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Imusporin Structure
Imusporin-25 Capsules:
- 25 mg - Cyclosporine USP;
Imusporin-50 Capsules:
- 50 mg - Cyclosporine USP;
Imusporin-100 Capsules:
- 100 mg - Cyclosporine USP;
Imusporin Indications
Psoriasis
Imusporin is indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy (e.g., PUVA, retinoids, or methotrexate) or in patients for whom other systemic therapies are contraindicated or cannot be tolerated.
While rebound rarely occurs, most patients will experience relapse with Imusporin as with other therapies upon cessation of treatment.
Rheumatoid Arthritis
Imusporin is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Imusporin can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone.
Kidney, Liver and Heart Transplantation
Imusporin is indicated for the prophylaxis of organ rejection in kidney, liver and heart allogeneic transplants. Imusporin has been used in combination with azathioprine and corticosteroids.
Imusporin Dosage
Imusporin has increased bioavailability in comparison to conventional cyclosporine. Imusporin and conventional cyclosporine are
not bioequivalent and cannot be used interchangeably without physician supervision.
The daily dose of Imusporin should always be given in two divided doses (BID). Imusporin is recommended that Imusporin 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 Imusporin 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, Imusporin therapy should be discontinued.
Psoriasis: The initial dose of Imusporin should be 2.5 mg/kg/day. Imusporin should be taken twice daily, as a divided (1.25 mg/kg BID) oral
dose. Patients should be kept at that dose for at least 4 weeks, barring adverse events. If significant clinical improvement has not
occurred in patients by that time, the patient`s dosage should be increased at 2-week intervals. Based on patient response, dose increases of approximately 0.5 mg/kg/day should be made to a maximum of 4.0 mg/kg/day.
Dose decreases by 25%-50% should be made at any time to control adverse events, e.g., hypertension, elevations in serum creatinine (>/=25% above
the 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, Imusporin should be discontinued.
Imusporin Contraindications
Psoriasis
Psoriasis patients who are treated with Imusporin should not receive concomitant PUVA or UVB therapy, methotrexate or other immunosuppressive agents, coal tar or radiation therapy. Psoriasis patients with abnormal renal function, uncontrolled hypertension or malignancies should not receive Imusporin .
Rheumatoid Arthritis
Rheumatoid arthritis patients with abnormal renal function, uncontrolled hypertension or malignancies should not receive Imusporin .
General
Imusporin is contraindicated in patients with a hypersensitivity to cyclosporine or to any of the ingredients of the formulation.
Imusporin Form
Strip of 5 capsules.
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