英文药名: CELLCEPT Powder Suspension 31.8%(Mycophenolate Mofetil)

中文药名: 霉酚酸酯粉末悬浮液31.8％

生产厂家: 中外制药

セルセプト懸濁用散31.8%

治疗类别名称
免疫抑制剂
商標名
CELLCEPT
一般名
ミコフェノール酸　モフェチル（Mycophenolate Mofetil）（JAN）
略名
MMF
化学名
2-morpholinyl（E）-6-（1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxoisobenzofuran-5-yl）-4-methyl-4-hexenoate
構造式

分子式
C23H31NO7
分子量
433.49
性状
它是一种白色结晶粉末。N，N-二甲基甲酰胺，以更可溶，微溶于乙腈，难溶在甲醇，乙醇（95）和微溶于乙醚，和几乎不溶于水。
熔化范围
94〜98℃（在从熔融起点之间熔化的2.5℃内端差）
条件批准
在建立药品风险管理计划的顶部，要正确实施。
药效药理
1. 作用机序
霉酚酸酯水解迅速MPA体内。MPA是，从头系统，所述打捞系统中的两个所述嘌呤生物合成途径的，缺乏竞争力肌苷单磷酸脱氢酶是从头合成途径的限速酶，通过抑制可逆和具体，GTP，耗尽脱氧GTP，抑制DNA合成。T，货币淋巴细胞而主要取决于从头基于核酸的合成，比免疫系统的其它细胞是依赖于从头，打捞两个系统。因为MPA不影响打捞酶，导致选择性抑制淋巴细胞的增殖，诱导排斥发育不全与器官移植后发生。
2. 免疫药理作用
1）体外试验
人淋巴细胞细胞系的增殖，人外周血淋巴细胞有丝分裂原的刺激和脾B淋巴细胞的增殖和抗体产生，以及强烈抑制人淋巴细胞的混合淋巴细胞反应。另一方面，人成纤维细胞，脐带的内皮细胞生长抑制轻微。
2）体内试验
小鼠细胞毒性T淋巴细胞，抗体产生抑制致敏小鼠和大鼠脾脏，血液自然产生抗体的脾切除大鼠的能力下降，致敏的小鼠淋巴结，诱导抑制表明DNA合成的脾的特异性抑制这是。
3. 移植免疫抑制作用
在同种器官移植的动物，它表现为进行性急性排斥反应（狗肾，大鼠心脏，小肠）的改善。此外，它能够抑制急性排斥反应中，移植，移植器官片的存活延长，增强由其他试剂的组合施用（狗肾，肝，大鼠心脏，小肠，小鼠胰腺）的免疫抑制效应。此外，在大鼠血管模型冠状动脉炎，抑制内膜增生和增厚。
适应病症
○难治性排斥肾移植术后治疗
（但不能为这样的现有治疗药物无效或副作用进行管理，当确诊为难治性排斥）
○排斥反应抑制在下面的器官移植
肾移植，心脏移植，肝移植，肺移植，胰腺移植
用法与用量
1. 肾移植
○难治性排斥肾移植术后治疗
成人，通常是膳食口服给药一次，每12小时，每天1,500mg两倍霉酚酸酯之后。此外，增加或减少取决于患者的年龄和症状。
○ 肾移植排斥反应的抑制
成人：饭后口服给药每天一次作为霉酚酸酯1000毫克每12小时两次。
此外，年龄，将根据症状进行调整，到最大1天3,000mg的。
孩子：饭后口服一次300〜600毫克/m2，每12天为霉酚酸酯小时的两倍。此外，年龄，将根据症状进行调整，到最大1天2,000mg。
2. 心脏移植，肝移植，肺移植，排斥反应的胰腺移植抑制的情况下。
成年人每天霉酚酸酯通常饭后口服一次500〜1,500mg每12小时两次。
然而，化学量和这种药物的有效量，因为从患者而异，小心的增加或减少是为了获得最佳的治疗效果需要的剂量。
3. 狼疮性肾炎
成人：饭后口服是每天给药一次250〜1000毫克，每12小时的两倍霉酚酸酯。
此外，年龄，将根据症状进行调整，到最大1天3,000mg的。
孩子：饭后口服一次150〜600毫克/m2，每12天为霉酚酸酯小时的两倍。
此外，年龄，将根据症状进行调整，到最大1天2,000mg的。
包装规格
粉末悬浮液31.8％
110克（瓶）

