Prescription Drug Name:

RESTASIS®, (cyclosporine ophthalmic emulsion) 0.05%

ID:

10aaf531-4033-442c-821d-69292ccf5f85

Code:

34391-3

DESCRIPTION


id: 7d27b0c6-d3e7-4cef-939b-a2c94ed38d26
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

RESTASIS
® (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: Structural Formula 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


id: eb7b985b-02ef-44fa-ada8-b174da7eeaca
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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.

CONTRAINDICATIONS


id: ce04413f-8c8a-4ddd-b41e-94d1c547483e
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

RESTASIS
® is contraindicated in patients with active ocular infections and in patients with known or suspected hypersensitivity to any of the ingredients in the formulation.

WARNING


id: 59487a9a-5ee6-4d32-9908-00ec3e2be6af
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

RESTASIS
® ophthalmic emulsion has not been studied in patients with a history of herpes keratitis.

ADVERSE REACTIONS


id: e608208a-2c6b-4976-8a1a-65f382057995
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


id: 7bdc1c5e-f5cc-4907-8f56-3635f4d7ce78
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.

HOW SUPPLIED


id: 430978c5-e125-48c5-a531-3ee544dca7a0
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

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

Storage: Store RESTASIS
® ophthalmic emulsion at 15 – 25° C (59 – 77° F). KEEP OUT OF THE REACH OF CHILDREN. Rx Only Revised: 02/2010 © 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. 71876US14B Relabeling of “Additional” bar code label by:

Physicians Total Care, Inc.
Tulsa, OK      74146

Label –


id: d226c570-ab6c-4730-a0bf-1b89c6db5aac
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 54868-4793-1 Restasis (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. Rx only