Zhenale: how to take the drug correctly if you suspect conception

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INN: Mifepristone, (Russia); Release form : 10 mg tablets, light yellow with a greenish tint, round, biconvex.

Composition: each Zhenale tablet contains:

active substance: mifepristone - 10 mg; excipients: lactose monohydrate - 123.4 mg, potato starch - 22 mg, povidone K25 - 6 mg, sodium carboxymethyl starch - 5 mg, magnesium stearate - 1.6 mg.

Pharmacodynamics

Mifepristone is a synthetic steroidal antigestagenic agent (blocks the action of progesterone at the receptor level) and does not have gestagenic activity. Antagonism with 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 choriodecidual cells, increasing the sensitivity of the myometrium to PG. As a result of the action of the drug, desquamation of the decidua occurs and the fertilized egg is expelled. Causes inhibition of ovulation, changes in the endometrium and prevents the implantation of a fertilized egg.

Instructions for Zhenale

How do pills work after intercourse ? "Zhenale" ® is a synthetic steroidal antiprogestogen drug. By blocking the action of progesterone at the level of receptors in peripheral organs (uterus and ovaries), its contraceptive effect is achieved. Depending on the phase of the menstrual cycle, it causes an increase in the contractility of the myometrium, stimulating and increasing the sensitivity of the uterine muscle to prostaglandins. As a result of the action of the drug after sexual intercourse, desquamation of the decidua occurs within 72 hours and the fertilized egg is expelled.

Used for emergency post-coital contraception, Zhenale inhibits ovulation, changes the endometrium and prevents the implantation of a fertilized egg into the uterus.

Application of zhenale

The main indication for taking the Zhenale tablet is emergency (postcoital) contraception within 72 hours after sexual intercourse without the use of contraceptives or methods.

Also recommended in case of unsuccessful use or absence of main contraceptives, including in situations:

• error in calculating the calendar method, • unsuccessful interruption of sexual intercourse, • rupture or slipping of the condom, • forced intercourse, • anal intercourse with a high probability of sperm entering the external genital area, • intimate intimacy in a virgin without penetration, but with ejaculation in the vaginal area, • other situations that are potentially unsafe with regard to the occurrence of unwanted conception.

Zhenale is not used to terminate a pregnancy that has taken place and is clinically confirmed! The composition and dosage of the product do not serve the purpose of stopping the development of the fertilized egg and cannot cause a miscarriage!

POSSIBLE SIDE EFFECTS

• Bloody discharge from the genital tract, discomfort and pain in the lower abdomen, exacerbation of inflammatory diseases of the uterus and appendages.
• From the digestive system: nausea, vomiting, diarrhea.
• From the side of the central nervous system: headache, dizziness.
• Other: weakness, hyperthermia, urticaria.

CONTRAINDICATIONS

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

Breastfeeding should be stopped for 14 days after taking the drug. Contraindicated in acute or chronic liver and liver failure. You can buy Zhenale in a pharmacy with a doctor's prescription.

Which is better: Genale or Postinor / Escapelle

Below is a table that shows a comparison of Postinor or Escapel, which are similar in their indications for taking drugs, and Zhenale tablets - which is better, more effective and, most importantly, has fewer side effects on the reproductive organs and the female body as a whole?

Reviews from specialists. Doctors believe that Zhenale is better, as evidenced by positive reviews from women, greater effectiveness, reasonable price, and much less frequently reported side effects. Postinor and ago analog Escapelle, in comparison with Zhenale, are less preferable tablets to take and have a number of negative qualities. If a woman is undergoing treatment, you should know that the list of drugs not recommended for simultaneous use with Postinor is quite wide (antibiotics, antiviral drugs, tetracycline, sleeping pills). It would be wiser to generally avoid situations that require the use of this method of contraception and select contraceptives in advance.

Contraindications

a history of hypersensitivity to mifepristone and/or auxiliary components;

adrenal insufficiency;

acute or chronic renal and/or liver failure;

long-term therapy with glucocorticosteroids;

porphyria;

anemia;

hemostasis disorders (including previous treatment with anticoagulants);

the presence of severe extragenital pathology;

pregnancy;

lactation period.

