Mycophenolate mofetil dispersible tablets

Mycophenolate mofetil (MMF) is a 2-ethyl ester derivative of mycophenolic acid (MPA). MPA is a highly effective, selective, non-competitive, and reversible inhibitor of inosine mononucleotide dehydrogenase (IMPDH), which can inhibit the classical synthesis pathway of guanine nucleotides. MPA has a highly selective effect on lymphocytes. Mycophenolate mofetil tablets are extremely effective in preventing rejection after renal transplantation and treating refractory rejection.

The main ingredient of this product is mycophenolate mofetil.

This product is an orange and blue two-color capsule, and the contents are white or off-white lumps or (and) powder.

It can be used to prevent rejection reactions in patients with allogeneic renal transplants and to treat refractory rejection reactions. Mycophenolate mofetil tablets can be used simultaneously with cyclosporine and corticosteroids.

The dose for preventing rejection should be started within 72 hours of transplantation. The recommended dose for renal transplant patients is 1 gram twice a day (2 grams a day), and oral mycophenolate mofetil tablets 2 grams/day are safer than oral 3 grams/day. Dosage for treating refractory rejection. In clinical trials, the recommended initial and maintenance dose for treating refractory rejection is 1.5 grams twice a day (3 grams/day). Special dose. If neutropenia occurs (absolute neutrophil count <1.3x103/microliter), the dose should be stopped or reduced. Severe renal impairment: For patients with severe chronic renal impairment (glomerular filtration rate <25 ml/min 1.73 square meters), a dose exceeding 1 gram twice a day should be avoided (except for use immediately after transplantation). These patients should be carefully observed. No dose adjustment or doctor's advice is required for patients with delayed recovery of renal function after transplantation. The safety and effectiveness of the drug for pregnant and lactating women have not been confirmed, and they should consult a doctor in a timely manner. The safety and effectiveness of the drug for children have not been confirmed. The pharmacokinetic data for children is limited, so more observation is required if used. The recommended dose for elderly patients is 1 g orally twice a day. Note that the risk of adverse reactions in the elderly is increased.

Major adverse reactions include diarrhea, leukopenia, sepsis, and vomiting, and frequently certain types of infections.

Contraindicated in patients with hypersensitivity to mycophenolate mofetil and mycophenolic acid. Avoid concurrent use with azathioprine.

Precautions for children: 1. Based on the pharmacokinetic and safety data of children after kidney transplantation, the recommended dose is 600 mg/m2 bid (up to 1 g bid) of mycophenolate mofetil taken orally. 2. The safety and effectiveness of pediatric patients receiving heart or liver allogeneic transplants have not been determined. Precautions for pregnancy and lactation: Animal experiments have found that this drug may cause fetal malformations. This drug should be taken only after a negative pregnancy test. During the use of this drug, effective contraceptive measures should be taken. MMF may have potentially serious side effects on breastfeeding infants. Precautions for the elderly: Clinical trials of mycophenolate mofetil did not include enough elderly people aged 65 or above, and it cannot be determined whether the effects on the elderly are different from those on young people. Other reported clinical experiences have not determined the difference in effects between the elderly and the young. In general, the dose selection for the elderly should be cautious because more elderly people have decreased kidney, heart and liver function and more concomitant use of other drugs. Compared with young people, adverse reactions may be more common in the elderly.

Acyclovir: When MMF and acyclovir are taken simultaneously, the plasma concentrations of MPAG and acyclovir are higher than when either drug is taken alone. When renal function is impaired, the plasma concentrations of both MPAG and acyclovir increase. The two drugs are competitively excreted through the renal tubules, which may further increase the blood concentrations of both drugs. Antacids and magnesium hydroxide and aluminum hydroxide: The absorption of MMF is reduced when antacids are taken simultaneously. Cholestyramine: Healthy people first took cholestyramine 4 grams three times a day, and after four days, a single dose of MMF 1.5 grams was given, and the area under the curve of MPA decreased by 40%. Cyclosporine A: The pharmacokinetics of CsA are not affected by MMF. Ganciclovir: No pharmacokinetic cross-talk was observed between MMF and intravenous ganciclovir. Oral contraceptives: No interaction has been found between MMF and the oral contraceptive 1 mg norethindrone/35 micrograms ethinyl estradiol, but this is only a conclusion drawn from a single-dose study and does not rule out the possibility that long-term use of mycophenolate mofetil tablets will change the pharmacokinetics of oral contraceptives, which may lead to reduced efficacy of oral contraceptives. Sulfadimethoxazole: No effect on the bioavailability of MPA. Other interactions: Giving monkeys probenecid and MMF at the same time can increase the area under the curve of plasma MPAG by 3 times. For this reason, other drugs excreted through the renal tubules can compete with MPAG, thereby increasing the concentration of plasma MPAG or these drugs. Patients with immune response disorders should not be vaccinated with live vaccines. Antibody responses to other vaccinations may be eliminated.

Keep tightly closed in a cool place.

0.25g

Tentative 24 months

Hunan Warrant Pharmaceutical Co., Ltd.

• Founded in:

  2001-04-30

• Address:

  Hunan Liuyang Biomedicine Park

• Tax NO.:

  914301007279773228

• Registered Funds:

  93.8 million yuan

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