Mifepristone Tablet: Mifepristone 10mg, 25mg, 200mg
Misoprostol Tablet Misoprostol 0.2mg
Co-packaged Mifepristone Tablet and Misoprostol Tablet
Combipack of Mifepristone 200 mg tablet and Misoprostol 4 x 0.2 mg vaginal tablets.
Mifepristone Tablets 10mg
Product Name: Mifepristone Tablets
Active Ingredient: Mifepristone
Chemical name: 11β-[4-(N, N - Dimethylamino)-phenyl-17β-hydroxy-17α-(1-propynyl)-estra-4,9-dien-3-one
Molecular Formula: C29H35NO2
Molecular Weight: 429.61
[Characteristics] Light yellow tablets, odorless; tasteless.
[Pharmacology]
Mifepristone is an antagonist of progestogen on the receptor level, without the activity of progestogen, estrogen, androgen and anti-estrogen. It can combine with the progestogen receptor, and its capability of integrating to the progestone receptor in endometrium is 5 times stronger than that of progesterone. Tits mechanism of emergency contraception is anti-embedment so that it restrains the normal physiological change during the embedding period, interferes with the process of embedment, and makes the embedding rate much lower and avoids pregnancy.
[Pharmacokinetics]
It can be absorbed quickly after administration orally. The blood level reaches peak after 1.5 hours, and the blood peak is 0.8mg/l, but it has obvious individual difference. The clearance in vivo is slow, of which the half -time is about 20 hours. The blood level reaches more quickly in nonpregnant women, the blood concentration is higher and the clearance half -time is longer. This product hasobvious first pass effect, and the metabolism level in blood 1-2 hours after taking orally is higher than the maternal compound.
[Indications and Usage]
This is an emergency contraceptive for women after sexual intercourse without protective measures, or failed contraceptive measures (such as worn or slipping condom, unsuccessful out-vagina ejaculation, wrong calculation on safe period, etc.) within 72 hours. It is a clinical remedial measure to prevent pregnancy.
[Dosage and Administration]
Take orally, within 72 hours after sex without protection or failed contraceptive measures. Take one Mifepristone tablet on an empty stomach or 2 hours after meal. Do not take food within 2 hours after administration.
[Adverse Reactions]
Sickness, tiredness, low abdominal pain, dizziness, bloated pain in breast, headache, vomiting etc, but the symptoms are light, no necessity to treat them..
[Contraindications ]
Subjects who are as following conditions cannot take this drug.
1. Be allergic to Mifepristone
2. With cardiovascular, liver, kidney disease or adrenal gland cortex malfunction
[Precautions]
1. Those who having at least one normal menses before this period could take this medicine in this menstrual period.
2. Avoid sexual behaver, or take effective contraceptive measures during the period from administration to the next menses, so as to prevent pregnancy after administration.
3. The next menses may be prolonged after administrating this product. If menses dose not occurs one week after expectation, then should take medical examination in hospital.
4. Regarding emergency contraceptives is a remedial measure, Mifepristone cannot be taken as regular contraceptives for every sexual intercourse or every month, and it cannot be used frequently. Subjects should take common contraceptive measures.
5. Emergency contraceptives can reduce 70-80% incidence of pregnancy, but there is failure rate in some extent. We suggest that the subjects failed in contraception taking abortion medicine to terminate pregnancy.
6. The emergency contraceptive dosage of Mifepristone cannot be used for abortion. Therefore, the subjects should take high sensitive examination to exclude pregnancy.
[Pregnancy or in lactation]
Mifepristone is indicated for use in the termination of pregnancy (through 49 days' pregnancy) and has no other approved indication for use during pregnancy.
[Specification]
Each tablet contains 10mg of Mifepristone.
[Package]
Aluminum foil and PVC blister
[Storage]
Sealed and protect from the light.
[Validity Period]
36 months.
Misoprostol Tablets
Product Name: Misoprostol Tablets
Active Ingredient: Misoprostol
Chemical name: (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate
Molecular Formula: C22H38O5
Molecular Weight: 382.54
[Characteristics] White tablets.
[Pharmacology]
Misoprostol tablet is a kind of medicine for terminating early-pregnancy. It can malacia cervix, strengthen uterus tension and intra-pressure. Using sequentially and combining with Mifepristone, it can increase or evoke the frequency and range of uterus auto-contraction. It has the pharmacological activity of E-Type prostaglandin. It has light stimulations on gastrointestinal smooth muscle and large dosage will inhibit secretion of gastric acid.
