Zhenale

General characteristics. Structure:

Active ingredient: 10 mg of mifepristone.

Excipients: lactoses monohydrate, potato starch, K25 povidone, carboxymethylstarch of sodium, magnesium stearate.

Post-coital contraceptive.

Pharmacological properties:

Pharmacodynamics. Synthetic steroid antiprogestagenny drug. Blocks effect of progesterone at the level of receptors, has no gestagenny activity. Antagonism with GKS due to the competition at the level of communication with receptors is noted.

Depending on a phase of a menstrual cycle causes increase in sokratitelny ability of a myometrium, stimulating release interleykina-8 in horiodetsidualny cells, increasing sensitivity of a myometrium to prostaglandins. Effect of drug is resulted by desquamation of a decidua and removal of fetal egg. Causes braking of an ovulation, change of an endometria and interferes with implantation of an oospore.

Pharmacokinetics. Absorption and distribution. After a single dose in Cmax it is reached in 1,3 h. Absolute bioavailability makes 69%. In a blood plasma mifepristone for 98% contacts proteins: albumine and acid α1-гликопротеином.

Removal. After a distribution phase removal at first happens slowly, concentration decreases twice between 12-72 h, then more quickly. T1/2 makes 18 h.

Indications to use:

— the emergency (post-coital) contraception during 72 h after sexual intercourse without the previous use of contraceptive means or methods, and also at their unsuccessful use (including a mistake at use of a calendar method, unsuccessful interruption of sexual intercourse, a gap or slipping of condom).

Route of administration and doses:

It is necessary to accept 1 таб. inside for 2 h to or in 2 h after meal (in the closest 72 h after the sexual intercourse unprotected by contraception), regardless of a phase of a menstrual cycle.

Features of use:

Drug does not protect from diseases, sexually transmitted and AIDS.

It is not recommended to use drug as planned, continuous contraception after each sexual intercourse, and also monthly.

After use as post-coital contraception and until the end of the current menstrual cycle the subsequent sexual intercourses without use of contraceptive means are not recommended. At further sexual intercourses it is necessary to use a barrier method of contraception.

The dose of drug of 10 mg is insufficient to cause abortion therefore before its further use it is necessary to carry out the highly sensitive test for pregnancy guaranteeing that this drug is used only in the absence of pregnancy. In case of pregnancy approach, despite drug use, its interruption is recommended by a medicamentous or surgical method. If the patient makes the decision to keep pregnancy, it is impossible to exclude completely risk for health of future child.

Influence on ability to driving of motor transport and to control of mechanisms. Influence of drug on ability to drive the car and to work with mechanisms is noted.

Use at pregnancy and feeding by a breast. Drug cannot be used at pregnancy. Breastfeeding should be stopped for 14 days after administration of drug.

Side effects:

From a reproductive system: bloody allocations from a genital tract, discomfort and pain in the bottom of a stomach, an exacerbation of inflammatory diseases of a uterus and appendages.

From the alimentary system: nausea, vomiting, diarrhea.

From TsNS: headache, dizziness.

Others: weakness, hyperthermia, small tortoiseshell.

Interaction with other medicines:

It is necessary to avoid use of NPVP within 8-12 days after administration of drug.

Contraindications:

— acute or chronic renal and/or liver failure;

— long therapy by glucocorticosteroid means;

— porphyria;

— anemia;

— disturbances of a hemostasis (including the previous treatment by anticoagulants);

— existence of heavy extragenital pathology;

— adrenal insufficiency;

— pregnancy;

— lactation period;

— existence in the anamnesis of hypersensitivity to mifepristone and/or auxiliary components.

Overdose:

In cases of overdose of drug adrenal insufficiency can be observed.

Storage conditions:

Drug should be stored in dry, protected from light, the place, unavailable to children, at a temperature not above 25 °C. A period of validity - 3 years.

Issue conditions:

According to the recipe

Packaging:

On 1 tablet in planimetric packaging and a cardboard pack.