SPL Set ID: 1952d4c7-a40e-4924-b669-c41400774cb9

Cyclosporine capsules, 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 -amino-butyryl- 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 Dehydrated alcohol................................................. (9.5% w/v or 12.0% v/v) Each 50 mg capsule contains: Cyclosporine, USP……………………………………………………………………………...50 mg Dehydrated alcohol................................................... (9.5% w/v or 12.0% v/v) Each 100 mg capsule contains: Cyclosporine, USP…………………………………………………………………………...100 mg Dehydrated alcohol.................................................. (9.5% w/v or 12.0% v/v) Inactive Ingredients: gelatin, glycerin, propylene glycol, titanium dioxide, ferric oxide black [25 mg and 100 mg], glyceryl monolinoleate, polyoxyl 40 hydrogenated castor oil, all-rac-alpha tocopherol [vitamin E synthetic], Ink contains- ammonium hydroxide 28%, iron oxide red, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol. The chemical structure of cyclosporine (also known as cyclosporin A) is: Chemical structure