Cyclosporine Soft Capsules

Cyclosporine is a new type of T lymphocyte regulator that can specifically inhibit the activity of helper T lymphocytes, but does not inhibit T lymphocytes, but promotes their proliferation. This product can also inhibit the activity of B lymphocytes. This product can also selectively inhibit interleukin-2 and γ-interferon secreted by T lymphocytes, and can also inhibit interleukin-1 secreted by monocytes and phagocytes. While significantly inhibiting host cell immunity, it also has an inhibitory effect on humoral immunity. It can inhibit the production of anti-graft antibodies in the body, and thus has an anti-rejection effect. This product does not affect the function of phagocytes and does not produce obvious bone marrow suppression.

The chemical name of this product is: [[(E)(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl

This product is a soft capsule, and the contents are light yellow or yellow oily liquid.

1. Confirmed indications (1) Transplantation a. Organ transplantation - prevention of allogeneic transplant rejection, including kidney, liver, heart, lung, combined heart-lung and pancreas transplantation. - Treatment of transplant rejection in patients who have received other immunosuppressants. b. Bone marrow transplantation - prevention of bone marrow transplant rejection. - Prevention and treatment of GVHD. (2) Non-transplant indications The person who diagnoses and prescribes this product should be a physician with experience in the use of immunosuppressants, especially cyclosporine. a. Endogenous uveitis - active non-infectious uveitis of the central or posterior part of the body with a risk of blindness, in which conventional therapy is ineffective or produces unacceptable adverse reactions. - Patients aged 7-70 years with Behcet's uveitis and recurrent retinitis with normal renal function. b. Psoriasis

Common oral dosage for adults: The initial dose is 12-15 mg/kg per day based on body weight, and the dose is gradually reduced after 1-2 weeks, generally reducing 5% of the initial dose each week, and the maintenance dose is about 5-10 mg/kg per day. For patients undergoing transplantation, the drug is administered 4-12 hours before transplantation.

1. Common gastrointestinal reactions include anorexia, nausea, vomiting, gingival hyperplasia with bleeding and pain. About 1/3 of the users have nephrotoxicity, and renal function damage such as increased serum creatinine and urea nitrogen, decreased glomerular filtration rate, and hypertension may occur. Gingival hyperplasia generally disappears 6 months after discontinuation of the drug. Chronic and progressive nephrotoxicity usually occurs about 12 months after treatment. 2. Uncommon convulsions may be caused by the nephrotoxicity and hypomagnesemia of this product. In addition, this product can also cause increased aminotransferase, cholestasis, hyperbilirubinemia, hyperglycemia, hirsutism, hand tremor, hyperuricemia with thrombocytopenia, microangiopathic hemolytic anemia, paresthesia of the limbs, painful cramps of the lower limbs, etc. In addition, there are reports that this product can promote ADP-induced platelet aggregation, increase the release of thromboxane A2 and the generation of thrombin, enhance the activity of factor VII, reduce the production of prostacyclin, and induce thrombosis. 3 Rare reactions include allergic reactions, pancreatitis, leukopenia, Raynaud's syndrome, diabetes, hematuria, etc. (Allergic reactions generally only occur in patients who are given the drug intravenously, and are manifested as redness of the face and neck, asthma, shortness of breath, etc.) Most of the serious adverse reactions are related to excessive dosage. The method to prevent reactions is to regularly monitor the blood concentration of this product and adjust the whole blood concentration of this product so that it can be maintained within the range that can clinically play an immunosuppressive role without causing serious adverse reactions. It has been reported that if the whole blood trough concentration of this product measured before the next dose is about 100-200ng/ml, the above effect can be achieved. If adverse reactions occur, appropriate treatment should be given immediately, and the dosage of this product should be reduced or discontinued.

1. This product is contraindicated when there is a viral infection: such as chickenpox, herpes zoster, etc. 2. This product is contraindicated for those who are allergic to it.

Precautions for children: There is limited data on the use of nephridine in children, so no recommendation is made for non-transplant patients under 16 years of age, except for nephrotic syndrome. Precautions for pregnancy and lactation: Animal reproduction studies have shown that this product has no teratogenic effects. However, there is a lack of controlled clinical trials for pregnant women. Existing data from organ transplant recipients show that compared with traditional treatments, nephridine does not increase the risk of side effects in patients' pregnancy and delivery. However, there is a lack of sufficient and complete controlled studies on pregnant women. Therefore, pregnant women can only receive nephridine treatment when the efficacy of the drug clearly exceeds its potential risk to the fetus. Cyclosporine can be secreted in breast milk, so mothers taking nephridine should not breastfeed. Precautions for the elderly: Not yet clear.

1. This product can increase the plasma concentration of this product when used in combination with estrogen, androgen, cimetidine, diltiazem, erythromycin, ketoconazole, etc. Therefore, the liver and kidney toxicity of this product may be increased. Therefore, caution should be exercised when used in combination with the above drugs, and the patient's liver and kidney function and the blood concentration of this product should be monitored. 2. When used in combination with non-steroidal anti-inflammatory analgesics such as indomethacin, the risk of renal failure may increase. 3. When using this product, if the stored blood stored for more than 10 days is transfused or this product is used in combination with potassium-sparing diuretics, high potassium-containing drugs, etc., blood potassium may increase. 4. Used in combination with liver enzyme inducers: Because it can induce liver microsomal enzymes, it increases the metabolism of this product. Therefore, the dosage of this product must be adjusted. 5. Used in combination with immunosuppressants such as adrenocortical hormones, azathioprine, chlorambucil, cyclophosphamide, etc. It may increase the risk of infection and lymphoproliferative diseases, so caution should be used. 6. When used in combination with lovastatin (a lipid-lowering drug) in patients with heart transplantation, the risk of rhabdomyolysis and acute renal failure may be increased. 7. When used in combination with drugs that can cause nephrotoxicity, the toxicity to the kidneys may be increased. If renal insufficiency occurs, the dosage of the drug should be reduced or the drug should be discontinued.

Keep in a dark and sealed place in a cool and dry place. Valid for 1.5 years.

50mg

24 months

Livzon (GROUP) Pharmaceutical FACTORY

• Founded in:

  1989-11-26

• Address:

  No. 38 Chuangye North Road, Jinwan District, Zhuhai City

• Tax NO.:

  91440400617489061P

• Registered Funds:

  450 million yuan

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