Restasis is a brand-name prescription eye drop that relieves the symptoms of chronic dry eye. Its active ingredient is cyclosporine, an immune suppressant usually used as a tablet or capsule to prevent organ rejection or treat rheumatoid arthritis or psoriasis. For Restasis, the cyclosporine is applied topically to the eyes twice daily about 12 hours apart. As an anti-inflammatory drug, it reduces swelling of the eye’s surface and inner eyelid by blocking the immune system. This helps increase tear production to better lubricate the eyes. That means it doesn’t work if tear production is deficient for any other reason besides inflammation, such as an infection.
Restasis is taken as an eye emulsion. For most people, that’s an unfamiliar dosage form, but eye emulsions are a common formulation for lubricating eye drops. An eye emulsion is an eye drop that contains both water and oil. The oil allows it to spread over the eye’s surface and protect the eye from drying out. To work properly, the Restasis vial or bottle should be rotated gently by turning it upside down and right-side up to mix the oil and water.
Eye emulsion (eye drops): 0.05%
Restasis relieves the symptoms of chronic dry eye, such as eye pain, discomfort, and visual problems if tear ducts don’t produce enough tears because of swelling. It will not help dry eye that doesn’t involve swelling. It will also not work in people already using ophthalmic anti-inflammatory drugs or punctal plugs (a medical device that blocks tear ducts).
Restasis dosage chart |
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Indication | Starting dosage | Standard dosage | Maximum dosage |
Dry eye with ocular inflammation | 1 drop in each eye every 12 hours (twice per day) | 1 drop every 12 hours (twice per day) | Not specified |
Restasis helps restore tear function in people with chronic dry eye disease accompanied by inflammation of the eye and inner eyelid. Called keratoconjunctivitis sicca, this is the most common medical condition that causes chronic dry eye. The immune system plays a major role in the problem, so cyclosporine, the active ingredient in Restasis, helps restore tear function by blocking the immune system. It also acts as a calcineurin inhibitor; calcineurin is a protein in the body that raises inflammation, including in the eyes. Because cyclosporine blocks it, it helps decrease inflammation and increases tear production. However, it may take several months of treatment for its effects to be noticeable. Doses are applied to each eye twice a day using either single-use eye drop vials or a multidose (5.5 ml) eye drop bottle.
Standard Restasis dosage for dry eye: 1 drop in each eye every 12 hours (twice per day)
The FDA has approved Restasis for use by adolescents 16 years of age and older. Healthcare professionals will prescribe the same dosage as they prescribe for adults.
Restasis is a topical medication applied to the surface of the eye. Very little of its active ingredient enters the bloodstream. For this reason, there are no dosage restrictions for people with kidney disease, liver disease, or age.
Like humans, dogs and cats suffer from occasional dry eye and chronic dry eye. Most chronic cases are immune-mediated, that is, inflammation results in poor tear production. The most commonly used treatments are ophthalmic cyclosporine and ophthalmic tacrolimus, which is an immunosuppressant very similar to cyclosporine.
When prescribing ophthalmic cyclosporine, veterinarians can choose between Restasis (0.05%), Cequa (0.09%), or Optimmune (0.2%), an eye ointment specifically formulated for pets. Restasis and Cequa are not FDA-approved for use in pets, but Optimmune is.
If either drug is prescribed, pet owners will need to first rinse the pet’s eyes with a sterile solution to remove debris. Both are applied every 12 hours directly onto the cornea or on the inner eyelid of each affected eye. Optimmune, however, is an ointment. Pet owners will apply a thin strip, about ¼ inch, directly on the cornea or inner eyelid of each affected eye.
As with humans, very little of the drug is absorbed into the body, so systemic side effects and drug interactions tend to be minimal.
Restasis doses are applied to each eye every 12 hours. People using Restasis can choose between single-use vials or a multidose bottle. Applying a dose will require some care to avoid potentially serious side effects such as eye injury or eye infection. Make sure you completely understand how to apply these eye drops before using them:
Your doctor will tell you how much medicine to use. Do not use more than directed.
Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
Wash your hands with soap and water before applying a dose.
Remove any contact lenses.
Do not replace contact lenses until 15 minutes after the dose has been applied.
Do not allow the vial tip or the bottle tip to touch the eye or any other surface including your fingers or skin.
Before using the Restasis Multidose bottle, the shipping cover must be removed. Do not use the bottle if the shipping cover or pull tab is damaged or missing.
Remove the shipping cover and dispose of it
Remove the pull tab
Remove the protective cap; do not throw it away
Prime the bottle by squeezing two drops onto a tissue paper
Don’t let the bottle tip touch the tissue and immediately throw out the tissue without touching the medicine on the tissue paper
Put the protective cap back on
HOW TO APPLY A DOSE
Turn the single-use package or the bottle upside down and right-side up gently a few times to mix the medicine before you use it.
Use the single-use vial right away if you open the package.
Remove the protective cap from the multidose bottle if that’s what you’re using.
Lie down or tilt your head back (looking upward).
With your index finger, pull down the lower lid of your eye to form a pocket.
Hold the vial or dropper upside down, close to your eye with the other hand.
Drop a single Restasis drop into the pocket between your lower lid and eyeball. (If the doctor prescribes more than one drop, apply the prescribed number of drops.)
