Hormonal pills of Visan. Visa Analogs and Prices

This page provides a list of all the analogues of Visane in composition and indication to use. A list of cheap analogues, and also be able to compare prices in pharmacies.

  • Most cheap analog Byzanna:
  • The most popular analogue of Byzanne:
  • ATX Classification: Progestogen
  • Existing substances / Composition: Dienenogest micronized

Cheap Visannalogs

When calculating the cost cheap analogues of Visan Considered the minimum price, which was found in the price list provided by pharmacies

Popular analogues of Visann

# Name Price in Russia Price in Ukraine
1 didrogesterone
-- 33 UAH
2 progesterone
Analogue in composition and indication
321 rubles 130 UAH
3 norethisterone
Analogue in composition and indication
96 rubles 56 UAH
4
Analogue in composition and indication
1901 rubles 77 UAH
5 progesterone
Analogue in composition and indication
100 rubles 3 UAH

The list of drug analogues Based on the statistics of the most requested medicinal preparations

All analogues of Visan

Analogs in composition and indication

Name Price in Russia Price in Ukraine
hydroxyprogesterone Caproat 644 rubles 41 UAH
hydroxyprogesterone Caproat -- 18 UAH
progesterone -- 242 UAH
polycarbophil, glyceride derivative of hydrogenated palm oil, sorbic acid, glycerin, sodium hydroxide, carbomer 974P, liquid paraffin, water prepared 1901 rubles 77 UAH
progesterone 100 rubles 3 UAH
progesterone 722 rubles 161 UAH
progesterone 321 rubles 130 UAH
progesterone 3235 rubles 77 UAH
72 rub --
progesterone -- 32 UAH
progesterone -- 8 UAH
progesterone -- 53 UAH
progesterone 255 rubles 400 UAH
Didrogesterone -- 33 UAH
Megestrol. 2900 rubles 700 UAH
Dienogest -- 300 UAH
Norethisterone 96 rubles 56 UAH
Norethisterone -- 33 UAH
Linastrenol 2305 rubles 300 UAH

The above list of the analogues of the drugs in which are indicated zesanne substitutesis the most appropriate because they have the same composition of the active ingredients and coincide the indication to use

To compile a list of cheap analogues of expensive drugs, we use prices that we provide more than 10,000 pharmacies throughout Russia. The database of drugs and their analogues is updated daily, so the information provided on our site is always relevant as of the current day. If you have not found an analog you are interested in, please use the search above and select the medicine youest interest from the list. On the page of each of them you will find all the possible options for the analogues of the search drug, as well as the prices and addresses of pharmacies in which it is in stock.

How to find a cheap analogue of dear medicine?

To find an inexpensive analogue of medicine, generic or synonym, forward, we recommend paying attention to the composition, namely, the same active substances and indications for use. The same drug actors and will indicate that the drug is synonymous drug, pharmaceutically equivalent or pharmaceutical alternative. However, do not forget about the inactive components of similar drugs that can affect safety and efficiency. Do not forget about the instruction of doctors, self-medication can harm your health, so before the drafting of anyone medical preparation Always consult your doctor.

Byzanne price

On the sites below you can find prices for Byzanne and learn about the presence in the pharmacy nearby

Byzanna instruction

Instruction
by medical application drug
Visanna

Release form:

Solid medicinal forms. Pills.

Structure:

Active substances: Dienenogest micronized 2,000 mg

Auxiliary substances: Lactoses of 62,800 mg monohydrate, starch potato 36,000 mg, microcrystalline cellulose 18,000 mg, povidone-K25 - 8,100 mg, talc - 4.050 mg, crosspindon -2,700 mg, magnesium stearate - 1,350 mg.

Description. Round white or almost white pills with a flat surface and beveled edges, engraving "in" on one side.

Farm Group: Sex hormones and sexual system modulators

Pharmacological properties:

Pharmacodynamics. The dienogest is a derivative of Northestosterone, characterizing the antagandrogenic activity that makes up about one third of the activity of ciproterone acetate. The dienogest is associated with progesterone receptors in the man's uterus, possessing only 10% of the relative affinity of progesterone. Despite the low affinity for progesterone receptors, the dienogest is characterized by a powerful progestogenic effect in vivo. The dienogest does not have a substantial mineralocorticoid or glucocorticoid activity in vivo.

The dienogest acts on endometriosis by suppressing the trophic effects of estrogen with respect to the euteopic and ectopic endometrium, due to the reduction of estrogen products in the ovaries and reduce their concentration in plasma.

With prolonged use, it causes initial decidualization of endometrial tissue with subsequent atrophy of endometrial foci. Additional properties of dienethest, such as immunological and anti-angiogenic effects, seem to contribute to its overwhelming effect on cell proliferation.

No reduction in mineral density bone tissue (IPC), as well as the essential effect of the preparation of Visagna to standard laboratory parameters, including general and biochemical indicators blood, hepatic enzymes, lipids and hbalc. The dienogest moderately reduces the production of estrogen in the ovaries.

Pharmacokinetics.