The most popular analogues of “Zhenale”

Postinor is a popular drug that has been on the market for a long time; the active ingredient is levonorgestrel 0.75 mg. Prevents implantation of a fertilized egg and inhibits ovulation. There are 2 pieces in a package, use no later than 3 days after fertilization.

Escapel - active ingredient - levonorgestrel 1.5 mg, an analogue of Postinor, use as soon as possible after contact, 1 tablet in a package.

Agesta - the active ingredient of the drug - mifepristone, 10 mg. An antigestagenic drug that blocks the attachment of the zygotic cell to the endometrium in the uterus. There are two tablets in the package.

The principle of action of the drug "Zhenale":

Once in the body, the active component, mifepristone, causes active contraction of the myometrium in the uterus, the release of interleukin-8 from choriodecidual cells, and detachment of the decidua, which causes the removal of the fertilized egg from the body.

Application is possible no later than three days from the moment of fertilization.

Precautionary measures

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 intercourse, or monthly.

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

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

Impact on the ability to drive a car or perform work that requires increased speed of physical and mental reactions. The effect of the drug on the ability to drive a car and operate machinery has not been noted.

Intrauterine methods

Copper-containing intrauterine system (coil)

The coil thickens cervical mucus and forms a barrier for sperm.
Copper has a toxic effect on sperm, immobilizing them, and also suppresses ovulation. pros

• prolonged action, allowing you to forget about contraception for several years
• no systemic effect on the body
• can be used during lactation

Minuses

• it cannot be used for nulliparous women, since against the background of the IUD there is a risk of the formation of intrauterine synechiae and adhesions, which can lead to infertility; also, due to anatomical features, nulliparous women have a narrower cervical canal, which makes it difficult to install the spiral.
• the IUD does not protect against STDs and, accordingly, is only suitable for women who have one permanent healthy sexual partner;
• using a copper-containing IUD increases the risk of inflammatory diseases of the uterus and appendages by 5–6 times compared to women who do not have IUDs;
• the IUD can cause longer and more painful menstruation;
• if a woman has a history of multiple abortions, invasive interventions, curettage, there is a risk of developing cervical insufficiency, i.e. incompetence of the cervix, which can lead to expulsion (loss) of the device.

Protected hormone-containing coils

The hormones contained in the system act in the uterine cavity, make the mucous membrane thinner, and immobilize sperm.
All this makes fertilization and implantation of the fertilized egg impossible. pros

• Reliable contraceptive effect for five years
• No systemic effect
• has a therapeutic effect: indicated for patients with a history of endometrial hyperplastic processes, uterine fibroids
• can be used during lactation

Minuses

• No protection against STDs
• Higher price compared to copper-containing spiral

Hormonal contraception

This is perhaps the most effective method of all existing today.

Hormonal drugs differ in dosage (minidose - estrogen content no more than 30 mcg, microdosed - no more than 20 mcg, large dosages are not currently used), components, and route of entry into the body.

There are two types of drugs: combined and “mini-pill” group. Combined contraceptives contain estrogens (ethinyl estradiol) and gestagens, “mini-pills” contain only gestagens.

Preparations from the “mini-pill” group are indicated for nursing women who cannot take estrogens, but only gestagens. Also, “mini-pills” can be taken by women who cannot tolerate the estrogen component.

Types of drugs: tablets (taken orally), vaginal ring (hormones penetrate through the vaginal mucosa) and patch (transdermal route - hormones enter through the skin).

Methods of administration. The tablets must be taken daily, at the same time. It is especially important to take drugs from the “mini-pill” group at the same time. The tablets are generally taken for 21 days, after which they take a break for 7 days.

The vaginal ring is inserted into the vagina for 21 days, after which a break is taken for a week.

The patch is changed every 7 days.

