Neoral

What is it?

A fungal metabolite, immuno-suppressant preparation available as a liquid taken by mouth containing 100mg of cyclosporin per ml. Also, NEORAL CAPSULES, available in 4 strengths, all soft gelatin and containing cyclosporin. Oval, white/yellow capsules contain 10mg; oval, grey/blue capsules contain 25mg; oblong, white/yellow capsules contain 50mg; oblong, grey/blue capsules contain 100mg. All are marked with strength and 'S' within a triangle.

Medical Uses

Active, severe rheumatoid arthritis that has not responded to other drugs; immunosuppression in bone marrow and organ transplant surgery and prevention and treatment of graftversus-host disease following transplants. Nephrotic syndrome which is serum dependent or resistant, severe psoriasis, severe atopic dermatitis which is resistant to other treatments or where these cannot be used.

Dosage

Adults, rheumatoid arthritis, 2.5mg per kg of body weight in two divided doses each day for first 6 weeks, then gradually increase over another period of 6 weeks according to response, the maximum daily dose is 4mg per kg of body weight. If no improvement is noted after 12 weeks, drug should be withdrawn. Transplant surgery, consult manufacturer's literature; nephrotic syndrome, 5mg per kg of body weight each day in 2 divided doses at first, then use lowest effective dose for maintenance - consult manufacturer's literature. Psoriasis, 1.25mg per kg of body weight twice each day at first, then gradually increase after 1 month to a maximum daily dose of 5mg per kg of body weight daily. Withdraw treatment if no improvement has occurred after 6 weeks on 5mg dose. Dermatitis, 1.25 to 2.5mg per kg of body weight twice each day for a maximum of 2 months. In psoriaisis and severe dermatitis, a starting dose of 5mg per kg of body weight per day can be given in some circumstances.

Special Care

Pregnancy, breastfeeding, high blood potassium levels, low blood magnesium levels, high levels of uric acid in blood. Treatment should only be given by specialist and must be assessed after 6 months. Serum lipid levels, blood pressure kidney and liver function should be monitored before and during course of treatment. In psoriasis and atopic dermatitis, pre- malignant and malignant skin disorders should be excluded before treatment begins and patient should avoid sunbathing. Also, special care if S. aureus skin infections or Herpes infections are present.

Avoid Use

Children, malignant conditions, kidney disorders, uncontrolled high blond pressure or infections that are not controlled. In psoriasis and dermatitis patients, UVB or PUVA therapy.

Possible Drug and Food Interactions

Nsamds, oetreotide, carbamazepine, danazol, kidney toxic drugs, calcium antagonists, orlistat, tacrolimus, azole antifungals, metoclopramide, amiodarone, digoxin, ACE inhibitors, phenytoin, danazol, carbamazepine, oral contraceptives, live vaccines, barbiturates, angiotensin II antagonists, rifampicin, erythromycin, allopurinol, HMG-CoA reductase (enzyme) inhibitors, nifedipine, clarithromycin, methylprednisolone, macrolide antibiotics, potassium-sparing diuretics, potassium supplements, St John's Wort, diclofenac, grapefruit juice.

Known Side Effects

Headache, gastrointestinal upset, liver and kidney disorders, pain in abdomen and muscles, muscle cramps, weight gain, anorexia, fluid retention, gum disorders, weakness, fatigue, sense of numbness/pins-andneedles sensation in fingers and toes, anaemia, tremor, abnormal hair growth, high blood lipid and potassium levels, low blood magnesium levels, thrombocytopenia (abnormal drop in blood platelets with bleeding), high levels of uric acid in blood, high blood pressure (treatment should be withdrawn if this is not controlled), symptoms of encephalopathy or demyelination. In rare cases, unusual blood disorders, pancreatitis, abnormal enlargement of breasts, disturbance of menstrual cycles, high blood glucose levels, disorders of lymph glands, fluid retention involving eyes, disorders of motor nerves, muscle weakness, damage and disease, malignancies.