Description

Loteprednol is 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. Tobramycin is a member of aminoglycoside which shows bactericidal activity by inhibiting protein synthesis of bacteria.

Presentation

    Lotepred Plus Ophthalmic Suspension: Each ml contains Loteprednol Etabonate INN 5 mg and Tobramycin USP 3 mg.

Indications

    Lotepred-Plus is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. It is also effective in post-operative inflammation.

Dosage & Administration

    Instill 1 drop of Lotepred-Plus into the conjunctival sac of the eye(s) every 4 to 6 hours.

Contrainidications

    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.

Warning & Precautions

    • For ophthalmic use only.
    • If this product 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.

Side effects

    Increased intraocular pressure, burning & stinging upon instillation, vision disorders, discharge, itching, photophobia, headache and other unspecified eye disorders may occur.

Drug interaction

Use in special groups

    Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Lotepred-Plus 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 Lotepred-Plus is administered to a nursing mother.
    Use in children: Safety and effectiveness in pediatric patients have not been established.

Packing

    Lotepred Plus Ophthalmic Suspension: Each LDPE dropper bottle contains 5 ml Sterile Eye Drops.