Cyclosporine ophthalmic emulsion 0.05% for increasing tear production in keratoconjunctivitis sicca

Cyclosporine ophthalmic emulsion 0.05% is a prescription eye medication used to increase tear production in patients with keratoconjunctivitis sicca (dry eye) caused by ocular inflammation. It helps improve tear production when inflammation is suppressing tear glands. This medication is provided as a sterile, preservative-free eye drop emulsion for topical use.

Cyclosporine ophthalmic emulsion 0.05% is specifically indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation related to keratoconjunctivitis sicca. It is not effective for patients currently using topical anti-inflammatory drugs or punctal plugs to treat dry eye symptoms.

Cyclosporine 0.05%

Cyclosporine is a calcineurin inhibitor with immunosuppressive properties. When applied topically to the eye, it acts as a partial immunomodulator to reduce inflammation thought to cause decreased tear production in keratoconjunctivitis sicca. The exact mechanism in the eye is not fully understood. Systemic absorption is negligible with topical use.

• Invert the single-use vial several times to mix the emulsion before use.
• Instill one drop of cyclosporine ophthalmic emulsion 0.05% into each eye twice daily, approximately 12 hours apart.
• The emulsion can be used with lubricant eye drops; wait at least 15 minutes between products.
• Do not reuse or save leftover emulsion; discard the vial immediately after use.

Do not use if you have known or suspected hypersensitivity to cyclosporine or any other ingredients in the formulation.

• Eye injury and contamination: Do not touch the vial tip to the eye or any other surface to avoid injury or contamination.
• Contact lenses: Do not administer cyclosporine ophthalmic emulsion while wearing contact lenses. Remove lenses before use and wait 15 minutes after instillation before reinserting them.

The most common side effect is ocular burning, occurring in about 17% of users. Other side effects (1% to 5%) include conjunctival redness, discharge, tearing, eye pain, foreign body sensation, itching, stinging, and temporary blurred vision.

Post-marketing reports include allergic reactions such as eye swelling, urticaria, rare severe angioedema (face, tongue, throat swelling), and superficial eye injuries from vial tip contact.

No specific interactions listed. Cyclosporine ophthalmic emulsion may be used concomitantly with lubricant eye drops if separated by at least 15 minutes.

Pregnancy

Topical ocular cyclosporine is not expected to result in fetal exposure as systemic absorption is undetectable. Animal studies with systemic cyclosporine at doses much higher than human topical doses showed teratogenic effects only at maternally toxic doses. No embryofetal toxicity was observed at doses many times higher than the human topical dose.

Lactation

Cyclosporine is known to be present in human milk after systemic use, but it is unknown whether topical ophthalmic use results in drug presence in milk. Because systemic levels are undetectable after topical administration, caution is advised when given to nursing women. Benefits of breastfeeding should be weighed against potential risks.

Store cyclosporine ophthalmic emulsion at 15°C to 25°C (59°F to 77°F) in its original packaging.