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[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure:
Cyclosporine is a fine white powder. RESTASIS
® 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 RESTASIS
® ophthalmic emulsion contains: Active: cyclosporine 0.05%. Inactives: glycerin; castor oil; polysorbate 80; carbomer copolymer type A; purified water; and sodium hydroxide to adjust pH.
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
The most common adverse event following the use of RESTASIS
® was ocular burning (17%).
Other events reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
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.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Storage: Store 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 each tray (30 vials) must be dispensed intact. RESTASIS
® is also provided in a 60 count (2 x 30) package (one month supply) that must be dispensed intact.
30 Vials 0.4 mL each – NDC 54868-4793-1
® ophthalmic emulsion at 15 – 25° C (59 – 77° F).
KEEP OUT OF THE REACH OF CHILDREN.
© 2010 Allergan, Inc.
Irvine, CA 92612, U.S.A.
® marks owned by Allergan, Inc.
U.S. Patent 5,474,979
Made in the U.S.A.
Relabeling of “Additional” bar code label by:
Physicians Total Care, Inc.
Tulsa, OK 74146
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
(Cyclosporine Ophthalmic Emulsion) 0.05%
30 Single-Use Vials (0.4 mL each)
Each mL contains: Active: cyclosporine 0.05% Inactives: glycerin; castor oil; polysorbate 80; carbomer copolymer type A; purified water; and sodium hydroxide to adjust the pH. Usual Dosage: Twice daily approximately 12 hours apart. Invert the vial before using. Use immediately after opening and then discard.
Note: Store at 15 – 25° C (59 – 77° F). Store vials in the thermoformed tray until use. The entire contents of each package (60 vials) must be dispensed intact.