Data from FDA - Curated by EPG Health - Last updated 15 June 2018

Indication(s)

INDICATIONS AND USAGE: For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitises 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. The particular anti-infective drugs in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus , Escherichia coli, Haemophilus influenzae , Klebsiella / Enterobacter species, Niesseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens and Streptococci, including Streptococcus pneumoniae.

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Advisory information

contraindications
CONTRAINDICATIONS: Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication. (Hypersensitivity to the antibiotic component occurs at a higher rate than for the other components.) The use of these combinations is always contraindicated after uncomplicated removal of a corneal foreign body.
Special warnings and precautions
PRECAUTIONS: The initial prescription and renewal of the medication order beyond 8 g 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, flourescein staining. The possibility of persistent fungal infections of the cornea should be considered after prolonged steroid dosing. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial ocular infection.
Adverse reactions
ADVERSE REACTIONS: Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available. Reactions occurring most often from the presence of the anti-infective ingredients are allergic sensitizations. The reactions due to the steroid component 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 the secondary infection has occurred after use of combination containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs. To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION: Apply a small amount into the conjunctival sac(s) up to three or four times daily. How to Apply neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment: Tilt your head back. Place a finger on your cheek just under your eye and gently pull down until a "V" pocket is formed between your eyeball and your lower lid. Place a small amount (about 1/2 inch) of neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment in the "V" pocket. Do not let the tip of the tube touch your eye. Look downward before closing your eye. Not more than 8 g should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.
Pregnancy and lactation
NURSING MOTHERS: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment is administered to a nursing woman.

More information

Category Value
Authorisation number ANDA062938
Agency product number 7S5I7G3JQL
Orphan designation No
Product NDC 68071-1744
Date Last Revised 04-06-2018
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder NuCare Pharmaceuticals,Inc.