Restasis

Name: Restasis

What special precautions should I follow?

Before using cyclosporine eye drops,

  • tell your doctor and pharmacist if you are allergic to cyclosporine (Neoral, Sandimmune) or any other medications.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention other eye drops for dry eye disease.
  • if you are using artificial tears, instill them at least 15 minutes before or after you instill cyclosporine eye drops.
  • tell your doctor if you have an eye infection, if you have a punctal plug (stopper inserted by a doctor in a tear duct to keep tears in the eye), and if you have or have ever had a herpes infection of the eye.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using cyclosporine eye drops, call your doctor.
  • you should know that cyclosporine eye drops should not be instilled while wearing contact lenses. If you wear contact lenses, remove them before instilling cyclosporine eye drops and put them back in 15 minutes later. Talk to your doctor about wearing contact lenses if you have dry eye disease.

Cyclosporine Dosage

Restasis eye drops come in a strength of 0.05 percent.

For dry eyes, a typical dose is one drop in each eye twice a day.

If you can, try to wait as close to 12 hours as possible between each dose.

Cyclosporine Overdose

Generally, overdosing on cyclosporine eye drops shouldn't be an issue.

But if you suspect an overdose, contact a poison control center or emergency room immediately.

You can get in touch with a poison control center at 800-222-1222.

Missed Dose of Cyclosporine

If you miss a dose of cyclosporine, try to take it as soon as you remember.

But skip the missed dose if it's almost time for your next scheduled dose.

Don't take extra medicine to make up for a missed dose.

Warnings

Contraindications

Hypersensitivity to ingredients

Cautions

Has not been studied in patients with history of herpes keratitis

Remove contact lenses prior to administration

Do not touch eyelids with vial tip to avoid contamination

Indications

RESTASIS® ophthalmic 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. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.

Side effects

The following serious adverse reactions are described elsewhere in the labeling:

  • Potential for Eye Injury and Contamination [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials, the most common adverse reaction following the use of RESTASIS®was ocular burning (17%).

Other reactions 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).

Post-marketing Experience

The following adverse reactions have been identified during post approval use of RESTASIS®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Reported reactions have included: hypersensitivity (including eye swelling, urticaria, rare cases of severe angioedema, face swelling, tongue swelling, pharyngeal edema, and dyspnea); and superficial injury of the eye (from the vial tip touching the eye during administration).

Clinical pharmacology

Mechanism Of Action

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, cyclosporine emulsion is thought to act as a partial immunomodulator. The exact mechanism of action is not known.

Pharmacokinetics

Blood cyclosporine A concentrations were measured using a specific high pressure liquid chromatography-mass spectrometry assay. Blood concentrations of cyclosporine, in all the samples collected, after topical administration of RESTASIS® 0.05%, twice daily, in humans for up to 12 months, were below the quantitation limit of 0.1 ng/mL. There was no detectable drug accumulation in blood during 12 months of treatment with RESTASIS® ophthalmic emulsion.

Clinical Studies

Four multicenter, randomized, adequate and well-controlled clinical studies were performed in approximately 1,200 patients with moderate to severe keratoconjunctivitis sicca. RESTASIS® demonstrated statistically significant increases in Schirmer wetting of 10 mm versus vehicle at six months in patients whose tear production was presumed to be suppressed due to ocular inflammation. This effect was seen in approximately 15% of RESTASIS® ophthalmic emulsion-treated patients versus approximately 5% of vehicle-treated patients. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.

No increase in bacterial or fungal ocular infections was reported following administration of RESTASIS®.

Restasis Interactions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • Any other eyedrop or eye ointment products

This is not a complete list of Restasis drug interactions. Ask your doctor or pharmacist for more information.

Restasis and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Restasis is excreted in human breast milk or if it will harm your nursing baby.

It is not known if Restasis crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Restasis.

