SPL Set ID: 2de1e8b1-625f-43ce-a1d5-d543be208b11

Cyclosporine capsules, USP MODIFIED are an oral formulation of cyclosporine, USP that immediately forms an emulsion in an aqueous environment. Cyclosporine, USP, the active principle in cyclosporine capsules, USP MODIFIED, is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Tolypocladium inflatum . Chemically, cyclosporine, USP is designated as [ R -[ R *, R *-( E )]]-cyclic-(L-alanyl-D-alanyl- N -methyl-L-leucyl- N -methyl-L-leucyl- N -methyl-L-valyl-3-hydroxy- N ,4-dimethyl-L-2-amino-6-octenoyl-L-α-amino-butyryl- N -methylglycyl- N -methyl-L-leucyl-L-valyl- N -methyl-L-leucyl) and has the following structural formula: Each soft gelatin capsule for oral administration contains either 25 mg, 50 mg or 100 mg of cyclosporine, USP MODIFIED and 15.8% v/v (12.4% wt./vol) dehydrated alcohol and has the following inactive ingredients: DL-alpha-tocopherol, gelatin, glycine, glycerol 99%, glyceryl monolinoleate, polyoxyl 40 hydrogenated castor oil, propylene glycol, sorbitol solution and titanium dioxide. In addition, the 25 mg and 50 mg contain ferric oxide (yellow) and the 100 mg contains ferric oxide (brown). structural formula