Zhenale, pills 10mg 1pc

Composition

Active ingredient:

mifepristone 10 mg;

Auxiliary substances:

lactose monohydrate-123.4 mg;

potato starch-22 mg;

povidone K

25-6 mg; sodium carboxymethyl starch (primogel) – 5 mg;

magnesium stearate-1.6 mg

Pharmacological action

of Zhenale-anti-gestogenic, contraceptive.

Pharmacodynamics

Mifepristone is a synthetic steroid anti-gestogenic agent (it blocks the action of progesterone at the level of receptors), it does not have progestogenic activity. Antagonism of SGCs was noted (due to competition at the level of communication with receptors).

Depending on the phase of the menstrual cycle, it causes an increase in the contractility of the myometrium, stimulating the release of interleukin-8 in choriodecidual cells, increasing the sensitivity of the myometrium to PG. As a result of the drug’s action, the decidual membrane is desquamated and the fetal egg is removed. Causes inhibition of ovulation, changes in the endometrium and prevents implantation of a fertilized egg.

Pharmacokinetics

After a single oral dose_{, cmax} is reached in 1.3 hours. Absolute bioavailability is 69%. In blood plasma, mifepristone binds to 98% of the following proteins: albumin and acidic α_-1-glycoprotein.

After the distribution phase, excretion is slow at first, the concentration decreases 2-fold between 12-72 hours, then more rapidly. T_1/2 is 18 hours.

Indications

Emergency (post-coital) contraception within 72 hours after sexual intercourse without previous use of contraceptives or methods, as well as in case of their unsuccessful use (including an error in the use of the calendar method, unsuccessful interruption of sexual intercourse, rupture or sliding of the condom).

Contraindications

• a history of hypersensitivity to mifepristone and / or auxiliary components;
• adrenal insufficiency;
• acute or chronic renal and/or hepatic insufficiency;
• long-term therapy with glucocorticosteroids;
• porphyria;
• anemia;
• hemostatic disorders (including previous treatment with anticoagulants);
• the presence of severe extragenital pathology;
• pregnancy;
• lactation.

Side effects

Spotting from the genital tract, discomfort and pain in the lower abdomen; exacerbation of inflammatory diseases of the uterus and appendages; weakness, headache, nausea, vomiting, diarrhea, dizziness, hyperthermia, urticaria.

Interaction

NSAIDs should be avoided for 8-12 days after taking the drug.

How to take, course of use and dosage

Inside. Take 1 tablet 2 hours before or 2 hours after a meal (in the next 72 hours after unprotected contraception sexual intercourse), regardless of the phase of the menstrual cycle.

Overdose

Symptoms:  in cases of overdose of the drug, adrenal insufficiency may occur.

Special instructions

The drug does not protect against sexually transmitted diseases and AIDS; it is not recommended to use the drug as a planned, permanent contraception after each sexual act, as well as monthly.

After use as a post-coital contraception and until the end of the current menstrual cycle, subsequent sexual acts without the use of contraceptives are not recommended. For further sexual acts, a barrier method of contraception should be used.

A 10 mg dose of the drug is not sufficient to cause an abortion, so a highly sensitive pregnancy test should be performed before its further use, ensuring that this drug is used only in the absence of pregnancy. In the event of pregnancy, despite the use of the drug, it is recommended to terminate it with medication or surgery. If the patient decides to save the pregnancy, it is impossible to completely exclude the risk to the health of the unborn child.

Influence on the ability to drive a car or perform work that requires an increased rate of physical and mental reactions. The effect of the drug on the ability to drive a car and work with mechanisms was not noted.

Composition

Tablet Form of production

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Mifepristone

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For women of childbearing age, For adults as prescribed by a doctor

Indications

Contraception