Summary of product characteristic
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Indications, posology and method of administration
THERAPEUTIC INDICATIONS
Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs)-induced gastric ulcers in patients at high risk of complications from gastric ulcer, eg, the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol should be taken for the duration of NSAID therapy. Misoprostol has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months’ duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.
Abortion according to the “National Guidelines on Reproductive Health Care Services” issued with Decision No. 4128/QĐ-BYT dated July 29, 2016, by the Minister of Health.
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended adult oral dose of misoprostol for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used. Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol should be taken with a meal, and the last dose of the day should be at bedtime.
Abortion according to the “National Guidelines on Reproductive Health Care Services” issued with Decision No. 4128/QĐ-BYT dated July 29, 2016, by the Minister of Health.
Procedure for performing an abortion:
A. Abortion up to 9 weeks and from the 10th to the 12th week:
Up to 63 days of gestation:
- Administer 200 mg of mifepristone.
- 24 to 48 hours after taking mifepristone, place 800 mcg of misoprostol sublingually or buccally, either at the healthcare facility or at home, depending on the gestational age and the patient's preference. For gestation between the 8th and 9th week, misoprostol should be administered, and the miscarriage should be monitored at the healthcare facility.
- Healthcare professionals should select the timing for administering misoprostol to ensure convenience for the patient when assistance is needed.
From 64 to 84 days of gestation:
- Administer 200 mg of mifepristone.
- 24 to 48 hours after taking mifepristone:
- Insert 800 mcg of misoprostol vaginally at the healthcare facility.
- Administer 400 mcg of misoprostol sublingually every 3 hours, up to a maximum of 4 doses, until complete miscarriage occurs.
- If no miscarriage occurs after the 5th dose of misoprostol, administer an additional 200 mg of mifepristone, allow the patient to rest for 9-11 hours, and repeat the misoprostol regimen as above until miscarriage is completed.
- If miscarriage does not occur after two cycles of this regimen, switch to an alternative abortion method.
Monitoring and care: For patients monitored at healthcare facilities.
Monitoring in the first few hours after administering misoprostol:
- Monitor vital signs.
- Observe vaginal bleeding, abdominal pain (analgesics may be administered as needed), and side effects such as nausea, vomiting, diarrhea, and fever.
- Provide contraceptive options or refer the patient to a location offering contraceptive methods.
Follow-up after 2 weeks:
- Assess the effectiveness of the treatment.
- Complete miscarriage: conclude treatment.
- Incomplete miscarriage or retained pregnancy tissue:
- Administer 400 mcg of misoprostol sublingually or
- Administer 600 mcg of oral misoprostol, which may be repeated.
- Perform suction curettage.
- If the pregnancy continues to develop, either perform suction abortion or continue the medical abortion regimen if the patient desires and the gestational age permits.
- Note: If heavy bleeding occurs (soaking 2 thick sanitary pads within 1 hour and lasting for 2 consecutive hours), immediate re-examination is required.
B. Abortion from 13 weeks to 22 weeks of gestation:
From 13 to 18 weeks of gestation:
- Administer 200 mg of mifepristone.
- 24 to 48 hours after taking mifepristone, insert 400 mcg of misoprostol vaginally. Every 3 hours, administer 400 mcg of misoprostol sublingually or buccally until miscarriage occurs. If no miscarriage occurs after 5 doses of misoprostol, administer an additional 5 doses of 400 mcg of misoprostol the next day, every 3 hours. If miscarriage still does not occur, repeat the regimen on the third day. If no miscarriage occurs after 3 days, switch to an alternative method.
From 19 to 22 weeks of gestation:
- Administer 200 mg of mifepristone.
- 24 to 48 hours after taking mifepristone, insert 400 mcg of misoprostol vaginally. Every 3 hours, administer 400 mcg of misoprostol sublingually or buccally until miscarriage occurs. If no miscarriage occurs after 5 doses of misoprostol, administer an additional 5 doses of 400 mcg of misoprostol the following day, every 3 hours. If miscarriage still does not occur, switch to another method.
Care during the procedure:
- Monitor the patient’s general condition, pulse, blood pressure, temperature, vaginal bleeding, and abdominal pain (uterine contractions) every 3 hours. Once strong uterine contractions begin, monitor every 1.5 hours.
- Perform a vaginal examination to assess the cervix before each dose of medication.
- Provide analgesia as needed, either orally, intramuscularly, or intravenously.
- After the miscarriage and delivery of the placenta, administer uterotonics as needed. Consider uterine control with an intrauterine device (IUD) if necessary. Administer antibiotics prior to IUD placement.
- If the fetus has been expelled but the placenta remains in the uterus, continue monitoring for an additional hour. If the placenta has not expelled, administer 400 mcg of misoprostol sublingually or buccally to aid in expulsion. If the placenta still does not expel, perform manual removal using appropriate instruments.
- Properly manage the fetus, placenta, waste, and instruments.
Post-procedure monitoring and care:
- After expulsion of the fetus, monitor vaginal bleeding and uterine contraction every hour until discharge.
- Discharge the patient after at least 2 hours post-abortion, provided the patient’s condition is stable, vital signs return to normal, and vaginal bleeding is within acceptable limits.
- Prescribe antibiotics as necessary.
- Provide post-procedure counseling on appropriate contraceptive methods.
- Schedule a follow-up visit after 2 weeks.
- Provide contraceptive options or refer the patient to a location offering contraceptive services.
Renal impairment: Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200 mcg dose is not tolerated.
CONTRAINDICATIONS
History of hypersensitivity to misoprostol or any component of the medication, or other prostaglandins.
Absolute contraindications:
- Mitral valve stenosis, vascular occlusion, and a history of vascular occlusion.
- Adrenal disorders.
- Coagulation disorders or use of anticoagulants.
- Severe or moderate anemia.
- Allergic reactions to mifepristone or misoprostol.
Relative contraindications:
- Long-term systemic corticosteroid treatment.
- Hypertension.
- Acute genital tract infections (must be treated first).
- Congenital genital abnormalities (should only be performed in central hospitals).
- History of cesarean section; caution is required: reduce the misoprostol dose and increase the interval between doses (should only be done in specialized obstetric hospitals at the provincial or central level).
For indications to terminate pregnancy up to 9 weeks and from the 10th to the 12th week, abortion is absolutely contraindicated if:
- Ectopic pregnancy is diagnosed or suspected.
- Pregnancy at the site of a previous cesarean scar.
For indications to terminate pregnancy from the 13th to the 22nd week, abortion is absolutely contraindicated if:
- There is a previous cesarean section scar in the uterine body.
- Placenta accreta.
This information is for reference only. Please read the leaflet inside.
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