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 interferon-β 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 content of cyclosporine (C62H111N11O12) should be 90.0% to 110.0% of the labeled amount. www

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

It is suitable for preventing rejection reactions occurring in allogeneic kidney, liver, heart, bone marrow and other organ or tissue transplants, and is also suitable for preventing and treating graft-versus-host reactions occurring in bone marrow transplants.

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 adverse reactions include allergic reactions, pancreatitis, leukopenia, Raynaud's syndrome, diabetes, hematuria, etc. (Allergic reactions generally only occur in patients who are given drugs via intravenous routes, manifested as redness of the face and neck, asthma, shortness of breath, etc.) Most 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 in case of viral infection: such as chickenpox, herpes zoster, etc. 2. This product is contraindicated in case of allergy.

Precautions for children: Common dosage for children: Initial dose for organ transplantation is 6-11 mg/kg per day based on body weight, and maintenance dose is 2-6 mg/kg per day. Precautions for pregnancy and lactation: Pregnant and lactating women are prohibited. Precautions for the elderly: Elderly patients are prone to renal insufficiency, so Xinsaisiping should be used with caution.

1. The combination of this product with estrogen, androgen, cimetidine, diltiazem, erythromycin, ketoconazole, etc. can increase the plasma concentration of this product. 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, drugs containing high potassium, etc., blood potassium may increase. 4. Used in combination with liver enzyme inducers: Because it can induce enzymes in liver microsomes, 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.

Store below 25°C.

10 mg

18 months

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

• Founded in:

  1992-12-31

• Address:

  No. 866, Moganshan Road, Gongshu District, Hangzhou City, Zhejiang Province

• Tax NO.:

  91330100609120774J

• Registered Funds:

  872.30813 million yuan

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