Pred-G®
Gentamicin 0.3% / Prednisolone 1% · ophthalmic suspension
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 drop into the conjunctival sac 2 to 4 times daily, increased up to 1 drop every hour during the initial 24 to 48 hours; not more than 20 mL 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 the ocular structures
- Known or suspected hypersensitivity to any ingredient of the preparation or to other corticosteroids
Available FormsGentamicin 0.3% and prednisolone acetate 1% suspension, 5 mL in 10 mL bottle
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. Gentamicin, an 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 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, and fortified preparations were not more toxic than the 0.3% solutions.
- 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.
- Route of administration: Not for injection, and never to be injected subconjunctivally or introduced directly into the anterior chamber.
Common Side Effects
- Ocular: Eye burning, stinging, irritation, ocular hyperemia, eye pain, eye discharge, increased lacrimation, eye edema, blurred vision, visual impairment, foreign body sensation.
- Superficial punctate keratitis: Reported occasionally, with onset typically after several days of use.
- 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 roughly 500 times the maximum recommended ophthalmic human dose depressed newborn body weight, kidney weight 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 human milk; systemically administered corticosteroids do appear in human 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.