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Cyclosporine oral solution

Function and Efficacy

The main drug of cyclosporine oral solution, 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) transplantation, and inhibit cell-mediated immune response (including allogeneic immune response, delayed skin hypersensitivity reaction, experimental allergic encephalomyelitis, Freund's adjuvant arthritis, graft-versus-host reaction 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 and does not affect phagocyte function. Patients using this product have a lower incidence of infection than those using other immunosuppressants.

Ingredients

This product contains cyclosporine, which should be 90.0% to 110.0% of the labeled amount.

Name Description Content CAS NO. Manufacturer
Cyclosporin AIngredients

It is a powerful immunosuppressant that acts reversibly and specifically on lymphocytes. It can prolong the survival time of allogeneic organ transplants, inhibit cell-mediated immune responses, inhibit the synthesis and release of lymphokines (including IL-2), and block the G0 phase and early G1 phase of the lymphocyte growth cycle. It does not inhibit erythropoiesis and does not affect phagocyte function. Patients using this product have a lower incidence of infection than those using other immunosuppressants.

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59865-13-3 20

Appearance

This product is a light yellow clear liquid.

Indication

Rejection or graft-versus-host disease, autoimmune disease

Usage and Dosage

The full daily dose is divided into two doses and taken at regular intervals. Use a special straw to correctly absorb the required amount of medicine each time. It is best to dilute it with orange or apple juice. It can also be diluted with soft drinks according to personal taste (but do not dilute it with grapefruit juice, because it may interfere with the P450-dependent enzyme system), and take it immediately after fully stirring. This product must be used up within 2 months after opening. 1 Organ transplantation: When using a triple immunosuppressive regimen, the initial 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. The maintenance dose is 2-6 mg/kg/day, taken orally in 2 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: Cyclosporine injection, 2.5 mg/kg/day, divided into 2 intravenous drips, is used from the day before transplantation. After the gastrointestinal reaction disappears (about 0.5 to 1 month), this product is taken instead, with an initial dose of 6 mg/kg/day, divided into 2 oral doses. 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 to 3 mg/kg/day, divided into 2 oral doses, 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: The initial dose is 4 to 5 mg/kg/day, divided into 2 to 3 oral doses. After the obvious therapeutic effect appears, the dose is slowly reduced to 2 to 3 mg/kg/day, and the course of treatment is more than 3 to 6 months. The dosage for children can be calculated according to or slightly higher than the adult dosage.

Adverse Reactions

The most common side effects are hirsutism, tremor, gastrointestinal discomfort, gingival hyperplasia, and liver and kidney toxicity. Fatigue, anorexia, paresthesia of the limbs, hypertension, amenorrhea, and convulsions may also be seen.

Precautions

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.

Special Population Medication

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: This product can enter breast milk. It may cause potential risks of adverse effects such as hypertension, nephrotoxicity, and malignant tumors to breastfeeding infants, so breastfeeding is not recommended during the use of this product. Precautions for the elderly: Elderly patients are prone to renal insufficiency, so this product should be used with caution.

Drug Interactions

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-mentioned 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, such as transfusing banked blood stored for more than 10 days or combining this product 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

Storage

Keep in a dark place and tightly sealed at room temperature (15-30℃).

Packaging Specification

50ml:5g

Validity Period

24 months

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