Cyclosporine Ophthalmic

Cyclosporine Ophthalmic is a prescription medication used to treat the symptoms of Dry Eye (Keratoconjunctivitis Sicca) and Vernal Keratoconjunctivitis.

• Cyclosporine Ophthalmic is available under various brand names: Restasis, Cequa, Verkazia

Common side effects of Cyclosporine Ophthalmic include:

• mild eye pain,
• redness or other irritation of the eye,
• watery eyes,
• blurred vision, and
• feeling like something is in the eye

Serious side effects of Cyclosporine Ophthalmic include:

• severe eye pain, burning or stinging after putting in the drops,
• swollen eyelids, and
• swelling, redness, severe discomfort, crusting, or drainage from the eye

Rare side effects of Cyclosporine Ophthalmic include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult  and pediatric dosage

Ophthalmic emulsion

• 0.05% (Restasis, generic; single-use)
• 0.05% (Restasis Multidose)
• 0.1% (Verkazia; single-dose vial)

Ophthalmic solution

• 0.09% (Cequa; single-use vial)

Keratoconjunctivitis Sicca

Adult dosage

• Instill 1 drop twice daily in each eye ~12 hr apart

Pediatric dosage

• Age below 16 years: Not studied
• Aged above 16 years
• Instill 1 drop twice daily in each eye ~12 hr apart

Vernal Keratoconjunctivitis

Adult dosage

• Instill 1 drop four times a day (morning, noon, afternoon, and evening) into the affected eye(s)

Pediatric dosage

• Aged above 4 years
• Instill 1 drop four times a day (morning, noon, afternoon, and evening) into the affected eye(s)

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Cyclosporine Ophthalmic has no noted severe interactions with any other drugs.
• Cyclosporine Ophthalmic has no noted serious interactions with any other drugs.
• Cyclosporine Ophthalmic has no noted moderate interactions with any other drugs.
• Cyclosporine Ophthalmic has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Known or suspected hypersensitivity to any of the ingredients in the formulation

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Cyclosporine Ophthalmic?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Cyclosporine Ophthalmic?”

Cautions

• Remove contact lenses prior to administration
• Do not touch eyelids with the vial tip to avoid contamination
• Do not use with contact lenses; lenses may be reinserted 15 minutes following administration of ophthalmic emulsion/solution
• Patients with decreased tear production typically should not wear contact lenses

Pregnancy & Lactation

• There are no adequate and well-controlled studies of administration in pregnant females to inform a drug-associated risk
• Infertility
  • No data are available on drug effects on human fertility
  • No impairment of fertility was reported in animals receiving intravenous cyclosporine
• Lactation
  • There is no information regarding drug presence in human milk following topical administration or on effects on breastfed infants and milk production
  • Administration of oral cyclosporine to rats during lactation did not produce adverse effects in offspring at clinically relevant doses