Data from FDA - Curated by EPG Health - Last updated 19 December 2016

Indication(s)

INDICATIONS AND USAGE: Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists.

Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation.

They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye (see CLINICAL PHARMACOLOGY:

Microbiology).

The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: 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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Advisory information

contraindications

CONTRAINDICATIONS: Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment is contraindicated in most viral diseases of the cornea and conjunctiva including: epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

This product is also contraindicated in individuals who have shown hypersensitivity to any of its components.

Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.

Special warnings and precautions

PRECAUTIONS: General: The initial prescription and renewal of the medication order beyond 8 grams should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

The possibility of fungal infections of the cornea should be considered after prolonged corticosteroid dosing.

Fungal cultures should be taken when appropriate.

If this product is used for 10 days or longer, intraocular pressure should be monitored (see WARNINGS).

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 the 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.

Long-term studies in animals (rats, rabbits, mice) showed no evidence of carcinogenicity or mutagenicity attributable to oral administration of corticosteroids.

Long-term animal studies have not been performed to evaluate the carcinogenic potential of topical corticosteroids.

Studies to determine mutagenicity with hydrocortisone have revealed negative results.

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.

Long-term animal studies have not been performed to evaluate the effect on fertility of topical corticosteroids.

Pregnancy: Teratogenic Effects: Pregnancy Category C. Corticosteroids have been found 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.

Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.

Because of the potential for serious adverse reactions in nursing infants from neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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

Adverse reactions

ADVERSE REACTIONS: Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, or the combination.

The exact incidence is not known.

Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitization reactions including itching, swelling and conjunctival erythema (see WARNINGS).

More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.

The reactions due to the corticosteroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Secondary Infection: The development of secondary infection has occurred after use of combinations containing corticosteroids and antimicrobials.

Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of a corticosteroid.

The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used.

Local irritation on instillation has also been reported.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION: Apply the ointment in the affected eye every 3 or 4 hours, depending on the severity of the condition. Not more than 8 grams should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS: above.
Pregnancy and lactation

Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.

Because of the potential for serious adverse reactions in nursing infants from neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

More information

Category Value
Authorisation number ANDA064068
Agency product number 58H6RWO52I
Orphan designation No
Product NDC 0904-2995
Date Last Revised 04-11-2010
Type HUMAN PRESCRIPTION DRUG
RXCUI 688708
Storage and handling Storage: Store between 15° - 30°C (59°- 86°F). KEEP OUT OF REACH OF CHILDREN. Rx only Revised November 2007 Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated 9113800 (Folded) 9113900 (Flat)
Marketing authorisation holder Major Pharmaceuticals