Prescription Drug Name:
RESTASIS®, (cyclosporine ophthalmic emulsion) 0.05%
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
® (cyclosporine ophthalmic emulsion) 0.05% contains a topical immunomodulator with anti-inflammatory effects. Cyclosporine’s chemical name is Cyclo[[(
® appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mOsmol/kg and a pH of 6.5-8.0. Each mL of
® ophthalmic emulsion contains:
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
® 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.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
® is contraindicated in patients with active ocular infections and in patients with known or suspected hypersensitivity to any of the ingredients in the formulation.
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
® ophthalmic emulsion has not been studied in patients with a history of herpes keratitis.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
® was ocular burning (17%).
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
® ophthalmic emulsion twice a day in each eye approximately 12 hours apart.
® can be used concomitantly with artificial tears, allowing a 15 minute interval between products. Discard vial immediately after use.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
® 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 each tray (30 vials) must be dispensed intact.
® is also provided in a 60 count (2 x 30) package (one month supply) that must be dispensed intact.
® ophthalmic emulsion at 15 – 25° C (59 – 77° F).
Irvine, CA 92612, U.S.A.
® marks owned by Allergan, Inc.
U.S. Patent 5,474,979
Made in the U.S.A.
Physicians Total Care, Inc.
Tulsa, OK 74146
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4