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Prednisolone/Gentamicin Ophthalmic

    DEA Class; Rx

    Common Brand Names; Pred G

    • Antibiotics/Corticosteroids, Ophthalmic

    Ophthalmic aminoglycoside antibiotic and corticosteroid combination
    For inflammatory ocular conditions with superficial bacterial infection or risk of infection

    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.

    Hypersensivity to any component

    Glaucoma, viral diseases of cornea & conjunctiva (epithelial herpes simplex keratitis, vaccinia, varicella), mycobacterial eye infection & fungal diseases of ocular structures

    • 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)

    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: 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

    Adults

    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).

    Geriatric

    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).

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Prednisolone/Gentamicin

    ophthalmic suspension

    • 1%/0.3%

    ophthalmic ointment

    • 0.6%/0.3%