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Neoral
T2005-23
NEORAL ® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED
NEORAL ® Oral Solution (cyclosporine oral solution, USP) MODIFIED
Rx only
Prescribing Information
DESCRIPTION
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).
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: Corn oil-mono-di-triglycerides, polyoxyl 40 hydrogenated castor oil NF, DL-α-tocopherol USP, gelatin NF, glycerol, iron oxide black, propylene glycol USP, titanium dioxide USP, carmine, 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, polyoxyl 40 hydrogenated castor oil NF, DL-α -tocopherol USP, propylene glycol USP.
The chemical structure of cyclosporine (also known as cyclosporin A) is:
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