The advantage of alternative routes of administration (ring, patch) is that you do not need to remember every day to take the pill and there is no primary passage through the liver and gastrointestinal tract, which reduces the load on them.
This is especially important if a woman has problems with the gastrointestinal tract or chronic cholecystitis. pros

• reliable contraceptive effect (if a woman does not miss taking pills, the guarantee is almost 100%)
• active protection of the ovaries and endometrium (mucous) of the uterus from cancer
• regulation of the menstrual cycle
• reduction of pain during menstruation
• cosmetic effect (some OCs help cope with acne and normalize skin condition)
• therapeutic effect (the doctor will help you choose hormonal contraceptives that are indicated for patients with uterine fibroids and endometriosis).

Minuses

• the need for strict discipline, control over taking medications at the same time (especially important for the “mini-pill”)
• do not protect against STDs
• any hormonal drugs affect metabolism (metabolism), which can lead to fluctuations in body weight, although in modern drugs this effect is minimal;
• there is an effect on the vascular link, on the blood coagulation system, therefore, when taking contraceptives, constant monitoring of hemostasis is necessary. If a woman has a predisposition to varicose veins, hypertension, or in the family there have been cases of diseases of the cardiovascular system, accompanied by thrombosis, heart attacks, strokes, then the patient needs a comprehensive examination of the hemostatic system before starting to take hormonal contraceptives;
• There is a period of adaptation to hormones. Over the course of 2–3 months, nausea, headaches and pain in the mammary glands may sometimes occur; there may be slight spotting in the middle of the cycle, changes in libido, and mood swings. Therefore, medical supervision of the use of drugs during the first months of use is mandatory.
• hormonal contraceptives have a number of contraindications: active smoking (more than 5 cigarettes per day), severe somatic diseases, severe decompensated diabetes mellitus, thrombosis, varicose veins, heart attacks, strokes, arterial hypertension, frequent migraines, etc.

Sterilization

Medical sterilization is a surgical technique that can be used on both men and women. This is a reliable method of 100% protection against pregnancy, a good choice for people who are definitely not planning any more children.

After the operation, the ability to conceive in women cannot be restored; in men, there is a small (less than 30%) chance of restoring reproductive function by repeating the operation within five years after the intervention.

Female sterilization is a laparoscopic operation during which the fallopian tubes are cut, which reliably prevents the possibility of pregnancy.

Male sterilization (vasectomy) is a simple operation that lasts about 20 minutes.
During surgery, the vas deferens is ligated and divided. Sterilization does not affect erection, the amount of seminal fluid and the ability to experience orgasm. pros

• 100% protection against unwanted pregnancy
• the issue is resolved once and for all

Minuses

• irreversibility of the operation
• need for surgery
• There are legal restrictions on this operation

Medical sterilization as a special medical intervention in order to deprive a person of the ability to reproduce or as a method of contraception can be carried out only upon a written application from a citizen over thirty-five years of age or a citizen who has at least two children, and in the presence of medical indications and informed voluntary consent citizen - regardless of age and presence of children. Article 57. Federal Law of November 21, 2011 N 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation”

Emergency contraception

In case of unprotected sexual intercourse, you can use so-called emergency contraception.
These drugs are aimed at contraception, they are not termination of pregnancy. The tablet contains a large dose of progestin drugs that cause rejection of the endometrial mucosa. pros

• The ability to avoid unplanned pregnancy even in a critical situation

Minuses

• This is a colossal dose of gestagens, which can lead to failures and cycle disorders. This remedy cannot be used on a regular basis - it is a huge stress for the body.

When choosing contraception, you should definitely contact a gynecologist. Before prescribing this or that drug, the doctor will conduct an examination, which includes an examination on a chair, taking a smear for oncocytology. Also, if there are signs of endocrinopathy (increased hair growth, acne), it is necessary to examine the hormonal levels. Since hormones thicken the blood and affect hemostasis (blood coagulation system), it makes sense to conduct a comprehensive examination of the state of the hemostatic system. In addition, it is recommended to do an ultrasound examination of the pelvic organs (uterus and appendages) and mammary glands. All these procedures are minimally invasive, painless, they are not difficult to complete, and they will help to avoid possible complications due to long-term use of contraceptives.

