Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4132
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rdfs:label |
Cortisporin (Ointment)
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dailymed-instance:dosage |
Apply the ointment in the affected eye every 3 or 4 hours,
depending on the severity of the condition. Not more
than 8 grams should be prescribed initially and the prescription should not
be refilled without further evaluation as outlined in PRECAUTIONS above.
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dailymed-instance:descripti... |
CORTISPORIN Ophthalmic Ointment (neomycin
and polymyxin B sulfates, bacitracin zinc, and hydrocortisone ophthalmic ointment)
is a sterile antimicrobial and anti-inflammatory ointment for ophthalmic use.
Each gram contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin
B sulfate equivalent to 10,000 polymyxin B units, bacitracin zinc equivalent
to 400 bacitracin units, hydrocortisone 10 mg (1%), and white petrolatum,
q.s. 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: Bacitracin
zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides
(mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus
subtilis var Tracy. It has a potency of not less than 40 bacitracin
units per mg. The structural formula is: 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... |
Corticosteroids suppress the inflammatory response to a
variety of agents and they probably delay or slow healing. Since corticosteroids
may inhibit the body's defense mechanism against infection, concomitant
antimicrobial drugs may be used when this inhibition is considered to be clinically
significant in a particular case. When a decision to
administer both a corticosteroid and antimicrobials is made, the administration
of such drugs in combination has the advantage of greater patient compliance
and convenience, with the added assurance that the appropriate dosage of all
drugs is administered. When each type of drug is in the same formulation,
compatibility of ingredients is assured and the correct volume of drug is
delivered and retained. The relative potency of corticosteroids
depends on the molecular structure, concentration, and release from the vehicle. Microbiology: The
anti-infective components in CORTISPORIN Ophthalmic Ointment are included
to provide action against specific organisms susceptible to it. Neomycin sulfate
and polymyxin B sulfate are active in vitro against susceptible strains of
the following microorganisms: Staphylococcus
aureus, streptococci including Streptococcus
pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species,
and Pseudomonas aeruginosa. The product
does not provide adequate coverage against Serratia
marcescens (see INDICATIONS
AND USAGE).
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dailymed-instance:activeIng... | |
dailymed-instance:contraind... |
CORTISPORIN Ophthalmic Ointment is contraindicated in most
viral diseases of the cornea and conjunctiva including: epithelial herpes
simplex keratitis (dendritic keratitis), vaccinia and varicella, and also
in mycobacterial infection of the eye and fungal diseases of ocular structures. CORTISPORIN
Ophthalmic Ointment is also contraindicated in individuals who have shown
hypersensitivity to any of its components. Hypersensitivity to the antibiotic
component occurs at a higher rate than for other components.
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dailymed-instance:supply |
Tube of 1/8 oz. (3.5 g) with ophthalmic tip (NDC 61570-035-35). Rx only. Store at 15��to 25��C (59��to 77��F). Rev. 9/98 Distributed
by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620 Manufactured
by: Draxis Pharma, Inc., Kirkland, Quebec H9H 4J4
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dailymed-instance:activeMoi... | |
dailymed-instance:inactiveI... | |
dailymed-instance:precautio... |
General: The initial prescription and renewal of the medication order
beyond 8 grams should be made by a physician only after examination of the
patient with the aid of magnification, such as slit lamp biomicroscopy and,
where appropriate, fluorescein staining. If signs and symptoms fail to improve
after two days, the patient should be re-evaluated. The
possibility of fungal infections of the cornea should be considered after
prolonged corticosteroid dosing. Fungal cultures should be taken when appropriate. If
this product is used for 10 days or longer, intraocular pressure should be
monitored . There
have been reports of bacterial keratitis associated with the use of topical
ophthalmic products in multiple-dose containers which have been inadvertently
contaminated by patients, most of whom had a concurrent corneal disease or
a disruption of the ocular epithelial surface (see PRECAUTIONS:
Information for Patients). 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: Patients should be instructed to avoid allowing the tip
of the dispensing container to contact the eye, eyelid, fingers, or any other
surface. The use of this product by more than one person may spread infection. Patients
should also be instructed that ocular products, if handled improperly, can
become contaminated by common bacteria known to cause ocular infections. Serious
damage to the eye and subsequent loss of vision may result from using contaminated
products . If
the condition persists or gets worse, or if a rash or allergic reaction develops,
the patient should be advised to stop use and consult a physician. Do not
use this product if you are allergic to any of the listed ingredients. Keep
tightly closed when not in use. Keep out of the reach of children.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals to evaluate carcinogenic or
mutagenic potential have not been conducted with polymyxin B sulfate or bacitracin.
