Classes
DEA Class; Rx
Common Brand Names; Zylet
- Antibiotics/Corticosteroids, Ophthalmic
Description
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.
Indications
Indicated for steroid-responsive ocular inflammations with risk of superficial bacterial infections
Shake vigorously before use
Contraindications
Hypersensitivity to any component of the formulation or to other corticosteroids
Viral, mycobacterial & fungal eye infections
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
24 drops/day loteprednol 0.5% and tobramycin 0.3% in the affected eye(s).
24 drops/day loteprednol 0.5% and tobramycin 0.3% in the affected eye(s).
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Tobramycin/loteprednol
ophthalmic suspension
- 0.3/0.5%
