Mifepristone

Detailed information about Mifepristone

Mifepristone - Summary of Product Characteristics

Mifepristone – also known as: mifegyne 200 mg tablets, mifepristone 200 mcg, RU-486 tablet

Pharmacological form – ooval or hexagonal tablet, white or yellow in color.

Clinical data – mifepristone can be used to terminate a pregnancy performed up to 12 weeks

Indications for use

If a pregnancy is terminated in the uterus, mifepristone should in this case be administered with the appropriate dose of misoprostol. A method that can be carried out by a woman herself at home.
Cervical softening and dilatation prior to surgical abortion in during the first trimester of pregnancy. The method used by the doctor.
Preparation for the action of prostaglandin analogues in the procedure of termination of pregnancy with for health reasons that occur after the end of the first trimester. The method used by the doctor.
Artificial induction of labor after intrauterine fetal death. The method used by the doctor.

Scientific characteristics of mifepristone containing medicinal products

Mifepristone is an anti-progestogenic chemical which competes with progesterone * to attach to progesterone receptors. This means that the drug is effective to inhibit the production of progesterone. Also known as RU-486, it belongs to the new generation products.

Progesterone is a female sex hormone, produced mainly by the luteal cells during the luteal phase (one of the phases of a woman’s menstrual cycle) and in early pregnancy, and through the placenta during later pregnancy. It is one of the most important hormones secreted by the ovaries and is responsible for the maintenance of pregnancy.

When given to women in doses of 1 mg / kg or higher, mifepristone prevents the effects of progesterone responsible for the rebuilding of the lining of the womb (the endometrium). During pregnancy, progesterone also sensitizes the muscle of the uterus to the artificially induced contractions of prostaglandins. It is the prostaglandin that stimulates uterine contractions during labor. Progesterone is necessary for the proper development of the endometrium, which underlies the development of pregnancy and the developing embryo, and then the baby. For this reason, these hormones are often administered to induce or accelerate labor, both intravenously and locally, into the cervical canal.

After taking the RU-486 abortion pill progesterone is blocked, and the endometrium is no longer able to develop the fetus, which if not nourished, dies and is excreted from the reproductive organs. The action of mifeprostone causes this medicine to be considered one of the methods used to induce labor. In the event of premature termination of pregnancy, the combination of a prostaglandin analog (misoprostol) following mifepristone leads to successful termination of pregnancy in approximately 98% of cases.

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Dosage and method of taking

Mifepriston tabletki 10mg
When terminating a developing pregnancy in the uterus, take 200 mg mifepristone orally followed by plenty of water. After 24 hours take misoprostol 600 mcg orally (3 tablets of 200 mcg each). After 3 hours, another dose of 600 mcg misoprostol orally should be administered (3 tablets of 200 mcg each).

Contraindications to the use of mifepristone

Chronic renal failure.
Liver failure.
Hypersensitivity to the active substance or to any of the excipients contained in the drug.
Severe asthma, also uncontrolled with medication.
Hereditary porphyria in any variety (a group of diseases related to the metabolism of the human body, the most common form of the disease is characterized by hypersensitivity to sunlight).
Pregnancy that has not been confirmed by ultrasound or biological tests.
A pregnancy lasting more than 12 weeks.
Suspicion of an ectopic pregnancy.

Risks and additional recommendations associated with the use of mifepristone

Failure of the method – in about 2 percent of cases there is a risk of unsuccessful termination of pregnancy. A follow-up visit is required after the use of drugs to be sure that the fetus has been completely removed from the genital organs.
Bleeding – prolonged vaginal bleeding occurs after taking mifepristone (average
for 14 days or more). It is characterized by a significant degree of intensity. Bleeding occurs in almost all cases. However, this fact does not confirm the complete expulsion of the fetus. For this reason, women should remain in close proximity to a medical facility after taking mifepristone if they experience any problems, especially severe vaginal bleeding, if they experience any problems.
Within 14 to 21 days of taking mifepristone, the woman should undergo a follow-up visit to check by appropriate means (physical examination, ultrasound, or beta-HCG measurement) that the fetus has completely expelled and has stopped bleeding. Prolonged vaginal bleeding may mean, for example, an incomplete miscarriage or an undiagnosed ectopic pregnancy. Such situations require proper treatment.
IUD – if you become pregnant while using an IUD, the use of mifepristone requires prior removal of the IUD.
Blood group with Rh factor – The use of mifepristone does not require prior determination of the presence of the Rh factor, and thus, the prevention of the process of producing antibodies after immunization with an antigen from another individual of the same species. However, it is good to have such knowledge.

