Cyclosporine Soft Capsules

The main drug of cyclosporine capsule, cyclosporine (also known as cyclosporine A), is a cyclic polypeptide composed of 11 amino acids. This product is a potent immunosuppressant that acts reversibly and specifically on lymphocytes. Animal experiments have shown that cyclosporine can prolong the survival time of allogeneic organ (skin, heart, kidney, pancreas, bone marrow, small intestine and lung) transplants, and inhibit cell-mediated immune responses (including allogeneic immune responses, delayed skin hypersensitivity reactions, experimental allergic encephalomyelitis, Freund's adjuvant arthritis, graft-versus-host reactions and T-cell-dependent antibody production). This product can also inhibit the synthesis and release of lymphokines (including IL-2) and block the G0 phase and early G1 phase of the lymphocyte growth cycle. This product does not inhibit erythropoiesis, nor does it affect phagocyte function. Patients using this product have a lower incidence of infection than those using other immunosuppressants.

The main ingredient of this product is ciclosporin, and its chemical name is: cyclo(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino-6-octenyl-L-α-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-valyl. Molecular formula C62H111N11O12 molecular weight 1202.625

Soft capsules.

1. Prevent and treat rejection or graft-versus-host reaction of allogeneic organ transplantation or bone marrow transplantation. 2. Treat autoimmune diseases such as lupus nephritis and refractory nephrotic syndrome that have not been effectively treated with other immunosuppressants.

1 Organ transplantation: When using a triple immunosuppressive regimen, the starting dose is 6-11 mg/kg/day, and the dose is adjusted according to the blood drug concentration. The dose is reduced by 0.5-1 mg/kg/day every 2 weeks according to the blood drug concentration, and the maintenance dose is 2-6 mg/kg/day, taken orally in 2 divided doses. During the entire treatment process, it must be carried out under the guidance of a doctor with experience in immunosuppressive treatment. 2 Bone marrow transplantation: Prevention of GVHD: Starting from the day before transplantation, cyclosporine injection, 2.5 mg/kg/day, is intravenously dripped in 2 times. After the gastrointestinal reaction disappears (about 0.5-1 month), this product is taken instead, with a starting dose of 6 mg/kg/day, taken orally in 2 times. The dose is slowly reduced after one month, and the total course of treatment is about half a year. Treatment of GVHD: This product is used alone or in addition to the original adrenal cortical hormone, 2-3 mg/kg/day, taken orally in 2 times, and the dose is slowly reduced after the condition stabilizes, and the total course of treatment is more than half a year. 3. Lupus nephritis, refractory nephrotic syndrome: initial dose 4-5 mg/kg/day, orally in 2-3 doses, slowly reduce the dose to 2-3 mg/kg/day after significant efficacy, the course of treatment is 3-6 months or more. The dosage for children can be calculated according to or slightly higher than the adult dosage.

1. The more common gastrointestinal reactions include anorexia, nausea, vomiting, etc., gingival hyperplasia with bleeding and pain, and about 1/3 of the users experience nephrotoxicity. Renal function damage, hypertension, etc. may occur, such as increased serum creatinine and urea nitrogen, decreased glomerular filtration rate, etc. Gingival hyperplasia generally disappears 6 months after stopping the drug. Chronic, progressive nephrotoxicity usually occurs about 12 months after treatment. 2. Uncommon symptoms include convulsions, which 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 and increase thromboxane A

1. Patients who are allergic to cyclosporine. 2. Patients with severe liver or kidney damage, uncontrolled hypertension, infection or malignant tumors should not use or use with caution.

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.

There have been reports of many drug interactions with this product. The following interactions are based on a large body of data and are considered clinically significant. A review entitled Interactions between Santobuc and Drugs, which lists all known interactions, including those with only one-time results or controversial reports, is available upon request. Drugs that can increase nephrotoxicity Acyclovir, aminoglycoside antibiotics (including gentamicin and tobramycin), amphotericin B, ciprofloxacin, furosemide, mannitol, melphalan, methoxazole (sulfamethoxazole), vancomycin, nonsteroidal anti-inflammatory drugs (including diclofenac, indomethacin, naproxen, and sulindac) Drugs that can reduce cyclosporine blood levels Barbiturates, imipenem, phenytoin, penicillin III, intravenous sulfamethoxazole, rifampin, octreotide, probucol, intravenous sulfamethoxazole. Drugs that can increase cyclosporine blood levels Chloroquine, macrolide antibiotics (erythromycin, josamycin, pristinamycin), ketoconazole, fluconazole and itraconazole, diltiazem, nicardipine, verapamil, metoclopramide, oral contraceptives, danazol, methylprednisolone (high dose), allopurinol, amiodarone, bile acid and its derivatives, doxycycline, propafenone. Other relevant drug interactions During treatment with nefovir, the effectiveness of vaccination may be reduced and live attenuated vaccines should be avoided (see Precautions). Compared with nefovir alone, the co-administration of nifedipine may increase the rate of gingival hyperplasia. The co-administration of nefovir and diclofenac has been found to result in a significant increase in the bioavailability of diclofenac and may cause reversible renal impairment. This increase is likely due to a reduction in the high first-pass effect of diclofenac. When sanofemidine is co-administered with NSAIDs with a low first-pass effect (e.g., acetylsalicylic acid), the increase in their bioavailability is usually unrelated to the co-administration. Sanofemidine can reduce the clearance of digoxin, colchicine, lovastatin, and prednisolone. This can lead to digoxin toxicity and increase the potential muscle toxicity of lovastatin and colchicine (causing muscle pain and weakness), myositis, and rhabdomyolysis.

Keep away from light, sealed and stored at room temperature

50 mg

24 months

Jiangsu Xinfu Pharmaceutical Co., Ltd.

• Founded in:

  2016-09-12

• Address:

  2nd Floor, Building B, Xingye Building, 97-1 Linghu Avenue, Xinwu District, Wuxi City

• Tax NO.:

  91320214MA1MU9TCXY

• Registered Funds:

  10 million yuan

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