Restasis

• Restasis^®

Restasis

Yes

Dosing Forms & Strength

ophthalmic emulsion

• 0.05%

Keratoconjuntivitis Sicca

1 gtt twice daily approximately 12 hours apart in each eye

May be used with artificial tears; allow 15-minute interval between products

Orphan Indications

Cornal Melting

• For use in corneal melting syndromes of known or presumed immunologic etiopathogenesis, including Mooren's ulcer
• Orphan indication sponsor: Allergan, Inc; 2525 Dupont Drive, P.O. Box 19534; Irvine, CA 92623-9534

Prevention of Graft Rejection

• Treatment of patients at high risk of graft rejection following penetrating keratoplasty
• Orphan indication sponsor: Allergan, Inc; 2525 Dupont Drive, P.O. Box 19534; Irvine, CA 92623-9534

Keratoconjunctivitis

• Treatment of vernal keratoconjunctivitis
• Treatment of herpes simplex virus stromal keratitis
• Orphan indication sponsor: NOVAGALI Pharma SA; Batiment Genavenir IV F-91058-Evry cedex; France

Keratoconjunctivitis Sicca

• Treatment of severe keratoconjunctivitis sicca associated with Sjogren's syndrome
• Orphan indication sponsor: University Of Georgia; College Of Veterinary Medicine, Department of Small Animal Medicine; Athens, GA 30602

Corneal Graft Rejection

• Prevention of corneal graft rejection
• Orphan indication sponsor: NOVAGALI Pharma SA; Batiment Genavenir IV F-91058-Evry cedex; France

Dosing Forms & Strength

ophthalmic emulsion

• 0.05%

Keratoconjuntivitis Sicca

<16 years

• Safety and efficacy not established

≥16 years

• 1 gtt twice daily approximately 12 hours apart in each eye
• May be used with artificial tears; allow 15-minute interval between products

>10%

Ocular burning (17%)

Frequency Not Defined

Conjunctival hyperemia

Discharge

Epiphora

Eye pain

Foreign body sensation

Pruritus

Postmarketing Reports

Hypersensitivity (including eye swelling, urticaria, rare cases of severe angioedema, face swelling, tongue swelling, pharyngeal edema and dyspnea)

Superficial injury of the eye (from the vial tip touching the eye during administration)

RESTASIS®(cyclosporine ophthalmic emulsion) 0.05% contains a topical calcineurin inhibitor immunosuppressant with anti-inflammatory effects. Cyclosporine's chemical name is Cyclo[[(E)-(2S,3R,4R)-3hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valylN-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure:

Structural Formula

Formula: C62H111N11O12     Mol. Wt.: 1202.6

Cyclosporine is a fine white powder. RESTASIS® appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mOsmol/kg and a pH of 6.5-8.0. Each mL of RESTASIS® ophthalmic emulsion contains: Active: cyclosporine 0.05%. Inactives: glycerin; castor oil; polysorbate 80; carbomer copolymer type A; purified water; and sodium hydroxide to adjust pH.

Do not use cyclosporine ophthalmic if you have any type of infection in the eye(s).

Cyclosporine ophthalmic is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not use cyclosporine ophthalmic without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether cyclosporine ophthalmic passes into breast milk. Do not use cyclosporine ophthalmic without first talking to your doctor if you are breast-feeding a baby.

Your pharmacist has additional information about cyclosporine ophthalmic written for health professionals that you may read.

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.

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Restasis is a prescription medication used to increase tear production in the eyes for the treatment of dry eyes caused by several different medical conditions. Restasis belongs to a group of drugs called topical immunomodulators. The mechanism by which Restasis works to increase tear production in the eyes is not yet fully understood.

Restasis comes in an eyedrop form and is typically administered into the affected eye(s) twice a day.

Common side effects of Restasis include eye burning, itching, and redness.

Restasis can also cause blurred vision. Do not take drive or operate heavy machinery until you know how Restasis affects you.

Use this medicine (Restasis) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

All products:

• For the eye only.
• Follow how to use as you have been told by the doctor or read the package insert.
• Take out contact lenses before using this medicine. Lenses may be put back in 15 minutes after this medicine (Restasis) is given. Do not put contacts back in if your eyes are irritated or infected.
• Do not touch the container tip to the eye, lid, or other skin.
• Wash hands before and after use.
• Turn upside down a few times to mix the drug before use.
• Tilt your head back and drop drug into the eye.
• After use, keep your eyes closed. Put pressure on the inside corner of the eye. Do this for 1 to 2 minutes. This keeps the drug in your eye.
• Space this medicine from artificial tears by 15 minutes.

Multi-dose container:

• Prime the bottle before first use by squeezing 2 drops onto a tissue. Do not touch the bottle tip to the tissue.
• Put the cap back on after you are done using your dose.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

An overdose of cyclosporine ophthalmic is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

You should not put this medicine in your eyes while wearing contact lenses. Wait at least 15 minutes after using this medicine before putting in your contact lenses. It may be best not to wear contact lenses if you have dry eyes. Talk with your doctor.