Restasis Usage

  • Use Restasis exactly as prescribed. 
  • Restasis comes in an eyedrop form and is typically administered into the affected eye(s) twice a day.
  • Restasis eye drops are for use only in the eye(s). Do not swallow or apply Restasis eye drops to the skin
  • Restasis eye drops come in single-use (one dose) vials. The liquid from one vial should be used immediately after opening. Do not save it for later use.
  • If you are wearing contact lenses, remove them before instilling Restasis and wait at least 15 minutes before putting them back in. If you are using artificial tears, instill them at least 15 minutes before or after you instill Restasis.

To instill the eye drops, follow these steps:

  1. Wash your hands thoroughly with soap and warm water
  2. Mix by turning the vial over a few times until the liquid inside looks white and not see-through
  3. Open the vial
  4. Do not allow the dropper to touch your eye or any other surface
  5. Tilt your head back, pull down the lower lid of your eye with your index finger to form a pocket
  6. While looking up, gently squeeze the dropper so that a single drop falls into the pocket made by the lower eyelid. Remove your index finger from the lower eyelid
  7. Close your eye for 2 to 3 minutes and tilt your head down, without blinking or squeezing eyelids
  8. Apply gentle pressure on the tear duct with your finger
  9. If you are to use more than one drop in the same eye, wait at least 5 minutes before instilling the next drop
  10. Replace and tighten the cap on the dropper bottle. Do not wipe or rinse the dropper tip
  11. Throw away the vial out of the reach of children even if it is not empty
  12. Wash your hands to remove any medication

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Restasis at the same time.

Restasis Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Burning or other discomfort of the eye
Less common
  • Blurred vision
  • clear or yellow fluid from the eye
  • difficulty with reading
  • eye pain
  • feeling of having something in the eye
  • halos around lights
  • itching skin
  • redness of the white part of your eyes or inside of your eyelids
  • sticky or matted eyelashes
  • stinging
  • watery eye

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Warningsand precautions

5.1       Potential for Eye Injury and Contamination

 Be careful not to touch the vial tip to your eye or other surfaces to avoid potential for eye injury and contamination.

5.2 Use with Contact Lenses

Restasis® 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 emulsion. Lenses may be reinserted 15 minutes following administration of Restasis® ophthalmic emulsion.

Principal display panel

NDC 0023-9163-60 
No. 94529

Restasis® 
(Cyclosporine Ophthalmic Emulsion) 0.05%

60 Single-Use Vials (0.4 mL each) One Month Supply Sterile, Preservative-Free

Restasis 
cyclosporine emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0023-9163
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOSPORINE (CYCLOSPORINE) CYCLOSPORINE 0.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN  
CASTOR OIL  
POLYSORBATE 80  
CARBOMER COPOLYMER TYPE A  
WATER  
SODIUM HYDROXIDE  
Packaging
# Item Code Package Description
1 NDC:0023-9163-12 5 VIAL, SINGLE-USE in 1 CARTON
1 0.4 mL in 1 VIAL, SINGLE-USE
2 NDC:0023-9163-30 30 VIAL, SINGLE-USE in 1 TRAY
2 0.4 mL in 1 VIAL, SINGLE-USE
3 NDC:0023-9163-60 60 VIAL, SINGLE-USE in 1 TRAY
3 0.4 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050790 04/01/2003
Labeler - Allergan, Inc. (144796497)
Establishment
Name Address ID/FEI Operations
Allergan, Inc. 362898611 MANUFACTURE(0023-9163)
Revised: 07/2017   Allergan, Inc.

What is cyclosporine ophthalmic?

Cyclosporine is an immunosuppressant. Cyclosporine ophthalmic (for use in the eye) can increase tear production that has been reduced by inflammation in the eye(s).

Cyclosporine ophthalmic is used to treat chronic dry eye that may be caused by inflammation.

Cyclosporine ophthalmic may also be used for purposes not listed in this medication guide.

Cyclosporine ophthalmic side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using cyclosporine ophthalmic and call your doctor at once if you have:

  • eye pain; or

  • eye swelling, redness, severe discomfort, crusting or drainage (may be signs of infection).

Common side effects may include:

  • mild burning or stinging in the eyes;

  • mild redness or itching;

  • blurred vision; or

  • feeling like something is in your eye.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 3.02.

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