SPL Set ID: 94461af3-11f1-4670-95d4-2965b9538ae3

Neoral is an oral formulation of cyclosporine that immediately forms a microemulsion in an aqueous environment. Cyclosporine, the active principle in Neoral, is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Beauveria nivea. Chemically, cyclosporine 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). chemical structure of cyclosporine Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED are available in 25 mg and 100 mg strengths. Each 25 mg capsule contains: cyclosporine………………………………………………………………………………25 mg alcohol, USP dehydrated......................................................................11.9% v/v (9.5% wt/vol.) Each 100 mg capsule contains: cyclosporine……………………………………………………………………………...100 mg alcohol, USP dehydrated.......................................................................11.9% v/v (9.5% wt/vol.) Inactive ingredients: Carmine, corn oil-mono-di-triglycerides, DL-α-tocopherol USP, gelatin NF, glycerol, iron oxide black, polyoxyl 40 hydrogenated castor oil NF, propylene glycol USP, titanium dioxide USP, and other ingredients. Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIED is available in 50 mL bottles. Each mL contains: cyclosporine……………………...............................................................................100 mg/mL alcohol, USP dehydrated.....................................................................11.9% v/v (9.5% wt/vol.) Inactive ingredients: Corn oil-mono-di-triglycerides, DL-α -tocopherol USP, polyoxyl 40 hydrogenated castor oil NF, and propylene glycol USP. The chemical structure of cyclosporine (also known as cyclosporin A) is: