Mifeston: Each Tablet contains Mifepristone 200 mg
2. Softening and dilatation of the cervix uteri prior to surgical pregnancy termination
3. Preparation for the action of prostaglandin analogues in the termination of pregnancy for medical reasons
4. Labour induction for the expulsion of a dead fetus (fetal death in utero).
1. As a medical alternative to surgical termination of intra-uterine pregnancy in early pregnancy: 600 mg Mifepristone (3 tablets) in a single oral dose followed 36-48 hrs later, by the administration of a prostaglandin analogue Misoprostol 400 mcg orally (up to 49 days) or Gemeprost 1 mg vaginally (up to 63 days).
2. Softening and dilatation of the cervix uteri prior to surgical pregnancy termination: 200 mg Mifepristone (one tablet), followed 36-48 hrs later (but not beyond) by a surgical termination of pregnancy.
3. Preparation for the action of prostaglandin analogues in the termination of pregnancy for medical reasons (to reduce the doses of prostaglandin): 600 mg of Mifepristone (3 tablets) taken in a single oral dose, 36-48 hrs prior to scheduled prostaglandin administration which will be repeated as often as indicated.
4. Labour induction for expulsion of a dead fetus (fetal death in utero): 600 mg of Mifepristone in a single oral daily dose for 2 consecutive days. Mifepristone alone leads to expulsion in about 60%. Labour should be induced by the usual methods if it has not started within 72 hrs following the first administration of Mifepristone.
There are no data on the safety and efficacy of Mifepristone in women with chronic medical conditions such as cardiovascular, hypertensive, hepatic, respiratory or renal disease; insulin-dependent diabetes mellitus; severe anemia or heavy smoking. Women who are more than 35 years of age and who also smoke 10 or more cigarettes per day should be treated with caution because such patients were generally excluded from clinical trials of Mifepristone.
Although there is no clinical evidence, the effectiveness of Mifepristone may be lower if Misoprostol is administered more than two days after Mifepristone administration.
Mifepristone should never be prescribed in patients with chronic adrenal failure, known allergy to Mifepristone or to any component of the product, severe asthma uncontrolled by corticosteroid therapy, porphyrias and renal failure, liver failure or malnutrition, or during breast feeding. Mifepristone is a lipophilic compound and may theoretically be excreted in the mother\'s breast milk, however no data is available.
Lactation: It is not known whether Mifepristone is excreted in human milk. Many hormones with a similar chemical structure, however, are excreted in breast milk. Since the effects of Mifepristone on infants are unknown, breast-feeding women should consult with their health care provider to decide if they should discard their breast milk for a few days following administration of the medications.
Use in children
Safety and effectiveness in pediatric patients have not been established.
Based on invitro inhibition information, co-administration of mifepristone may lead to an increase in serum levels of drugs that are CYP3A4 substrates.
Limited evidence suggests that co-administration of NSAIDs on the day of prostaglandin administration does not adversely influence the effects of Mifepristone or the prostaglandin on cervical ripening or uterine contractility and does not reduce the clinical efficacy of medical termination of pregnancy.