Treatment of cultured human lymphocytes in vitro with neomycin increased the
frequency of chromosome aberrations at the highest concentrations (80��g/mL)
tested; however, the effects of neomycin on carcinogenesis and mutagenesis
in humans are unknown. Long-term studies in animals
(rats, rabbits, mice) showed no evidence of carcinogenicity or mutagenicity
attributable to oral administration of corticosteroids. Long-term animal studies
have not been performed to evaluate the carcinogenic potential of topical
corticosteroids. Studies to determine mutagenicity with hydrocortisone have
revealed negative results. Polymyxin B has been reported
to impair the motility of equine sperm, but its effects on male or female
fertility are unknown. No adverse effects on male or female fertility, litter
size, or survival were observed in rabbits given bacitracin zinc 100 gm/ton
of diet. Long-term animal studies have not been performed to evaluate the
effect on fertility of topical corticosteroids.<br/>Pregnancy:<br/>Teratogenic
Effects: Pregnancy Category C. Corticosteroids have been found 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. CORTISPORIN Ophthalmic Ointment should be used
during pregnancy only if the potential benefit justifies the potential risk
to the fetus.<br/>Nursing Mothers: It is not known whether topical administration of corticosteroids
could result in sufficient systemic absorption to produce detectable quantities
in human milk. Systemically administered corticosteroids appear in human milk
and could suppress growth, interfere with endogenous corticosteroid production,
or cause other untoward effects. Because of the potential for serious adverse
reactions in nursing infants from CORTISPORIN Ophthalmic Ointment, a decision
should be made whether to discontinue nursing or to discontinue the drug,
taking into account the importance of the drug to the mother.<br/>Pediatric Use: Safety and effectiveness in children have not been established.
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dailymed-instance:genericMe... |
neomycin sulfate, polymyxin B sulfate, bacitracin zinc and hydrocortisone
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dailymed-instance:fullName |
Cortisporin (Ointment)
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dailymed-instance:adverseRe... |
Adverse reactions have occurred with corticosteroid/anti-infective
combination drugs which can be attributed to the corticosteroid component,
the anti-infective component, or the combination. The exact incidence is not
known. Reactions occurring most often from the presence
of the anti-infective ingredient are allergic sensitization reactions including
itching, swelling, and conjunctival erythema .
More serious hypersensitivity reactions, including anaphylaxis, have been
reported rarely. The reactions due to the corticosteroid
component in decreasing order of frequency are: elevation of intraocular pressure
(IOP) with possible development of glaucoma, and infrequent optic nerve damage;
posterior subcapsular cataract formation; and delayed wound healing. Secondary Infection: The development of the secondary
infection has occurred after use of combinations containing corticosteroids
and antimicrobials. Fungal and viral infections of the cornea are particularly
prone to develop coincidentally with long-term applications of a corticosteroid.
The possibility of fungal invasion must be considered in any persistent corneal
ulceration where corticosteroid treatment has been used. Local
irritation on installation has been reported.
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dailymed-instance:warning |
NOT FOR INJECTION INTO THE EYE. CORTISPORIN Ophthalmic Ointment
should never be directly introduced into the anterior chamber of the eye.
Ophthalmic ointments may retard corneal wound healing. Prolonged
use of corticosteroids may result in ocular hypertension and/or glaucoma,
with damage to the optic nerve, defects in visual acuity and fields of vision,
and in posterior subcapsular cataract formation. Prolonged
use may suppress the host response and thus increase the hazard of secondary
ocular infections. In those diseases causing thinning of the cornea or sclera,
perforations have been known to occur with the use of topical corticosteroids.
In acute purulent conditions of the eye, corticosteroids may mask infection
or enhance existing infection. If these products are
used for 10 days or longer, intraocular pressure should be routinely monitored
even though it may be difficult in uncooperative patients. Corticosteroids
should be used with caution in the presence of glaucoma. The
use of corticosteroids after cataract surgery may delay healing and increase
the incidence of filtering blebs. Use of the ocular
corticosteroids may prolong the course and may exacerbate the severity of
many viral infections of the eye (including herpes simplex). Employment of
corticosteroid medication in the treatment of herpes simplex requires great
caution. Topical antibiotics, particularly neomycin
sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity
reactions (primarily skin rash) due to topical antibiotics is not known. The
manifestations of sensitization to topical antibiotics are usually itching,
reddening, and edema of the conjunctiva and eyelid. A sensitization reaction
may manifest simply as a failure to heal. During long-term use of topical
antibiotic products, periodic examination for such signs is advisable, and
the patient should be told to discontinue the product if they are observed.
Symptoms usually subside quickly on withdrawing the medication. Applications
of products containing these ingredients should be avoided for the patient
thereafter .
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dailymed-instance:indicatio... |
CORTISPORIN Ophthalmic Ointment is indicated for steroid-responsive
inflammatory ocular conditions for which a corticosteroid is indicated and
where bacterial infection or a risk of bacterial infection exists. Ocular
corticosteroids are indicated in inflammatory conditions of the palpebral
and bulbar conjunctiva, cornea, and anterior segment of the globe where the
inherent risk of corticosteroid use in certain infective conjunctivitides
is accepted to obtain a diminution in edema and inflammation. They are also
indicated in chronic anterior uveitis and corneal injury from chemical, radiation,
or thermal burns, or penetrationof foreign bodies. The
use of a combination drug with an anti-infective component is indicated where
the risk of infection is high or where there is an expectation that potentially
dangerous numbers of bacteria will be present in the eye (see CLINICAL
PHARMACOLOGY: Microbiology). The particular
anti-infective drugs in this product are active against the following common
bacterial eye pathogens: Staphylococcus aureus , streptococci, including Streptococcus
pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacterspecies, Neisseria species,
and Pseudomonas aeruginosa. The
product does not provide adequate coverage against Serratia
marcescens.
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dailymed-instance:represent... | |
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dailymed-instance:name |
Cortisporin
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