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

Excipients: lactose monohydrate - 123.4 mg, potato starch - 22.0 mg, povidone K25 - 6.0 mg. sodium carboxymethyl starch 5.0 mg, magnesium stearate 1.6 mg.

Description:Tablets are round, biconvex light yellow with a greenish shade of color.

Pharmacotherapeutic group:Antigestagen

ATX: & nbsp

G.03.X.B.01 Mifepristone

Pharmacodynamics:

Mifepristone is a synthetic, steroidal, anti-progestagenic agent (blocks the action of progesterone at the receptor level), does not possess gestagenic activity.Antagonism with glucocorticosteroids (GCS) 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 choroidectid cells, increasing the sensitivity of the myometrium to the prostaglandins. As a result of the action of the drug desquamation of the decidual membrane occurs and excretion of the fetal egg. It causes inhibition of ovulation, changes in the endometrium and prevents the implantation of a fertilized egg.

Pharmacokinetics:

Suction

After a single oral intake in a dose of 600 mg, the maximum concentration of mifepristone in the blood plasma - 1.98 mg / l is achieved after 1.3 hours.

Distribution

Absolute bioavailability after taking mifepristone in a dose of 20 mg is 69%. In the blood plasma mifepristone 98% bind to proteins: albumin and acid α1-glycoprotein.

Metabolism

Metabolism of mifepristone occurs during the "primary" passage through the liver by N-demethylation and hydroxylation with the formation of three major metabolites.

Excretion

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. In blood plasma is not determined for 11 days. Mifepristone is derived mainly through the intestine.

Indications:Emergency (postcoital) contraception within 72 hours after sexual intercourse without previous use of contraceptives or methods, and also in case of unsuccessful use (including error in using the calendar method, unsuccessful interruption of the sexual intercourse, tearing or slipping of the condom).

Contraindications:Presence in the anamnesis of hypersensitivity to mifepristone and / or any other of auxiliary substances, adrenal insufficiency, acute or chronic renal and / or hepatic insufficiency, long-term therapy of SCS, hereditary porphyria, severe extragenital pathology, pregnancy, breast-feeding period, children and adolescents age to 16 years; lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Carefully:In chronic obstructive pulmonary diseases, including severe bronchial asthma; severe arterial hypertension, heart rhythm disturbances, chronic heart failure, hemostasis disorders (including previous treatment with anticoagulants).

Pregnancy and lactation:The drug should not be used during pregnancy. Breastfeeding should be discontinued for 14 days after taking the drug.

Dosing and Administration:

Inside, one tablet of preparation Zhenale® 10 mg for 72 hours after unprotected sexual intercourse for 2 hours or 2 hours after eating, regardless of the phase of the menstrual cycle.

In the case of an irregular menstrual cycle, you must first exclude the presence of pregnancy. After taking the drug for emergency contraception, before the next menstrual period, barrier contraceptives should be used (for example, a condom). The use of the drug with repeated unprotected intercourse during one menstrual cycle is not recommended because of the increased risk of acyclic bleeding / spotting.

Side effects:Acyclic bleeding / bleeding from the genital tract, discomfort and pain in the abdomen, menstrual irregularity (delay in menstruation), weakness, headache, nausea, vomiting, diarrhea, dizziness, hyperthermia, urticaria.

Overdose:There is no specific antidote. In cases of drug overdose, adrenal insufficiency may occur. Symptomatic treatment, including the administration of dexamethasone, is performed.

Interaction:

You should avoid the use of non-steroidal anti-inflammatory drugs for 8-12 days after taking the drug.

Given that CYP3A4 is involved in the metabolism of mifepristone, it is possible that ketoconazole, itraconazole, erythromycin, grapefruit juice with joint application can increase the concentration of mifepristone in blood plasma. Rifampicin, dexamethasone, preparations of St. John's wort perfumed, phenytoin, phenobarbital, carbamazepine when combined, can reduce the concentration of mifepristone in the blood plasma. Caution should be exercised when using mifepristone together with preparations that are substrates of CYP3A4.With the simultaneous use of mifepristone and glucocorticosteroids, it is necessary to increase the dose of the latter.

Special instructions:

The drug does not protect against sexually transmitted diseases and AIDS; It is not recommended to use the drug as a planned, constant contraception after each sexual intercourse, and also monthly.

After applying as postcoital contraception and until the end of the current menstrual cycle, subsequent sexual acts are not recommended without the use of contraceptives. With further sexual intercourse, a barrier method of contraception should be used.

The dose of 10 mg is not enough to cause abortion, so before its further use, a highly sensitive pregnancy test should be carried out, ensuring that the drug is used only in the absence of pregnancy. In the case of pregnancy, despite the use of the drug, it is recommended that it be interrupted by a medical or surgical method. If the patient decides to keep the pregnancy, it is impossible to completely exclude the risk to the health of the unborn child.

It is possible to use the drug in adolescents under 16 years only in exceptional cases (including rape) and only after consulting a gynecologist (with a second consultation after emergency contraception).

Effect on the ability to drive transp. cf. and fur:The effect of the drug on the ability to drive vehicles and work with mechanisms is not noted. In case of development of weakness, dizziness should refrain from managing vehicles and mechanisms that require increased concentration and speed of psychomotor reactions.

Form release / dosage:Tablets 10 mg.

Packaging:

1 tablet per contour cell packaging made of polyvinylchloride film and aluminum foil printed lacquered. 1 or 2 contour squares, together with instructions for use, are placed in a pack of cardboard.

1 or 2 tablets in a jar of orange glass. On 1 bank together with the instruction on application place in a pack from a cardboard.

Storage conditions:

In dry, dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-000572

Date of registration:01.08.2011 / 04.10.2016

Expiration Date:Unlimited

The owner of the registration certificate:IZVARINO PHARMA, LLC IZVARINO PHARMA, LLC Russia

Manufacturer: & nbsp

IZVARINO PHARMA, LLC Russia

Information update date: & nbsp19.05.2017

Illustrated instructions

Instructions

Genale® (Zhenale)