Sporium solution: Each ml solution contains Cyclosporine USP 100 mg.
- Solid organ transplantation
- Bone marrow transplantation
• Non-transplantation indications
- Endogenous uveitis
- Nephrotic syndrome
- Rheumatoid arthritis
- Atopic dermatitis.
Bone marrow transplantation: Initially 12.5 to 15 mg/kg given in 2 divided doses, starting on the day before transplantation. Maintenance treatment of 12.5 mg/Kg in 2 divided doses should be continued for at least 3 months (and preferably for 6 months) before the dose is gradually decreased to zero by 1 year after transplantation.
Endogenous uveitis: Initially 5 mg/kg per day orally given in 2 divided doses are recommended. For maintenance treatment, the dose should be slowly reduced to the lowest effective level.
Nephrotic syndrome: Initially 5 mg/kg for adults and 6 mg/kg for children given in 2 divided doses. In case of renal impairement, the initial dose should not exceed 2.5 mg/kg per day. For maintenance treatment, the dose should be slowly reduced to the lowest effective level.
Rheumatoid arthritis: For the first 6 weeks, the recommended dose is 3 mg/kg per day in 2 divided doses. To achieve full effectiveness, up to 12 weeks of Sporium therapy may be required. For maintenance treatment, the dose has to be titrated individually according to tolerability.
Psoriasis & Atopic dermatitis: Initially 2.5 mg/kg per day orally given in 2 divided doses and 5 mg/kg per day for patients whose condition requires rapid improvement. For maintenance treatment, doses have to be titrated individually to the lowest effective level.
Nervous system: Tremor, headache, paraesthesia.
Gastrointestinal tract and liver: Anorexia, nausea, vomiting, abdominal pain, diarrhoea, gingival hyperplasia and hepatic dysfunction.
Metabolic: Hyperlipidaemia, hyperuricaemia, hyperkalaemia, hypomagnesaemia.
Musculoskeletal: Muscle cramps, myalgia and rarely muscle weakness, myopathy.
Haemopoietic: Usually uncommon but anaemia, thrombocytopenia can occur.
Skin and appendages: Hypertrichosis and allergic rashes.
Cyclosporine may develop bacterial, fungal, parasitic and viral infections. So therapeutic strategies should be employed for long-term immunosuppressive therapy.
A reversible increase in serum creatinine and urea may occur during the first few weeks of Sporium therapy and usually responding to dose reduction. In elderly patients, renal function should be monitored with particular care.
Regular monitoring of blood pressure is required during Sporium therapy; if hypertension develops, appropriate antihypertensive treatment must be instituted.
Cyclosporine enhances the risk of hyperkalaemia, especially in patients with renal dysfunction. Caution is also required when Cyclosporine is co-administered with potassium sparing drugs. Cyclosporine enhances the clearance of magnesium. If considered necessary, magnesium supplementation should be given. Caution should be observed in treating patients with hyperuricaemia. During treatment with Cyclosporine, vaccination may be less effective; the use of live-attenuated vaccines should be avoided.
Non-transplant patients with impaired renal function, uncontrolled hypertension, uncontrolled infections, or any kind of malignancy should not receive Cyclosporine.
Lactation: Cyclosporine passes into breast milk. Mothers receiving treatment with Sporium should not breast-feed.
Drugs that increase Cyclosporine levels: Macrolide antibiotics (e.g., erythromycin, azithromycin and clarithromycin), ketoconazole, fluconazole, itraconazole, voriconazole, diltiazem, nicardipine, verapamil, lercanidipine, metoclopramide, oral contraceptives, danazol, methylprednisolone (high dose), allopurinol, amiodarone, cholic acid and derivatives, protease inhibitors, imatinib, colchicine.
Other relevant drug interactions: Cyclosporine may reduce the clearance of digoxin, colchicine, prednisolone and HMG-CoA reductase inhibitors (statins).
The oral solution should be diluted with, preferably, orange or apple juice; however, other drinks such as soft drinks can be used. Immediately before taking the oral solution, it should be stirred well. Owing to its possible interference with the P450-dependent enzyme system, grapefruit juice should be avoided for dilution. To use Sporium solution properly, follow the steps below:
Raise the plastic cap.
Push the white stopper firmly into the neck of the bottle.
Insert the syringe into the white stopper.
Draw up prescribed volume of solution.
Expel any large bubbles by depressing and withdrawing plunger a few times before removing syringe containing prescribed dose from bottle. The presence of a few tiny bubbles is of no importance and will not affect the dose in any way.
Push the medicine out of the syringe into a small glass with some liquid, but no grapefruit juice. The medicine can be mixed just before you take it. Stir and drink the entire mixture right away. Please take the medicine immediately after preparation.
After use, wipe syringe on outside only with a dry tissue. White stopper should remain in bottle. Close bottle with cap provided.