Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1959
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| rdf:type | |
| rdfs:label |
Neosporin (Ointment)
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| dailymed-instance:dosage |
Apply the ointment every 3 or 4 hours for 7 to 10 days,
depending on the severity of the infection.
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| dailymed-instance:descripti... |
NEOSPORIN OPHTHALMIC OINTMENT (neomycin and polymyxin B
sulfates and bacitracin zinc ophthalmic ointment) is a sterile antimicrobial
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, 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:
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| dailymed-instance:clinicalP... |
A wide range of antibacterial action is provided by the
overlapping spectra of neomycin, polymyxin B sulfate, and bacitracin. Neomycin
is bactericidal for many gram-positive and gram-negative organisms. It is
an aminoglycoside antibiotic which inhibits protein synthesis by binding with
ribosomal RNA and causing misreading of the bacterial genetic code. Polymyxin
B is bactericidal for a variety of gram-negative organisms. It increases the
permeability of the bacterial cell membrane by interacting with the phospholipid
components of the membrane. Bacitracin is bactericidal
for a variety of gram-positive and gram-negative organisms. It interferes
with bacterial cell wall synthesis by inhibition of the regeneration of phospholipid
receptors involved in peptidoglycan synthesis. Microbiology: Neomycin sulfate, polymyxin B sulfate,
and bacitracin zinc 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.
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| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
Neosporin Ophthalmic Ointment is contraindicated in individuals
who have shown hypersensitivity to any of its components.
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| dailymed-instance:supply |
Tube of 1/8 oz (3.5 g) with ophthalmic tip (NDC 0081-0732-86). Caution: Federal law prohibits dispensing without
a prescription. Store at 15��to 25��C (59��to 77��F). Manufactured
by: Burroughs Wellcome Inc. Kirkland;
Que., Canada H9H 4J4 for BURROUGHS WELLCOME CO. Research
Triangle Park, NC 27709
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| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:precautio... |
General: As with other antibiotic preparations, prolonged use of
NEOSPORIN Ophthalmic Ointment may result in overgrowth of nonsusceptible organisms
including fungi. If superinfection occurs, appropriate measures should be
initiated. Bacterial resistance to NEOSPORIN Ophthalmic
Ointment may also develop. If purulent discharge, inflammation, or pain become
aggravated, the patient should discontinue use of the medication and consult
a physician. 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 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 vitrowith neomycin increased the frequency of chromosome aberrations
at the highest concentration (80��g/mL) tested; however, the effects
of neomycin on carcinogenesis and mutagenesis in humans are unknown. 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.<br/>Pregnancy:<br/>Teratogenic
Effects: Pregnancy Category C. Animal reproduction studies have not
been conducted with neomycin sulfate, polymyxin B sulfate, or bacitracin,
It is also not known whether NEOSPORIN Ophthalmic Ointment can cause fetal
harm when administered to a pregnant woman or can affect reproduction capacity.
NEOSPORIN Ophthalmic Ointment should be given to a pregnant woman only if
clearly needed.<br/>Nursing Mothers: It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised
when NEOSPORIN Ophthalmic Ointment is administered to a nursing woman.<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 bacitracin zinc
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| dailymed-instance:fullName |
Neosporin (Ointment)
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| dailymed-instance:adverseRe... |
Adverse reactions have occurred with the anti-infective
components of NEOSPORIN Ophthalmic Ointment. The exact incidence is not known.
Reactions occurring most often are allergic sensitization reactions including
itching, swelling, and conjunctival erythema .
More serious hypersensivity reactions, including anaphylaxis, have been reported
rarely. Local irritation on instillation has also been
reported.
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| dailymed-instance:warning |
NOT FOR INJECTION INTO THE EYE. NEOSPORIN OPHTHALMIC OINTMENT
should never be directly introduced into the anterior chamber of the eye.
Ophthalmic ointments may retard corneal wound healing. 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. Application of products containing these ingredients should
be avoided for the patient thereafter (see PRECAUTIONS:
General).
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| dailymed-instance:indicatio... |
NEOSPORIN Ophthalmic Ointment is indicated for the topical
treatment of superficial infections of the external eye and its adnexa caused
by susceptible bacteria. Such infections encompass conjunctivitis, keratitis
and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.
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| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Neosporin
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