Pred-G® Ointment
gentamicin 0.3% / prednisolone 1% · ophthalmic ointment
Antibiotic/Steroid
Approved uses
Steroid-responsive ocular inflammation with superficial bacterial infection or a risk of it, including chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or foreign body penetration
1/2 inch ribbon in the conjunctival sac 1 to 3 times daily; not more than 8 g initially
Contraindications
- Most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella
- Mycobacterial infection of the eye
- Fungal diseases of ocular structures
- Known or suspected hypersensitivity to any ingredient of the preparation or to other corticosteroids
Available FormsGentamicin 0.3% and prednisolone acetate 0.6% ointment, 3.5 g tube
Mechanism of ActionThe corticosteroid suppresses the inflammatory response to a variety of agents and probably delays or slows healing, acting in part through glucocorticoid-induced annexin-1, which inhibits cytosolic phospholipase A2 and the release of arachidonic acid. The aminoglycoside binds the bacterial 30S ribosomal subunit to block protein synthesis, giving in vitro activity against S. aureus, S. pyogenes, S. pneumoniae, H. influenzae, P. aeruginosa and other common gram-negative ocular pathogens.
Warnings & Precautions
- Elevated IOP: Prolonged corticosteroid use may result in glaucoma with optic nerve damage and defects in visual acuity and fields of vision; monitor IOP routinely when used 10 days or longer, and use with caution in the presence of glaucoma.
- Posterior subcapsular cataract: Prolonged corticosteroid use may produce cataract formation.
- Secondary ocular infection: Prolonged use suppresses the host immune response; acute purulent infection may be masked or enhanced, and secondary bacterial, fungal and viral infection has occurred with steroid and antimicrobial combinations.
- Corneal epithelial toxicity: Ocular irritation and punctate keratitis are associated with use of this combination; in rabbits, gentamicin was among the most toxic of eight topical antibiotic solutions tested on corneal epithelial wound healing, though that study tested solutions and not an ointment vehicle.
- Corneal and scleral thinning: Various ocular diseases and long-term topical corticosteroid use cause thinning, and use over thin tissue may lead to perforation.
- Fungal invasion: Suspect fungal infection in any persistent corneal ulceration where a corticosteroid has been used or is in use, and take fungal cultures when appropriate.
- Viral keratitis exacerbation: Ocular steroids may prolong the course and exacerbate the severity of many viral eye infections including herpes simplex; a history of herpes simplex demands great caution and frequent slit lamp microscopy.
- Delayed healing after cataract surgery: Steroid use may delay healing and increase the incidence of bleb formation.
Common Side Effects
- Ocular, most frequent: Ocular discomfort, irritation on instillation, and punctate keratitis, which resolved on discontinuation.
- Ocular, other: Eye burning, stinging, ocular hyperemia, eye pain, eye discharge, increased lacrimation, eye edema, blurred vision, visual impairment, foreign body sensation.
- Steroid component: In decreasing order of frequency, elevated IOP with possible development of glaucoma and infrequent optic nerve damage, then posterior subcapsular cataract formation, then delayed wound healing.
- Anti-infective component: Allergic sensitization is the reaction occurring most often from the antibiotic.
- Hypersensitivity: Ocular allergy such as conjunctivitis, angioedema such as tongue edema, and allergic skin reactions such as rash and contact allergy.
- Systemic: Dysgeusia.
Pregnancy & LactationPregnancy: Systemic gentamicin in pregnant rats at approximately 500 times the maximum recommended ophthalmic human dose depressed newborn body weights, kidney weights and median glomerular counts, and prednisolone is teratogenic in mice at 1 to 10 times the human ocular dose, with a significant increase in cleft palate after ocular application 5 times daily on gestation days 10 through 13; no adequate well-controlled studies in pregnant women, so use only if the potential benefit justifies the potential risk to the fetus.
Lactation: Unknown whether topical administration produces detectable quantities in breast milk; systemically administered corticosteroids do appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production, or cause untoward effects, so weigh discontinuing nursing against discontinuing the drug.
Pediatric UseSafety and effectiveness in pediatric patients have not been established.