Drug Name:Mifepristone Capsules (5mg)
Product License Number:Guoyaozhunzi H20050395
Drug Description:Sequentially incorporation of mifepristone capsules with prostaglandin agents can be used in termination of pregnancy within 49 days after menolipsis.This product is a capsule containing slight yellow powder.
Pharmaceutical ingredients
Active component: Mifepristone
Chemical Name: 11β-[4-(N, N - Dimethylamino)-phenyl-17β-hydroxy-
17α-(1-propynyl)-estra-4,9-dien-3-one
Molecular Formula: C29H35NO2 
Molecular Weight: 429.61
Drug Specifications
5mg
Drug application
[Usage and dosage]
a) Recommended usage and dosage:
For the healthy early pregnant woman after menolipsis for not more than 49 days, orally take mifepristone capsules 25-50 mg each time in emptying stomach or 2 hours after meal, twice daily for 2-3 days. Fast for 2 hours after each dose and the total dosage is 150 mg. Orally administer misoprostol 600 mg (200 mg/tablet x 3 tablets), or put a carboprost methylatein suppository (1 mg) into the posterior fornix of vagina, or orally administer other similar prostaglandin in the early morning of day 3-4. Then rest in bed for 1-2 hours and is observed outpatiently for 6 hours. Watch out for bleeding, discharge of pregnant product and adverse reaction after dosing.
 
b) For the early pregnant woman who intolerate the total dosage of 150 mg of this product, can decrease the total dosage to 75 mg. Fast for 2 hours before and after each dose. Orally administer mifepristone capsules 30 mg (6 capsules) in the morning of day 1, and take another 15 mg (3 capsules) after 12 hours; orally administer mifepristone capsules 15 mg (3 capsules) in the morning of day 2, and take another 15 mg (3 capsules) after 12 hours. Thus, the total dosage is 75 mg. Orally administer misoprostol 600 mg (200 mg/tablet x 3 tablets) in the early morning of day 3. Then rest in bed for 2 hours and is observed outpatiently for 6 hours. Watch out for bleeding, discharge of pregnant product and adverse reaction after dosing.
 
A multicenter, randomized, double-blind clinical trial to study the termination of early pregnancy was organized by Family Planning Institute of Tongji Medical College, Huazhong Science and Technology University. 240 early pregnant women administered with the total dosage of 75 mg of mifepristone capsules in separate dose were compared with 240 women administered with the total dosage of 150 mg of mifepristone tablets in combination with misoprostol in separate dose.
 
The complete abortion rates for mifepristone capsules group and mifepristone tablets group were 96.25% and 95.42%, respectively. The incomplete abortion rates for both groups were 3.33% and 3.75%, respectively. The ongoing pregnancy rates for both groups were 0.42% and 0.83%, respectively. Its permitted error was 0.03 by statistical analysis of the result of non-inferiority test. The complete abortion rate for capsules group was not inferior to that for tablets group by comparison of both groups. Its permitted error was 0.03 by statistical analysis of the result of equivalence test. The failure rate of abortion for capsules group was equivalent to that for tablets group by comparison. The abortion procedures of both groups were basically identical. The discharge rates of embryo sac within 6 hours were 85.42% for capsules group and 80% for tablets group, and those within 2 hours were 39.58% and 27.50%, respectively. Its permitted error was 0.015 by statistical analysis of the result of non-inferiority test. The cumulative discharge rate for capsules group was not inferior to tablets group by comparison of both groups. For the vaginal bleeding, the difference of initial bleeding time between capsules group and tablets group was not more than 4 hours by statistical analysis of the result of equivalence test, which showed both groups were equivalent. For the span of bleeding time, the total days of bleeding and the days to menstrual reoccurrence, the permitted error was 3 days, and capsules group was equivalent to tablets group. The incidence of bleeding volume exceeding menstrual flow volume for both groups were 16.32% and 7.92%, respectively with the permitted error was 0.03, which showed that capsules group was not equivalent to tablets group. There were no hemorrhea occurred in both groups. The total days of vagina bleeding for capsules group was 15.26±9.09 days, which was slightly longer than 13.99±6.45 days of tablets group. The incidences of other adverse reactions were similar for both groups, which showed no significant statistical difference.
 
[Precautions]
1. This product must be used under the supervision of an experienced clinician.
2. For the patients who are confirmed to be early pregnant, the days after menolipsis should be not more than 49 days. 
3. Mifepristone capsules must be used under the conditions with first aid, uterine apoxesis and infusion, and transfusion. This product must not be sold over the counter.
4. The patients must be informed the results of treatment and the possible adverse reactions before dosing. If hemorrhea or other abnormal conditions occur during the treatment or follow-up, the patient should go to hospital timely.
5. A few vaginal bleeding may generally occur in the early time after dosing with the average time of 9-16 days. The bleeding time after abortion of a part of the women is longer, of which 8% of the women can reach to 30 days or longer. The bleeding time of 69 days was reported. In some patients, the excessive bleeding may need to be treated with vasoconstrictor, uterine apoxesis, and infusion of physiological saline solution or transfusion. 
6. A few early pregnant women may spontaneously abort after administering mifepristone. About 80% of pregnant women discharge the villus sac within 6 hours after using prostaglandins, and about 10% of the pregnant women discharge the pregnant products within 1 week after dosing.
7. The patients should return to the treatment unit for rediagnosis to determine the effect of abortion. The B-type ultrasonic examination or blood HCG measurement should be performed if necessary. If the patient is diagnosed as incomplete abortion or continuous pregnancy, the treatment should be performed timely.
8. The patients who fail to terminate the early pregnancy after using this product must receive curettage to terminate pregnancy.
9. There are no safety and efficacy data of this product in women with chronic diseases such as cardiovascular, hypertensive, hepatic, respiratory or renal diseases, type-I diabetes mellitus and serious anaemia, or severe smokers. The women over 35 years old or smoke more than 10 cigarettes daily should use this drug cautiously.
10. If any adverse event and/or adverse reaction occur during dosing of this product, please consult the doctors.
11. If concomitantly use other drugs, please inform the doctors.
12. Keep this product out of reach of children.