[Drug Name]

Co-package of Mifepristone 200 mg Tablet and Misoprostol 4×200 mcg Tablets

[Appearance]

Mifepristone 200 mg Tablet: Yellowish, biconvex round tablets.

Misoprostol 200 mcg Tablet: Hexagonal white tablets.

[Indications and administration method]

1. Medical termination of pregnancy at less than 12 weeks of gestation:

200 mg of mifepristone (i.e. 1 tablet of 200 mg) is taken as a single oral dose under the supervision of a health care provider, followed 1 to 2 days later by 800 μg of misoprostol (i.e. 4 × 200 μg tablets) by the vaginal, buccal or sublingual route.

2. Medical termination of pregnancy at more than 12 weeks of gestation:

200 mg of mifepristone (i.e. 1 tablet of 200 mg) is taken as a single oral dose under the supervision of a health care provider, followed 1 to 2 days later by 400 μg of misoprostol (i.e. 2 × 200 μg tablets) preferably by the vaginal route but buccal or sublingual route may also be used. An additional dose of 400μg of misoprostol should be given three hours later.

Further doses of 400 μg of misoprostol may be given every three hours if required.

[Pharmacological Properties]

Mifepristone

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 at least 1mg/kg, mifepristone antagonises the endometrial and myometrial effects of progesterone. During pregnancy it sensitises the myometrium to the contraction-inducing action of prostaglandins. The effect is greatest when a prostaglandin is administered 36 to 48 hours after mifepristone.

Mifepristone induces softening and dilatation of the cervix, which are detectable from 24 hours after administration of mifepristone and increase to a maximum after approximately 36-48 hours.

Misoprostol

Misoprostol is a synthetic analogue of prostaglandin E1. At the recommended dosages, misoprostol induces contractions of the smooth muscle in the myometrium and relaxation of the uterine cervix. The uterotonic properties of misoprostol facilitate cervical dilatation and evacuation of the product of conception.

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]

1 tablet of mifepristone 200 mg and 4 tablets of misoprostol 200 mcg are packed in an Alu/Alu blister. Each blister is supplied in a box.

[Shelf life]

24 months