[Pharmacokinetics]
It can be absorbed quickly after administration orally. It is absorbed completely after 1.5 hours. The active plasm metabolite misoprostol acid level reaches peak after 15 minutes, and the average blood peak is 0.309ug/l when administrate 200ug orally. The clearance half-time is 36-40minutes. The metabolite is ejected mainly by urine.
[Indications and Usage]
Using sequentially and combining with Mifepristone can terminate early-pregnancy which is within 49 days after menolipsis.
[Dosage and Administration]
36-72 hours after administerion first Mifeprisone tablet, take 0.6mg (3 tablets) Misoprostol tablet on an empty stomach.
[Adverse Reactions]
Part of early-pregnant women will appear light nausea, vomiting, dizziness, inertia and inferior belly pain. Very occasionally flushing, fever and itching have been reported and very few administered women were found allergic shock.
[Contraindications ]
1. With have heart, liver and kidney disease or dysfunction of adrenal cortex.
2. With abstinence diseases for prostaglandin, such as glaucoma, asthma and hypersensitive body constitution.
3. Pregnant women with intrauterine device (IUD) or doubted ectopic pregnancy.
[Precautions]
1. When using for terminating early pregnancy, Misoprostol must used with Mifepristone together.
2. When combining with Mifepristone, it should be used under the doctor's instruction. It can only be used in the units with the condition of emergency uterine curettage, transfusion and blood transfusion under the doctor's supervision. This medicine is not a OTC.
3. Before administration, the patient should be informed the cure effect and adverse effect perhaps caused in detail. The patient should stay and be observed in hospital for 4-6 hours after administration. During treat and follow-up period, the patient should receive medical treatment in time when finding mass bleeding or other abnormal condition.
4. After administration, generally, patients will appear a small quantity vaginal hemorrhage, part women will have a long time of vaginal hemorrhage. A few early pregnant women have nature abortion after taking mifepristone and they should also administrate misoprostol tablet according to the regulation. After administration, about 80% women eject villous placenta within 6 hours and about 10% women eject villous placenta within one week.
5. Patients should be re-diagnosed in former hospital 8-15 days after administration. Ultrasonic or serum HCG examination should be taken if necessary. Proper measures should be adopted in time if incomplete abortion or continual pregnancy is confirmed.
6. If failed in termination of early pregnancy by the administration of Mifepristone, induced abortion must be held.
[Pregnancy or in lactation]
Except for the women for terminating early-pregnancy, it is inhibited for other pregnant women. The women in lactation should use this medicine carefully.
[Interaction of medicine]
The patient can't administrate aspirin and other non-steroidal anti-inflammatory within one week after taking this medicine.
[Specification]
Each tablet contains 0.2mg of Misoprostol.
[Storage]
Keep in a sealed package, store in a dry place and protect from light.
[Validity Period]
24 months.
Co-packaged Mifepristone Tablet and Misoprostol Tablet
Combipack of Mifepristone 200 mg tablet and 4 tabs of Misoprostol 0.2 mg tablets.
Product list:
| Item |
Products Name |
Specification |
| 1 |
Mifepristone Tablets |
10mg |
| 2 |
Mifepristone Tablets |
25mg |
| 3 |
Mifepristone Tablets |
200mg |
| 4 |
Misoprostol Tablets |
0.2mg |
| 5 |
Levonorgestrel Tablets |
0.75mg |
| 6 |
Levonorgestrel Tablets |
1.5mg |
| 7 |
Levonorgestrel and Ethinylestradiol Tablets |
0.15mg and 0.03mg |
| 8 |
Levonorgestrel and Ethinylestradiol Tablets |
Triphasic |
| 9 |
Norethindrone and Ethinylestradiol Tablets |
0.6mg and 0.035mg |
| 10 |
Cyproterone Acetate and Ethinylestradiol Tablets |
2mg and 0.035mg |
| 11 |
Compound Ethinylestradiol Tablets |
Compound |
| 12 |
Compound Megestrol Acetate Tablets |
Compound |
| 13 |
Megestrol Acetate Tablets |
2mg |
| 14 |
Ethinylestradiol Tablets |
0.005mg/0.0125mg |
| 15 |
Norethindrone Tablets |
0.625mg/5mg |
| 16 |
Medroxyprogesterone Acetate Tablets |
2mg/4mg |
| 17 |
Megestrol Acetate Tablets |
160mg |
| 18 |
Methyltestosterone Tablets |
5mg |
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