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Mifepristone Tablets

Function and Efficacy

Mifepristone is an anti-progestogen drug at the level of progesterone receptors, with obvious anti-luteal, anti-implantation, anti-ovulation and menstruation induction effects. It can also affect the movement of pregnant eggs. This product has no obvious anti-estrogen effect, nor does it have estrogen and androgen-like activity. It also has a certain ability to bind to glucocorticoid receptors and has a certain anti-glucocorticoid effect. Toxicological studies: 1. General pharmacological tests: No obvious effects were found on the cardiovascular and respiratory systems of rats. There was no obvious effect on the spontaneous activities and coordinated movements of mice. Only when a large dose of mifepristone was combined with sodium pentobarbital, the sleep time was prolonged. 2. Mutagenicity test: Including Ames test, mouse micronucleus test and artificial culture cell chromosome aberration test, the results were all negative. 3. Reproductive toxicity test: This product was tested for teratogenicity and embryotoxicity in rats, and the results showed no teratogenic effect. 4. Long-term toxicity: Rats took 0.2g/kg of this product orally every day for a total of one month, and macaques took 80mg/kg of this product orally every day for a total of one month, and no obvious toxic reactions occurred. 5. Acute toxicity test: The oral LD50 of rats is greater than 5.0g/kg, and the intraperitoneal injection LD50 of rats is greater than 2.5g/kg.

Ingredients

The main ingredient of this product is: Mifepristone.

Name Description Content CAS NO. Manufacturer
MifepristoneIngredients

Mifepristone is an anti-progestogen drug at the progesterone receptor level, with obvious anti-luteal, anti-implantation, anti-ovulation and menstruation induction effects. It can also affect the movement of fertilized eggs. This product has no obvious anti-estrogen effect, nor estrogen and androgen-like activity. It also has a certain ability to bind to glucocorticoid receptors and has a certain anti-glucocorticoid effect.

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84371-65-3 10

Appearance

This product is slightly yellow tablet, odorless and tasteless.

Indication

Mifepristone tablets can be used in combination with prostaglandin drugs to terminate pregnancy within 49 days of amenorrhea.

Usage and Dosage

Within 72 hours of unprotected sexual intercourse or contraceptive failure, the earlier the medicine is taken, the better the effect of preventing pregnancy. Take 25 mg (1 tablet) orally on an empty stomach or 2 hours after eating. Do not eat for 1 to 2 hours after taking the medicine.

Adverse Reactions

Adverse reactions include nausea, fatigue, lower abdominal pain, dizziness, breast swelling, headache, vomiting, etc., but the incidence is low and the symptoms are mild, so no treatment is required.

Precautions

1. People who are allergic to this product. 2. People with heart, liver, kidney diseases and adrenal cortex insufficiency.

Special Population Medication

Precautions for children: Not yet clear. Precautions for pregnancy and lactation: Contraindicated for pregnant women; the content of mifepristone in breast milk and its effect on infants have not yet been concluded, so it is not recommended for lactating women. Precautions for the elderly: Not yet clear.

Drug Interactions

Mifepristone is mainly metabolized by the CYP3A4 enzyme in the liver in the body. Combination with ketoconazole, itraconazole, erythromycin and other drugs may increase the serum level of mifepristone. Combination with rifampicin, adrenocortical hormones and certain anticonvulsants (phenytoin sodium, phenobarbital, carbamazepine, etc.) can induce the activity of liver drug metabolizing enzymes, thereby reducing the serum level of mifepristone. Therefore, this product should not be used simultaneously with the above drugs. In addition, this product should not be used in combination with griseofulvin and non-steroidal anti-inflammatory drugs.

Storage

Keep away from light and store in sealed container.

Packaging Specification

25mg

Validity Period

60 months

Manufacturer

Shanghai New Hualian Pharmaceutical Co., Ltd.

  • Founded in:

    2010-11-24
  • Address:

    No. 217, Minle Road, Xinghuo Development Zone, Haiwan Town, Fengxian District, Shanghai
  • Tax NO.:

    913101205648476887
  • Registered Funds:

    107.636649 yuan
  • Email:

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