Approval date: October 24, 2006
Revision date: October 01, 2010
Revision date: December 27, 2013
Revision date: December 01, 2015
Mifepristone Tablets Instructions (for Emergency Contraception) Please read the instructions carefully and use under the guidance of a physician
[Drug Name]
Generic Name: Mifepristone Tablets
Trade Name: Simeon
English Name:Mifepristone Tablets
Hanyu Pinyin:Mifeisitong Pian
[Ingredients]
The main ingredient of this product is mifepristone, whose chemical name is:11β-[4-(N,N-dimethylamine)-1-phenyl]-17β-hydroxy-17α-(1-propargyl)–estra-4,,9-dienium-3-oneone =”font-family:Arial”>
The chemical structure formula is:
Molecular Formula:C29H35NO2
Molecular weight:429.61
[Characteristic]
This product is a slightly yellow tablet.
[Indications]
For use after unprotected (without any contraceptive measures) sex or after contraceptive failure (e.g. condom breakage or slippage, failure of in vitro ejaculation, miscalculation of safety period, etc.)within 72 hours as a remedy to prevent unintended pregnancy.
[Specifications]
25mg
[dosage]
within 72 hours of unprotected sex or contraceptive failure. The earlier the dose is taken, the more effective it is in preventing pregnancy, on an empty stomach or after eating2hours orally25mg, fasting after taking the drug1～. span>2hours.
[Adverse Reactions]
Adverse reactions include nausea, fatigue, lower abdominal pain, dizziness, breast swelling, headache, and vomiting, but the incidence is low and the symptoms are mild and do not require treatment.
[Contraindicated]
Hypersensitivity to this product.
Patients with cardiac, hepatic or renal disease and adrenal cortical insufficiency.
[Precautions]
Women taking this product should use this emergency contraceptive method only if they have had at least one normal menstrual period prior to the current cycle and if they are having unprotected sex for the first time during the current cycle.
After taking the pill, no further unprotected sex should be had until the menstrual cycle turns menstrual. If you have sex again, you must use effective contraception.
This product is an emergency contraceptive tablet and is not intended to be used for abortion.
This medication should not be taken as a regular contraceptive after each sexual intercourse or monthly, but only as a remedy for contraceptive failure.
Use this product as an emergency contraceptive and if contraception fails, termination of pregnancy is recommended.
[For pregnant and lactating women]
Pregnant women are contraindicated; mifepristone is not recommended for use in nursing women as the levels in breast milk and the effects on the infant are inconclusive.
[Pediatric use]
is unclear.
[Geriatric use]
is unclear.
[Drug Interactions]
Mifepristone is metabolized in vivo primarily by the hepatic enzyme CYP3A4 , co-administration with ketoconazole, itraconazole, and erythromycin may increase serum mifepristone levels. Combination with rifampin, adrenocorticosteroids and certain anticonvulsants (phenytoin, phenobarbital, carbamazepine, etc.) may induce hepatic drug metabolizing enzyme activity, thus reducing mifepristone serum levels. Therefore, this product should not be used together with the above drugs. In addition, it should not be combined with ashwagandha and NSAIDs.
[Overdose]
When ingesting too large a dose, attention should be paid to its anti-glucocorticoid effects and adrenal function.
[Pharmacology and Toxicology]
Mifepristone is a progesterone receptor level antiprogestin with significant anti-luteal, anti-fertilization, anti-ovulatory and menstrual induction effects. It may also affect the operation of the progesterone egg. It has no significant anti-estrogenic effects, nor estrogenic or androgenic-like activity, and also has some binding ability to glucocorticoid receptors and has some anti-glucocorticoid effects.
Toxicological studies:
General pharmacological tests: No significant effects on the cardiovascular and respiratory systems of rats were observed. There were no significant effects on spontaneous activity and coordinated movement in mice, and only prolonged sleep time was induced when high-dose mifepristone was combined with pentobarbital sodium.
Mutagenic tests: including Ames test, mouse micronucleus test and chromosome aberration test in artificially cultured cells, all with negative results.
Reproductive toxicity test: No teratogenic effect in rat teratogenicity and embryotoxicity test.
Long-term toxicity test: rats were given oral doses of this product daily200 mg/kg per day for one month, and rhesus macaques were given 80 mg/kg, which was administered for one month, showed no significant toxic reactions.
Acute toxicity test: mice were given oral LD50greater than5.0g/kg, administered intraperitoneally to miceLD50is greater than2.5g/kg.
[Pharmacokinetics]
The product is rapidly absorbed orally, about 1.5hours Peak, blood peak0.8 mg, but with significant individual variation. Elimination in vivo is slow, with an elimination half-life of approximately 20hours. Non-pregnant women generally have faster time to peak, higher blood concentrations, and longer elimination half-life. It has a significant first-pass effect, and oral dosing1to2Hours later blood levels of metabolites can already exceed the parent compound.
[Storage]
Store under shade and seal.
