Cyclosporine oral solution

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.

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

This product is a light yellow or yellow clear oily liquid.

Rejection or graft-versus-host disease, autoimmune disease

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.

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.

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 this product 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 its use in pregnant women. Existing data from organ transplant recipients show that compared with traditional treatments, this product does not increase the risk of side effects during pregnancy and delivery. However, there is a lack of adequate and complete controlled studies on pregnant women. Therefore, pregnant women can only receive treatment with this product when the efficacy of the drug clearly outweighs its potential risk to the fetus. Cyclosporine can be secreted in breast milk, so mothers taking this product should not breastfeed. Precautions for the elderly: See pharmacokinetics for special cases.

Many drug interactions with this product have been reported. The following interactions are summarized based on a large amount of data and are considered to be clinically significant. 1. Drugs that can increase nephrotoxicity: acyclovir, aminoglycoside antibiotics (including gentamicin and tobramycin), amphotericin B, ciprofloxacin, furosemide, mannitol, phenylalanine nitrogen mustard, methoxybenzylamine (sulfamethoxazole), vancomycin, nonsteroidal anti-inflammatory drugs (including diclofenac, indomethacin, naproxen and sulindac) 2. Drugs that can reduce cyclosporine blood concentrations: barbiturates, acylamicin, phenytoin sodium, penicillin III, intravenous sulfadimethoxazole, rifampicin, octreotide, probucol, intravenous sulfamethoxazole. 3. Drugs that can increase the blood concentration of cyclosporine Chloroquine, macrolide antibiotics (erythromycin, josamycin, prinamycin), ketoconazole, fluconazole and itraconazole, diltiazem, nicardipine, verapamil, metoclopramide, oral contraceptives, danazol, methylprednisolone (high dose), allopurinol, amiodarone, bile acid and its derivatives, doxycycline, propafenone. 4. Interactions with other related drugs During the treatment of this product, the effect of vaccination may be reduced, and the use of live attenuated vaccines should be avoided (please refer to [Precautions]). Compared with the use of this product alone, the combined use of nifedipine can increase the rate of gingival hyperplasia. It has been found that the combined use of cyclosporine and diclofenac can cause a significant increase in the bioavailability of the latter and may cause reversible renal damage. This increase is likely due to the weakening of the high first-pass effect of diclofenac. When cyclosporine is co-administered with nonsteroidal anti-inflammatory drugs with a low first-pass effect (e.g., acetylsalicylic acid), the increase in their bioavailability is usually unrelated to the combined use. Cyclosporine 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. 5. Introduction In certain cases, if drugs with the same effects as cyclosporine must be used, the following basic measures should be closely followed: (1) Drugs that can increase nephrotoxicity should closely monitor renal function (especially serum creatinine). In the event of significant renal impairment, the dose of other drugs should be reduced or alternate dosing should be considered. (2) Drugs that can reduce or increase bioavailability In organ transplant recipients, cyclosporine blood levels should be measured frequently, especially at the beginning and end of combined medication. If necessary, the dose of this product should be adjusted. In patients with non-transplant indications, since the dose-effect relationship of this product has not been confirmed, it is not necessary to measure the blood concentration of cyclosporine. In cases where this product is used in combination with drugs that can increase the blood concentration of cyclosporine, more frequent monitoring of renal function and close observation of adverse reactions to cyclosporine may be more appropriate than measuring the concentration of cyclosporine. (3) During the use of this product, patients who develop gingival hyperplasia should avoid the use of nifedipine. (4) When this product is used in combination with non-steroidal anti-inflammatory drugs with a high first-pass effect, the latter should be used at a lower dose. If this product is used in combination with digoxin, colchicine or lovastatin, careful clinical monitoring must be carried out to detect toxic effects early so that the dose can be reduced or the drug can be discontinued. 6. Food interactions This product can increase the bioavailability of cyclosporine when taken simultaneously with grapefruit juice.

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

50ml:5g

24 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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