Cortisporin

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Side Effects & Adverse Reactions

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.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

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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History

There is currently no drug history available for this drug.

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Other Information

CORTISPORIN Cream (neomycin and polymyxin B sulfates and hydrocortisone acetate cream, USP) is a topical antibacterial cream. Each gram contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone acetate 5 mg (0.5%). The inactive ingredients are liquid petrolatum, white petrolatum, propylene glycol, polyoxyethylene polyoxypropylene compound, emulsifying wax, purified water, and 0.25% methylparaben added as a preservative. Sodium hydroxide or sulfuric acid may be added to adjust pH.

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 µg of neomycin standard per mg, calculated on an anhydrous basis. The structural formulae are:

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:

Hydrocortisone acetate is the acetate ester of hydrocortisone, an anti-inflammatory hormone. Its chemical name is 21-(acetyloxy)- 11β,17-dihydroxypregn-4-ene-3,20-dione. Its structural formula is:

The base is a smooth vanishing cream with a pH of approximately 5.0.

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Cortisporin Manufacturers

Pfizer Laboratories Div Pfizer Inc

Cortisporin | Pfizer Laboratories Div Pfizer Inc

A small quantity of the cream should be applied 2 to 4 times daily, as required. The cream should, if conditions permit, be gently rubbed into the affected areas.

No Recall
Physicians Total Care, Inc.

Cortisporin | Physicians Total Care, Inc.

A small quantity of the cream should be applied 2 to 4 times daily, as required. The cream should, if conditions permit, be gently rubbed into the affected areas.

No Recall
Monarch Pharmaceuticals, Inc.

Cortisporin | Monarch Pharmaceuticals, Inc.

Therapy with this product should be limited to 10 consecutive days.

The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator.

For adults, four drops of the solution should be instilled into the affected ear 3 or 4 times daily. For infants and children, three 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 solution. This wick should be kept moist by adding further solution every 4 hours. The wick should be replaced at least once every 24 hours.

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Monarch Pharmaceuticals, Inc.

Cortisporin | Cardinal Health

Adults and children 12 years and over

1-2 tablets every 4 hours or 2-3 tablets every 6 hours while symptoms last, not more than 12 tablets in 24 hours.

Children 6 to 11 years

1 tablet every 4 hours while symptoms last, not more than 5 tablets in 24 hours.

Children under 6 years

do not use

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Pfizer Laboratories Div Pfizer Inc

Cortisporin | Pfizer Laboratories Div Pfizer Inc

Therapy with this product should be limited to 7 days. A thin film is applied 2 to 4 times daily to the affected area.

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