Bacitracin, Neomycin, Polymyxin B, and Hydrocortisone (Topical)

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Use as you have been told, even if your signs get better.
• Follow how to take bacitracin, neomycin, polymyxin B, and hydrocortisone as you have been told by your doctor. Do not use more than you were told to use.
• Do not take this medicine by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about bacitracin, neomycin, polymyxin B, and hydrocortisone, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about bacitracin, neomycin, polymyxin B, and hydrocortisone. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using bacitracin, neomycin, polymyxin B, and hydrocortisone.

Review Date: October 4, 2017

(bas i TRAY sin, nee oh MYE sin, pol i MIKS in bee, & hye droe KOR ti sone)

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Ointment, External:

Cortisporin: Bacitracin 400 units, neomycin 3.5 mg, polymyxin B 5000 units, and hydrocortisone 10 mg per g (15 g)

Hypersensitivity to bacitracin, neomycin, polymyxin B, hydrocortisone, or any component of the formulation.

There are no dosage adjustments provided in the manufacturer's labeling.

Concerns related to adverse effects:

• Adrenal suppression: Systemic absorption of topical corticosteroids may cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.

• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines.

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).

• Neomycin sensitization: Neomycin may cause cutaneous sensitization. Symptoms of neomycin sensitization include itching, reddening, edema, and failure to heal. Discontinuation of product and avoidance of similar products should be considered.

• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas. Neomycin can induce permanent sensorineural hearing loss due to cochlear damage; risk is greater with prolonged use.

Special populations:

• Pediatric: Topical corticosteroids: Infants and small children may absorb proportionally larger amounts of corticosteroids after topical application and may be more prone to systemic effects due to larger skin surface area to body mass ratio, particularly if applying to >20% of BSA. HPA axis suppression, intracranial hypertension, and Cushing syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.

Dosage form specific issues:

• Topical ointment: Limit therapy to 7 days of treatment.

There are no data on the excretion of bacitracin/hydrocortisone/neomycin/polymyxin B topical into human milk. Orally administered corticosteroids are excreted into human milk and systemic absorption of hydrocortisone may occur following topical administration. The manufacturer recommends that caution be used when administering bacitracin/hydrocortisone/neomycin/polymyxin B topical to nursing women.