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NEORAL (CYCLOSPORINE) CAPSULES AND ORAL SOLUTION: DOSAGE AND ADMINISTRATION

Neoral (Cyclosporine) has increased bioavailability in comparison to Sandimmune. Neoral and Sandimmune are not bioequivalent and cannot be used interchangeably without physician supervision. The daily dose of Neoral should always be given in two divided doses (BID). It is recommended that Neoral be administered on a consistent schedule with regard to time of day and relation to meals. Grapefruit and grapefruit juice affect metabolism, increasing blood concentration of cyclosporine, thus should be avoided.

Rheumatoid Arthritis

The initial dose of Neoral is 2.5 mg/kg/day, taken twice daily as a divided (BID) oral dose. Salicylates, nonsteroidal anti-inflammatory agents, and oral corticosteroids may be continued. Onset of action generally occurs between 4 and 8 weeks. If insufficient clinical benefit is seen and tolerability is good (including serum creatinine less than 30% above baseline), the dose may be increased by 0.5-0.75 mg/kg/day after 8 weeks and again after 12 weeks to a maximum of 4 mg/kg/day. If no benefit is seen by 16 weeks of therapy, Neoral therapy should be discontinued.

Dose decreases by 25%-50% should be made at any time to control adverse events, e.g., hypertension elevations in serum creatinine (30% above patient's pretreatment level) or clinically significant laboratory abnormalities.

If dose reduction is not effective in controlling abnormalities or if the adverse event or abnormality is severe, Cyclosporine (Neoral) should be discontinued. The same initial dose and dosage range should be used if Neoral is combined with the recommended dose of methotrexate. Most patients can be treated with Neoral doses of 3 mg/kg/day or below when combined with methotrexate doses of up to 15 mg/week.

There is limited long-term treatment data. Recurrence of rheumatoid arthritis disease activity is generally apparent within 4 weeks after stopping cyclosporine.

Recommendations for Administration of Neoral Oral Solution (cyclosporine oral solution, USP)

To make Neoral Oral Solution (cyclosporine oral solution, USP) more palatable, it should be diluted with orange or apple juice that is at room temperature. Patients should avoid switching diluents frequently. Grapefruit juice affects metabolism of cyclosporine and should be avoided. The combination of Neoral solution with milk can be unpalatable. The effect of milk on the bioavailability of cyclosporine when adminstered as Neoral Oral Solution has not been evaluated.

Take the prescribed amount of Neoral Oral Solution (cyclosporine oral solution, USP) from the container using the dosing syringe supplied, after removal of the protective cover, and transfer the solution to a glass of orange or apple juice. Stir well and drink at once. Do not allow diluted oral solution to stand before drinking. Use a glass container (not plastic). Rinse the glass with more diluent to ensure that the total dose is consumed. After use, dry the outside of the dosing syringe with a clean towel and replace the protective cover. Do not rinse the dosing syringe with water or other cleaning agents. If the syringe requires cleaning, it must be completely dry before resuming use.

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