FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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).
History
There is currently no drug history available for this drug.
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.
Sources
Cortisporin Manufacturers
- Pfizer Laboratories Div Pfizer Inc
- Physicians Total Care, Inc.
- 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.
- 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
- Pfizer Laboratories Div Pfizer Inc
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