Absorption

After oral reception The dienogest is quickly and almost completely absorbed. The maximum concentration in serum, component of 47 ng / ml, is achieved by about 1.5 hours after one-time oral administration. Bioavailability is about 91%. Pharmacokinetics of dienogest in the dose range from 1 to 8 mg is characterized by dose-dependence.

Distribution

The dienogest is associated with serum albumin and does not associate with globulin connecting sex hormones (GSPG), as well as with corticosteroid-binding globulin (KSG). 10% of the total concentration of the substance in the blood serum is in the form of a free steroid, while about 90% is non-specific associated with albumin.

The apparent amount of dienethest distribution is 40 liters.

Metabolism

The dienogest is almost completely metabolized mainly by hydroxylation with the formation of several practically inactive metabolites. Based on the results of research in vitro and in vivo, the main enzyme involved in the metabolism of dienogest is CYP3A4. Metabolites are derived very quickly, so that the prevailing fraction in the blood plasma is unchanged dienogest.

The velocity of metabolic clearance from serum is 64 ml / min.

Elimination

The concentration of serum dienethest is reduced by two-phase. The half-life in the terminal phase is approximately 9-10 hours after meal in a dose of 0.1 mg / kg, the dienogest is derived in the form of metabolites, which are allocated through the kidneys and intestines in the ratio of approximately 3: 1. The half-life of the metabolites during their excretion by the kidneys is 14 hours after oral administration of approximately 86% of the obtained dose is derived within 6 days, and the main part is derived for the first 24 hours, mainly by the kidneys.

Equilibrium concentration

Pharmacokinetics of dienogest does not depend on the level of the GSPG. The concentration of dienogest in serum after daily intake increases by about 1.24 times, reaching an equilibrium concentration after 4 days of reception. Pharmacokinetics of dienethest after repeated reception, the mobble can be predicted on the basis of pharmacokinetics after one-time reception.

Indications for use:

Treatment of endometriosis

Method of use and dose:

For receiving inside.

The drug Byzanne is appointed for 6 months. The decision on further therapy is made by a doctor, depending on the clinical picture.

Reception scheme

Receive tablets can be started on any day menstrual cycle.

Take one tablet per day without interruption, preferably at the same time every day, if necessary, drinking water or other liquid. Tablets must be taken continuously regardless of the bleeding from the vagina. After the reception of the tablets from one package is started receiving tablets from the following, without making a break in the reception of the drug.

When the tablets are passed and in case of vomiting and / or diarrhea (if it occurs within 3-4 hours after taking a tablet), the effectiveness of the Visan drug may decrease. In the case of passing one or more tablets, a woman should take one tablet as soon as she remembers about it, and then the next day to continue receiving tablets at normal time. Instead of a pill that was not absorbed due to vomiting or diarrhea, one tablet should also drink.

Features of application:

Before receiving the preparation of Vizanna, it is necessary to exclude pregnancy. During the reception of the preparation of Byzanne, if necessary, contraceptive patients, it is recommended to use non-flame contraceptive methods (for example, barrier).

Fertility

According to reports, during the reception of the drug, the majority of patients is suppressed by ovulation. However, Vizanna is not a contraceptive.

According to reports, the physiological menstrual cycle is restored within 2 months after the cessation of the preparation of the preparation of Byzanne.

The question of the use of the preparation of Byzanne in women with ectopic pregnancy in history or with a function impairment uterine pipes It should be solved only after a thorough assessment of the ratio of expected benefits and possible risk.

Since Vesanna is a drug only with a gestagne component, it can be assumed that special warnings and precautions when using other drugs of this type are valid and in relation to the preparation of Byzanne, although not all of them are confirmed in the process clinical studies Preparation of Visan.

In the presence or exacerbation of any of the states listed below or risk factors, before starting or continuing to receive the preparation of the Visan drug, it is necessary to conduct an individual assessment of the ratio of benefit and risk.

Circulatory disorders

In the process of epidemiological studies, insufficient facts were obtained confirming the existence of the connection between the use of drugs only with the gestagne component and an increased risk of myocardial infarction or brain vessel thromboembolism. The risk of cardiovascular episodes and violations of cerebral circulation is associated, rather, with an increase in age, arterial hypertension and smoking. The risk of stroke in women with arterial hypertension can be slightly increased against the background of drugs only with a gestagne component.

Epidemiological studies indicate the possibility of statistically not meaningful increase Risk of venous thromboembolism (deep veins thrombosis, embolism pulmonary artery) Due to the use of drugs, only with a gestagne component. Related risk factors for the development of venous thromboembolism (VTE) include the appropriate family history (VTE at the brother, sisters or one of the parents in relatively early age), age, obesity, long-term immobilization, extensive surgical intervention or massive injury. In the case of long-term immobilization, it is recommended to stop the reception of the preparation of Byzanne (with a planned operation, at least four weeks before it) and resume the use of the drug only two weeks after full recovery Motor ability.

An increased risk of thromboembolism in the postpartum period should be taken into account.

When developing or suspected of the development of arterial or venous thrombosis, the drug should be discontinued immediately.

