Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 08 February 2017

Indication(s)

INDICATIONS AND USAGE: Neomycin and polymyxin B sulfates and bacitracin zinc 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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Advisory information

contraindications
CONTRAINDICATIONS: Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is contraindicated in those individuals who have shown hypersensitivity to any of its components.
Special warnings and precautions

PRECAUTIONS: General As with other antibiotic preparations, prolonged use of neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment may result in overgrowth of nonsusceptible organisms including fungi.

If superinfection occurs, appropriate measures should be initiated.

Bacterial resistance to neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment 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 (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.

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).

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.

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 concentration (80 mcg/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.

Pregnancy; 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 neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment should be given to a pregnant woman only if clearly needed.

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 neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Adverse reactions

ADVERSE REACTIONS: Adverse reactions have occurred with the anti-infective components of neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment.

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.

Local irritation on instillation has also been reported.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION: Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.
Pregnancy and lactation
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 neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is administered to a nursing woman.

More information

Category Value
Authorisation number ANDA064064
Orphan designation No
Product NDC 57319-343
Date Last Revised 04-11-2010
Type HUMAN PRESCRIPTION DRUG
RXCUI 308493
Storage and handling Storage: Store between 15° - 30°C (59°- 86°F). KEEP OUT OF REACH OF CHILDREN. Revised November 2007 Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated 9113600 (Folded) 9113700 (Flat)
Marketing authorisation holder Phoenix Pharmaceutical, Inc.