Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1118
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Cortisporin (Suspension)
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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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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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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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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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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. Stinging and 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 product if 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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Cortisporin
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