Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1788
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rdfs:label |
Cortisporin (Suspension)
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dailymed-instance:dosage |
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, 4 drops of the suspension should be instilled
into the affected ear 3 or 4 times daily. For infants and children,
3 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 suspension. This wick should
be kept moist by adding further suspension every 4 hours. The wick
should be replaced at least once every 24 hours. SHAKE WELL BEFORE USING.
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dailymed-instance:descripti... |
CORTISPORIN Otic Suspension (neomycin
and polymyxin B sulfates and hydrocortisone otic suspension, USP)
is a sterile antibacterial and anti-inflammatory suspension for otic
use. Each mL contains: neomycin sulfate equivalent to 3.5 mg neomycin
base, polymyxin B sulfate equivalent to 10,000 polymyxin B units,
and hydrocortisone 10 mg (1%). The vehicle contains thimerosal 0.01%
(added as a preservative) and the inactive ingredients cetyl alcohol,
propylene glycol, polysorbate 80, and Water for Injection. 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 mcg 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, 11��,17, 21-trihydroxypregn-4-ene-3, 20-dione,
is an anti-inflammatory hormone. Its structural formula is:
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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. Neomycin
sulfate and polymyxin B sulfate together are considered active against
the following microorganisms: Staphylococcus
aureus, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter
species, Neisseria species, and Pseudomonas aeruginosa. This 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.
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dailymed-instance:activeIng... | |
dailymed-instance:contraind... |
This product is contraindicated in those individuals
who have shown hypersensitivity to any of its components, and in herpes
simplex, vaccinia, and varicella infections.
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dailymed-instance:supply |
Bottle of 10 mL with sterilized dropper. (NDC 61570-033-10).
Store at 15��to 25��C (59��to 77��F). Also Available: CORTISPORIN Otic Solution bottle of 10 mL with sterilized dropper. PEDIOTIC Suspension bottle of 7.5 mL
with sterilized dropper.
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dailymed-instance:inactiveI... | |
dailymed-instance:precautio... |
General: As with other antibiotic preparations, prolonged
use may result in overgrowth of nonsusceptible organisms, including
fungi. If the infection is not improved after
1 week, cultures and susceptibility tests should be repeated to verify
the identity of the organism and to determine whether therapy should
be changed. Treatment should not be continued
for longer than 10 days. Allergic cross-reactions
may occur which could prevent the use of any or all of the following
antibiotics for the treatment of future infections: kanamycin, paromomycin,
streptomycin, and possibly gentamicin.<br/>Information for Patients: Avoid contaminating the dropper with material from
the ear, fingers, or other source. This caution is necessary if the
sterility of the drops is to be preserved. If sensitization or irritation
occurs, discontinue use immediately and contact your physician. Do not use in the eyes. SHAKE WELL
BEFORE USING.<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: Long-term 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 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 Otic Suspension is used by a nursing
woman.<br/>Pediatric Use: The safety and effectiveness of CORTISPORIN Otic Suspension in otitis extema have been established
in the pediatric age group 2 years to 16 years of age. There is inadequate
data to establish safety and effectiveness in otitis extema for pediatric
patients under 2 years of age.<br/>Geriatric Use: Clinical studies of CORTISPORIN Otic
Suspension 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.
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dailymed-instance:genericMe... |
neomycin sulfate, polymyxin B sulfate and hydrocortisone
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dailymed-instance:fullName |
Cortisporin (Suspension)
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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. Stingingand burning have been
reported rarely when this drug has gained access to the middle ear.
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dailymed-instance:warning |
Neomycin can induce permanent sensorineural hearing
loss due to cochlear damage, mainly destruction of hair cells in the
organ of Corti. The risk is greater with prolonged use. Therapy should
be limited to 10 consecutive days . Patients being treated with eardrops containing neomycin should
be under close clinical observation. CORTISPORIN Otic
Suspension should not be used in any patient with a perforated tympanic
membrane. Discontinue promptly if sensitization
or irritation occurs. Neomycin sulfate may
cause cutaneous sensitization. A precise incidence of hypersensitivity
reactions (primarily skin rash) due to topical neomycin is not known. When using neomycin-containing products to control secondary
infection in the chronic dermatoses, such as chronic otitis externa
or stasis dermatitis, it should be borne in mind that the skin in
these conditions is more liable than is normal skin to become sensitized
to many substances, including neomycin. The manifestation of sensitization
to neomycin is usually a low-grade reddening with swelling, dry scaling,
and itching; it may be manifest simply as a failure to heal. Periodic
examination for such signs is advisable, and the patient should be
told to discontinue the productif they are observed. These symptoms
regress quickly on withdrawing the medication. Neomycincontaining
applications should be avoided for the patient thereafter.
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dailymed-instance:indicatio... |
For the treatment of superficial bacterial infections
of the external auditory canal caused by organisms susceptible to
the action of the antibiotics, and for the treatment of infections
of mastoidectomy and fenestration cavities caused by organisms susceptible
to the antibiotics.
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dailymed-instance:name |
Cortisporin
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