Gently close your eyes.
Place your index finger over the inner corner of your eye for one minute.
Do not rinse or wipe the dropper or allow it to touch anything, including your eye.
If using the multidose bottle, immediately replace the protective cap without touching the bottle tip.
You might not use all of the medicine in each single-use vial. Discard each single-use vial after using it, even if there is solution remaining.
Wait at least 15 minutes before you use other lubricant eye drops (including artificial tears).
Store the medicine in a closed container at room temperature.
Symptom relief can take anywhere from three weeks to six months after starting Restasis. Large-scale survey studies found that the majority of patients experienced some symptom relief in three to five weeks.
Restasis is a topical prescription drug. Very little of the drug enters the bloodstream. In initial clinical studies of people using Restasis eye drops, the amount of cyclosporine detected in the blood was below measurable levels.
If a dose is missed, take it when it’s remembered. If it’s almost time for the next dose, skip the missed dose and take the next dose on time. Do not take extra doses or extra medicine to make up for a missed dose. If you are unsure whether to take or skip a missed dose, talk with your doctor or pharmacist.
Restasis is intended for long-term use. It will be prescribed for as long as necessary provided that it works and there are no allergic reactions or serious eye problems.
Restasis can be stopped at any time without causing withdrawal or other adverse effects. However, always get medical advice from the prescriber or other healthcare provider before stopping treatment with Restasis.
Although a maximum dosage has not been specified, do not exceed the prescribed dose of Restasis. The recommended dose is one eye drop in each eye every 12 hours. Taking more than this usually will not help relieve symptoms but may make side effects like eye discomfort, burning, and redness more likely.
A Restasis overdose is very unlikely because so little of the medicine gets into the bloodstream. To avoid problems, never apply more than a single dose to each eye and never allow the medicine to touch your skin.
Because nearly undetectable levels of cyclosporine enter the bloodstream when Restasis is applied to the eyes, Restasis has no drug interactions. The only concern is the use of lubricating eye drops. Most people prescribed Restasis will also be using lubricating eye drops to provide moisture on the surface of the eye. These can be used with Restasis, but do not apply lubricating eye drops until 15 minutes after a Restasis dose has been applied to that eye.
Although Restasis has no known drug interactions, make sure the prescribing healthcare provider knows about all prescription drugs, over-the-counter medications, supplements, and eye drops that you’re using.
People can drink alcohol when using Restasis.
Because so little cyclosporine enters the bloodstream when it’s applied to the eye, healthcare providers consider it safe to use during pregnancy. Even so, always tell the prescriber if you are pregnant or planning to get pregnant.
Although there are no studies on women who are breastfeeding, Restasis is considered safe to use when breastfeeding. Healthcare professionals expect that very little of its active ingredient is present in breast milk.
Restasis has only a few side effects. The most significant adverse effect is a burning sensation on the eye, a complaint made by 17% of the participants in clinical trials. Less common side effects include eye pain, itching, discharge, and blurred vision.
The most serious side effects of Restasis are eye injury, eye contamination, or an eye infection. You must be extra careful not to touch the tip of the single-use vial or the multidose bottle to the surface of the eye or to any surface to avoid contamination.
Restasis comes in single-use vials (60 vials in a container) while Restasis Multidose comes in a bottle containing about 120 doses. In both cases, the mixture does not have preservatives to protect against contamination. The single-use vials will usually have medicine left over, but because they’re thrown away, the mixture is less likely to become contaminated. The bottle has extra medicine in it that can be used, but there’s a possibility that the tip or the mixture can be contaminated if it’s applied incorrectly or mishandled.
Cyclosporine—ophthalmic, VCA Animal Hospitals
Dry eye disease: An immune-mediated ocular surface disorder, JAMA
Keratoconjunctivitis sicca (KCS) or dry eye in cats, VCA Animal Hospitals
Keratoconjunctivitis sicca (KCS) or dry eye in dogs, VCA Animal Hospitals
Optimmune ophthalmic cyclosporine ointment veterinary prescribing information, NIH National Library of Medicine
Patient and physician perspectives on the use of cyclosporine ophthalmic emulsion 0.05% for the management of chronic dry eye, Clinical Ophthalmology
Restasis cyclosporine emulsion prescribing information, NIH National Library of Medicine
Restasis multidose cyclosporine emulsion prescribing information, NIH National Library of Medicine
Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. CsA Phase 3 Study Group, Ophthalmology (2000)
Understanding emulsion eye drop technology, Review of Optometry
Sammy Yafai holds a Doctor of Pharmacy from the University of Buffalo as well as an Executive MBA in Business Administration, Management, and Operations from Quantic School of Business and Technology. Currently serving as the pharmacy supervisor at NYC HHC Coney Island Hospital, Dr. Yafai manages daily operations in a team of 15+. Previously, as a pharmacy manager at CVS Health, Dr. Yafai was selected for the Foundation for Leading 2020 development program and played a pivotal role in the Immunization program during the challenging times of the COVID-19 pandemic. He received a 2020 Best of the Best Pharmacy Award from SingleCare and was recognized as one of the Top 50 Most Influential Leaders in Pharmacy by Pharmacy Podcast Network in 2023. Dr. Yafai is an active member ACCP, ASHP, and APhA.
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