Indication and Usage: RESTASIS® Ophthalmic Emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
Important Safety Information:
Contraindications: RESTASIS® is contraindicated in patients with active ocular infections and in patients with known or suspected hypersensitivity to any of the ingredients in the formulation.
Warning: RESTASIS® Ophthalmic Emulsion has not been studied in patients with a history of herpes keratitis.
Precautions: RESTASIS® should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to the administration of the emulsion.
Adverse Reactions: The most common adverse event was ocular burning (upon instillation) – 17%. Other events reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).
Please see full prescribing information for RESTASIS® Ophthalmic Emulsion.