A steroid/anti-infective combination is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a 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 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.
The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: Staphylococcus aureus; Escherichia coli; Hemophilus influenzae; Klebsiella/ Enterobacter species; Neisseria species; and Pseudomonas aeruginosa.
The product does not provide adequate coverage against: Serratia marcescens; Streptococci, including Streptococcus pneumoniae.

TO TREAT THE EYE: Instill 1 or 2 drops every 3 or 4 hours, or more frequently as required. Acute infections may require administration every 30 minutes, with frequency of administration reduced as the infection is brought under control. TO TREAT THE LIDS: Instill 1 or 2 drops in the eye every 3 to 4 hours, close the eye and rub the excess on the lids and lid margins.
Not more than 20 milliliters should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in the PRECAUTIONS section above.

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 the ocular structures. Hypersensitivity to a component of the medication. (Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.) The use of these combinations is always contraindicated after uncomplicated removal of a corneal foreign body.

NOT FOR INJECTION INTO THE EYE.
Prolonged use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.
Employment of a steroid medication in the treatment of herpes simplex requires great caution.
There exists a potential for neomycin sulfate to cause cutaneous sensitization. The exact incidence of this reaction is unknown. 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:
The initial prescription and renewal of the medication order beyond 20 milliliters 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.

The possibility of persistent fungal infections of the cornea should be considered after prolonged steroid dosing.
As with other antimicrobial preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.
Bacterial resistance to Neopred-P may also develop. If purulent discharge, inflammation, or pain becomes aggravated, the patient should discontinue use of the medicatioin and consult a physician.
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.
Children Safety and effectiveness in pediatric patients have not been established. Secondary infection
The development of secondary infection has occurred after use of combinations 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.

None well documented.

Pregnancy
Neomycin/polymyxin B/prednisolone ophthalmic has been assigned to pregnancy category C by the FDA. Animal studies have shown corticosteroids to be teratogenic in mice and rabbits following multiple dose topical ophthalmic application. There are no controlled data in human pregnancy.
Neomycin/polymyxin B/prednisolone ophthalmic is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.
Corticosteroids have been shown to produce fetal resorptions and cleft palate in mice. In addition, they have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, and palate in rabbits.

Lactation
Topically applied steroids have been reported to be absorbed systemically. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue the drug or to discontinue nursing, taking into account the importance of the drug to the mother. Prednisolone is considered compatible with breast-feeding by the American Academy of Pediatrics.
This drug is excreted in human milk. Caution should be exercised when (prednisolone, neomycin and polymyxin b) ophthalmic suspension is administered to a nursing woman.

Temporary blurred vision and stinging of the eye are the most common side effects and to contact health care provider if these symptoms occur and are bothersome. Patients must be advised not to drive or operate machines until clear vision is restored.

Hypersensitivity
Hypersensitivity reactions have occurred due to allergic sensitization.
Ocular
Ocular side effects associated with the corticosteroid component have included elevated intraocular pressure with possible development of glaucoma, optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing. In addition, perforation of the cornea and sclera have occurred when administering topical steroids to patients with diseases that cause thinning of the cornea or sclera.
Other
The development of a secondary infection has been reported in patients treated with antimicrobial and corticosteroid combinations. Fungal and viral infections of the cornea can develop with long-term application of corticosteroids.
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 including itching, swelling, and conjunctival erythema. More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely. The reactions due to the steroid 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.
Although systemic effects are extremely uncommon, there have been rare occurences of systemic hypercorticoidism after use of topical steroids.
Corticosteroid-containing preparations have also been reported to cause perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, and conjunctival hyperemia have occasionally been reported following local use of steroids.

Secondary infection: The development of secondary infection has occurred after use of combinations 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.

No information provided.

Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.
The anti-infective components in Neopred-P are included to provide action against specific organisms susceptible to them. Neomycin sulfate and polymyxin B sulfate are considered active against the following microorganisms: Staphylococcus aureus; Escherichia coli; Hemophilus influenzae; Klebsiella/ Enterobacter species; Neisseria species; and Pseudomonas aeruginosa.
When a decision to administer both a corticosteroid and an antimicrobial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered. When both types of drugs are in the same formulation, compatibility of ingredients is assured and the correct volume of drug is delivered and retained.
The relative potency of corticosteroids depends on the molecular structure, concentration and release from the vehicle.

Not available

Not applicable.

Sodium acetate Sodium chloride Propylene glycol Tween 80 Hydroxypropyl methylcellulose (Hypermellose 2911) Thiomersal Highly purified water. 

No information provided.

2 years

Do not store above 30 °C. Discard contents four weeks after opening.

LDPE bottle with LDPE dropper and HDPE cap.

No special requirements.