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 effect. However, there is still a lack of controlled trials for clinical use in pregnant women. Data from existing organ transplant recipients show that compared with traditional treatments, this product does not increase the risk of side effects in patients' pregnancy and delivery, but there is still a lack of sufficient and complete controlled studies on pregnant women. Therefore, pregnant women can only receive this product when the efficacy of the drug clearly exceeds 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: Not yet clear.

There have been reports of many drugs interacting with this product. The following interactions are summarized based on a large amount of data and are considered to be clinically significant. - Drugs that can increase nephrotoxicity: acyclovir, aminoglycoside antibiotics (including gentamicin and tobramycin), amphotericin B, ciprofloxacin, furosemide, mannitol, phenylalanine mustard, methoxybenzylamine (sulfamethoxazole), vancomycin, nonsteroidal anti-inflammatory drugs (including diclofenac, indomethacin, naproxen and sulindac). --- Drugs that can reduce the blood concentration of cyclosporine: barbiturates, carbamazepine, phenytoin sodium, neopentyl penicillin III, intravenous sulfamethoxazole, rifampicin, octreotide, probucol, intravenous sulfamethoxazole. --- Drugs that can increase the blood concentration of cyclosporine: chloroquine,

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

50 ml: 5 g

24 months

Fujian Kerui Pharmaceutical Co., Ltd.

• Founded in:

  1999-09-07

• Address:

  No. 1069-15, Niuzhai Village, Haikou Town, Fuqing City, Fuzhou City, Fujian Province

• Tax NO.:

  913501816110101446

• Registered Funds:

  25 million yuan

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