What is cyclosporine-ophthalmic, and how does it work (mechanism of action)?
Restasis ophthalmic emulsion is a prescription eye
drop that helps patients increase their eyes’ natural ability to produce tears.
It is used to treat a type of chronic dry eye condition caused by inflammation.
Cyclosporine, the medicine in Restasis, is also available in oral and injectable
formulations that are used to treat various conditions including treatment or
prevention of rejection of transplanted organs, psoriasis, and rheumatoid
arthritis. Following oral administration or injection, cyclosporine is absorbed
in the blood stream and works systemically to suppress the body’s immune system.
However, cyclosporine eye drop emulsion is thought to work differently. Restasis
is believed to work locally in the eye as a partial modulator of the immune
system. Tear production is thought to be decreased when lymphocytes, a type of
white blood cell of the immune system, die and accumulate in the tear glands.
Restasis reverses this condition, increasing tear production. Restasis does not
produce its effect immediately. An increase in tear production may not be
noticed until 3 to 6 months after starting treatment. Restasis ophthalmic
emulsion was approved by the FDA in January, 2003.
What brand names are available for cyclosporine-ophthalmic?
Is cyclosporine-ophthalmic available as a generic drug?
GENERIC AVAILABLE: No
Do I need a prescription for cyclosporine-ophthalmic?
What are the side effects of cyclosporine-ophthalmic?
The most common side effect of cyclosporine ophthalmic emulsion is a temporary burning
sensation in the eye. Other side effects include:
- eye redness,
- watery eyes,
- eye pain,
- foreign body sensation,
- stinging, and
- blurred vision.
What is the dosage for cyclosporine-ophthalmic?
One drop should be instilled in each eye twice daily. Patients may
use Restasis with artificial tears or over-the-counter eye lubricants, allowing
a 15 minute interval between products.
Restasis should not be used while wearing contact lenses. Patients with
chronic dry eye are generally advised not to wear contact lenses. If contact
lenses are worn, they should be removed before applying Restasis. Lenses may be
inserted 15 minutes after applying Restasis.
The safety and effectiveness of Restasis has not been established in children
below the age of 16.
Which drugs or supplements interact with cyclosporine-ophthalmic?
The effectiveness of Restasis may be affected if administered with other eye
drops. Patients using other eye drops should consult with their eye doctor for
advice. Patients may use Restasis with artificial tears or over-the-counter eye
lubricants, allowing a 15 minute interval between products.
Is cyclosporine-ophthalmic safe to take if I’m pregnant or breastfeeding?
Due to the lack of conclusive safety data, Restasis should be used
in pregnancy only if clearly needed. Restasis is classified as FDA pregnancy
risk category C (it caused harm in studies with animals, but use during
pregnancy in humans has not been adequately evaluated).
It is not known if cyclosporine is excreted into breast milk following administration into the eye. Although blood levels were undetectable
following ophthalmic administration, Restasis should be used cautiously during
What else should I know about cyclosporine-ophthalmic?
What preparations of cyclosporine-ophthalmic are available?
Ophthalmic emulsion (eye drops): 0.5 mg/ml cyclosporine.
Restasis is supplied in a sterile, preservative-free single-use vial.
How should I keep cyclosporine-ophthalmic stored?
Restasis should be stored at room temperature, between 15 C to 25 C
(59 F to 77 F).