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Restasis Indications, Dosage, Storage, Stability - Cyclosporine

Restasis Indications, Dosage, Storage, Stability - Cyclosporine

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 0.9mL LDPE vial; 32 vials are packaged in a polypropylene tray with an aluminum peelable lid.

RESTASIS™ 32 Vials 0.4 mL each-NDC 0023-9163-32

Storage: Store RESTASIS™ ophthalmic emulsion at 15°to 25°C (59°to 77°F). KEEP OUT OF THE REACH OF CHILDREN.

©2003 Allergan, Inc. Irvine, CA 92612, U.S.A., ® and Marks owned by Allergan, Inc. US PAT 4,649,047; 4,839,342; 5,474,979.

Updated Nov 25, 2003.

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