制造厂商
中外制药有限公司
完整处方资料附件：http://www.info.pmda.go.jp/go/pack/3999017B1025_1_07/
CELLCEPT Powder for Oral Suspension 31.8%（Mycophenolate mofetil）
CELLCEPT Powder for Oral Suspension 31.8%（セルセプト懸濁用散31.8％） 
Brand name : CELLCEPT Powder for Oral Suspension 31.8%
　Active ingredient: Mycophenolate mofetil
　Dosage form: white powder
　Print on wrapping: 
Effects of this medicine
This medicine controls immune function by suppressing lymphocyte growth.
It is usually used to treat refractory rejection after renal transplant (when you do not respond to the existing medicines, or can not be treated due to side effects, and when the rejections are diagnosed as refractory), to suppress rejection in renal/heart/liver/lung/pancreas transplant and for Lupus nephritis.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you are a patient with digestive disease, chronic renal failure, phenylketonuria or hereditary fructose intolerance.
If your renal function is showing slow recovery after renal transplant.
•If you are pregnant, possibly pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•To treat refractory rejection after renal transplant: In general, for adults, take 1,500 mg of the active ingredient at a time, twice a day, every 12 hours after meals. It should be adjusted according to the age and symptoms.
To suppress rejection after renal transplant: In general, for adults, take 1,000mg of the active ingredient at a time, twice a day, every 12 hours after meals. It should be adjusted according to the age and symptoms. The maximum dosage is 3,000mg of the active ingredient a day. In general, for children, take 300 to 600mg/m2 of the active ingredient at a time, twice a day, every 12 hours after meals. It should be adjusted according to the age and symptoms. The maximum dosage is 2,000mg of the active ingredient a day.
To suppress rejection after heart/liver/lung/pancreas transplant: In general, for adults, take 500 to 1,500mg of the active ingredient at a time, twice a day, every 12 hours after meals. The tolerance dose and the effective dose vary according to each patient. The dosage should be carefully adjusted to obtain the optimum curative effect.
Lupus nephritis: In general, for adults, take 250 to 1,000mg of the active ingredient at a time, twice a day, every 12 hours after meals. It should be adjusted according to the age and symptoms. The maximum dosage is 3,000mg of the active ingredient a day. In general, for children, take 150 to 600mg/m2 of the active ingredient at a time, twice a day, every 12 hours after meals. It should be adjusted according to the age and symptoms. The maximum dosage is 2,000mg of the active ingredient a day.
This medicine is a made-up suspension by adding purified water to the powder at the pharmacy/healthcare facility. 1 mL of made-up suspension contain 200mg of the active ingredient.
Strictly follow the instructions in any case.
•The maximum dosage for severe chronic renal failure is 1,000mg of the active ingredient at a time, twice a day.
•If you miss a dose, take the missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time.
•If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist immediately.
•Do not stop taking this medicine unless your doctor instructs you to do so. (Your life can be endangered by discontinuing the medicine, or adjusting the dose on your own just because you feel better)
Precautions while taking this medicine
•In using the medicine, you and your family need to be informed of these precautions as follows until everyone fully understands them.
-Teratogenic action (possibility to cause fetal malformation) has been reported in humans. If you have a possibility to become pregnant, pregnancy test will be performed before use of the medicine in order to confirm that you are not already pregnant. You must avoid pregnancy and confirm that you do not become pregnant before/during use of the medicine and for 6 weeks after discontinuing it. If you think you may be pregnant, tell your doctor immediately.
-Contact your doctor immediately when you notice that you are having infectious symptoms, oblivious bruise, internal bleeding, bleeding, anemia, and diarrhea.
-In order to avoid the risk of skin cancer caused by sunlight/ultraviolet rays, put on clothes such as a hat and effective sunscreen.
