[Drug name]

Generic name: Mifepristone 25mg Tablets

English name: Mifepristone 25mg Tablets

[Composition]

The main ingredient of this product is mifepristone, and 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]

This product is yellowish tablets

[Indications]

Sequential combination of mifepristone tablets and misoprostol tablets can be used to terminate intrauterine pregnancies up to 16 weeks (112 days), including: (i) for terminating pregnancies up to 7 weeks (49 days); and (ii) for terminating pregnancies up to 8 to 16 weeks (50 to 112 days).

[Posology and Method of Administration]

①For termination of pregnancy up to 7 weeks (49 days): 25 mg to 50 mg (1 - 2 tablets) of mifepristone tablets orally twice a day for 2 - 3 days on an empty stomach or 2 hours after eating, for a total of 150 mg (6 tablets), fasting for 2 hours after each dose, and misoprostol 600 μg (200 μg/tablet x 3 tablets) or carboprost methylate suppository1 pcs (1 mg) placed in the posterior vaginal vault early in the morning of the 3rd - 4th day. Bed rest for 1 ~ 2 hours, outpatient observation for 6 hours. Pay attention to the post-dose bleeding and whether there are pregnancy products and side effects.

②For termination of pregnancy up to 8-16 weeks (50-112 days): on the first and second day, take mifepristone 100mg (4 tablets) with a total dose of 200mg (8 tablets) on an empty stomach or 2 hours after eating, respectively. Fasting for 2 hours after each dose. On the third day, take misoprostol 400 μg (2 tablets) orally at 36-48 hours after the first oral dose of mifepristone, and repeat misoprostol 400 mg (2 tablets) once at an interval of 3 hours depending on the clinical situationm, up to a maximum of 4 doses.

[Clinical Trial]

A multicenter, randomized, controlled clinical trial included 629 women with 8-16 weeks (50-112 days) of pregnancy, who were divided into two groups: oral misoprostol group (hereinafter referred to as "oral group") (419 cases) and vaginal misoprostol group (hereinafter referred to as "vaginal group") (210 cases). Method of administration: on the first and second day, take mifepristone 100mg (4 tablets) respectively, with a total dose of 200mg (8 tablets). On the third day, misoprostol 400 μg (2 tablets) is taken orally, and 600μg (3 tablets, taken at a draught) is given to the vaginal group. Misoprostol 400 mg (2 tablets) is given once at an interval of 3 hours (orally) or 6 hours (via vagina) depending on the clinical situationm, up to a maximum of 4 doses.

Clinical effectiveness included complete and incomplete abortion rates. The results showed that (1) The complete abortion rate was 76.50% in oral group and 76.44% in vaginal group. There was no significant difference between the two groups (P=0.870). The incomplete abortion rate was 15.11% in oral group and 16.83% in vaginal group. (2) The complete abortion rate in 8 ~ 9 weeks (50 ~ 63 days) was 83.84% in oral group and 87.88% in vaginal group; The incomplete abortion rate was 10.10% in oral group and 5.05% in vaginal group. (3) The complete abortion rate in 10 ~ 16 weeks (64 ~ 112 days) was 69.86% in oral group and 66.06% in vaginal group; The incomplete abortion rate was 19.63% in oral group and 27.52% in vaginal group.

[Pharmacological Effect]

Mifepristone is a receptor-level antiprogestin, which has the effects of terminating pregnancy, anti-implantation, inducing menstruation and promoting cervical ripening. It competes with endogenous 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 pregnancy satisfactorily.

[Storage]

Sealed, protected from the light.

[Package]

Aluminum-plastic package, 6 tablets per sheet, 1 sheet per pack.

Aluminum-plastic package, 8 tablets per sheet, 1 sheet per pack.

[Shelf Life]

60 months