SPL Set ID: f3dc2a50-1084-4190-a6f3-37034a04db86

Cyclosporine oral solution, USP MODIFIED is an oral formulation of cyclosporine, USP that immediately forms an emulsion in an aqueous environment. Cyclosporine, USP, the active principle in cyclosporine oral solution, 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 mL of cyclosporine oral solution, USP MODIFIED contains 100 mg/mL cyclosporine, USP and 15.3% v/v (12.18% wt/vol) dehydrated alcohol, USP and has the following inactive ingredients: polyoxyl 40 hydrogenated castor oil, polyglycerol (3) oleate and polyglycerol (10) oleate. Cyclosporine Chemical Structure