DESCRIPTION: 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 Injection.
Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the
growth of Streptomyces fradiae Waksman
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.
CONTRAINDICATIONS: NEOSPORIN Ophthalmic Solution is contraindicated in individuals
who have shown hypersensitivity to any of its components
WARNINGS: NOT FOR INJECTION INTO THE EYE. NEOSPORIN Ophthalmic Solution should
never be directly introduced into the anterior chamber of the eye or injected subconjunctivally.
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
PRECAUTIONS: General: 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 initiated.
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 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