NEOSPORIN® Ophthalmic Solution Sterile(neomycin
and polymyxin B sulfates and gramicidin ophthalmic solution, USP)
polymyxin b sulfate and
gramicidin solution Monarch Pharmaceuticals, Inc.
NEOSPORIN® Ophthalmic Solution Sterile (neomycin
and polymyxin B sulfates and gramicidin ophthalmic solution, USP)
Neosporin Ophthalmic Solution (neomycin and polymyxin B
sulfates and gramicidin ophthalmic solution) is a sterile antimicrobial solution
for ophthalmic use. Each mL contains: neomycin sulfate equivalent to 1.75
mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units,
and gramicidin 0.025 mg. The vehicle contains alcohol 0.5%, thimerosal 0.001%
(added as a preservative), and the inactive ingredients propylene glycol,
polyoxyethylene polyoxypropylene compound, sodium chloride, and Water for
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 µg of neomycin standard per mg, calculated on an
anhydrous basis. The structural formulae are:
B sulfate is the sulfate salt of polymyxin B1 and B2 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:
Gramicidin (also called Gramicidin
D) is a mixture of three pairs of antibacterial substances (Gramicidin A,
B, and C) produced by the growth of Bacillus
brevis Dubos (Fam. Bacillaceae). It has a potency of not less than
900 µg of standard gramicidin per mg. The structural formulae are:
A wide range of antibacterial action is provided by the
overlapping spectra of neomycin, polymyxin B sulfate, and gramicidin.
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.
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.
Gramicidin is bactericidal
for a variety of gram-positive organisms. It increases the permeability of
the bacterial cell membrane to inorganic cations by forming a network of channels
through the normal lipid bilayer of the membrane.
Neomycin sulfate, polymyxin B sulfate, and gramicidin 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
Indications and Usage
NEOSPORIN Ophthalmic Solution 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.
NEOSPORIN Ophthalmic Solution is contraindicated in individuals
who have shown hypersensitivity to any of its components.
NOT FOR INJECTION INTO THE EYE. NEOSPORIN Ophthalmic Solution
should never be directly introduced into the anterior chamber of the eye or
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:
As with other antibiotic preparations, prolonged use of
NEOSPORIN Ophthalmic Solution may result in overgrowth of nonsusceptible organisms
including fungi. If superinfection occurs, appropriate measures should be
Bacterial resistance to NEOSPORIN Ophthalmic
Solution may also develop. If purulent discharge, inflammation, or pain becomes
aggravated, the patient should discontinue use of the medication and consult
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
Information for Patients).
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.
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 (see PRECAUTIONS: General).
the condition persists or gets worse, or if a rash or other 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
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 gramicidin.
Treatment of cultured human lymphocytes in vitro with neomycin increased the
frequency of chromosome aberrations at the highest concentration (80 µg/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.
Pregnancy Category C. Animal reproduction studies have not
been conducted with neomycin sulfate, polymyxin B sulfate, or gramicidin.
It is also not known whether NEOSPORIN Ophthalmic Solution can cause fetal
harm when administered to a pregnant woman or can affect reproduction capacity.
NEOSPORIN Ophthalmic Solution should be given to a pregnant woman only if
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 Solution is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not
Adverse reactions have occurred with the anti-infective
components of NEOSPORIN Ophthalmic Solution. The exact incidence is not known.
Reactions occurring most often are allergic sensitization reactions including
itching, swelling, and conjunctival erythema (see WARNINGS). More serious hypersensitivity
reactions, including anaphylaxis, have been reported rarely.
irritation on instillation has also been reported.
Dosage and Administration
Instill one or two drops into the affected eye every 4 hours
for 7 to 10 days. In severe infections, dosage may be increased to as much
as two drops every hour.
Drop Dose® of 10 mL (plastic dispenser bottle)
Store at 15° to 25°C (59°
to 77°F) and protect from light.