Source: FDA, National Drug Code (US) Revision Year: 2021
RESTASIS (cyclosporine ophthalmic emulsion) 0.05% contains a topical calcineurin inhibitor immunosuppressant 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-NmethylglycylN-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
Formula: C62H111N11O12
Mol. Wt.: 1202.6
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.
| Dosage Forms and Strengths |
|---|
|
Ophthalmic emulsion containing cyclosporine 0.5 mg/mL. |
| How Supplied |
|---|
|
Product: 50090-1242 NDC: 50090-1242-0 .4 mL in a VIAL, SINGLE-USE / 30 in a TRAY Irvine, CA 92612, Made in the U.S.A. |
| Drug | Countries | |
|---|---|---|
| RESTASIS | Brazil, Canada, Ecuador, Hong Kong, Israel, Mexico, Turkey, United States |
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