RESTASIS™ (cyclosporine ophthalmic emulsion) 0.05% contains a topical immunomodulator with anti-inflammatory effects. Cyclosporines chemical name is Cyclo[[(E)-(2S,3R,4 R)-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 to 8.0.

Each mL of RESTASIS™ ophthalmic emulsion contains: Active: cyclosporine 0.05%. Inactives: glycerin; castor oil; polysorbate80; carbomer 1342; purified water, and sodium hydroxide to adjust the pH.

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