Vero-ziklosporin

Roman name

Vero-cyclosporin

The composition and the form of

1 capsule contains cyclosporine 25, 50 or 100 mg; in a contour acheikova packing 10 pcs. , in a cardboard bundle five packages.

Of drugs

Immunodepressivne. It stops development reactions immunity cell types, including reaction "to the transplant owner, skin гиперчувствительност ь slow type allergic encephalomyelitis, arthritis due to adjuvant Freinda, produce antibodies depending on the T-helperov. It has the ability to block the activation of lymphocytes in phases G_0 G_1 or cell cycle, synthesis and release of Cytokines, cell growth (interleikina-2). Provides Indiscriminate Effects, and has no depressing effect on the blood and faguoqitarnoe link immunity.

Pharmacokinetics

Absorbed in the gut. Bioavailability 30% increases, depending on the length of treatment and dose size. C_max plasma achieved through 1-5 hours Best concentration of cyclosporine A in the blood are in the range from 300 to 800 ng / J Distributed mainly outside blood bed, though found in erythrocytes, granoulozitah, Lymphocytes. Penetrates into breast milk. T_1/2-19 hours of the adults and 160161 in children. Metabolised education 15 metabolites. Write mainly jelchew, in the urine is found in the form of metabolites about 6% rate.

Indications

Prophylaxis and treatment of rejection reactions after transplant bone marrow transplantation and solid organs (kidney, liver, heart, serdern-legochny transplant, lungs or pancreases), including : in patients who had been receiving other immunosuppressants; prevention and treatment response "to the transplant owner; autoimmunity : capitalist uveit (active threatening impaired middle and rear of their disability in the etiology inefficiency usual therapy or major side effects in the treatment; uveit Behceta with emergent crises inflammation, including retina); argued syndrome in adults and children, �люкокортикоидозавис��мый and rezistennetary to them from vascular pathology clubocka (Nephropathy minimal changes stable and segmentarnyi glomeroelskleros, membranosny glomerulonefrit) to remission induction and maintenance, as well as to maintain remission induced glukokortikoidami and their elimination; severe rheumatoid arthritis with a high degree of activity (in the cases ineffective when classical slow protivorevmaticalkie existing drugs or their use is not possible); severe psoriasis, atopic dermatitis (with systemic therapy).

Pregnancy and lactation

Experience with the pregnant limited. Data from the patients with peresajennami authorities show that in comparison with the traditional methods of treatment, therapy ziklosporinom is at risk of adverse effects on the course and outcome of pregnancy. At the time of treatment should stop breastfeeding.

Contraindications

Гиперчувствительност ь to ziklosporino or up.

Side-Effects

From the nervous system and sensory organs : a sense of fatigue, headache, parestesia, convulsions; Rarely muscle cramp, miopatia, Tremor.u patients after liver transplantation were described signs of encephalopathy, being visually impaired consciousness of coordination Dwijeni.so part of the intestine : giperplazia intestines, loss of appetite, nausea, vomiting, diarrhea, stomachache, pancreatitis; reversible possible violations of the liver, increasing the concentration cium, liver enzymes in the blood (the severity of these violations depends on the dosage). From the urogenital system : violations of the kidneys, increasing the concentration of creatinine and urea in serum (seen in the first few weeks of treatment are dozozawisimy and decreased at lower doses). In long-term care to the development of structural changes in the kidneys (intersticialny fibrosis). From the circulatory system and blood (blood, gemostaz) : enhancing AD (especially in patients after heart transplants); Anemia (slightly), leiko-, Trombopenia.prochie : ginekomastia, dismenorea, girsutizm, acne, gipertrihoz, tissue hypertrophy, a swelling, increased body mass index; Giperkaliemia, gipomagniemia, increasing the concentration of uric acid in the blood, rarely forming an increase in the level of lipids in the cell; the infectious, malignant and limfoproliferativeh diseases.

Patient interaction

Together with the appointment of drugs or potassium kalisbergatmi dioretikami increased risk of giperkaliemii; With aminoglikozidami, amfoteritinom B ciprofloksacinom, melfalanom, kolhitinom, trimetoprimom, NPVS-risk nefrotoksicnosti; With lovastatinom-risk of muscle pain and weakness. Different drugs can increase or decrease the concentration of cyclosporine in the plasma through suppression or induction of liver enzymes that participate in the metabolism and elimination. Ketokonazol, makrolida (including erythromycin and jozamitsin), doxycycline, oral contraceptives, propafenon, BAC (including verapamil, diltiazem, nikardeepin) to the concentration of cyclosporine in plasma; Barbiturates, carbamazepine, phenytoin, metamizol sodium, rifampicin, nafcillin, sulfadimidin, trimethoprim with them / in a lower-. The combined use of drugs needed to be carefully monitor the concentration of cyclosporine in the blood and changes in dose Vero-ziklosporina. Ciclosporin lowers klirens PREDNISOLONE treating high doses metilprednizolona increases the concentration of cyclosporine in the blood.

Overdosing

Symptoms : forming of the Pocek.lechenie : symptomatic. Haemodialysis and gemoperfuzia using activated carbon ineffective.

Precautions

During treatment of a systematic monitoring of the kidneys and liver, the level of potassium in the plasma (especially in patients with impaired kidney), before and after one month of treatment the concentrations of lipids. The steady increase of urea, creatinine, cium, liver enzymes should be decreased dose of the drug. In developing hypertension should gipotenzivne treatment with high lipids in the cell-reduced dosage and / or control of the fat Dieta.neobhodimo avoid excessive suppression Immuniteta.v treatment should not be vaccinated living weakened vaccines against mumps, measles, rubella, Poliomielita.ne that simultaneous application with lovastatinom, zitostatikami (melfalanom).

Dosing and Administration

Inside, and organ transplants, in the dose of 10-15 mg / kg for 12 hours before the operation, and then once daily for 1-2 weeks; Further dose gradually reduce to support (typically 2-6 mg / kg). In autoimmune diseases, including revmatoidnom arthritis-3 mg / kg in two stages during the first six weeks. If not effect the daily dose gradually increased on the basis of satisfactory endurance. The maximum daily dose of 5 mg / kg The course of treatment is 12 Ned.dla maintenance therapy dose picked individually strength on the preparation. Perhaps combined with small doses glukokortikoidami and / or Npvs.pri minutes for induction of remission, 2.5 mg / kg / day in two reception in difficult cases for the rapid achievement of the initial effect dose of 5 mg / kg (if in the application in a daily dose of 5 mg / kg for 6 weeks no clinical effect, a product override). In atopicescom Acne initial dose of 2.5 mg / kg / day, in severe cases, increased to 5 mg / kg / sut. In achieving positive clinical outcome dose gradually reduced until full repeal.

Storage conditions

caps. : List B. In dry the dark place at a temperature of no higher than 25 ° C

Shelf life

caps. : 2 grams.

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