DrugindexOnline^{2nd edition}

Pronouncation: (pred-NISS-oh-lone ASS-uh-TATE/NEE-oh-MY-sin SULL-fate/pahl-ee-MIX-in BEE SULL-fate)
Class: Corticosteroid, Antibacterial

Trade Names:
Poly-Pred Liquifilm
- Ophthalmic Suspension 0.5% prednisolone acetate/neomycin sulfate equiv. to 0.35% neomycin base/10,000 units/mL polymyxin B sulfate

Mechanism of Action

Pharmacology

Prednisolone

Depresses formation, release, and activity of endogenous mediators of inflammation including prostaglandins, kinins, histamine, liposomal enzymes, and complement system.

Neomycin

Inhibits protein synthesis by binding to ribosomal RNA, causing bacterial genetic code misreading.

Polymyxin B

Interacts with phospholipid components of bacterial cell membrane, increasing cell wall permeability.

Indications and Usage

Treatment of steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists; 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 conjunctivitis is accepted to obtain a diminution in edema and inflammation; chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns or penetration of foreign bodies; when risk of infection is high or where there is expectation that potentially dangerous numbers of bacteria will be present in the eye.

Contraindications

Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the corneal and conjunctiva; mycobacterial eye infections; fungal diseases of the ocular structures; uncomplicated removal of a corneal foreign body; hypersensitivity to any component of the product.

Dosage and Administration

Eye

Ophthalmic Instill 1 or 2 gtt in the eye q 3 or 4 hr or more frequently as required. Acute infections may require administration every 30 min, with decreasing frequency as the infection is brought under control.

Lids

Ophthalmic Instill 1 or 2 gtt in the eye q 3 to 4 hr, close the eye, and rub the excess on the lids and lid margins.

General Advice

• For ophthalmic use only. Not for use in the ears or on the skin.
• Shake well before instilling gtt.
• Do not allow tip of dropper bottle to touch eye, eyelid, fingers, or any other surface.
• If using other topical ophthalmic medications, instill drops first, wait at least 5 min, and instill ointment last.

Storage/Stability

Store at controlled room temperature (less than 77°F). Keep bottle tightly capped and protect from freezing.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

EENT

Elevated IOP with possible development of glaucoma; optic nerve damage; posterior subcapsular cataract formation; delayed wound healing; secondary infection; fungal infection; acute anterior uveitis and perforation of the globe.

Miscellaneous

Allergic sensitivity.

Precautions

Pregnancy

Category C .

Lactation

Excreted in breast milk.

Children

Safety and efficacy have not been established.

Superinfection

Prolonged use may result in bacterial or fungal overgrowth of nonsusceptible microorganisms.

Cross-sensitivity

Allergic cross-sensitivity to kanamycin, paromomycin, streptomycin, and, possibly, gentamicin may occur.

Glaucoma

Prolonged use may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.

Secondary infection

Secondary bacterial ocular infection following suppression of host responses may occur.

Patient Information

• Explain name, dose, action, and potential side effects of drug.
• Review prescribed dosing schedule with patient, family, or caregiver.
• Remind patient, family, or caregiver that suspension is for use in the eye only.
• Teach patient, family, or caregiver proper technique for instilling suspension: wash hands; do not allow tip of dropper bottle to touch eye, eyelid, fingers, or any other surface. Tilt head back, look up; pull lower eyelid down to form pocket; place prescribed number of drops in the pocket. Look downward before closing eye. Do not rub eye.
• Advise patient, family, or caregiver that if more than 1 topical ophthalmic drug is being used, instill eye drops first, wait at least 5 min and then instill ointment last.
• Inform patient that 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.
• Advise patient to contact eye doctor if eye or eyelid inflammation is noted or if eye symptoms do not improve or worsen.
• Advise patient that the entire course of therapy must be completed to ensure maximal benefit and to complete full course of therapy even if symptoms have resolved.
• Instruct patient not to wear contact lenses during treatment.
• Remind patient, family, or caregiver that follow-up eye examinations may be necessary while using this medication and to keep appointments.