Mifepristone+Misoprostol

Innovator's Monograph

Pharmacology

Each Kit box contains 2 strips including 1 tablet of Mifepristone USP 200 mg and 4 tablets of Misoprostol BP 200 mcg. The pharmacology of Mifepristone and Misoprostol are given below:

Mifepristone: Mifepristone is a synthetic steroid with anti-progestational activity resulting from competitive interaction with progesterone at progesterone-receptor sites. Based on studies with various oral doses in several animal species, the compound inhibits the activity of endogenous or exogenous progesterone and the Menstrual Regulation (MR) results. During pregnancy, the compound sensitizes the myometrium to the contraction-inducing activity of prostaglandins.
Misoprostol: Misoprostol is a synthetic analog of prostaglandin E1. It causes myometrial contractions by interacting with specific receptors on myometrial cells. This interaction results in a change in calcium concentration, thereby initiating muscle contraction. By interacting with prostaglandin receptors, Misoprostol causes the cervix to soften and the uterus to contract, resulting in the expulsion of the uterine contents.

Uses of Mifepristone+Misoprostol

Mifepristone+Misoprostol Kit is indicated for menstrual regulation (MR) through 63 days of pregnancy from the first date of the last menstrual period. In other words, it is indicated for the termination of pregnancy up to the 9th week of gestation, early menstrual regulation.

Dosage and Administration

If a woman chooses menstrual regulation or pregnancy termination with a Mifepristone+Misoprostol kit, she must take Mifton at the first visit to a medical professional. After 24-48 hours, she will take Misotol between the cheek and gum or under the tongue, either at home or in the clinic. 10 to 14 days after taking Mifton, she will return to her doctor for confirmation. Follow the steps:

First Day: (In front of the doctor) Take the first tablet of Mifton (Mifepristone) orally and Take plenty of water.
Second Day: (At home) Place Misotol (Misoprostol) tablets (2+2) on both sides of the cheek & gum or 4 tablets under the tongue, Wait for 30 minutes. After that, swallow the remaining part of 4 tablets. If you have pain in the lower abdomen, take Ibuprofen/Naproxen tablets 4 - 6 hourly. The best choice is to contact your doctor.
10 - 14th Day: If you have lower abdominal pain take one Ibuprofen/Naproxen. For confirmation of complete recovery, contact your doctor. 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 is recommended to manage Menstrual Regulation (MR)/termination of pregnancy failures.

Interaction

Mifepristone:

With Medicine: Although specific drug or food interactions with Mifepristone have not been studied, on the basis of this drug's metabolism by CYP3A4, it is possible that ketoconazole, itraconazole, and erythromycin.
With Food and Others: Grapefruit juice may inhibit its metabolism (increasing serum levels of Mifepristone).

Misoprostol:

With Medicine: Misoprostol has not been shown to interfere with the beneficial effects of aspirin and the signs and symptoms of rheumatoid arthritis. Misoprostol does not exert clinically significant effects on the absorption, blood levels and antiplatelet effects of therapeutic doses of aspirin.
With Food and Others: There is no interaction with food.

Contradiction

Allergy to Mifepristone or Misoprostol, adrenal insufficiency, current steroid use, coagulopathy or anticoagulant use, IUD in place, no access to follow-up.

Side Effects of Mifepristone+Misoprostol

Vaginal bleeding and cramping are normal. These symptoms are often described as similar to a long, intense menstrual period with cramping. Side effects may include-

Nausea,
Vomiting,
Diarrhea,
Headache,
Chills,
Shivering and transient fever lasting less than a day.

Pregnancy

Mifepristone and Misoprostol combination is indicated for Menstrual Regulation (MR) (through 63 days of pregnancy) and has no other approved indication for use during pregnancy.

Lactation

Freston (Mifepristone): It is not known whether Mifepristone is excreted through human milk. Many hormones with a similar chemical structure, however, are excreted in breast milk. Since the effects of Mifepristone on infants are unknown, breastfeeding women should consult with their doctor to decide if they should discard their breast milk for a few days following the administration of the medications. Miptol (Misoprostol): Although it is not known whether Misoprostol is excreted through human milk, Misoprostol should not be administered to nursing mothers because the potential excretion of misoprostol acid could cause diarrhea in nursing infants.