Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3889
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| rdf:type | |
| rdfs:label |
Cortisporin (Cream)
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| dailymed-instance:dosage |
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.
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| dailymed-instance:descripti... |
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��g of neomycin standard per mg, calculated on an anhydrous basis. The
structural formulae are: Polymyxin B sulfate is the sulfate
salt of polymyxin Band B, 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)- 11��,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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| dailymed-instance:clinicalP... |
Corticoids suppress the inflammatory response to a variety
of agents and they may delay healing. Since corticoids may inhibit the body's
defense mechanism against infection, a concomitant antimicrobial drug may
be used when this inhibition is considered to be clinically significant in
a particular case. The anti-infective components in
the combination are included to provide action against specific organisms
susceptible to them. Polymyxin B sulfate and neomycin sulfate together are
considered active against the following microorganisms: Staphylococcus
aureus, Escherichia coli, Haemophilus influenzae, Klebsiella- Enterobacter species, Neisseria species,
and Pseudomonas aeruginosa. The product
does not provide adequate coverage against Serratia
marcescens and streptococci, including Streptococcus
pneumoniae. The relative potency of corticosteroids
depends on the molecular structure, concentration, and release from the vehicle. The
acid pH helps restore normal cutaneous acidity. Owing to its excellent spreading
and penetrating properties, the cream facilitates treatment of hairy and intertriginous
areas. It may also be of value in selective cases where the lesions are moist.
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| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
Not for use in the eyes or in the external ear canal if
the eardrum is perforated. This product is contraindicated in tuberculous,
fungal, or viral lesions of the skin (herpes simplex, vaccinia, and varicella).
This product is contraindicated in those individuals who have shown hypersensitivity
to any of its components.
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| dailymed-instance:supply |
Tube of 7.5 g (NDC 61570-032-75). Store at 15��to 25��C (59��to 77��F).
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| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:precautio... |
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.<br/>Information for Patients: If redness, irritation, swelling or pain persists or increases,
discontinue use and notify physician. Do not use in the eyes.<br/>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.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Longterm studies in animals (rats, rabbits, mice) showed
no evidence of carcinogenicity attributable to oral administration of corticosteroids.<br/>Pregnancy:<br/>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.<br/>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.<br/>Geriatric Use: Clinical studies of Cortisporin Cream 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.<br/>Pediatric Use: Safety and effectiveness in pediatric patients have not
been established .
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| dailymed-instance:genericMe... |
neomycin sulfate, polymyxin B sulfate and hydrocortisone acetate
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| dailymed-instance:fullName |
Cortisporin (Cream)
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| dailymed-instance:adverseRe... |
Neomycin occasionally causes skin sensitization. Ototoxicity
and nephrotoxicity have also been reported .
Adverse reactions have occurred with topical use of antibiotic combinations
including neomycin and polymyxin B. Exact incidence figures are not available
since no denominator of treated patients is available. The reaction occurring
most often is allergic sensitization. In one clinical study, using a 20% neomycin
patch, neomycin-induced allergic skin reactions occurred in two of 2,175 (0.09%)
individuals in the general population.In another study, the incidence
was found to be approximately 1%. The following
local adverse reactions have been reported with topical corticosteroids, especially
under occlusive dressings: burning, itching, irritation, dryness, folliculitis,
hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis,
allergic contact dermatitis, maceration of the skin, secondary infection,
skin atrophy, striae, and miliaria. When steroid preparations
are used for long periods of time in intertriginous areas or over extensive
body areas, with or without occlusive non-permeable dressings, striae may
occur; also there exists the possibility of systemic side effects when steroid
preparations are used over large areas or for a long period of time.
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| dailymed-instance:warning |
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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| dailymed-instance:indicatio... |
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 .
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| dailymed-instance:represent... | |
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| dailymed-instance:name |
Cortisporin
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