Prednisolone Acetate / Gentamicin Sulfate

Pronunciation: pred-NISS-oh-lone ASS-uh-TATE/JEN-tuh-MY-sin SULL-fate Pred-G
Class: Corticosteroid, Antibiotic

Trade Names

Pred-G
- Ophthalmic Suspension 1% prednisolone acetate and gentamicin sulfate equiv. to 0.3% gentamicin base

Pred-G S.O.P.
- Ophthalmic Ointment 0.6% prednisolone acetate and gentamicin sulfate equiv. to 0.3% gentamicin base

Pharmacology

Prednisolone

Depresses formation, release, and activity of endogenous mediators of inflammation as well as modifying body's immune response.

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

Gentamicin

Inhibits production of bacterial protein, causing bacterial cell death.

Indications and Usage

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

Contraindications

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

Dosage and Administration

Adults

Topical Ointment Apply small amount (½ inch ribbon) in the conjunctival sac 1 to 3 times/day. Suspension Instill 1 drops into the conjunctival sac 2 to 4 times/day. During the initial 24 to 48 h, the dosing frequency may be increased if necessary, up to 1 drop every h. If signs and symptoms fail to improve after 2 days, re-evaluate the patient.

General Advice

  • For ophthalmic use only. Not for use in the ears or on the skin.
  • Shake well before instilling drops.
  • Do not allow tip of dropper bottle or tube 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 ointment at controlled room temperature (59° to 86°F). Keep tube capped.
  • Store suspension at controlled room temperature (59° to 77°F). Keep bottle tightly capped and protect from freezing.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

EENT

Ocular discomfort; irritation upon instillation; punctate keratitis; elevation of IOP with possible development of glaucoma; optic nerve damage; posterior subcapsular cataract formation; delayed wound healing; secondary infection; fungal infections of the cornea.

Miscellaneous

Allergic sensitizations

Precautions

Pregnancy

Category C .

Lactation

Prednisolone

Excreted in breast milk.

Children

Safety and efficacy not established.

Superinfection

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

Bacterial resistance

Bacterial resistance to components of the product may develop.

Ocular damage

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.

Patient Information

  • Review prescribed dosing schedule with patient, family, or caregiver.
  • Remind patient, family, or caregiver that suspension and ointment are 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 and 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.
  • Teach patient or caregiver proper technique for instilling ointment: wash hands; do not allow tip of tube to touch eye, eyelid, fingers, or any other surface. Tilt head back and look up; pull lower eyelid down to form pocket; place prescribed amount of ointment 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 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.

Copyright © 2009 Wolters Kluwer Health.

Hide
(web1)