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Cyclorin

Cyclosporine USP

NAME STRENGTH PACK SIZE DOSAGE FORM
Cyclorin 0.05% w/v 5 ml Eye drops

Description

Cyclosporine, a topical immunomodulator, with anti-inflammatory effects. Cyclosporine is an immunosuppressive agent when administered systemically. In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, topical Cyclosporine is thought to act as a partial immunomodulator.

Cyclorin Eye Emulsion: Each ml of Cyclorin Eye Emulsion contains Cyclosporine USP 0.5mg.

Cyclorin Eye 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 (dry eye syndrome).

Instill one drop of Cyclorin Eye Emulsion into the affected eye twice a day. Cyclorin Eye Emulsion can be used concomitantly with artificial tears, allowing a 15 minute interval between products

The most common adverse effect of Cyclosporine Eye Emulsion is ocular burning. Other effects 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).

Cyclosporine Eye Emulsion should not be administered while wearing contact lenses. Patients with decreased tear production typically should not wear contact lenses. If contact lenses are worn, they should be removed prior to the administration of the Cyclosporine Eye Emulsion. Lenses may be reinserted after 15 minutes of administration of Cyclosporine Eye Emulsion.

There are no adequate and well-controlled studies of Cyclosporine Eye Emulsion in pregnant women. It should be administered to pregnant women only if clearly needed. Cyclosporine is known to be excreted in human milk following systemic administration but excretion in human milk after topical treatment has not been investigated. Although blood concentrations are undetectable after topical administration of Cyclosporine Eye Emulsion, caution should be exercised when Cyclosporine Eye Emulsion is administered during lactation.

Store at room temperature (15°-25°C) and dry place protected from light. Do not use more than 30 days after first opening. Keep out of the reach of children.

Cyclosporine is contraindicated in patients with active ocular infections and in patients with known or suspected hypersensitivity to any of the ingredients in the formulation.

Cyclorin Eye Emulsion: Each plastic dropper bottle contains 5 ml sterile Eye Emulsion.