Mifepristone Tablets
Chemical name:
(11ß,17a)-[4-(Dimethylamino)-phenyl]-17-hydroxy-17-(1-prnopynyl)-estra-4,9-dien-3-one
Specification:
10mg*15*2, 10mg*1
Description:
Light yellow tablets
Pharmacology:
Mifepristone is an antagonist of progestogen on the receptor level, without the activity of progestogen, estrogen, androgen and anti-estrogen. It can combine with the progestogen receptor, and its capability of integrate to the progestone receptor in endometrium is 5 times stronger than to the pregnendione. The mechanism of this product for emergent contraception by anti-embedment is that it restrains the normal physiological variation during the embedding period, interferes with the process of embedment, and so makes the embedding rate much lower and terminates pregnancy.
Pharmacokinetics:
It can be absorbed quickly after administration orally. The blood level reaches peak after 1.5 hours, and the blood peak is 0.8mg/l, while it has diversity among different bodies. The clearance in vivo is slow, of which the half -time is 20 hours. The blood level reaches more quickly in pregnant women, and the blood concentration is higher and the clearance half -time is longer. This product has brain first-pass effects, and the metabolism level in blood after taken orally 1-2 hours is higher than the maternal compound.
Indication:
Sexual intercourse without protective measures, or failed contraceptive measures (such as worn or slipping condom, unsuccessful out-vagina ejaculation, wrong calculation on safe period, etc.),the term of which should be less than 72 hours . It is a clinical temporary remedial measure to prevent pregnancy.
Usage and dosage:
Orally taken, within 72 hours after sex without protection or defeated contraceptive measures. Take one Mifepristone tablet on the empty stomach condition or 2hours after having food. Do not have food in 2 hours after administration.
Adverse effects:
Sickness, tiredness, abdominal pain, dizziness, bloated pain in breast, headache, vomiting etc, yet there is no necessity to treat the light symptom.
Contraindications:
1. Be allergic to Mifepristone.
2. With cardiovascular, liver, kidney disease or adrenal gland cortex malfunction.
Precaution:
1. Having at least one normal menses before this period could be subject to this emergent plan in this period.
2. Avoid sexual intercourse, or take effective contraceptive measures during the period from administration to the next menses, so as to prevent pregnancy after administration.
3. The next menses may be prolonged while administrating this product. If menses dose not come in one week after expectation, then should take inspection in hospital.
4. Regarding emergency contraceptives is a temporary remedial measure, Mifepristone cannot be taken as common contraceptives for every sexual intercourse or every month, and it cannot be used frequently. Subjects should take common contraceptive measures.
5. Afterward emergency contraceptives can reduce 70-80% expectations, so there is still defeated chance. We suggest the subjects failed in contraception taking medicines to end pregnancy.
6. The emergency contraceptive dosage of Mifepristone cannot be used for abortion. Therefore, the subjects should take high sensitive examination before to before to assure having not yet be pregnant.
Package:
10mg/tablet *1tablets/blister
Storage:
Hermetically store in a dry place and protect from the light.