SANDIMMUNE Capsule, Oral solution, Solution for injection Ref.[27440] Active ingredients: Ciclosporin

Cyclosporine, the active principle in Sandimmune (cyclosporine) 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-NmethylglycylN-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl).

Sandimmune Soft Gelatin Capsules (cyclosporine capsules, USP) are available in 25 mg and 100 mg strengths.

Each 25 mg capsule contains:

Cyclosporine, USP: 25 mg

Alcohol, USP dehydrated: max 12.7% by volume

Each 100 mg capsule contains:

Cyclosporine, USP: 100 mg

Alcohol, USP dehydrated: max 12.7% by volume

Inactive Ingredients: corn oil, gelatin, iron oxide red, linoleoyl macrogolglycerides, sorbitol, and titanium dioxide. May also contain glycerol. 100 mg capsules may contain iron oxide yellow.

Sandimmune Oral Solution (cyclosporine oral solution, USP) is available in 50 mL bottles.

Each mL contains:

Cyclosporine, USP: 100 mg

Alcohol, Ph. Helv.: 12.5% by volume

dissolved in an olive oil, Ph. Helv./Labrafil M 1944 CS (polyoxyethylated oleic glycerides) vehicle which must be further diluted with milk, chocolate milk, or orange juice before oral administration.

Sandimmune Injection (cyclosporine injection, USP) is available in a 5 mL sterile ampul for intravenous (IV) administration

Each mL contains:

Cyclosporine, USP: 50 mg

^* Cremophor EL (polyoxyethylated castor oil): 650 mg

Alcohol, Ph. Helv.: 32.9% by volume

Nitrogen: qs

which must be diluted further with 0.9% Sodium Chloride Injection or 5% Dextrose Injection before use.

The chemical structure of cyclosporine (also known as cyclosporin A) is