SPL Set ID: 5baaf78c-90f6-abcf-52c8-814490f3cf9f

Cyclosporine capsule, USP (modified) is an oral formulation of cyclosporine that immediately forms a microemulsion 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 Beauveria nivea. 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-aminobutyryl- N -methylglycyl- N -methyl- L -leucyl- L -valyl- N -methyl- L -leucyl). Cyclosporine capsules, USP (modified) (Soft Gelatin Capsules) are available in 25 mg, 50 mg and 100 mg strengths. Each 25 mg capsule contains: cyclosporine, USP…………………………………………………………………...25 mg benzyl alcohol..................................................................... 7.79% v/v (8.13% wt/vol.) Each 50 mg capsule contains: cyclosporine, USP…………………………………………………………………...50 mg benzyl alcohol......................................................................7.79% v/v (8.13% wt/vol.) Each 100 mg capsule contains: cyclosporine, USP…………………………………………………..……………...100 mg benzyl alcohol....................................................................... 7.79% v/v (8.13% wt/vol.) Inactive Ingredients: Polyethylene glycol 400, polyoxyl 35 castor oil, and propylene glycol monolaurate. The capsule shell contains the following inactive ingredients: gelatin, glycerine, iron oxide black (25 mg and 100 mg capsules only) and titanium dioxide. The capsule imprinting ink contains hypromellose, iron oxide black, and propylene glycol. The chemical structure of cyclosporine is: structure