[Drug name]

Generic Name: Misoprostol Tablets

English Name: Misoprostol Tablets

[Ingredients]

The major component of this product is Misoprostol

Chemical Name: (±) methyl 11α, 16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate

[Description] This product is a white or almost white tablet.

[Indication]

Using sequentially and combining with Mifepristone can terminate early-pregnancy which is within 49 days after menolipsis.

[Strength] 0.2mg

[Usage and dosage]

36-72 hours after administering 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.    The women who have heart, liver and kidney disease or dysfunction of adrenal cortex.

2.    The women who have abstinence diseases for prostaglandin, such as glaucoma, asthma and hypersensitive body constitution.

3.    The pregnant women who use intrauterine device or doubted ectopic pregnancy.

[Precautions]

1.  When using for terminating early pregnancy, Misoprostol must used with Mifepristone together and can’t be used alone.

2.  When combining with Mifepristone, it should be used under the doctor’s instruction. It can only be used in the units that have the condition of emergency uterine curettage, transfusion and blood transfusion under the doctor’s supervision. This medicine can’t be sold over the counter.

 3. Before administration, the patient should be informed the curative effect and adverse reactions 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 administer misoprostol tablet according to the regulation. After administration, about 80% women discharge villous placenta within 6 hours and about 10% women discharge 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 ongoing pregnancy is confirmed.

6. If failed in termination of early pregnancy by the administration of misoprotol, it must be terminated by induced abortion.

[Usage for women in 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.

[Usage for children] No data available.

[Usage for aged people] No data available.

[Drug interactions]

The patient can’t administer aspirin and other non-steroidal anti-inflammatory within one week after taking this medicine.

[Overdose] No data available.

[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 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.

[Storage] Store in a dry place, sealed and protect from light.

[Packing]

Packaged with aluminum foil and aluminum foil blister

3 tablets per blister strip and 1 blister strip per box.

[Shelf Life]
24 months

[Specification]

WS₁-(X-037)-2005Z

[Product Licence Number] Guoyaozhunzi H20000668

[Manufacturer]

Name:  Beijing Zizhu Pharmaceutical Co., Ltd.

Manufacture site: No. 27, Chaoyang North Rd, Chaoyang District, Beijing

Postal code: 100024

Hotlines:

0086-10-62240419, 0086-10-62262389 (after-sales service)

0086-10-65483355-2221 (production)

Fax: 0086-10-62219316

Website: http:// www.zizhu-pharm.com