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Sunmedabon is a combination drug Mifepriston and Misoprostol. Sunmedabon is indicated for the termination of pregnancy under 22 weeks. The following article will provide you with information on how to use Sunmedabon safely and effectively.
1. What does Sunmedabon do?
Sunmedabon is a combination pack consisting of 1 Mifepriston 200mg tablet and 4 Misoprostol 200mcg tablets. Sunmedabon is available in the form of uncoated tablets.
Mifepriston:
Mifepriston is a synthetic steroid with anti-progesterone effects by competing with progesterone at the progesterone receptor.
At oral doses of 3 to 10 mg/kg, Mifepriston inhibits the activity of endogenous or exogenous progesterone in various animal species (such as rats, rabbits, monkeys). This effect has been shown to terminate pregnancy in rodents.
For women taking doses greater than or equal to 1mg/kg, Mifepriston inhibits the effect of progesterone on the uterine lining and uterine muscle. During pregnancy, Mifepriston increases the sensitivity of uterine contractions as a result of the use of prostaglandins. Maximum effect when using prostaglandin 36-48 hours after using Mifepriston.
Mifepriston is shown to soften and dilate the cervix after 24 hours and increase up to 36 to 48 hours after administration.
Mifepristone binds to the glucocorticoid receptor. In animals, at doses ranging from 10 to 25 mg/kg, Mifepriston inhibited the activity of dexamethasone. In humans, anti-glucocorticoid effects have been demonstrated at doses equal to or greater than 4.5 mg/kg by compensatory increases in ACTH and cortisol. The biological activity of glucocorticoid bioactivity (GBA) can be inhibited for several days following a single 200 mg dose of Mifepriston for termination of pregnancy. The clinical relevance of this inhibition is unclear, but may cause increased nausea and vomiting in susceptible women. Mifepriston has a mild anti-male hormone effect and is only present in animals with prolonged use at very high doses.
Misoprostol:
Misoprostol is a synthetic prostaglandin E1-like substance. At the recommended dose, Misoprostol induces contractions of the smooth muscles of the uterus and dilates the cervix. The tone-enhancing effect of Misoprostol will open the cervix and push out the fetus.
Using Misoprostol vaginally or sublingually will have a lasting effect on the uterine muscles and cause regular uterine contractions afterward.
In the case of early termination of pregnancy, using a prostaglandin-like combination after mifepriston has been used increases the success rate and improves the expulsion rate. In a clinical trial of the World Health Organization, the success rate was 93.9 - 95.4% when using 200mg of Mifepriston in combination with vaginal or sublingual 800mcg Misoprostol to terminate pregnancy until the end of the week. 22nd from the last menstrual period. The failure rate ranges from 4.6 to 6.1% of the total cases, of which 0.3 to 1.1% continues to develop and 2.8 to 4.3% has an incomplete miscarriage. .
2. Indications and contraindications of the drug Sunmedabon
Indication of the drug Sunmedabon:
The drug Sunmedabon can only be prescribed and used according to the "National Guidelines for Reproductive Health Services" issued together with Decision No. 4128/QD-BYT dated 29 July 2016 by the Minister of Health. Sunmedabon is indicated for intrauterine termination of pregnancy with gestational age up to the end of the 22nd week. Absolute contraindications:
Allergy to Mifepriston, Misoprostol or any ingredient of the drug. History of allergy to prostaglandins. Mitral stenosis, history of embolism, embolism. Severe asthma not controlled by treatment. Adrenal gland disease. Hereditary disorders of porphyrin metabolism. Pregnancy has not been confirmed by clinical examination, ultrasound or laboratory testing. Blood clotting disorder, currently taking anticoagulants. Anemia (severe and moderate). Confirmed or suspected ectopic pregnancy, pregnancy in old uterine scar. Placenta comb teeth. Relative contraindications:
Long-term systemic corticosteroid therapy. Hypertension . Having an acute infection of the genital tract, which needs to be treated. Genitourinary malformations (in this case, drugs can only be used at the central level). Patients with old uterine scars should be cautious: Reduce the dose of Misoprostol and increase the time interval between doses (only at central or provincial hospitals). Sunmedabon is contraindicated in women who have had their genitals removed unless a trained physician examines and screens for any anatomical abnormalities that interfere with medical abortion.
There are no data but Sunmedabon is contraindicated for women under 16 years old. In these cases, vacuum aspiration can be performed.
