Active substance of Neoral
Cyclosporine, immunosuppressive agents
Dosage Form of Neoral
capsules, soft capsules, the concentrate for solution for infusion, oral solution, oral solution (Oil).
Contraindications of Neoral
– Hypersensitivity (including a polyoxyethylated castor oil – For dosage forms containing it); cancer, precancerous skin conditions; children’s age (up to 1 year), lactation, infancy (for use in the treatment of psoriasis and rheumatoid arthritis) .C caution.
– Chickenpox (currently or recently transferred, including the recent contact with a patient), Varicella zoster (risk of generalization of the process), and others.
– Viral diseases, renal and / or hepatic impairment, hyperkalemia, hypertension, infections, malabsorption syndrome.
Dosage and administration of Neoral
B / drip: adults, bone marrow transplant on the day before transplantation, – 2-6 mg / kg / day.
The introduction of this dose, continue during the immediate post-transplant period, for 2 weeks, then move on to maintenance oral therapy. During transplantation of solid organs, for 4-12 hours is prior to surgery – once, 3-5 mg / kg.
Within 1-2 weeks after the operation daily at the same dose. The dose was gradually reduced, under the control of blood cyclosporine concentrations, to achieve a maintenance dose of 0.7-2 mg / kg / day.
Inside: adults, with solid organ transplants, treatment should be started 12 hours before surgery (at a dose of 10-15 mg / kg divided into 2 doses). Within 1-2 weeks after the operation daily, at the same dose. Later, the dose is gradually reduced (5% / week) until the support – 2.6 mg / kg / day.
When is a bone marrow transplant: the day before the transplant, and transplant period, for 2 weeks, at a daily dose of 12.5-15 mg / kg. Then begins a maintenance therapy: at a dose of about 5.12 mg / kg / day.
Pharmacologic effect of Neoral
Immunosuppressive agent, a cyclic polypeptide consisting of 11 amino acids.
The drug inhibits the development of cell-type reactions, including immunity in respect of the allograft. It suppresses cutaneous delayed-type hypersensitivity, allergic encephalomyelitis, arthritis, caused by Freund’s adjuvant, disease, “graft versus host” and dependent T-lymphocyte antibody formation. At the cellular level, the drug blocks the resting lymphocytes in the G0 or G1 phase of the cell cycle. Drugs are acting on the cells is reversible. The drug does not suppress hematopoiesis and does not affect the functioning of phagocytic cells.
Side effects of Neoral
Post-transplant lymphoproliferative disease lymphoma, malignant diseases of the skin.
Anaphylactic reactions (skin rash, acute respiratory distress syndrome, tachycardia, “tides” of blood to the skin of the face and upper body, bronchospasm, reduction in blood pressure, tachycardia, and in severe cases – shock), the occurrence of which is associated with polyoxyethylated castor oil, falling within the composition of the concentrate for infusion.
Gingival hyperplasia, increased blood pressure (often asymptomatic, especially in patients after heart transplantation), hypertrichosis, nephropathy (often asymptomatic; interstitial fibrosis with glomerular atrophy, hematuria), hypomagnesemia, hyperkalemia, decreased appetite, nausea, vomiting, diarrhea; pancreatitis, abdominal pain, liver toxicity (increased transaminases, bilirubin), increased fatigue, a burning sensation in the hands and soles of the feet, swelling.
Weight gain, tremor, headache, paresthesia, epileptic syndrome, hypersensitivity, muscle cramps, myasthenia, myopathy; encephalopathy, impaired vision, impaired consciousness, impaired motor.
Dysmenorrhea, amenorrhea; anemia; thrombocytopenia, against microangiopathic haemolytic anemia and renal failure – arrhythmia, bronchospasm, weakness; allergic reactions. Giperlipidemiya.
Overdose of Neoral
Symptoms: impaired renal function.
Treatment: when indicated symptomatic therapy.
Special instructions of Neoral
Treatment should be performed only in specialized hospitals.