last Revised 18-04-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 657561
Marketing authorisation holder Pfizer Laboratories Div Pfizer Inc