Restasis 0.05% Eye Drops
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Indications & Clinical Uses
- Restasis (cyclosporine ophthalmic emulsion) 0.05% is manufactured by Allergan, an AbbVie company (USA).
- It is a calcineurin-inhibitor immunomodulator used to increase tear production in adults whose reduced tear production is presumed to be due to ocular inflammation associated with keratoconjunctivitis sicca (chronic dry eye disease).
- In clinical studies, increased tear production was not seen in patients already using topical anti-inflammatory eye drops or punctal plugs at the same time.
- Restasis is for topical ophthalmic use only - one drop instilled in each affected eye twice a day, about 12 hours apart - and is not a treatment for allergic conjunctivitis or eye infections.
- It is not interchangeable with other cyclosporine ophthalmic products marketed at different concentrations for dry eye (such as 0.09% or 0.1% formulations), which have their own separate dosing and approvals.
Side Effects
- The most common side effect of Restasis, reported in about 17% of patients, is a temporary burning sensation in the eye after instillation.
- Less common reactions, each affecting roughly 1% to 5% of patients, include conjunctival redness, eye discharge, excessive tearing, eye pain, a foreign body sensation, itching, stinging and blurred vision immediately after the drop is used.
- Restasis carries no boxed warning.
- Most reactions are mild and improve with continued use, but contact an eye care provider if burning, pain or redness is severe, worsens, or is accompanied by vision changes that do not clear soon after blinking.
- Do not rub the eye immediately after instillation, and discard each single-use vial after one use, even if emulsion remains in it.
Precautions & Warnings
- Restasis is contraindicated in anyone with known or suspected hypersensitivity to cyclosporine or any other ingredient in the emulsion.
- Do not touch the vial tip to the eye, eyelid or any other surface, to avoid contaminating the emulsion and causing eye injury or infection.
- Remove contact lenses before instilling Restasis; lenses may be reinserted about 15 minutes afterward, since the product is not intended for use while lenses are worn.
- Topical use produces undetectable systemic cyclosporine blood levels, so significant fetal exposure is not expected, but caution is advised during breastfeeding since cyclosporine passes into human milk after systemic use.
- Restasis has not been established as safe and effective in children under 16 years of age.
- Store unopened foil pouches at 15C to 25C, and keep used single-use vials in the original pouch to protect from light.
Avoid Interactions
- No formal drug interaction studies have been conducted with Restasis, and it is not expected to interact with systemic medicines because topical use results in undetectable blood cyclosporine levels.
- If more than one topical eye product is needed, Restasis can be used together with artificial tears (lubricant eye drops), but the two products should be given at least 15 minutes apart so one does not wash out the other.
- Tell the eye care provider about any other eye drops, ointments or contact lens solutions in use, since preservatives in other products can affect the ocular surface.
- Do not mix Restasis with any other eye drop in the same vial, and always use a fresh single-use vial for each application.
References
Frequently Asked Questions
Restasis (cyclosporine ophthalmic emulsion) 0.05% is used to increase tear production in adults with chronic dry eye (keratoconjunctivitis sicca) caused by eye inflammation. It works less well if you're already using anti-inflammatory eye drops or punctal plugs. It treats underlying inflammation, not infections or allergies.
Instil one drop of Restasis into each affected eye twice daily, about 12 hours apart. Remove contact lenses first; you can put them back in after about 15 minutes. Use a fresh single-use vial each time and discard it after one use.
The most common Restasis side effect is a temporary burning feeling in the eye, affecting about 17% of users. Less often, redness, watering, itching, stinging or blurred vision can occur. Contact your eye doctor if burning or redness is severe or doesn't settle quickly.
Avoid touching the vial tip to your eye or any surface, which can cause contamination or injury. Don't wear contact lenses while instilling Restasis; wait about 15 minutes before reinserting them. If using artificial tears too, space the two products at least 15 minutes apart.
Yes. Restasis can be used alongside lubricating artificial tears, but give them at least 15 minutes apart so one drop doesn't wash out the other. Use your prescribed Restasis dose first, then add artificial tears separately if your eyes still feel dry.
Topical Restasis produces undetectable cyclosporine levels in the blood, so major fetal exposure isn't expected, but it hasn't been formally studied in pregnancy. Caution is advised while breastfeeding. Restasis hasn't been established as safe or effective in children under 16.

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