When there is an emergency, it is very important to access appropriate medical services, this method will not be indicated if the user does not have access to medical facilities with sufficient means to conduct an abortion surgery in the case of incomplete abortion or emergency blood transfusion or resuscitation from the first visit to the completion of the termination procedure. This entire process must be performed by qualified medical personnel.
Patients should not take Sunmedabon if they do not understand the effects of the drug break or do not adhere to treatment.
3. How to take Sunmedabon
Sunmedabon should only be prescribed by qualified medical personnel who know how to assess gestational age and diagnose ectopic pregnancy. Qualified medical personnel must also be qualified to perform surgical interventions in the event of an incomplete miscarriage or heavy bleeding. Caregivers and patients must have access to medical facilities that are qualified for blood transfusion and resuscitation. Patients should be consulted for medical abortion by qualified medical staff before proceeding.
Counseling for the patient includes:
Introduction to the medical abortion process: How to take the pill and normal symptoms after taking the pill (vaginal bleeding, abdominal pain). It is necessary to re-examine 1 to 2 weeks after taking the drug. Advise patients on self-monitoring and post-abortion care. Pay special attention to symptoms that require immediate medical attention. Prescribe pain relievers. Provide contact information in an emergency situation. Counseling about the possibility of becoming pregnant again after a medical abortion. Introduce contraceptive methods, help users choose the right method and guide users to use them. Hormonal methods of contraception can be started as soon as a medical abortion is completed. The IUD can be inserted when it is certain that the patient is no longer pregnant and there are no contraindications.
4. Implementation Process
Abortion to the end of 9 weeks and from the 10th to the end of 12 weeks:
Pregnancy to the end of 63 days: Take 200mg of Mifepriston. After taking Mifepriston from 24 to 48 hours, take under the tongue or on the cheek 800mcg Misoprostol at a medical facility or at home depending on the gestational age and the user's wishes. Gestational age from 8 weeks to the end of 9 weeks should use Misoprostol and monitor miscarriage in medical facilities. Medical staff should choose the time to use Misoprostol to facilitate the user when needing support. Pregnancy from 64 to 84 days. Take 200mg of Mifepristone. After taking Mifepriston from 24 - 48 hours: Insert the same vaginal bag 800mcg Misoprostol at a medical facility. Misoprostol 400mcg sublingually every 3 hours, up to a maximum of 4 doses until complete abortion. If after 3 hours after taking the 5th dose of Misoprostol without miscarriage, continue taking 200mg of Mifepriston, give the user a break of 9-11 hours, repeat the Misoprostol doses as above until miscarriage. If after 2 times following the above regimen, there is still no miscarriage, then switch to another method of abortion. Monitoring and taking care of users: Monitoring in the first hours after taking Misoprostol: Vital signs; Vaginal bleeding, abdominal pain and side effects symptoms; provide contraception to the patient or advise where contraception is to be provided. Re-examination after 2 weeks: Complete miscarriage: end of treatment. Incomplete or residual miscarriage: 400mcg Misoprostol sublingually or 600mcg Oral Misoprostol, can be repeated. In some cases, it is possible to aspirate the uterus. The fetus continues to grow, can abort or continue the medical abortion process if the user wishes and within the allowed age limit. Note: If there is a lot of bleeding (wetting 2 thick tampons in 1 hour and lasting 2 hours in a row) must be examined immediately.
