Cyclosporine Ciclosporin, Cyclosporine A

Sandimmune with NDC 0078-0240 is a a human prescription drug product labeled by Novartis Pharmaceuticals Corporation. The generic name of Sandimmune is cyclosporine. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Novartis Pharmaceuticals Corporation 

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

Product Type: Human Prescription Drug 

SANDIMMUNE ACTIVE INGREDIENT(S)

INACTIVE INGREDIENT(S) 

• ALCOHOL (UNII: 3K9958V90M)
• GELATIN (UNII: 2G86QN327L)
• GLYCERIN (UNII: PDC6A3C0OX)
• OLIVE OIL (UNII: 6UYK2W1W1E)
• FERRIC OXIDE RED (UNII: 1K09F3G675)
• SORBITOL (UNII: 506T60A25R)
• TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
• CORN OIL (UNII: 8470G57WFM)
• CASTOR OIL (UNII: D5340Y2I9G)

ADMINISTRATION ROUTE(S)

• Oral - Administration to or by way of the mouth.

WARNING

Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Sandimmune (cyclosporine). Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.Sandimmune (cyclosporine) should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression.Sandimmune Soft Gelatin Capsules (cyclosporine capsules, USP) and Sandimmune Oral Solution (cyclosporine oral solution, USP) have decreased bioavailability in comparison to Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED and Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIED.Sandimmune and Neoral are not bioequivalent and cannot be used interchangeably without physician supervision.The absorption of cyclosporine during chronic administration of Sandimmune Soft Gelatin Capsules and Oral Solution was found to be erratic. It is recommended that patients taking the soft gelatin capsules or oral solution over a period of time be monitored at repeated intervals for cyclosporine blood concentrations and subsequent dose adjustments be made in order to avoid toxicity due to high concentrations and possible organ rejection due to low absorption of cyclosporine. This is of special importance in liver transplants. Numerous assays are being developed to measure blood concentrations of cyclosporine. Comparison of concentrations in published literature to patient concentrations using current assays must be done with detailed knowledge of the assay methods employed. (See Blood Concentration Monitoring under DOSAGE AND ADMINISTRATION)

PHARMACOLOGICAL CLASS(ES)

• Calcineurin Inhibitor Immunosuppressant - [EPC] (Established Pharmacologic Class)c
• Calcineurin Inhibitors - [MoA] (Mechanism of Action) 
• Cytochrome P450 3A4 Inhibitors - [MoA] (Mechanism of Action) 
• P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)