雷帕鸣中文说明书

Indian Biocon’s Chinese instruction manual

[Common name] Sirolimus tablets

[Indications/Function Indications] Suitable for patients undergoing kidney transplantation to prevent organ rejection. Recommended for use in combination with cyclosporine and corticosteroids.

[Specification model] 0.5mg tablet/1mg tablet/oral liquid

【Usage and Dosage】

Take orally, once daily. It should be started as soon as possible after transplantation. For new transplant recipients, the loading dose that should be taken for the first time is three times the maintenance dose. The recommended loading dose for kidney transplant patients is 6 mg and the maintenance dose is 2 mg/day. Although the loading dose of 15 mg and the maintenance dose of 5 mg/day used in clinical trials are safe and effective, the therapeutic benefits of doses above 2 mg are unclear for kidney transplant patients. The overall safety profile of patients taking Rapamune 2 mg daily was better than that of patients taking Rapamune 5 mg daily.

【Adverse reactions】

Clinical studies have shown that the use of sirolimus (i.e. rapamin) can increase blood lipid levels. Excessive cholesterol in the blood causes a large amount of cholesterol to be deposited on the intima of the arteries, leading to arteriosclerosis and increased blood viscosity, further promoting the occurrence of arteriosclerosis and thrombosis. Hyperlipidemia can also promote the occurrence of chronic rejection of kidney transplants. Sirolimus can significantly increase serum total cholesterol levels and low-density lipoprotein levels. Other adverse reactions caused by sirolimus include lung infection, digestive system symptoms, leukopenia, etc. Store in a cool, dry, dark environment.

【Taboo】

It is contraindicated for use in patients who are allergic to sirolimus, sirolimus derivatives, or any component of this drug's oral solution, and to pregnant and lactating women.

【Notes】

Grapefruit juice slows the metabolism of Biocon's Rapamin, which is regulated by CYP3A4, and should not be used to administer or dilute this drug. It is recommended to take cyclosporine oral solution (improved version) and/or cyclosporine capsules (improved version) 4 hours after taking it.

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