Abortion from week 13 to the end of week 22:
Gestational age from 13 to 18 weeks: Take 200mg of Mifepriston (1 tablet). After 24 - 48 hours, insert the bag with the vagina Misoprostol at a dose of 400mcg (2 tablets). Every 3 hours, sublingual or buccal 400mcg Misoprostol (2 capsules) until miscarriage. If after 5 doses of 400mcg Misoprostol every 3 hours sublingual or buccal until miscarriage. If there is no miscarriage, continue using Misoprostol on the 3rd day according to the above regimen. After 3 days without miscarriage, use another method. Gestational age from 19 to 22 weeks: Take 200mg of Mifepriston (1 tablet). After 24 - 48 hours insert the bag with the vagina 400mcg Misoprostol (2 tablets). Every 3 hours, sublingual or buccal 400mcg Misoprostol until miscarriage. If after 5 doses of Misoprostol there is no miscarriage, then the next day take another 5 doses of 400mcg Misoprostol every 3 hours under the tongue or in the cheek until miscarriage. If there is no miscarriage, use another method. Intra-procedural care: Monitor overall status: blood pressure, pulse, temperature, vaginal bleeding, and abdominal pain (uterine contractions) every 3 hours, when strong uterine contractions begin every 3 hours. 1.5 hours/time. Vaginal examination of the cervix before each administration of the drug. Give pain medication orally, intramuscularly, or intravenously if necessary. After miscarriage and placenta: the patient can be given drugs to increase uterine contractions if needed. Instrumental uterine control is indicated (if necessary) and antibiotics are given to the patient prior to uterine control. If the placenta has been removed and the placenta is still in the uterus, monitor for another 1 hour, if the placenta is still not delivered, add 400mcg Misoprostol under the tongue or on the cheek to help the placenta pass. If the placenta does not pass, the placenta is removed by instrument. Handling fetus, placenta, waste and instruments. Monitoring and care: After pregnancy, monitor vaginal bleeding, uterine contractions at least every 1 hour, until discharge. Discharge from the hospital at least 2 hours after giving birth, if the patient's health is stable with normal vital signs and vaginal bleeding at an acceptable level. Prescribe antibiotics if needed. Counsel the patient after the procedure about appropriate contraception. See you again in 2 weeks. Provide contraception or refer to a birth control site. Sunmedabon overdose and treatment:
There are no reports of Sunmedabon overdose cases. In the case of careless use of many Sunmedabon drugs, there may be signs of adrenal insufficiency. Signs of acute poisoning may require special treatment, including the administration of dexamethasone.
5. Cases of caution when using Sunmedabon
Patients with prosthetic heart valves or a history of endocarditis require pharmacological prophylaxis.
This treatment requires the active participation of the woman and she must be informed of its requirements:
The need to incorporate Misoprostol at the 2nd visit. It is necessary to have a follow-up visit (3rd visit) within 10-14 days after taking Mifepriston to check for a complete miscarriage. The possibility of method failure from which another method of termination may be necessary. In case of IUD pregnancy, the IUD should be removed before taking Mifepriston.
Pregnancy can be miscarried before Misoprostol is used (about 1 to 2% of total cases). In such cases, the woman still has to come back for a check-up to make sure the pregnancy has completely miscarried.
6. Hazards associated with the method
Failure:
The risk of failure is undeniable, about 4.6 - 6.1% of all cases, making a follow-up visit mandatory to check for a complete miscarriage . Users should be informed that surgical methods can be used to complete an abortion, but this is unlikely. Bleeding:
Users should be informed of possible prolonged double bleeding (average of about 13 days after taking Mifepriston up to 3 weeks in some women). In some cases, there may be heavy bleeding that requires surgical removal of the uterus. Most failed cases also bleed and it is not evidence of complete termination of pregnancy. A follow-up visit should be performed between the 10th and 14th day after administration of Mifepriston, using appropriate means (clinical examination, ultrasound or beta-hCG test) to determine if pregnancy has occurred. Has the miscarriage completely stopped and has the bleeding stopped or has decreased significantly? If there is still bleeding (even light bleeding) at the follow-up visit, the test should be repeated a few weeks later. If further development is suspected, further ultrasound should be performed to assess fetal status. Continued bleeding at this time may signal a missed pregnancy or an ectopic pregnancy cannot be ruled out, in which case further treatment or testing should be considered. In the event that the follow-up examination finds that the pregnancy continues to develop, the patient should be advised to proceed with the termination of the pregnancy by another method. Since there are still 0.2 to 1.8% of total medical abortions with heavy bleeding requiring hemostasis, extreme caution should be exercised in users with blood abnormalities such as coagulopathy or anemia. . Bacterial infections:
The genital tract is susceptible to retrograde infection when the cervix is dilated after a miscarriage or childbirth. There are few data on pelvic inflammatory disease with specific clinical signs after medical abortion, but this complication is rare. Many of the symptoms of pelvic inflammatory disease are nonspecific and therefore difficult to make an accurate diagnosis. Women with clinical signs such as pelvic pain, abdominal or adnexal pain, abnormal vaginal discharge, or fever should be treated with broad-spectrum antibiotics. Rare cases of anaerobic infection after medical abortion without fever. With the reported cases, the patient had only mild fever or no fever, nausea or not, weakness, abdominal pain; rapidly worsening within hours or days; tachycardia and hypotension; heavy bleeding; increased erythrocyte sedimentation rate and white blood cell count. These patients suffered from Clostridium sordellii-associated toxic shock. Other risks:
Pregnancy-related symptoms such as nausea and vomiting may increase after taking Misoprostol, but these symptoms will decrease and disappear during the miscarriage. Lower abdominal pain and cramping are common symptoms and are related to the effects of misoprostol and the process of miscarriage. If pain continues after a miscarriage, the cause of the pain should be evaluated. Diarrhea is a common side effect associated with misoprostol use and usually does not require treatment. Some patients experience chills or hyperthermia after taking Misoprostol. Other risks of using Sunmedabon are similar to those of surgical abortion. With regard to the identification of the Rh factor and the prevention of Rh- allele immunity, general measures should be taken when using Mifepriston for pregnancy termination. Any reproductive tract infection must be treated before an abortion with Sunmedabon is indicated. During clinical trials, there were cases of re-pregnancy after abortion and before menses returned. To avoid the possibility of pregnancy again, after using Mifepriston, it is recommended to avoid pregnancy immediately after a miscarriage. Therefore, it is necessary to start using a reliable method of contraception after using Misoprostol.