[Packaging]
Aluminum-plastic package, per plate1tablet, per box1plate.
[Expiration date]
60months
[Implementation Standard]
[Approval number]
State Drug CertificateH10950003
[Production Unit]
Company Name: China Resources Zizhu Pharmaceutical Co.
Land
Address: Chaoyang North Road, Chaoyang District, BeijingNo.27
Postal Code:100024
Phone Number:400-6508-662(After-sales call)
010-62262389(after-sales phone)
010-62250419(after-sales service)
010-65483355-2221(Production)
Fax Number:010-62219316
Net
Address:http://www.zizhu-pharm.com.cn ®
Approval Date:2015 Year07Moon07Day
Revision Date:2015 Year12March01Day
Mifepristone Tablets Instructions
Please read the instructions carefully and use under the guidance of a physician
[Drug Name]
Generic Name: Mifepristone Tablets
English Name:Mifepristone Tablets
Hanyu Pinyin:Mifeisitong Pian
[Ingredients]
The main ingredient of this product is mifepristone, whose chemical name is:11β-[4-(N,N-dimethylamine)-1-phenyl]-17β-hydroxy-17α-(1-propargyl)–estra-4,,9-dienium-3-oneone =”font-family:Arial”>
The chemical structure formula is:
Molecular Formula:C29H35NO2
Molecular weight:429.61
[Characteristic]
This product is a slightly yellow tablet.
[Indications]
Mifepristone tablets in sequential combination with misoprostol tablets can be used to terminate16weeks (112days), including: 1) for termination of intrauterine pregnancy up to 7 weeks (49 days) span>within 7 weeks (49 days); and (ii) for termination of pregnancy within 8 to 16 weeks (50 to 112 days).
[Specifications]
25mg
[dosage]
①for termination7weeks () 49days) of pregnancy: fasting or eating2hours after eating, take 25mg~50mg(1 to 2tablets) mifepristone tablets a day2times a day2to “font-family:Arial”>3days, total150mg(6tablets) with fasting after each dose2hours and the first3to4days early morning oral misoprostol600μg(200μg/piece x 3tablets) or carboprost suppositories placed in the posterior vaginal vault1 one (1mg). Bed rest1 to2hours and outpatient observation6hours. Watch for bleeding after dosing, any pregnancy product excretion and side effects.
②For termination of pregnancy within 8-16 weeks (50-112 days): 100 mg (4 tablets) of mifepristone on an empty stomach or 2 hours after eating on the first and second days, respectively, for a total of 200 mg (8 tablets), with 2 hours of fasting after each dose, and misoprostol 400 μg (2 tablets) given orally on the third day, 36-48 hours after the first oral mifepristone dose. μg (2 tablets), with repeat misoprostol 400 mg (2 tablets) once at 3-hour intervals, depending on clinical conditions, up to a maximum of 4 doses.
[Adverse Reactions]
Some pregnant women experienced mild nausea, vomiting, dizziness, fatigue, lumbago, lower abdominal pain and distension, anal cramping and uterine bleeding after taking the drug.
Individual pregnant women may experience headache, diarrhea, fever, breast tenderness, and skin rash.
[Contraindicated]
1. Hypersensitivity to this product.
2. Patients with cardiac, hepatic, or renal disease and adrenal cortical insufficiency.
3. Early pregnancy with IUD and suspected ectopic pregnancy.
[Precautions]
1. For termination of pregnancy up to 16 weeks (112 days), Mifepristone tablets and Misoprostol tablets should be used in combination and not alone. Mifepristone tablets should be used in combination with misoprostol tablets and not alone.
2. Mifepristone tablets sequentially combined with prostaglandin analogues for termination of pregnancy up to 16 weeks (112 days) must be used in the setting of an emergency, a curettage, an infusion, or an infusion. The use of mifepristone tablets sequentially combined with prostaglandins for termination of pregnancy up to 16 weeks (112 days) must be used in a healthcare facility with emergency, curettage and infusion and transfusion conditions.
(1) Termination of pregnancies up to 9 weeks (63 days) of menopause may be used on an outpatient observation basis.
(2) Termination of pregnancy at 10 to 16 weeks (64 to 112 days) of menopause necessitates inpatient abortion or induction of labor.
3. Misoprostol tablets administered orally at 3 to 4 hour intervals can maintain better contractions and achieve better abortion, due to individual As misoprostol itself is a PGE1 drug, the PGE1 class of drugs has a stimulating effect on the central temperature, and the drug needs to be considered when the patient is clinically judged to be infected due to the elevated temperature phenomenon. The drugs themselves.
4. The medication should be taken and followed up under the guidance of a physician, who must inform the patient in detail about the effects of treatment and possible side effects before taking the medication.
(1) Patients with less than 7 weeks (49 days) of menopause must be observed in the hospital for 4-6 hours or hospitalized while taking this product.
