Loteprednol Etabonate + Tobramycin
Loteprednolis a corticosteroid which is thought to act by the induction of phospholipase A2 inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.Tobramycinis a member of aminoglycoside which shows bactericidal activity by inhibiting protein synthesis of bacteria.
Shake well before use. Apply one drop into the conjunctival sac of the affected eye(s) every four to six hours. During the initial 24 to 48 hours, the dosing may be increased, to every one to two hours.
Since Loteprednol Etabonate is not detected in plasma following the topical administration, it is not expected to affect the pharmacokinetics of systemically administered medicinal products.
Contraindicated in most viral diseases of the cornea and conjunctiva. Also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
Increased intraocular pressure, burning and stinging upon instillation, vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, and other unspecified eye disorders may occur. The incidence of non-ocular adverse events (headache) also reported.
Use in pregnancy:There are no adequate and well-controlled studies in pregnant women. Loteprednol Etabonate & Tobramycin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Use in lactation:Caution should be exercised when Loteprednol Etabonate & Tobramycin is administered to a nursing mother.
For ophthalmic use only.If Lotrel T is used for 10 days or longer, intraocular pressure should be monitored.Fungal infections of the cornea are particularly prone to develop coincidentally with long-term use of steroid topically.Prolonged use may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs, appropriate therapy should be initiated.Cross-sensitivity to other aminoglycoside antibiotics may occur.
Ophthalmic steroid - antibiotic combined preparations
Store at room temperature & protect from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used four weeks after first opening of the bottle. Protect from freezing.
Use in children:Safety and effectiveness in pediatric patients have not been established.
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