Mifolian - Instructions For The Use Of Tablets, Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Mytholian

Mifolian: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. In case of impaired renal function
11. 11. For violations of liver function
12. 12. Drug interactions
13. 13. Analogs
14. 14. Terms and conditions of storage
15. 15. Terms of dispensing from pharmacies
16. 16. Reviews
17. 17. Price in pharmacies

Latin name: Mofolian

ATX code: G03XB01

Active ingredient: mifepristone (mifepristone)

Producer: Shanghai Hualian Pharmaceutical (China)

Description and photo updated: 28.08.

Mifolian is a synthetic steroidal antiprogestogenic drug (progesterone blocker at the receptor level) that does not have gestagenic activity.

Release form and composition

Dosage form - tablets: light yellow, round (1 or 3 pcs. In blisters, in a cardboard box 1 blister and instructions for use of Mifolian).

Composition of 1 tablet:

• Active ingredient: mifepristone - 0.2 g;
• Auxiliary components: hypromellose, lactose, sodium carboxymethyl starch, starch, magnesium stearate.

Pharmacological properties

Pharmacodynamics

Mifepristone - the active component of Mifolian, is a synthetic steroidal antiprogestogen agent that blocks the action of progesterone at the receptor level. The substance does not possess gestagenic activity.

Due to competition at the level of communication with receptors, antagonism with glucocorticosteroids is noted.

Increases the contractility of the myometrium, which occurs due to the stimulation of the release of interleukin-8 in choriodecidual cells, increasing the sensitivity of the myometrium to prostaglandins. The result of the application of Mifolian is the desquamation of the decidua and the removal of the ovum.

Pharmacokinetics

After a single oral dose of 600 mg of mifepristone, the maximum concentration is reached in 90 minutes and is 1.98 mg / l. Absolute bioavailability - 69%.

The substance in plasma binds to proteins (albumin and acidic α ₁ -glycoprotein) by 98%.

At the end of the distribution phase, the elimination of mifepristone occurs slowly at first, the concentration decreases by half between 12–72 hours, then the process proceeds faster. The half-life is 18 hours.

Indications for use

• Pharmabort in the early stages of uterine pregnancy (up to 42 days of amenorrhea);
• Full-term delivery: to prepare for delivery and induction of labor.

Contraindications

Absolute:

• Anemia;
• Inflammatory diseases of the reproductive organs;
• Long-term therapy with glucocorticosteroids;
• Adrenal insufficiency;
• Myoma of the uterus;
• Impaired hemostasis (including previous anticoagulant therapy);
• Porphyria;
• A scar on the uterus;
• Severe extragenital pathology;
• Chronic or acute hepatic and / or renal failure;
• History of hypersensitivity to mifepristone.

In addition, contraindications for medical abortion are:

• Pregnancy over 42 days of amenorrhea;
• Pregnancy that occurs after the abolition of hormonal contraceptives or against the background of the use of an intrauterine device;
• Pregnancy not confirmed by clinical studies;
• Ectopic pregnancy (including presumed pregnancy).

Additional contraindications to the use of Mifolian for preparation and induction of labor:

• Eclampsia, preeclampsia, severe preeclampsia;
• Postterm or premature pregnancy.

Relative (the drug is used with caution in view of the high likelihood of side effects): chronic obstructive pulmonary disease (including bronchial asthma), severe arterial hypertension, heart rhythm disturbances and heart failure.

Smoking women over the age of 35 should not use the drug without first consulting a therapist.

Mifolian, instructions for use: method and dosage

Mifolian should be used only in specialized institutions, with the necessary equipment and appropriately trained medical personnel.

The tablets are for oral administration.

Recommended dosing regimen for medical abortion: in the presence of a doctor, take 3 tablets of Mifolian, 0.2 g each (0.6 g mifepristone) once. At least 2 hours after administration, you should be under the supervision of medical personnel. After 36-48 hours after the application of mifepristone, the patient must undergo an ultrasound control. After 1-2 weeks, ultrasound control and clinical examination are repeated, in addition, the level of β-chorionic hormone is determined to confirm the absence of pregnancy. If the effect of the drug is not observed after 2 weeks (ongoing pregnancy or incomplete abortion), vacuum aspiration is done, and then a histological examination of the aspirate.

Recommended dosing regimen for preparation and induction of labor: 1 tablet Mifolian (0.2 g mifepristone) per day, once, in the presence of a doctor. A day later - repeated intake of 0.2 g of the drug. After 48-72 hours, the condition of the birth canal is assessed, then, if necessary, oxytocin or prostaglandins are prescribed.

Side effects

• The consequence of the therapeutic procedure: painful sensations in the lower abdomen, menstrual-like spotting from the genital tract, exacerbation of inflammatory diseases of the appendages and uterus;
• The consequence of the use of mifepristone: dizziness, headache, weakness, nausea, vomiting, hyperthermia, a feeling of discomfort in the lower abdomen.

Overdose

Adverse reactions usually do not occur when taking mifepristone up to 2 g. In case of an overdose of the drug, adrenal insufficiency may occur.

special instructions

In the absence of the expected effect from the use of Mifolian on days 10-14 from admission (continuing pregnancy or incomplete abortion), it is required to terminate the pregnancy in any other way, since malformations may form in the fetus due to the intake of abortive substances.

Mifepristone in a dose of up to 2 g does not cause undesirable side reactions in the patient.

Prior to the use of mifepristone, it is required to carry out general measures accompanying abortion, including measures to reduce Rh alloimmunization.

During lactation for 2 weeks after the application of Mifolian, it is required to stop breastfeeding.

Application during pregnancy and lactation

Contraindications for medical abortion:

• ectopic pregnancy or suspicion of it;
• pregnancy that occurs after the abolition of hormonal contraceptives or during the use of an intrauterine device;
• pregnancy for a period of 42 days of amenorrhea;
• ectopic pregnancy (including alleged pregnancy);
• pregnancy not confirmed by the results of clinical trials.

Contraindications in preparation for childbirth and their induction:

• preeclampsia;
• eclampsia;
• severe gestosis;
• premature / post-term pregnancy.

After using Mifolian, breastfeeding can be resumed after 14 days.

With impaired renal function

In acute / chronic renal failure, Mifolian tablets are contraindicated.

For violations of liver function

In acute / chronic hepatic insufficiency, Mifolian is contraindicated.

Drug interactions

The simultaneous use of non-steroidal anti-inflammatory drugs with mifepristone should be avoided.

Analogs

The analogues of Mifolian are: Agesta, Ginepristone, Pencrofton, Zhenale, Mifepristone, Miropriston, Mifegin, Ginestril, Mifeprex.

Terms and conditions of storage

Keep out of reach of children, protected from light and moisture, at temperatures up to 25 ° C.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Mytholian

Reviews about Mifolian are few and most of them relate to the use of the drug for medical abortion. Evaluation of therapeutic efficacy and tolerance is highly variable and depends on many factors.

Price for Mytholian in pharmacies

The price of Mifolian is unknown, since the drug is not available in pharmacies.

The approximate cost of analogs: Miropristone (3 tablets) - 2298 rubles, Ginepristone (1 tablet) - 367-519 rubles.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!