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Tobramycin/Loteprednol

    DEA Class; Rx

    Common Brand Names; Zylet

    • Antibiotics/Corticosteroids, Ophthalmic
     

    Ophthalmic suspension of a corticosteroid (loteprednol) plus aminoglycoside antibiotic (tobramycin); indicated for steroid-responsive inflammatory conditions associated with superficial bacterial ocular infection or a risk thereof.

    Indicated for steroid-responsive ocular inflammations with risk of superficial bacterial infections

    Shake vigorously before use

    Hypersensitivity to any component of the formulation or to other corticosteroids

    Viral, mycobacterial & fungal eye infections

    History of herpes simplex infections

    May exacerbate infections by nonsusceptible organisms

    Monitor IOP if used >10 d

    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

    Discontinue use if sensitivity reaction to tobramycin develops

    Corticosteroid use following cataract surgery may delay healing

    Do not allow the dropper tip to touch any surface, as this may contaminate the suspension

    As with all ophthalmic preparations containing benzalkonium chloride, patients should be advised not to wear soft contact lenses while receiving therapy

    There are no adequate and well-controlled studies with loteprednol etabonate or tobramycin in pregnant women.

    There are no data on presence of loteprednol etabonate or tobramycin in human milk, effects on breastfed infants, or on milk production

    Adults

    24 drops/day loteprednol 0.5% and tobramycin 0.3% in the affected eye(s).

    Elderly

    24 drops/day loteprednol 0.5% and tobramycin 0.3% in the affected eye(s).

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Tobramycin/loteprednol

    ophthalmic suspension

    • 0.3/0.5%