SANDIMMUN-NEORAL CAPSULES 50MG

Packaging

50 pcs.

Mechanism of action

Sandimmune Neoral - an immunosuppressive agent, a cyclic polypeptide consisting of 11 amino acids. Suppresses the development of cell-type reactions, including immunity against allograft, delayed-type skin hypersensitivity, allergic encephalomyelitis, arthritis due to Freund's adjuvant, graft versus host disease, and antibody-dependent T-lymphocytes. At the cellular level, blocks resting lymphocytes in the G0 or G1 phases of the cell cycle and suppresses the antigen-triggered production and secretion of cytokines (including interleukin2, T-lymphocyte growth factor) with activated T-lymphocytes. Affects lymphocytes reversibly. It does not suppress hemopoiesis and does not affect the functioning of phagocytic cells.

Indications and usage

In combination with other immunosuppressive drugs and corticosteroids - for the prevention of the rejection reaction during the transplantation of bone marrow, kidney, liver, heart, combined cardiopulmonary transplant, lung or pancreas. Graft versus host disease (prevention and treatment), graft rejection in patients previously treated with other immunosuppressants. Autoimmune diseases, endogenous uveitis (active, eye-threatening uveitis of the middle or posterior part of the eye of a non-infectious etiology, if conventional therapy does not work or leads to severe side effects) in cases where systemic therapy is indicated); nephrotic syndrome (in remission, steroid-dependent and steroid-resistant form); psoriasis (severe persistent course, inadequate response to systems treatment; rheumatoid arthritis (severe active forms in cases where the classic slow-acting antirheumatic drugs are ineffective or their use is impossible).

Contraindications

Hypersensitivity; malignant neoplasms, precancerous skin diseases; children's age (up to 1 year), lactation period, children's age (for use in the treatment of psoriasis and rheumatoid arthritis).C caution. Chickenpox (currently or recently experienced, including recent contact with the patient), Varicella zoster (risk of generalization of the process), etc.viral diseases, renal and / or liver failure, hyperkalemia, arterial hypertension, infections, malabsorption syndrome.

Dosage and administration

Sandimmune Neoral is taken orally: for adults with a transplant of solid organs, treatment should be started 12 hours before the operation at a dose of 10-15 mg / kg, divided into 2 doses. Within 1-2 weeks after the operation - every day, in the same dose, after which the dose is gradually reduced (5% / week) until a maintenance dose is reached - 2-6 mg / kg / day. When administered in combination with GCS or other immunosuppressants, use smaller doses (3-6 mg / kg / day in the initial phase of treatment). For bone marrow transplantation - on the day preceding the transplant, and during the transplantation period, for 2 weeks, at a daily dose of 12.5-15 mg / kg, then switch to maintenance therapy at a dose of about 12.5 mg / kg / day (with impaired absorption, require higher oral doses or a transition to / in the introduction). Maintenance treatment is continued for at least 3-6 months (preferably 6 months), after which the dose is gradually reduced, so that, 1 year after transplantation, treatment is stopped. In some patients, after cessation of treatment, the reaction of rejection develops, in which case the treatment should be resumed. With endogenous uveitis, for the induction of remission - in the initial daily dose of 5 mg / kg, in 1 or several doses, until inflammation subsides and improves visual acuity. In severe cases, the dose can be increased to 7 mg / kg / day for a limited period.During maintenance therapy, the dose should be slowly reduced until the lowest effective dose is reached, which should not exceed 5 mg / kg / day during the remission of the disease. With nephrotic syndrome, for the induction of remission - in a daily dose of 5 mg / kg for adults and 6 mg / kg - for children (in 2 doses), provided that there is no decrease in kidney function (except in cases of proteinuria). For patients with impaired renal function, the initial daily dose should not exceed 2.5 mg / kg. If cyclosporin monotherapy fails to achieve the desired effect, it may be combined with small doses of GCS, orally. If after 3 months of treatment there is no positive effect, treatment should be discontinued. For maintenance treatment, the dose should be slowly reduced to the minimum effective. In rheumatoid arthritis during the first 6 weeks of treatment, the daily dose is 3 mg / kg for 2 doses. In case of insufficient effect, the daily dose can be gradually increased under the condition of satisfactory tolerance (no more than 5 mg / kg / day). The course of treatment is up to 12 weeks. For maintenance therapy, the dose should be selected individually depending on tolerance (can be prescribed in combination with small doses of GCS and / or NSAIDs). In psoriasis, for the induction of remission, the daily dose is 2.5 mg / kg in 2 doses. In severe cases of the disease, when rapid effect is required, the initial daily dose may be 5 mg / kg. If it was not possible to achieve an adequate effect when applied in a daily dose of 5 mg / kg for 6 weeks, the drug should be discontinued.The dose for maintenance treatment of psoriasis should be minimally effective (should not exceed 5 mg / kg / day). With atopic dermatitis - the initial dose of 2.5 mg / kg / day. In severe cases, the dose may be increased to 5 mg / kg / day. When a positive result is achieved, the dose should be gradually reduced to complete abolition.