7. Be careful when using drugs
In case of suspected acute renal failure, dexamethasone should be used, 1mg of dexamethasone neutralized 1 dose of 400mg of Mifepriston. Theoretically, the effectiveness of the method could be reduced due to the anti-prostaglandin properties of non-steroidal anti-inflammatory drugs, including Aspirin. There is limited evidence that concomitant use of nonsteroidal anti-inflammatory drugs and prostaglandins will not affect the effect of mifepristone or prostaglandins on cervical softening or uterine contractions and does not reduce clinical efficacy. of medical abortion. Although rare, cardiovascular effects have been reported following intramuscular prostaglandin administration. For this reason, patients with cardiovascular risk factors or with cardiovascular disease should be cautious when prescribing Sunmedabon for abortion. When the patient is discharged from the hospital, it is necessary to provide all necessary drugs and give full advice on possible signs and to be able to access the medical facility by phone or come in person. There are no adequate clinical data demonstrating the potential for fetal malformations when Misoprostol is administered vaginally or sublingually during pregnancy. However, in some cases of self-administration of Misoprostol for self-abortion, adverse effects of Misoprostol have been reported including: malformations of limbs, cranial nerve malformations (abnormalities in sucking, swallowing and eye movements). To date, the risk of malformation has not been ruled out. Mifepriston may theoretically be excreted in human milk. Sunmedabon should not be used by women who are breastfeeding.
8. Undesirable effects of the drug Sunmedabon
Urological - genitourinary:
Bleeding: Heavy bleeding occurs in about 5% of cases and may require curettage and blood transfusion in about 1.8% of cases. Uterine contractions and cramping are common in 70-80% of cases, usually within a few hours of taking Misoprostol. During second-trimester abortion or induction of labor to expel a dead fetus in the third trimester, uterine rupture is not common after prostaglandin administration but is particularly common in women with multiple births or women. old cesarean scar. Post-abortion infections: suspected or confirmed bacterial infections (endocarditis, pelvic inflammatory disease) have been reported in less than 1% of all women using Sunmedabon. Very few cases of shock have been reported from toxic effects of Clostridium sordellii endocarditis, without fever or other obvious signs of infection. Gastrointestinal:
May experience cramping, mild or moderate pain (common). Nausea, vomiting, diarrhea. Hypersensitivity and skin reactions:
Rarely skin pruritus, urticaria, skin redness, epidermal dermatitis, erythema in some cases. Other symptoms:
Low blood pressure; Rarely headache, malaise, vagal symptoms, fever.
9. Drug interactions
No interaction studies have been performed with a single dose. On the basis of the metabolism of Mifepristone by CYP3A4, it is possible that drugs such as Ketoconazole, Itraconazole, Erythromycin and grapefruit juice will inhibit the metabolism of Mifepristone, resulting in increased serum concentrations of Mifepristone. Rifampicin, Dexamethasone and some anticonvulsants (Phenytoin, Phenobarbital, Carbamazepine) may increase the metabolism of Mifepristone, reducing the serum concentration of Mifepristone.
Based on in vitro inhibition results, concomitant use of Mifepristone may increase serum concentrations of CYP3A4-derived drugs. Due to the slow elimination of Mifepristone by the body, this interaction can persist for a long time after use. Caution should be exercised when mifepristone is used with drugs of CYP3A4 origin and with a narrow therapeutic range, including some agents used in general anesthesia.
Above is information about uses, doses and precautions when using Sunmedabon. To ensure safety for your health and maximize the effectiveness of your treatment, you need to take Sunmedabon exactly as directed by your doctor.
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