[Drug Name]

Generic name: Mifepristone Tablets 200mg

[Appearance]

Yellowish, round biconvex tablets.

[Indications and administration method]

1) Medical termination of developing intra-uterine pregnancy

Up to 49 days of amenorrhea:

200 mg of mifepristone (i.e. 1 tablet of 200 mg) is taken in a single oral dose, followed 24 to 48 hours later by the administration of 400 μg of the prostaglandin analogue misoprostol orally, or 800μg misoprostol per vaginal, buccal or sublingual route.

Between 50-63 days of amenorrhea

200 mg of mifepristone (i.e. 1 tablet of 200 mg) is taken in a single oral dose, followed 24 to 48 hours later by the administration of 800 μg misoprostol per vaginal, buccal or sublingual route.

Between 64 and 84 days

200 mg mifepristone (i.e. 1 tablet of 200 mg) is taken in a single oral dose, followed 36 to 48 hours later by 800μg misoprostol administered vaginally in a health-care facility. Subsequent misoprostol doses should be 400μg, administered either vaginally or sublingually, every 3 hours up to four further doses until expulsion of the product of conception.

2) Softening and dilatation of the cervix uteri prior to surgical termination of pregnancy during the first trimester

200 mg of mifepristone (one tablet), followed 36 to 48 hours later (but not beyond) by surgical termination of pregnancy.

3) Preparation for the action of prostaglandin analogues in the termination of pregnancy for medical reasons (beyond the first trimester)

200 mg of mifepristone (i.e. 1 tablet of 200 mg) is taken in a single oral dose, 36 to 48 hours prior to scheduled prostaglandin administration which will be repeated as often as indicated:

400 μg oral or 800 μg vaginal misoprostol followed by 400 μg vaginal or sublingual misoprostol every 3 hours up to a maximum of five doses, administered in a health-care facility. For pregnancies of gestational age greater than 24 weeks, the dose of misoprostol should be reduced due to the greater sensitivity of the uterus to prostaglandins. The lack of clinical studies precludes specific dosing recommendations.

[Pharmacological Properties]

Mifepristone is a synthetic steroid with an antiprogestational action as a result of competition with progesterone at the progesterone receptors.

In women at doses of greater than or equal to 1mg/kg, mifepristone antagonises the endometrial and myometrial effects of progesterone. During pregnancy it sensitises the myometrium to the contraction inducing action of prostaglandin. During the first trimester, pre-treatment with mifepristone allows the dilatation and opening of the cervix uteri. For early termination of pregnancy, the combination of a prostaglandin analogue used in a sequential regimen after mifepristone leads to an increase in the success rate and accelerates the expulsion of the conceptus.

[Storage]

Do not store above 30°C. Protect from light. Store in the original package.

[Package]

Al/PVC, 1 tablets/strip, 1 strip/box;

Al/PVC, 3 tablets/strip, 1 strip/box;

[Shelf life]

36 months