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Other information about mifepristone

Pharmacokinetic properties of mifepristone

After a single oral administration of mifepristone, the drug is absorbed after approximately 1.3 hours. Mifepristone is excreted 90% via the faeces. The rest of the substance is eliminated from the body in the urine.

Side effects

Disorders of the genitourinary system.
Too much bleeding.
Too frequent uterine contractions.
Infections following a miscarriage, including endometritis, pelvic inflammatory disease.
A pharmacological abortion in which a woman has ingested 200 mg of mifepristone and misoprostol tablets vaginally (which is not recommended) may cause fatal toxic shock due to mucositis. Oral administration of misoprostol is essential.
Gastrointestinal disorders.
Hypotension (rare).
Hypersensitivity and skin disorders (skin rashes, hives).
Very rarely, exfoliative dermatitis, erythema nodosum and epidermal necrolysis.
Sudden hot flushes with facial flushing, dizziness and chills.
If you accidentally swallow too much medicine, symptoms may occur
adrenal insufficiency or acute poisoning

Mifepristone – taking with other medications

Medicines that may affect the operation of mifepristone contain the following active substances:

ketoconazole, itraconazole (medicines to treat mycoses),
erythromycin, rifampicin (antibiotics),
St. John’s wort (a natural remedy usually used to treat mild depression),
phenytoin, phenobarbital, carbamazepine (medicines to treat seizures and epilepsy).

Mifepristone – taking with other foods

Do not drink grapefruit juice while you are taking and working with mifepristone.

Pregnancy, breastfeeding and re-pregnancy

Mifepristone may pass into the milk and thus enter the baby’s body together with the food. Breastfeeding is not recommended during the treatment. It is recommended that after taking the abortion pill mifepristone a woman should not become pregnant again during the same menstrual cycle.

How to prepare for an abortion with mifepristone and misoprostol

Before the procedure, it is worth preparing:

a supply of large pads,
painkillers (e.g. paracetamol, ibuprofen, pyralgin, ketonal), you must NOT use antispasmodics,
a warm blanket in case of chills,
a hot water bottle or a bottle of warm water,
drinking water,
something light to eat.

In order to accelerate the miscarriage, it is also worth taking care of some activity – preferably in movement. In the case of nagging ailments and heavy bleeding, it is good to lie down and focus on your thoughts, e.g. with a book or film. It is also worth taking care of your psychological comfort by ensuring the company of a person during the procedure, in whom the woman feels good. Before and during the abortion, the woman should eat and drink (adequate hydration is very important in cases of heavy bleeding). One of the side effects may be vomiting. For this reason, the meal should be light. You must not drink alcohol or take drugs during the procedure. There are no contraindications for smoking.

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History of the discovery of mifepristone

In April 1980, the compound initially designated RU-486 was synthesized by the French chemist Georges Urbain. Initially, the drug was to be used in the treatment of Cushing’s syndrome *.

Cushing’s syndrome – a group of disease symptoms associated with the presence of an increased level of the steroid hormone produced by the band layer of the adrenal cortex in the blood serum. The most common cause of Cushing’s syndrome is long-term administration of glucocorticoids to treat other diseases.

However, the obtained chemical compound turned out to be much more effective in blocking the action of structurally related progesterone receptors. It took a long time before researchers investigating the clinical application of RU-486 were able to determine the mode of action of this formulation.

Mifepristone molecular structure

In the initial period, it was recommended to use RU-486 as the so-called morning pill after intercourse. However, it was quickly found that the substance was not effective in the early stages of pregnancy, before progesterone levels had reached a critical threshold. Later, the preparation was recommended as the so-called menstrual regulator. The woman, taking the pill every month, might not even know that she was terminating the pregnancy. However, even in this case, low effectiveness was found. It was also noted that mifepristone caused a phenomenon of desynchronization in which the ovulatory and menstrual periods were disrupted, which reduced the effectiveness of the preparation in terminating pregnancy. As a result of these discoveries, in October 1981 the endocrinologist Étienne-Émile Baulieu proposed to test the effectiveness of mifepristone as a means of inducing abortion.

After numerous trials of the medicine, France requested the Committee for Human Medicinal Products (CHMP) to give an opinion on the benefits and risks of using mifepristone as an abortion medicine . An application has been made for approval of a 200 mg dose of mifepristone as the medical termination of a developing intrauterine pregnancy. Based on clinical data and international guidelines, the CHMP gave an opinion on the posology of mifepristone when used in combination with the prostaglandin analogue named misoprostol.

The CHMP confirmed the use of a 200 mg dose of mifepristone with misoprostol (administered orally in three equal doses) to terminate pregnancy and confirmed the safety of these drugs in termination of pregnancy. The Committee considered that the effectiveness of mifepristone depends on the length of the menstrual period, the type of prostaglandin and the method of administration.