Cyclosporine Emulsion (Ophthalmic)
Brand Name: Restasis
Common Dosage Forms:
Single-Dose Vials: Each vial contains 0.4 mL of a 0.05% cyclosporine emulsion.
Multi-Dose Vials: Each vial contains 5.5 mL of a 0.05% cyclosporine emulsion.
FDA Indications/Dosages:
To increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca: Invert the unit dose vial a few times to obtain a uniform, white, opaque emulsion before using. Instill one drop twice a day in each eye approximately 12 hours apart. Allow a 15 minute interval between this product and artificial tears.
Pharmacology/Pharmacokinetics: When used systemically, cyclosporine is a potent immunosuppressive agent. Its exact mechanism of action to increase tear production is unknown. Cyclosporine is thought to act as a partial immunomodulator in patients whose tear production is suppressed from ocular inflammation due to keratoconjunctivitis sicca. Cyclosporine ophthalmic emulsion is not absorbed systemically in any measurable amount.
Drug Interactions: A 15 minute interval should be allowed between using cyclosporine ophthalmic emulsion and artificial tears.
Contraindications/Precautions: Contraindicated in patients with active ocular infections and in patients with known or suspected hypersensitivity to any ingredient. Do not administer while wearing contact lenses. Generally, patients with decreased tear production should not wear contact lenses. If contact lenses are worn, wait at lease 15 minutes after each dose before inserting contact lenses. Pregnancy Category C.
Adverse Effects: The most common adverse effect is ocular burning (17%). Less common adverse effects (<5%) include conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and blurring.
Patient Consultation:
Invert the unit dose vial a few times to obtain a uniform, white, opaque emulsion before using.
Discard open single-dose vials immediately after use.
Do not administer while wearing contact lenses.
A 15 minute interval should be allowed between cyclosporine ophthalmic emulsion and artificial tears.
If a dose is missed by more than 4 hours, skip it and return to normal dosing schedule.
