Cortisporin Ointment

DRUG DESCRIPTION

CORTISPORIN Ointment (neomycin and polymyxin b sulfates, bacitracin zinc, and hydrocortisone) (neomycin and polymyxin B sulfates, bacitracin zinc, and hydrocortisone ointment, USP) is a topical antibacterial ointment. Each gram contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 5,000 polymyxin B units, bacitracin zinc equivalent to 400 bacitracin units, hydrocortisone 10 mg (1%), and white petrolatum, qs.

Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 ?g of neomycin standard per mg, calculated on an anhydrous basis. The structural formulae are:

Neomycin sulfate structural formula illustration

Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2, which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are:

Polymyxin B sulfate structural formula illustration

Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis (Fam. Bacillaceae). It has a potency of not less than 40 bacitracin units per mg. The structural formula is:

Bacitracin zinc structural formula illustration

Hydrocortisone, 11?,17,21-trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone. Its structural formula is:

Hydrocortisone structural formula illustration

What are the precautions when taking neomycin and polymyxin b sulfates, bacitracin zinc, and hydrocortisone (Cortisporin Ointment)?

Before using this product, tell your doctor or pharmacist if you are allergic to neomycin, bacitracin, polymyxin, or hydrocortisone; or to aminoglycoside antibiotics (e.g., gentamicin, tobramycin); or to other corticosteroids (e.g., dexamethasone, prednisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used to treat an infection in the outer ear canal if the eardrum is torn (perforated).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, a weakened immune system.

Children may be more sensitive to the effects of too much...

Read All Potential Precautions of Cortisporin Ointment


Cortisporin Ointment Consumer (continued)

SIDE EFFECTS: Burning, redness, irritation, or dryness of the skin may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: stretch marks, skin thinning/discoloration, acne, extreme/unwanted hair growth, "hair bumps" (folliculitis).

Rarely, use of this medication for prolonged or repeated periods may result in other types of skin infections (e.g., fungal or other bacterial infections). Contact your doctor if you notice any unusual skin symptoms or if your condition does not improve.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to neomycin, bacitracin, polymyxin, or hydrocortisone; or to aminoglycoside antibiotics (e.g., gentamicin, tobramycin); or to other corticosteroids (e.g., dexamethasone, prednisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used to treat an infection in the outer ear canal if the eardrum is torn (perforated).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, a weakened immune system.

Children may be more sensitive to the effects of too much corticosteroid medication. Consult your doctor for more details.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.



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