Misoprostol: Misoprostol is a synthetic analogue of prostaglandin E1. It causes myometrial contractions by interacting with specifc receptors on myometrial cells. This interaction results in a change in calcium concentration, thereby initiating muscle contraction. By interacting with prostaglandin receptor, Misoprostol causes the cervix to soften and the uterus to contract, resulting in the expulsion of the uterine contents.
Dosage & Administration
and to diagnose ectopic pregnancies. Physicians must also be able to provide surgical intervention in cases of incomplete abortion or severe bleeding, or have made plans to provide such care through others, and be able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.
Day One: One 200 mg tablet of Mifepristone is taken in a single oral dose.
Day Two: The patient will take four 200 µg tablets (800 µg) of Misoprostol buccaly within 24-48 hours after ingesting Mifepristone at home. She should wait for 30 minutes. During the period immediately following the administration of Misoprostol, the patient may need medication for cramps or gastrointestinal symptoms. The patient should be given instructions on what to do if signifcant discomfort, excessive vaginal bleeding or other adverse reactions occur and should frequently communicate with physician.
Day 14: Post-Treatment Examination Patients will return to a clinic or hospital under the supervision of the concerned physician for a follow-up visit approximately 14 days after the administration of Mifepristone. This visit is very important to confrm by clinical examination or ultrasonographic scan that a complete termination of pregnancy has occurred. Persistence of heavy or moderate vaginal bleeding at this visit, however, could indicate an incomplete abortion.
Patients who have an ongoing pregnancy at this visit have a risk of fetal malformation resulting from the treatment. Surgical termination is recommended to manage medical abortion treatment failures or as directed by the physician.
Misoprostol: Misoprostol has not been shown to interfere with the benefcial efects of aspirin on signs & symptoms of rheumatoid arthritis. Misoprostol does not exert clinically signifcant efects on the absorption, blood levels and antiplatelet efects of therapeutic doses of aspirin.
- Confrmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the
- treatment procedure will not be efective to terminate an ectopic pregnancy)
- IUD in place
- Chronic adrenal failure
- History of allergy to Mifepristone, Misoprostol or other prostaglandin
- Hemorrhagic disorders or concurrent anticoagulant therapy
Misoprostol: Gastro-intestinal side effects like diarrhea, abdominal pain, nausea, flatulence, dyspepsia, headache, vomiting and constipation, shivering, hyperthermia, dizziness, pain due to uterine contractions, severe vaginal bleeding, shock, pelvic pain, uterine rupture (requiring surgical repair, hysterectomy and/or salpingo-oophorectomy).
Pregnancy & Lactation
It is not known whether Mifepristone is excreted in human milk. Many hormones with a similar chemical structure, however, are excreted in breast milk. Since the efects of Mifepristone on infants are unknown, breast-feeding women should consult with their health care provider to decide if they should discard their breast milk for a few days following administration of the medications
Misoprostol: Clinical signs that may indicate an overdose are sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhoea, fever, palpitations, hypotension or bradycardia. Symptoms should be treated with supportive therapy. However, because Misoprostol is metabolized like a fatty acid, it is unlikely that dialysis should be appropriate treatment for overdosage.
Use in Special Population
Pediatrics (less than 18 years of age): There are insufficient data in patients less than 15 years old to establish efficacy and safety.