"The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.
Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSS"...
Because of the concern of nephrotoxicity and ototoxicity associated with neomycin, this combination should not be used over a wide area or for extended periods of time.
General: As with any antibacterial preparation, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs. Use of steroids on infected areas should be supervised with care as anti- inflammatory steroids may encourage spread of infection. If this occurs, steroid therapy should be stopped and appropriate anti- bacterial 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.
Specifically, sufficient percutaneous absorption of hydrocortisone can occur in pediatric patients during prolonged use to cause cessation of growth, as well as other systemic signs and symptoms of hyperadrenocorticism.
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 studies in animals (rats, rabbits, mice) showed no evidence of carcinogenicity attributable to oral administration of corticosteroids.
Pregnancy: Teratogenic Effects: Pregnancy Category C. 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 acetate 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 Cream is used by a nursing woman.
Geriatric Use: Clinical studies of Cortisporin Cream (hydrocortisone, neomycin, polymyxin b) 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 the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Pediatric Use: Safety and effectiveness in pediatric patients have not been established (see PRECAUTIONS: General).
Last reviewed on RxList: 4/28/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Cortisporin Cream Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.