Restasis (Cyclosporine) Drug Information: Clinical Pharmacology

Pill Identifier Search

May 27, 2012

Restasis

Eye Allergy »

Eye allergy facts

Most allergic eye conditions are more irritating than dangerous.
Allergic or vernal keratoconjunctivitis may result in scarring of the cornea and visual problems.
Itchy eyes are probably allergic eyes.
Topical antihistamine/decongestant preparations are effective and safe for mildly itchy, red eyes.
Patanol, a topical mast-cell stabilizer, is a safe, highly effective, long-acting treatment.
Topical steroids should be used with caution and under the supervision of an ophthalmologist.
If in doubt, seek medical advice sooner rather than later.

Eye allergy introduction

The eyes are the windows to the soul because they reflect our state of mind. This certainly can't be true if our eyes are red, swollen, watery, and itchy from an allergic reaction. Severe allergic eye symptoms can be very distressing and are a common reason fo...

Read the Eye Allergy article »

« Previous
1
2
3
4
5
6
7
8
9
10
11
12
13
Next »

Restasis User Reviews >>

Restasis

Eye Diseases and Conditions Slideshow Pictures

Pink Eye Slideshow Pictures

Cataracts Slideshow Pictures

font size

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 cyclosporin 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® (cyclosporine) 0.05%, BID, 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® (cyclosporine) ophthalmic emulsion.

Clinical Evaluations

Four multicenter, randomized, adequate and well-controlled clinical studies were performed in approximately 1200 patients with moderate to severe keratoconjunctivitis sicca. RESTASIS® (cyclosporine) 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® (cyclosporine) 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® (cyclosporine) .

Last reviewed on RxList: 7/9/2010
This monograph has been modified to include the generic and brand name in many instances.