1. family and parenting
2. motherhood
3. pregnancy

Mif
®
Mifepristone 200mg tablet
Presentation
Mif: Each tablet contains Mifepristone 200mg
Description
Mifepristone is an antiprogestin; that is, it blocks the action of progesterone,
a naturally produced hormone that prepares the inner lining of the uterus for
implantation of a fertilized ovum and support of a growing embryo and
placenta. The drug is taken orally in a prescribed dose during the first seven
to nine weeks of pregnancy, and within two days the uterine lining begins to
deteriorate, usually causing bleeding similar to that experienced during
normal menstruation. The Mifepristone is then followed up by a dose (taken
orally or as a vaginal suppository) of the synthetic prostaglandin Misoprostol,
which stimulates the uterus to undergo contractions. The embryo and other
uterine contents are expelled in a process very similar to spontaneous
abortion or miscarriage.
Indication and Usage
As a medical alternative to surgical termination of intra-uterine pregnancy
Softening and dilatation of the cervix uteri prior to surgical pregnancy
termination
Preparation for the action of prostaglandin analogues in the termination of
pregnancy for medical reasons
Labour induction for the expulsion of a dead fetus (fetal death in utero).
Dosage and Administration
There are no precautions for timing in relation to food.
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).
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.
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.
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.
Side-effects
It is very common for women to experience uterine contractions or cramping
(10-45%) in the hours following prostaglandin intake. Bleeding increases
with gestational age. Heavy bleeding occurs in about 5% of cases and from
0-1.4% may require haemostatic curettage. Uterine rupture, hypotension,
skin rashes, urticaria, hot flashes and dizziness have been uncommonly
reported.
Contraindications
Mifepristone must not be administered if there is doubt as to the existence or
age of the pregnancy or if an extra-uterine pregnancy is suspected. An
ultrasound scan and/or measurement of Beta-hCG must be performed
before administration. For first trimester abortions, Mifepristone is
contraindicated if the pregnancy is beyond 49 days of amenorrhoea when
used with Misoprostol, or beyond 63 days of amenorrhoea when used with
Gemeprost.
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.
Precautions
Mifepristone is available only in single dose packaging. Administration must
be under the supervision of a qualified physician.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.
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Use in Pregnancy and Lactation
Pregnancy: Mifepristone is indicated for use in the termination of pregnancy
(through 49 days' pregnancy) and has no other approved indication for use
during pregnancy.
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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.
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Use in children
Safety and effectiveness in pediatric patients have not been established.
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Although there is no clinical evidence, the effectiveness of Mifepristone may
be lower if Misoprostol is administered more than two days after
Mifepristone administration.
Drug interactions
No interaction studies have been performed. On the basis of this drug's
metabolism by CYP3A4, it is possible that ketoconazole, itraconazole,
erythromycin and grapefruit juice may inhibit its metabolism (increasing
serum levels of mifepristone). Furthermore, rifampicin, dexamethasone, St
John's Wort and certain anticonvulsants (phenytoin, phenobarbital,
carbamazepine) may induce mifepristone metabolism (lowering serum levels
of Mifepristone). 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.
Overdosage
Single doses of Mifepristone up to 2G caused no unwanted reaction. In the
event of massive ingestion, signs of adrenal failure might occur. Acute
intoxication may require admission to hospital and if relevant treatment with
dexamethasone.
Storage
Store in a cool and dry place, away from light & children.
Commercial Pack
Mif® : Each box contains 1 x 3’s tablets in Alu-Alu blister strips.
® Trade Mark
Renata Limited
Mirpur, Dhaka, Bangladesh
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