Conclusion

Emergency contraception is a necessary procedure. The drug "Zhenale" is a modern medicinal method of emergency post-coital contraception for women, which can with a high probability prevent the attachment of the egg and prevent pregnancy with minimal risk to the patient's body.

MAKE AN APPOINTMENT

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Abortion and contraception clinic in St. Petersburg - department of the medical gynecological association "Diana"

Make an appointment, tests or ultrasound via the contact form or by calling +8 (812) 62-962-77. We work seven days a week from 09:00 to 21:00.

We are located in the Krasnogvardeisky district, next to the Novocherkasskaya, Ploshchad Alexander Nevsky and Ladozhskaya metro stations.

The cost of a medical abortion in our clinic is 3,300 rubles. The price includes all pills, an examination by a gynecologist and an ultrasound to determine the timing of pregnancy.

Yu.N. Melnyk, Head of the Department of Prenatal Diagnostics, Kyiv City Center for Reproductive and Perinatal Medicine

He who knows nothing believes everything.

Johann Wolfgang Goethe

Emergency or otherwise emergency, “fire” contraception is a generalized concept that includes various methods of contraception in the first hours after sexual intercourse in order to prevent unwanted pregnancy and reduce the frequency of abortions. Over the entire period of its existence, humanity has been striving to find the optimal way to prevent unwanted pregnancy after unprotected sexual intercourse.

Attitudes towards emergency contraception (EC) can vary and depend on our beliefs. However, many will agree that abortion and its complications can cause significant harm to a woman’s health, which can be avoided by using a safer method - EC (Prilepskaya V.N. et al., 2007). Fears and erroneous conclusions about the EC method are primarily associated with insufficient knowledge of information. Improper counseling on this issue can add to the woman's stress and push her to decide to have an abortion. This is especially important for pharmacy staff, who are often the first to advise women on contraception.

In such a situation, when a woman is at a loss, professional and most correct consultation is necessary. We invite you to review the most frequently asked questions.

What are the indications for using the EC method?

EC should be recommended to women for protection against unwanted pregnancy in the following cases:

● during unprotected sexual intercourse, when the planned method of contraception was not used for some reason;

● defect of barrier methods of contraception (for example, if the integrity of the condom is broken);

● if you violate the rules for taking hormonal pills (missing 1 pill or more);

● in case of rape, especially among teenagers.

What types of EC are there?

EC is used as contraceptives:

● combined estrogen-gestagen drugs (use of combined oral contraceptives according to a special Yuzpe regimen);

● gestagens (levonorgestrel, drugs Postinor and Escapelle);

● antiprogestins (mifepristone, gynepristone);

● intrauterine contraceptives (IUDs).

Is there a classification of
EC tablet preparations based on the hormonal/non-hormonal principle?
There is no such classification. According to the latest international ATS classification of drugs (WHO, 2008), all tablet drugs belong to the same heading G - Drugs affecting the genitourinary system and sex hormones (estrogens, gestagens, their homologues and antagonists). Mifepristone and levonorgestrel are biologically active substances with a steroid structure.

What is the effectiveness of EC products?

According to the results of a multicenter WHO study involving more than 4136 women, published in The Lancet, the effectiveness of the use of 10 mg of mifepristone and levonorgestrel (2 doses of 0.75 mg at an interval of 12 hours or a single dose of 1.5 mg) within 120 hours after unprotected sexual intercourse act did not differ significantly (von Hertzen H. et al., 2002).

At the same time, the effectiveness of using EC means depends on the time of their use after unprotected sexual intercourse (in the first 24-72 hours it is maximum).

Escapelle can be used within 96 hours after unprotected intercourse, but it must be remembered that its effectiveness is higher in the first 72 hours, and then it

decreases.

What is the mechanism of action of EC drugs?