•While taking the medicine, you may have to take a blood test frequently.
•Avoid breastfeeding.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include diarrhea, cytomegalus virus infection, pneumonia, herpes zoster and anemia. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•cold-like symptoms, general dullness, fever, vomiting [infection]
•absent-mindedness, impaired mind, memory loss, loss of consciousness, paralysis of the limbs, difficulty speaking, convulsion [progressive multifocal leukoencephalopathy]
•general dullness, headache, fever, swelling, lower abdominal pain, frequent urination, feeling of residual urine, bloody urine, decreased urinary volume [BK virus associated nephropathy]
•general dullness, dizziness, palpitation, shortness of breath, headache, fever, sore throat, ear ringing, nose/gum/subcutaneous bleeding, bleeding tendency, blue spot, continuous bleeding [pancytopenia, neutropenia, agranulocytosis, leukopenia, thrombocytopenia, anemia, pure red cell aplasia]
•swollen lymph node, night sweat, fever, weight loss, loss of appetite, bleeding tendency, anemia [malignant lymphoma, lymphoproliferative disease]
•itchy/painful/bleeding/growing mole, red-brown scab, mole turning into ulcer [malignancy (especially on the skin)]
•bloody/black stool, feeling sick at the stomach, nausea, vomiting, vomiting of blood, stomachache, severe abdominal pain, failure of passing stool/gas [gastrointestinal ulcer, gastrointestinal bleeding, perforation of the digestive tract, ileus]
•sweat, muddy stool, watery stool, severe abdominal pain, nausea [severe diarrhea]
•impaired mind/judgment, decreased consciousness, dull headache, hyperventilation, breathing difficulty, brief cessation of breathing, dizziness, shaky hands and legs, feeling of weariness, general dullness, decreased urinary volume, thirst [acidosis, hypoxia, dehydration]
•excess intake of water, increased urinary volume, general dullness, weight loss, thirst [diabetes]
•nausea, vomiting of blood, enlarged feeling of abdomen, vomiting, chest pain, chest constrictive/oppressive feeling, severe abdominal/leg pain, bleeding, sensory numbness [thrombosis]
•fever, decreased urinary volume, headache, loss of appetite, dry mouth, swollen hands and legs/face [serious renal disorder]
•easy breathing in upright position, breathing difficulty, shortness of breath, swollen body, general dullness, easy fatigability, loss of appetite, palpitation, chest pressured/constrictive feeling, cold sweat, chest pain, loss of consciousness, cessation of breathing [cardiac failure, angina, pulmonary hypertension, pericardial effusion collection, cardiac arrest]
•disturbed pulse, chest disorder feeling, chest uncomfortable feeling, chest pain, palpitation, decreased consciousness, dizziness, faint, shortness of breath [arrhythmia (extrasystole, atrial fibrillation, atrial flutter, supraventricular/ventricular tachycardia, etc.)]
•yellowness in the skin and/or the white of the eye, dark urine, vomiting, nausea, loss of appetite, itch, general dullness [hepatic function disorder, jaundice]
•shortness of breath, breathing difficulty, nausea, vomiting, easy breathing in upright position, cessation of breathing for more than 10 seconds, chest pain [pulmonary edema, apnea, pneumothorax]
•convulsion, confused/disturbed consciousness, impaired mind, seeing or hearing something that is not really there, inability to get along with others, bad temper, good mood, inability to control emotion [convulsion, confusion, hallucination,psychosis]
•asthma, hives, stuffy/runny nose, itchy eye, sneeze [allergic reaction]
•inability to hear voices/sounds, difficulty hearing, ear ringing [hearing loss]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•Keep out of the reach of children. Store at room temperature (1 to 30℃), away from direct sunlight. It can be stored in the refrigerator. Avoid freezing.
•Use the made-up suspension within 60 days. The expiration date will be written on the bottle label.
•Discard the remainder. Do not store them. Ask the pharmacist or healthcare facility how to discard them.
Chugai Pharmaceutical Co., Ltd.Internal
Published: 8/2016
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.