(2) Patients with 8 to 9 weeks of menopause (50 to 63 days) must be observed for 24 hours after termination of pregnancy if non-hospitalized before discharge from the hospital.
(3) Patients with 10 weeks (64 days) or more of menopause must be hospitalized. If heavy bleeding or other abnormalities occur during treatment or follow-up, promptly seek medical attention for appropriate management.
5. After taking the drug, a small amount of vaginal bleeding usually occurs, and in a very small number of pregnant women taking mifepristone before prostaglandin is administered, a Miscarriage has occurred in a very small number of pregnant women who have taken mifepristone before prostaglandin. A follow-up visit to the original treatment unit should be made 8 to 21 days after taking the drug to determine the effect of abortion. Ultrasound or blood HCG measurement should be done if necessary, and if incomplete abortion or continued pregnancy is confirmed, prompt management should be done.
6. If the pregnancy is not completely expelled within 24 hours after the use of this product, the pregnancy must be promptly terminated by other methods. If one of the following conditions occurs, symptomatic treatment must be given promptly and scraping may be considered if necessary.
(1) If the embryo or fetus or placenta is not expelled after the drug is administered and the amount of vaginal bleeding is >100ml(2) If the fetus is expelled and the amount of vaginal bleeding is >100ml or there is The amount of vaginal bleeding after fetal expulsion is > 100ml or there is active bleeding(3) The placenta is not expelled one hour after fetal expulsion(4) The amount of vaginal bleeding after embryo or fetus or placenta expulsion> 100ml(5) The placenta has obvious defect
[For pregnant and lactating women]
Unspecified.
[Children’s medication]
Unclear.
[Geriatric use]
Unclear.
[Drug Interactions]
Avoid taking aspirin and other NSAIDs while taking this product.
[Overdose]
Unspecified.
[Clinical trial]
A multicenter randomized controlled clinical trial enrolling629cases of pregnancy8to16weeks (50 to 112days) for women, divided into 2group, misoprostol oral group (hereinafter referred to as “oral group”)419 The vaginal administration of misoprostol (hereinafter referred to as the “vaginal group”)210 cases. The dose was administered as a single dose of mifepristone 100 mg on the first and second days (4 tablets) for a total of 200mg (8tablets), and on the third day start misoprostol, oral group 400μg(2tablets in a single dose), vaginal group600 “font-family:equine”>μg(3tablets in a single dose) at intervals of 3hours depending on clinical conditions (oral ) or6hours (vaginal) followed by repeat misoprostol400mg(2tablets) once, up to a maximum of4times.
Clinical validity included both complete and incomplete miscarriage rates. The results showed that (1) complete miscarriage rate:oral group76.50%,vaginal group76.44%, with no statistical difference between the two groups (P=0.870). Incomplete abortion rate: oral group15.11%, vaginal group16.83%. (2)8to9weeks () :Arial”>50to63days) complete abortion rate:oral group83.84%,vaginal group87.88%; incomplete abortion rate: oral group10.10%, vaginal group5.05%. (3)10to16weeks () family:Arial”>64to112days) Complete abortion rate:Oral group69.86%,vaginal group66.06%; Incomplete abortion rate: oral group19.63%, vaginal group27.52%.
[Pharmacological Toxicology]
Mifepristone is a receptor-level antiprogestational agent with effects on termination of pregnancy, antimutation, induction of menstruation, and promotion of cervical maturation, competing with endogenous progesterone for receptors to antagonize progesterone, and binding to glucocorticoid receptors. Mifepristone can significantly increase the sensitivity of the pregnant uterus to prostaglandins. Low-dose mifepristone sequentially combined with prostaglandin analogs can result in satisfactory termination of pregnancy.
[Pharmacokinetics]
This product is rapidly absorbed orally, with peak blood concentrations of semisynthetic and synthetic mifepristone, respectively1.5, 0.81hours, with peak blood levels 0.8 mg/L and 2.34 mg/L, respectively , but there were significant individual differences. Elimination in vivo is slow, with an elimination half-life of about 20 to 34hours. Blood levels can be maintained at 72hours after dosing at 0.2 mg/Lor so. This product has a significant first pass effect, and oral administration1to2Hours later blood levels of metabolites can already exceed the parent compound.
[Storage]
Store under shade and seal.
[Packaging]
Aluminum-plastic package, per plate6tablets, per box1plate.
Aluminum-plastic package, per plate8tablets, per box1plate.
[Expiration date]
60months
[Executive Standard]
[Approval number]
State Drug CertificateH10950003
[Production Unit]
Company Name: China Resources Zizhu Pharmaceutical Co.
Land
Address: Chaoyang North Road, Chaoyang District, BeijingNo.27
Postal Code:100024
Phone Number:400-6508-662(After-sales call)
010-62262389(after-sales phone)
010-62250419(after-sales service)
010-65483355-2221(Production)
Fax Number:010-62219316
Net
Address:http://www.zizhu-pharm.com.cn ®