Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/162
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Cortisporin (Ointment)
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| dailymed-instance:dosage |
Therapy with this product should be limited to 7 days. A
thin film is applied 2 to 4 times daily to the affected area.
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| dailymed-instance:descripti... |
CORTISPORIN Ointment (neomycin and polymyxin B sulfates,
bacitracin zinc, and hydrocortisone ointment, USP) is a topical antibacterial
ointment. Each gram contains: neomycin sulfate equivalent to 3.5 mg neomycin
base, polymyxin B sulfate equivalent to 5,000 polymyxin B units, bacitracin
zinc equivalent to 400 bacitracin units, hydrocortisone 10 mg (1%), and white
petrolatum, qs. 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 (Fam. Bacillaceae). 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... |
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, bacitracin zinc, and neomycin sulfate
together are considered active against 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. The relative potency of corticosteroids
depends on the molecular structure, concentration, and release from the vehicle.
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| 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 (for example, herpes simplex or varicella zoster) lesions
of the skin. This product is contraindicated in those individuals who have
shown hypersensitivity to any of its components.
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Tube of 1/2 oz with applicator tip (NDC 61570-031-50). Store at 15��to 25��C (59��to 77��F).
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| dailymed-instance:precautio... |
General: As with other antibiotic preparations, prolonged use may
result in overgrowth of nonsusceptible organisms, including fungi. Treatment
should not be continued for longer than 7 days. 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.
Allergic cross-reactions may occur which could prevent the use of any or all
of the aminoglycoside antibiotics for the treatment of future infections. Use
of steroids on infected areas should be supervised with care as anti-inflammatory
steroids may encourage spread of infections. If this occurs, steroid therapy
should be stopped and appropriate antibacterial 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.<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 and Mutagenesis and 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 Ointment is used by
a nursing woman.<br/>Pediatric Use: Safety and effectiveness in pediatric patients have not
been established. Sufficient percutaneous absorption of hydrocortisone can
occur in infants and children during prolonged use to cause cessation of growth,
as well as other signs and symptoms of hyperadrenocorticism.<br/>Geriatric Use: Clinical studies of Cortisporin Ointment 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 elderly and younger patients.
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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... |
Neomycin occasionally causes skin sensitization. Ototoxicity
and nephrotoxicity have also been reported.
Adverse reactions have occurred with topical use of antibiotic combinations
including neomycin, bacitracin, 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 |
Neomycin can induce permanent sensorineural hearing loss
due to cochlear damage, mainly destruction of hair cells in the organ of Corti.
The risk of ototoxicity is greater with prolonged use. Therapy
with this product should be limited to 7 days of treatment. Neomycin
sulfate may cause cutaneous sensitization. A precise incidence of hypersensitivity
reactions (primarily skin rash) due to topical neomycin is not known. Discontinue
promptly if sensitization or irritation occurs. When
using neomycin-containing products to control secondary infection in the chronic
dermatoses, such as chronic otitis extema 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. Neomycin-containing applications
should be avoided for the patient thereafter.
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| dailymed-instance:indicatio... |
For the treatment of corticosteroidresponsive 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:name |
Cortisporin
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