These drugs interact with sex hormone receptors, but in different ways. The mechanism of action of levonorgestrel, which is a synthetic derivative of testosterone, is due to inhibition of ovulation, inactivation (immobilization) of sperm, prevention of fertilization, as well as changes in the properties of the endometrium, which prevents implantation. However, levonorgestrel is ineffective if implantation has already occurred and does not cause abortion. Thus, levonorgestrel is not an abortifacient and does not terminate an already developing pregnancy.

Contraindications to the use of levonorgestrel are individual sensitivity and pregnancy (from the instructions for the drug).

Unlike levonorgestrel, mifepristone acts on receptors not only for progesterone (blocking them), but also for glucocorticosteroids. These fundamental differences determine their pharmacological effects, which explain certain restrictions on the use of mifepristone.

Contrary to the existing misconception that mifepristone is the “only non-hormonal drug” for EC and is supposedly completely harmless, the list of contraindications for gynepristone compared to contraceptives containing levonorgestrel is more extensive.

Contraindications to taking mifepristone 10 mg: adrenal insufficiency, long-term treatment with corticosteroids, acute and chronic renal and liver failure, the presence of severe extragenital pathology (from the instructions for the drug mifepristone 10 mg).

What can you say about contraindications to the
use of drugs containing levonorgestrel (Postinor, Escapelle)?
According to the instructions for medical use of these drugs, this is individual sensitivity and age under 16 years (since there is insufficient experience of use in children).

Taking these drugs is not advisable if pregnancy has already occurred. The safety of levonorgestrel drugs for the purpose of EC has been confirmed by WHO and the US Food and Drug Administration, as well as many years of experience in use.

Is it safe to take Postinor and Escapel if
pregnancy has already occurred?
The use of levonorgestrel is safe and will not harm the health of the mother and fetus (instructions for the drug, WHO, 2005). This is especially important if the woman was not sure about her pregnancy and was taking levonorgestrel. In such a situation, the decision to continue the pregnancy can be made without fear.

What data are available on the teratogenic effects of mifepristone at a dose of 10 mg on the fetus?

There is no information on this fact in the instructions for the drug (it is not known what recommendations should be given to the woman). The instructions for drugs that contain mifepristone in a dose of more than 10 mg state that if pregnancy continues to develop after using mifepristone for the purpose of medical abortion, the possible negative effect of this drug on the fetus (the formation of congenital anomalies of fetal development) should be taken into account. If there is no effect, the woman should be informed about the need to terminate the pregnancy in another way. There is no data in the instructions for mifepristone that with a dose reduction there is no negative effect of the drug on the fetus. This fact is very important for women who took EC drugs and did not know about their pregnancy.

Is EC contraindicated in adolescents?

The instructions for the drug Escapelle do not say that there is insufficient data on the use of the drug by adolescents under 16 years of age. Studies in a group of girls aged 13 to 16 years have shown that the use of EC pills is safer compared to the possible consequences of abortion at this age (“Essentials of contraceptive methods”, WHO, Division of Reproductive Health and Research, Institute of Public Health. Johns Hopkins Bloomberg Information Program Center, US Agency for International Development, Bureau of International Health, Division of Population and Reproductive Health, 2008).

Tell us about the features of the release form
of the drug Escapelle.
Levonorgestrel at a dose of 1.5 mg, according to WHO recommendations, can be used for EC once. In addition, Escapelle is effective for 96 hours after unprotected intercourse, which significantly expands the time frame. Thus, Postinor is recommended for use for 72 hours. Among the advantages of Escapel is a single dose. Consequently, a woman does not need to constantly remember the need to re-use the drug; she is spared unnecessary worries.

What side effects may occur when
taking mifepristone 10 mg and levonorgestrel in
different doses?