Adverse reactions

Lymphoproliferative diseases after transplantation: lymphoma, malignant skin diseases. Anaphylactic reactions (skin rash, acute respiratory distress syndrome, tachycardia, blood flushes to the skin of the face and upper body, bronchospasm, decrease in blood pressure, tachycardia; in severe cases - shock), the occurrence of which is associated with polyoxyethylated castor oil the composition of the concentrate for infusion. Gum 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, hepatotoxicity (increased activity of transaminases, bilirubin), increased feeling of fatigue, burning in the hands and feet, swelling. Weight gain, tremor, headache, paresthesia, epileptic syndrome, hyperesthesia, muscle spasms, myasthenia, myopathy; encephalopathy, impaired vision, impaired consciousness, impaired movement.Dysmenorrhea, amenorrhea; anemia; thrombocytopenia, on the background of microangiopathic hemolytic anemia and renal failure - hemolyticocouremic syndrome: arrhythmias, bronchospasm, weakness; allergic reactions. Hyperlipidemia.

Special notes

Treatment should be carried out only in specialized medical institutions. If arterial hypertension develops, it is necessary to start antihypertensive treatment.

Drug Interactions

Enhances the action of quinidine, theophylline, sodium valproate. When treating cyclosporine, excessive K + intake should be avoided (with food, with potassium-containing drugs), and potassium-saving diuretics, potassium-containing penicillins, Heparin, ACE inhibitors, beta-adrenergic blockers, cardiac glycosides, suxametonium should not be prescribed. When using cyclosporine together with other immunosuppressive drugs (azathioprine, chlorambucil, GCS, cyclophosphamide, mercaptopurine), there is a risk of developing excessive immunosuppression, which can lead to increased sensitivity to infections and the development of lymphoproliferative diseases. Increases the risk of nephrotoxicity of aminoglycosides, amphotericin B, fluoroquinolones, melphalan, colchicine, trimethoprim, NSAIDs (it is necessary to reduce the dose of both drugs). Reduces the clearance of prednisone, treatment with high doses of prednisone can increase the concentration of cyclosporine in the blood.Allopurinol, Bromocriptine, cimetidine, Clarithromycin, androgens, estrogens, danazol, diltiazem, some macrolide antibiotics (including Erythromycin and josamycin), Doxycycline, oral contraceptives, propafenone, some BCCI (including Verapamil, diltiazem, nicardipine ), miconazole, Fluconazole, itraconazole, Ketoconazole, HIV protease inhibitors, Metoclopramide, immunosuppressants, grapefruit juice can increase the concentration of cyclosporine (inhibiting the CYP3A isoenzyme), increasing the risk of hepato- and nephrotoxicity. Inductors P450 isoenzyme CYP3A (barbiturates, Carbamazepine, phenytoin, metamizole sodium, benzodiazepine derivatives, aminoglutetimid, estrogen-gestagenic drugs, Progesterone, isoniazid, rifampicin, nafcillin, as well as sulfadimidine and trimemma, as well as sulfimeter and trima, and in the same, they will be able to use it. Statins (lovastatin and simvastatin) increase the risk of rhabdomyolysis and acute renal failure. Colchicine increases the risk of developing myalgia and weakness; Nifedipine - gum hyperplasia. NSAIDs (indomethacin, Diclofenac, naproxen) increase the risk of renal failure and hyperkalemia. Activated carbon, metoksalen, trioxalen, PUVA therapy (psoriasis) increase the risk of developing malignant skin tumors. NSAIDs can potentially reduce the size of the glomerular filtration, adding them or increasing the dose should be accompanied by strict control of the kidney function (especially in the initial stages of treatment). Vaccination may be less effective during treatment with cyclosporin (use of live attenuated vaccines should be avoided).

Symptoms: Experience with overdose of Sandimmune Neoral is limited. Possible development of renal dysfunction, which is likely to be reversible with drug withdrawal. When ingested cyclosporine in a dose of up to 10 g (about 150 mg / kg) in most cases there were slightly pronounced clinical manifestations, such as vomiting, dizziness, headache, tachycardia. In some cases, reversible impaired renal function of a moderate degree was observed. However, in the case of an accidental parenteral overdose of cyclosporine in premature babies in the neonatal period, severe toxic complications were reported.
Treatment: symptomatic therapy, there is no specific antidote. During the first 2 hours after ingestion, the drug can be removed from the body by causing vomiting or by washing the stomach. Cyclosporine is practically not excreted by hemodialysis and hemoperfusion using activated carbon.

Keep out of reach of children at a temperature not exceeding 25 ° C.

3 years.

Sandimmune neoral