[Drug name]

Generic Name: Mifepristone 5mg Capsules

English name: Mifepristone 5mg Capsules

[Ingredients] The main ingredient of this product is mifepristone, its chemical name is: 11 β-[4-(N, N-dimethylamino)-1-phenyl]-17 β-hydroxy-17 α-(1-propynyl)-estra-4, 9-dien-3-one

[Description] The content of this product is faint yellow particle or powder.

[Indications]

Mifepristone capsules may be used sequentially in combination with prostaglandin drugs to terminate pregnancy within 49 days of menopause.

[Posology and Method of Administration]

1. Recommended usage and dosage: Healthy early pregnant women with menopause ≤ 49 days, taking mifepristone capsules 25mg-50mg once, twice a day for 2-3 days on an empty stomach or 2 hours after eating, fasting for 2 hours after each dose, total 150mg, taking misoprostol 600 μ g (200 μ g/tablet × 3 tablets) in the morning of day 3-4, or placing carboprost methylate suppositories (1mg) in the vaginal posterior fornix, or taking other prostaglandin drugs of the same kind, resting in bed for 1-2 hours, observing for 6 hours in the outpatient department, and paying attention to post-dose bleeding, excretion of prenancy products and side effects.

2. For early pregnant women who cannot tolerate the total dose of 150mg of this product, the total dose can be reduced to 75mg. Fasting for 2 hours before and after the dose. Mifepristone capsules 30mg (6 capsules) in the morning of the first day, 15mg (3 capsules) 12 hours later, mifepristone capsules 15mg (3 capsules) in the morning of the second day, 15mg (3 capsules) 12 hours later, 75mg in total. Misoprostol 600μg (200μg/tablet x 3 tablets) orally in the early morning of the third day. Bed rest for 2 hours, outpatient observation for 6 hours. Pay attention to the post-dose bleeding and whether there are pregnancy products and side effects.

[Pharmacological action] Mifepristone is a receptor-level antiprogestin, which has the effects of terminating early pregnancy, anti-implantation, inducing menstruation and promoting cervical ripening. It competes with progesterone receptor to antagonize progesterone, and also has a certain binding force with glucocorticoid receptor. Mifepristone can significantly increase the sensitivity of pregnant uterus to prostaglandins. Low-dose mifepristone combined with prostaglandin drugs can terminate early pregnancy satisfactorily.

[Storage] Stored in tightly closed containers in a dark and dry place.

[Packaging] Aluminum-plastic package, 15 capsules per sheet, 1 sheet per pack.

[Shelf Life] 24 months.