Classes
DEA Class; Rx
Common Brand Names; Pred G
- Antibiotics/Corticosteroids, Ophthalmic
Description
Ophthalmic aminoglycoside antibiotic and corticosteroid combination
For inflammatory ocular conditions with superficial bacterial infection or risk of infection
Indications
Indicated for Ocular Anti-inflammatory/Anti-infective.
For steroid-responsive inflammatory ocular inflammation conditions (e.g., uveitis, bacterial conjunctivitis, corneal abrasion) for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular/ophthalmic infection exists.
Contraindications
Hypersensivity to any component
Glaucoma, viral diseases of cornea & conjunctiva (epithelial herpes simplex keratitis, vaccinia, varicella), mycobacterial eye infection & fungal diseases of ocular structures
Adverse Effects
- 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
- Allergic sensitizations
- Rash
- Superinfection (herpes)
- Eye burning
- Eye stinging
- Ocular hyperemia
- Eye pain
- Eye discharge
- Lacrimation increased
- Eye edema
- Visual impairment
- Foreign body sensation in eyes
- Dysgeusia
- Blurry vision
- Hypersensitivity including signs and symptoms related to ocular allergy (e.g. conjunctivitis), angioedema (e.g. tongue edema) and allergic skin reactions (e.g. rash and contact allergy)
Warnings
Bacterial keratitis reported from inadvertent contamination of multiple dose ophthalmic solution Immunosuppression resulting from prolonged use of steroid use may result in secondary bacterial and fungal infections; steroids may also mask symptoms of infections and enhance existing ocular infections
Ocular hypertension and/or glaucoma reported with prolonged corticosteroid use
Corticosteroid and gentamicin use following cataract surgery may delay healing
Discontinue use if sensitivity reaction to gentamicin develops
Prolonged gentmicin use may result in fungal or bacterial superinfection
Pregnancy and Lactation
Pregnancy: C
Lactation: Unknown whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk; systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause untoward effects
Maximum Dosage
24 drops/day per affected eye of the suspension (dispense no more than 20 ml without re-evaluation); 1/2 inch ointment per affected eye up to three times daily (dispense no more than 8 grams without re-evaluation).
24 drops/day per affected eye of the suspension (dispense no more than 20 ml without re-evaluation); 1/2 inch ointment per affected eye up to three times daily (dispense no more than 8 grams without re-evaluation).
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Prednisolone/Gentamicin
ophthalmic suspension
- 1%/0.3%
ophthalmic ointment
- 0.6%/0.3%