According to an international study (WHO, Lancet, 2002), all these drugs have the same side effects (nausea, vomiting, etc.). The exception is “early menstruation” and delays in the onset of regular menstruation. Bleeding in the first 7 days was more common in the levonorgestrel group (31%) compared to the mifepristone group (19%). If we exclude women who began menstruating within the first 7 days (possibly it was menstruation), then this figure is halved and equal to 16% for the two groups of levonorgestrel and 9.4% for mifepristone.

The onset of menstruation or bleeding (“early menstruation”) means for a woman relief from worries associated with a possible pregnancy. Irregular bleeding caused by taking levonorgestrel stops on its own and is not a sign of any disease or pregnancy (USAID, WHO, 2008).

In women using mifepristone, the frequency of menstruation delay by more than 7 days was significantly higher than when taking levonorgestrel (von Hertzen H. et al., 2002).

A missed period can cause anxiety because a woman is unsure whether an unwanted pregnancy has been prevented. This requires additional tests to exclude the possibility of conception and delays the time of starting to take planned contraception.

How do Postinor and Escapelle affect the menstrual cycle?

Doctors are more concerned about the irreversible consequences of abortion than about possible reversible changes in the menstrual cycle. According to the results of a study involving more than 4 thousand women, when using levonorgestrel and mifepristone, more than 50% of subjects had menstruation within 2 days of the expected period (Hertzen H. et al., 2002).

Postinor and Escapelle can be taken on any day of the menstrual cycle. After using Escapel, menstruation, as a rule, appears at the usual time and proceeds normally; this does not require additional methods to exclude pregnancy. Fears about menstrual irregularities in the form of bleeding are sometimes exaggerated.

Irregular bleeding caused by taking levonorgestrel stops on its own and is not a sign of any disease or pregnancy (Cheng L., Gulmezoglu AM, 2008). In this case, we are talking about early menstruation and the peculiarities of the mechanism of action of levonorgestrel. Early menstruation indicates absence of pregnancy.

How does mifepristone 10 mg affect
the menstrual cycle?
Taking this drug causes a delay in ovulation, i.e. causes certain hormonal changes in the body, which is accompanied by a high frequency of delays in the onset of menstruation. In this case, the risk of pregnancy may increase when there have been repeated unprotected sexual intercourses after taking mifepristone (distant menstruation may coincide with repeated sexual intercourse, which increases the risk of fertilization). This is an additional undesirable aspect of this EC regimen for both the physician and the patient.

While taking mifepristone, bleeding occurs in 9.4% of cases (WHO, Lancet, 2002).

Is it possible to take Escapelle and mifepristone 10 mg during breastfeeding without
taking a break from feeding?
Escapelle - yes! It can be used immediately after feeding and you can avoid breastfeeding after taking it.

While using mifepristone 10 mg, you should refrain from breastfeeding for 14 days (according to the instructions for the drug). This limits breastfeeding.

What are the advantages of Escapel over other
EC means?
The advantages of Escapelle are as follows:

● first choice drug for EC;

● its effectiveness and safety have been proven by WHO studies;

● effective within 96 hours after unprotected sexual intercourse (there is more time to make the right decision);

● can be taken on any day of the menstrual cycle;

● ease of use (once);

● can be used when a woman did not have time to take Postinor in the period 72-96 hours after sexual intercourse;

● safety – does not have a teratogenic effect;

● possible use during breastfeeding;

● after a single dose, most women have subsequent menstruation at the expected time.

Thus, from everything said above we can draw conclusions.

1. EC is primarily a method of “fire” contraception and an alternative to abortion and its complications.

2. After EC, a woman should be recommended methods of planned contraception.

3. According to the existing classifications of drugs, there are no non-hormonal methods of EC.

4. A single dose regimen of levonorgestrel (Escapel in Ukraine) from a practical point of view has an advantage over its double use at a dose of 0.75 mg (WHO, Geneva, 2005).

In particular, a single regimen of levonorgestrel at a dose of 1.5 mg (Escapelle) is highly effective and has a good safety profile. According to WHO, increasing the dose of levonorgestrel to 1.5 mg does not lead to an increase in the number of side effects compared to its dose of 0.75 mg (WHO, 2005).