Generic Name

Mifepristone + Misoprostol

Precaution

Mifepristone + Misoprostol must not be administered if there is doubt as to the existence or age of the pregnancy or if an extra-uterine pregnancy is suspected. An ultrasound scan and/or measurement of Beta-hCG must be performed before administration. For first trimester abortions, Mifepristone is contraindicated if the pregnancy is beyond 49 days of amenorrhoea when used with Misoprostol. Mifepristone + Misoprostol should never be prescribed in patients with chronic adrenal failure, known allergy to Mifepristone or to any component of the product, severe asthma uncontrolled by corticosteroid therapy, porphyrias and renal failure, liver failure or malnutrition, or during breast feeding. Patients w/ conditions that predispose to diarrhoea (e.g. inflammatory bowel disease); CV disease; disease states where hypotension may precipitate severe complications (e.g. cerebrovascular disease, coronary artery disease or severe peripheral vascular disease including HTN). Patients in whom dehydration would be dangerous. Renal impairment. Lactation. Monitoring Parameters Conduct pregnancy test in women of reproductive potential prior to therapy. Monitor uterine activity and foetal condition when used for labour induction.

Indication

Termination of pregnancy upto 9th week(63 days) of gestation, Early menstrual regulation.

Contra Indication

Confirmed or suspected ectopic pregnancy, chronic adrenal failure, concurrent long-term corticosteroid therapy, history of allergy to mifepristone, misoprostol or other prostaglandin, haemorrhagic disorders or concurrent anticoagulant therapy, porphyria, hepatic or renal impairment; pregnancy and lactation; IUD in place; undiagnosed adnexal mass.

Dose

N/A

Side Effect

Mifepristone: The treatment is designed to induce the vaginal bleeding and uterine cramping necessary for menstrual Regulation (MR). Commonly reported side effects were nausea, vomiting and diarrhea, pelvic pain, fainting, headache, dizziness and asthenia occurred rarely. 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 Category

Mode of Action

Mifepristone is a progesterone antagonist with antiglucocorticoid activity. It binds to the intracellular progesterone receptor where it competitively inhibits progesterone attachment. It is also a partial progesterone agonist. Misoprostol, a synthetic prostaglandin E1 analogue, exerts its antisecretory activity by directly acting on specific prostaglandin receptors found on the surface of gastric parietal cells. It exerts its protective effects on the mucosa by replacing the prostaglandins consumed during prostaglandin-inhibiting therapies e.g. NSAIDs.

Interaction

Decreased efficacy with aspirin and NSAIDs. Efficacy of corticosteroids (including inhaled) decreased, monitor patients during co-admin and for several days afterwards. May increase effects of oxytocin. Increased risk of misoprostol-induced diarrhoea with magnesium-containing antacids.

Pregnancy Category Note

N/A

Adult Dose

Day 1 (First visit): Mifepristone administration Day 1 One tablet of Mifepristone (200 mg) is taken in a single oral dose under the supervision of a qualified medical professional in a clinic, medical office or hospital. Day 2 (second visit): Misoprostol administration 24-48 hours after ingesting of Mifepristone tablet, the patient takes 4 tablets of 200 microgram (800 micrograms) of Misoprostol buccally. Misoprostol tablets can be administered by the patient herself (place two tablets on each side of cheek & gum). She should wait for 30 minutes. During the period immediately following the administration of Misoprostol, the patients may need medication for cramps or gestational symptoms. The patient should be given a phone number to call if she has questions following the administration of Misoprostol. Day 10 to 14 Patients must return to the clinic, medical office or hospital within 10 to 14 days after the administration of Mifepristone. This visit is very important to confirm by clinical examination or ultrasonographic scan that a complete termination of pregnancy has occurred. Patients who have an ongoing pregnancy at this visit have a risk of fetal malformation resulting from the treatment. Surgical termination/MVA (Manual vaccum Aspiration) is recommended to manage Menstrual Regulation (MR)/termination of pregnancy failures.

Child Dose

N/A

Renal Dose

N/A

Administration

N/A