Mifolian - instructions for use, doses, side effects, contraindications

Mifolian - a synthetic steroidal anti-progestagenic agent (blocks the action of progesterone at the receptor level), does not possess gestagenic activity.Antagonism with GCS was noted (due to competition at the level of communication with receptors).

Increases the contractility of the myometrium, stimulating the release of interleukin-8 in choroidectid cells, increasing the sensitivity of the myometrium to prostaglandins. As a result of the action of the drug desquamation of the decidual membrane occurs and excretion of the fetal egg.

Pharmacokinetics:

After a single oral dose of 600 mg, the maximum concentration of 1.98 mg / l is achieved after 1.30 hours. Absolute bioavailability is 69%.

In the plasma mifepristone 98% bound to proteins: albumin and acid alpha-1 glycoprotein.

After the distribution phase, the excretion first occurs slowly, the concentration decreases 2 times between 12-72 hours, then more rapidly. The half-life is 18 hours.

Indications:Drug interruption of uterine pregnancy in early periods (up to 42 days amenorrhea). Preparation and induction of labor in term pregnancy.

Contraindications:

The presence in the anamnesis of hypersensitivity to mifepristone, adrenal insufficiency and long-term glucocorticosteroid therapy,acute or chronic renal and / or hepatic insufficiency, porphyria, uterine myoma, the presence of scar on the uterus, anemia, hemostasis disorders (including the previous treatment with anticoagulants), inflammatory diseases of female genital organs, the presence of severe extragenital pathology. Do not use smoking women over 35 years old (without consulting a therapist).

For drug abortion: Suspicion of ectopic pregnancy. Pregnancy, not confirmed by clinical studies, exceeds the 42-day amenorrhoea due to the use of intrauterine contraception, or after the abolition of hormonal contraception.

For the preparation and induction of labor: Severe gestosis, preeclampsia, eclampsia, preterm or premature pregnancy.

Carefully:With caution the drug is prescribed for chronic obstructive pulmonary diseases (including bronchial asthma), severe arterial hypertension, heart rhythm disorders and heart failure.

Pregnancy and lactation:Breastfeeding should be discontinued for 14 days after taking mifepristone.

Dosing and Administration:

The drug should be used in institutions that have appropriately trained medical personnel and the necessary equipment.

For drug abortion: 600 mg of mifepristone (3 tablets of 200 mg) are taken orally once in the presence of a doctor. The patient should be under the supervision of medical personnel, at least within 2 hours after application.

After 36-48 hours after taking Mifoliana, the patient should report for ultrasound. After 8-14 days, a clinical examination and ultrasound monitoring is repeated, and the level of beta-chorionic hormone is determined to confirm that the miscarriage has occurred. In the absence of the effect of the drug on day 14 (incomplete abortion or continuing pregnancy), a vacuum is performed followed by a histological examination of the aspirate.

For the preparation and induction of labor: once 200 mg of mifepristone (1 tablet) per day in the presence of a doctor. After 24 hours, a second dose of 200 mg. After 48-72 hours assesses the state of the birth canal, and, if necessary, prostaglandins or appointed oxytocin.

Side effects:

A. Associated with the procedure of treatment: Bloody discharge from the genital tract. Pain in the lower abdomen. Exacerbation of inflammatory processes of the uterus and appendages.

B. Associated with the reception of Mytholian. Feeling of discomfort in the lower abdomen, weakness, headache, nausea and vomiting, dizziness, hyperthermia.

Overdose:The intake of mifepristone in doses up to 2 g does not cause undesirable reactions. In cases of drug overdose, adrenal insufficiency may occur.

Interaction:Use of non-steroidal anti-inflammatory drugs (NSAIDs) should be avoided.

Special instructions:

Patients should be informed that if there is no effect from the use of the drug on the 10-14 day (incomplete abortion or continuing pregnancy), pregnancy should be interrupted in any other way, as it is possible to form congenital malformations in the fetus.

The use of the drug requires the prevention of rhesus alloimmunization and other common activities associated with abortion.

Form release / dosage:Pills.

Packaging:A cardboard box containing a blister of 1 tablet of 200 mg, with a nested instruction for medical use.

Storage conditions:In a dry place, protected from light, out of reach of children, at a temperature not exceeding 25 ° C.

Shelf life:3 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:For hospitals

Registration number:P N014743 / 01-2002

Date of registration:29.06.2009

Expiration Date:Unlimited

The owner of the registration certificate:Shanghai New Hualian Pharmaceutical Co., Ltd.Shanghai New Hualian Pharmaceutical Co., Ltd. China

Manufacturer: & nbsp

Shanghai New Hualian Co., Ltd. China

Information update date: & nbsp09.06.2018

Illustrated instructions

Instructions

Mythophianus (Mofolian)