Restasis

DRUG DESCRIPTION

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

Structural Formula:

RESTASIS®
(cyclosporine) Structural Formula Illustration

Formula: C62H111N11O12     Mol. Wt.:1202.6

Cyclosporine is a fine white powder. RESTASIS® (cyclosporine) 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® (cyclosporine) 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.

What are the possible side effects of cyclosporine ophthalmic (Restasis)?

Serious side effects are not expected to occur during treatment with this medication.

Eye burning, redness, tearing, discharge, pain, itching, stinging, or visual blurring may occur.

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...

Read All Potential Side Effects and See Pictures of Restasis »

What are the precautions when taking cyclosporine (Restasis)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: an eye infection.

Before using this medication, tell your doctor or pharmacist your medical history.

This drug may cause blurred vision. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

This medication should be used only when clearly needed during pregnancy. Discuss...

Read All Potential Precautions of Restasis »


Restasis Consumer (continued)

SIDE EFFECTS: Burning, stinging, redness, pain, or itching of the eye may occur. Blurred vision, feeling as if something is in the eye, or eye discharge may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, severe itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: an eye infection.

Before using this medication, tell your doctor or pharmacist your medical history.

This drug may cause blurred vision. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Restasis Patient Information Including Side Effects

Brand Names: Restasis

Generic Name: cyclosporine ophthalmic (Pronunciation: SYE kloe SPOR een off THAL mik)

  • What is cyclosporine ophthalmic (Restasis)?
  • What are the possible side effects of cyclosporine ophthalmic (Restasis)?
  • What is the most important information I should know about cyclosporine ophthalmic (Restasis)?
  • What should I discuss with my healthcare provider before using cyclosporine ophthalmic (Restasis)?
  • How should I use cyclosporine ophthalmic (Restasis)?
  • What happens if I miss a dose (Restasis)?
  • What happens if I overdose (Restasis)?
  • What should I avoid while using cyclosporine ophthalmic (Restasis)?
  • What other drugs will affect cyclosporine ophthalmic (Restasis)?
  • Where can I get more information?

What is cyclosporine ophthalmic (Restasis)?

Cyclosporine is an immunosuppressive agent. Cyclosporine ophthalmic may reduce 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 other than those listed in this medication guide.

What are the possible side effects of cyclosporine ophthalmic (Restasis)?

Serious side effects are not expected to occur during treatment with this medication.

Eye burning, redness, tearing, discharge, pain, itching, stinging, or visual blurring may occur.

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.

What is the most important information I should know about cyclosporine ophthalmic (Restasis)?

Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye(s).

Do not use cyclosporine ophthalmic while wearing contact lenses. Contact lenses may be reinserted 15 minutes following administration of cyclosporine ophthalmic, unless otherwise directed by your doctor.

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