Cyclosporine

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Cyclosporine

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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 corticosteroids 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, in 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 the treatment is stopped 1 year after transplantation. In some patients, after the 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 in 2 divided doses. In case of insufficient effect, the daily dose can be gradually increased, provided satisfactory tolerability (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 tolerability (can be administered 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 cancellation.

Adverse reactions

Many of the side effects associated with the use of cyclosporine, dose-dependent and reversible with decreasing dose. The spectrum of side effects is generally the same for different indications, although the frequency and severity of side effects may vary. In transplant patients, due to the higher dose and longer duration of treatment, side effects are more common and usually more pronounced than in patients with other indications.

Frequency of side effects: very often - ≥ 10%; often from ≥ 1% to <10%; sometimes from ≥ 0.1% to <1%; rarely from ≥ 0.01% to <0.1%; very rarely - <0.01%.

From the urinary system:

Very often - impaired renal function.

Since the cardiovascular system:

Very often - increase blood pressure.

From the side of the central nervous system and peripheral nervous system:

Very often - tremor, headache; often - Paresthesia; sometimes signs of encephalopathy, such as convulsions, lethargy, disorientation, slow reactions, agitation, sleep disturbances, visual disturbances, cortical blindness, coma, paresis, cerebellar Ataxia; rarely, motor polyneuropathy; very rarely - swelling of the optic nerve head (including the nipple of the optic nerve), secondary to benign intracranial hypertension.

From the digestive system:

Often - Anorexia, nausea, vomiting, abdominal pain, diarrhea, gingival hyperplasia, abnormal liver function; rarely - pancreatitis.

Metabolism:

Very often - hyperlipidemia; often - hyperuricemia, hyperkalemia, hypomagnesemia; rarely - hyperglycemia.

From the musculoskeletal system

Often - muscle spasms, myalgia; rarely - muscle weakness, myopathy.

From the hemopoietic system:

Sometimes - anemia, thrombocytopenia; rarely - microangiopathic hemolytic anemia, hemolytic uremic syndrome.

Dermatological reactions:

Often - hypertrichosis; sometimes an allergic rash.

On the part of the body as a whole:

Often - fatigue; sometimes - swelling, weight gain.

On the part of the endocrine system:

Rarely - a violation of the menstrual cycle, gynecomastia.

Contraindications

Hypersensitivity (including to polyoxyethylated castor oil - for dosage forms containing it); 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).

With caution. Varicella zoster (risk of process generalization) and other viral diseases, renal and / or liver failure, hyperkalemia, arterial hypertension, infections, malabsorption syndrome, varicella (currently or recently transferred, including recent contact with the patient).

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. Varicella zoster (risk of process generalization) and other viral diseases, renal and / or liver failure, hyperkalemia, arterial hypertension, infections, malabsorption syndrome, varicella (currently or recently transferred, including recent contact with the patient).

Drug interactions

Enhances the action of quinidine, theophylline, sodium valproate. When treating cyclosporin, 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 immunodepression, 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). It 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 BCC (includingverapamil, diltiazem, nicardipine), miconazole, fluconazole, itraconazole, ketoconazole, HIV protease inhibitors, metoclopramide, immunosuppressants, grapefruit juice may increase the concentration of cyclosporine (inhibiting CYP3A isoenzyme), increasing the risk of hepatosyrosis, and you can have an organism. P450 inducers of CYP3A isoenzyme (barbiturates, carbamazepine, phenytoin, sodium metamizole, benzodiazepine derivatives, aminoglutetimid, estrogen-gestagenic drugs, progesterone, isoniazid, rifampicin, nafcillin, as well as sulfadimidine and trimetham, as well as sulfimetimine, and triacimer, as a part of the procedure for the production of steroids; 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, methoxen, trioxalene, 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).

Pregnancy and Lactation

Special instructions

Overdosage