|
英文药名: Mifeprex (Mifepristone Tablets)
中文药名: 米非司酮片
药品说明
通用名: 米非司酮片
英文名: MIFEPRISTONE TABLETS
药品类别: 雌激素及孕激素类
药理毒理:
米非司酮为受体水平抗孕激素药，具有终止早孕、抗着床、诱导月经及促进宫颈成熟等作用，与孕酮竞争受体而达到拮抗孕酮的作用，与糖皮质激素受体亦有一定结合力。米非司酮能明显增高妊娠子宫对前列腺素的敏感性。小剂量米非司酮序贯合并前列腺素类药物，可得到满意的终止早孕效果。
药代动力学:
本品口服吸收迅速，半合成及合成米非司酮血药浓度达峰时间分别为1.5-0.81小时，血药峰值分别为0.8 mg/L 和2.34mg/L，但有明显个体差异。体内消除缓慢，消除半衰期约20-34小时。服药后72小时血药水平仍可维持在0.2mg/L左右。本品有明显首过效应，口服1-2小时后血中代谢产物水平已可超过母体化合物。
适应症:
米非司酮片与前列腺素药物序贯合并使用，可用于终止停经49天内的妊娠。
用法用量:
停经≤49天之健康早孕妇女，空腹或进食2小时后，口服25-50mg米非司酮片一日2次，连服2-3天，总量150 mg，每次服药后禁食二小时，第3-4天清晨于阴道后穹窿放置卡前列甲酯栓1枚（1mg），或使用其他同类前列腺素药物。卧床休息1-2小时，门诊观察6小时。注意用药后出血情况，有无妊娠产物和副反应。
不良反应:
1. 部分早孕妇女服药后，有轻度恶心、呕吐、眩晕、乏力和下腹痛，肛门坠胀感和子宫出血。
2. 个别妇女可出现皮疹。
3. 使用前列腺素后可有腹痛，部分对象可发生呕吐、腹泻。少数有潮红和发麻现象。
禁忌症:
1. 对本品过敏者。
2. 心、肝、肾疾病患者及肾上腺皮质功能不全者。
3. 有使用前列腺素类药物禁忌者：如青光眼、哮喘及对前列腺素类药物过敏等。
4. 带宫内节育器妊娠和怀疑宫外孕者，年龄超过35岁的吸烟妇女。
注意事项:
1. 确认为早孕者，停经天数不应超过49天，孕期越短，效果越好。
2. 米非司酮片必须在具有急诊、刮宫手术和输液、输血条件下使用。本药不得在药房自行出售。
3. 服药前必须向服药者详细告知治疗效果，及可能出现的副反应。治疗或随诊过程中，如出现大量出血或其他异常情况，应及时就医。
4. 服药后，一般会较早出现少量阴道出血，部分妇女流产后出血时间较长。少数早孕妇女服用米非司酮片后，即可自然流产。约80％的孕妇在使用前列腺素类药物后，6小时内排出绒毛胎囊，约10％孕妇在服药后一周内排出妊娠物。
5. 服药后8~15天应去原治疗单位复诊，以确定流产效果。必要时作B型超声波检查或血HCG测定，如确诊为流产不全或继续妊娠，应及时处理。
6. 使用本品终止早孕失败者，必须进行人工流产终止妊娠。
孕妇及哺乳期妇女用药: 除终止早孕妇女外，其他禁用。
药物相互作用: 服用本品1周内，避免服用阿斯匹林和其他非甾体抗炎药。
贮藏: 遮光，干燥处保存。
包装: 200mg
Brand names: Mifeprex™
Chemical formula:
Mifepristone Oral tablet
What is this medicine?
MIFEPRISTONE (mi FE pri stone) is a hormone-like drug. It is used in combination with other medicines to end an early pregnancy (usually during the first 7 weeks). This medicine is only available in a doctor's office, health clinic, or hospital.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
•adrenal gland problems
•bleeding problems
•cannot easily get emergency medical help in the 2 weeks after you take this medicine
•cannot return for follow up appointments after you take this medicine
•have intrauterine device (IUD)
•it has been more than 49 days (7 weeks) since your last menstrual period began
•other medical problem
•porphyria
•take medicines that treat or prevent blood clots like enoxaparin, warfarin
•take steroid medicines like prednisone or cortisone
•tubal or ectopic pregnancy
•an unusual or allergic reaction to mifepristone, misoprostol, prostaglandins, or other medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding
How should I use this medicine?
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Before you take this medicine, read the information your doctor or health care provider gives you. Talk to your doctor about any questions you have. Take your medicine exactly as directed. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
•cerivastatin
•cisapride
•dofetilide
•medicines that treat or prevent blood clots like enoxaparin, warfarin
•pimozide
•ranolazine
•steroid medicines like prednisone or cortisone
This medicine may also interact with the following medications:
•erythromycin
•grapefruit juice
•medicines for fungal infections like ketoconazole, itraconazole
•medicines for seizures like carbamazepine, phenytoin, phenobarbital
•medicines used in surgery for anesthesia
•rifampin
•St. John's wort or other herbal products
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
For your safety, you must visit your doctor as directed after taking this medicine. Report any unusual effects to your doctor. This medicine can cause birth defects. You will need surgery if this medicine fails to cause a full abortion.
After you take this medicine, some vaginal bleeding is normal. Heavy bleeding may be a sign that something is wrong. If you soak through 2 thick full-size sanitary pads each hour for 2 hours, get medical help right away. Tell the health care provider that you have taken this medicine.
Call your doctor if you have a fever, stomach pain or tenderness, nausea, vomiting, diarrhea, or feel weak. This may be a sign that something is wrong. You may have a serious infection or complication and need medical help.
Keep the MedGuide for this medicine. If you need emergency medical care, show your healthcare provider the MedGuide.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
•breathing problems
•fast, irregular heartbeat
•feeling faint, lightheaded
•fever
•stomach pain
•unusually weak or tired
•vaginal discharge with bad smell
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
•back pain
•diarrhea
•headache
•loss of appetite
•nausea, vomiting
•stomach cramps
•vaginal bleeding
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
This drug is given in a hospital or clinic and will not be stored at home. | 
