Restasis (Cyclosporine Ophthalmic) - Indications and Dosage

INDICATIONS AND USAGE

RESTASIS ^® ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.

DOSAGE AND ADMINISTRATION

Invert the unit dose vial a few times to obtain a uniform, white, opaque emulsion before using. Instill one drop of RESTASIS ^® ophthalmic emulsion twice a day in each eye approximately 12 hours apart. RESTASIS ^® can be used concomitantly with artificial tears, allowing a 15 minute interval between products. Discard vial immediately after use.

HOW SUPPLIED

RESTASIS ^® ophthalmic emulsion is packaged in single use vials. Each vial contains 0.4 mL fill in a 0.9 mL LDPE vial; 30 vials are packaged in a polypropylene tray with an aluminum peelable lid. The entire contents of this tray (30 vials) must be dispensed as one unit.

RESTASIS ^® 30 Vials 0.4 mL each - NDC 0023-9163-30

Storage: Store RESTASIS ^® ophthalmic emulsion at 15° to 25° C (59°-77° F).

KEEP OUT OF THE REACH OF CHILDREN.

Rx Only

Revised January 2008

© 2008 Allergan, Inc.
Irvine, CA 92612, U.S.A.
® marks owned by Allergan, Inc.
U.S. Patents 4,839,342 and 5,474,979
www.restasis.com

INSPIRE®
PHARMACEUTICALS INC.
Inspire and the Inspire logo are registered trademarks of Inspire Pharmaceuticals Inc.

71876US10U