The meta-analysis of 54 epidemiological studies revealed a slight increase in the relative risk (OR \u003d 1.24) development of breast cancer in women who used oral contraceptives (PCs) at the time of study, predominantly estrogen-gestagenic drugs. This increased risk gradually disappears within 10 years after the termination of the use of combined oral contraceptives. Since breast cancer is rarely found in women under 40 years of age, a slight increase in the number of similar diagnoses in women who take combined oral contraceptives at the present moment or used combined oral contraceptives earlier, it is small in relation to common indicator risk of breast cancer. The risk of breast cancer detection in women using hormonal contraceptives only with a gestagne component may be similar in magnitude with the appropriate risk due to the use of combined oral contraceptives. However, the facts relating to drugs only with the gestagne component are based on much smaller populations using their women and therefore less convincing than data on combined oral contraceptives. To establish causal relationships based on these studies is not possible. The identified picture of risk increases can be caused by more early diagnosis breast cancer in women taking PCs, biological action of a PC or a combination of both factors. Malignant breast tumors that are diagnosed in women ever used PCs are usually clinically less pronounced than women who have never used hormonal contraception.

In rare cases, against the background of the use of hormonal substances similar to the one that is contained in the preparation of Byzanne, benign, and even less often - Slog-quality tumors Liver. In some cases, these tumors led to a pose a threat to life intra-abdominal bleeding. If the woman hosts the preparation of Byzanne takes place strong pain In the top of the abdomen, the liver is increased or there are signs of intra-abdominal bleeding, then differential diagnosis The probability of the presence of a hepatic tumor should be taken into account.

Changing the nature of bleeding

Most women have a welding of Visan drug affects the nature of menstrual bleeding.

Against the background of the use of the preparation of Byzanne, uterine bleeding can be enhanced, for example, in women with adenomyosis or leomyoma of the uterus. Abundant and prolonged bleeding can lead to anemia (in some cases heavy). In such cases, consider the abolition of the drug Byzanne.

Other states

Patients with depressions in history need careful observation. If depression recurrences in a serious form, the drug should be canceled.

In general, Vesanna, apparently, does not affect blood pressure in women with normal arterial pressure. However, if a resistant clinically significant arterial hypertension occurs on the background of the preparation of Byzann, it is recommended to cancel the drug and prescribe antihypertensive treatment.

With a recurrence of cholestatic jaundice and / or cholestatic itch, first arising against the background of pregnancy or preceding the use of germ steroids, the preparation of the wiser must be canceled.

Byzann can have a slight effect on peripheral insulin resistance and glucose tolerance. Women suffering from diabetes, especially in the presence of diabetes of pregnant women in history, during the reception of the preparation of Visann need careful observation.

In some cases, there may have a chloa, especially in women with pregnant women in history. Women prone to the development of chloasma, during the reception of the drug Visann, the impact of the sun or ultraviolet radiation should be avoided.

During the use of the drug, the ovarian persistent follicles may occur (often referred to as ovarian functional cysts). Most of these follicles are asymptomatic, although some may be accompanied by pain in the pelvis area.

In one tablet, the preparation of the Visann contains 63 mg of the lactose of the monohydrate. Located on a lactose-free diet to patients with rare hereditary disorders, such as the intolerance of galactose, lactase deficiency Lapp or glucose-galactose macabsorption, the volume of lactose contained in the preparation is mounted.

Additional information on some groups of patients

Byzanne is contraindicated for children and adolescents up to 18 years old (the effectiveness and safety of applications in adolescents are not installed). Women in postmenopausal does not apply.

Patients with renal failure

There is no data indicating the need to adjust the dose in patients with kidney disease.

Medical examination

Before you begin or resume the admission of Visan drug, you should familiarize yourself with the history of the patient's disease and conduct physical and gynecological examination. The frequency and nature of such surveys should be based on existing standards medical practice With the necessary accounting of individual characteristics of each patient (but at least 1 time in 3 - 6 months) and should include measurement arterial pressure, assessing the state of the mammary glands, abdominal cavity and pelvic organs, including a cytological study of the epithelium of the cervix.

Impact on the ability to control the car and mechanisms

As a rule, the Preparation of Byzanne does not affect the ability to control the car and working with mechanisms, however, patients who have violations of the concentration of attention should be careful.

Side effects:

Hemolymphatic systemiamia

Metabolism and alimentary impairment of mass body mass body

Raising Appetitis

Nervous SystemsGolly Pain

Reduced mood

Sleep disorder (including insomnia)

Nervousness

Loss of libido

Changing the peripheral nervous system

Violation of attention

Anxiety

Depression

Mood oscillations

Organ's surrounding eye

Body Slukazvon in the ears

Cardiovascular System Audio Blood Disturbance

Heartbeat

Arterial hypotension

Respiratory system

Digestive system

Pain in the abdomen (including pain at the bottom of the abdomen and pain in the epigastrics)

Flatulence

Sensation of abdominal cutting

Rvotadiarey

Discomfort in the abdomen

Inflammatory diseases of the gastrointestinal tract

Gingivitis

Leather and subcutaneous cellulakac

Alopecia skin

Hypergidrosis

Hair growth anomalies, including hyperstism and hyperitrihosis

Onichoklasia

Dermatitis

Reactions photosensitivity

Pigmentation disorder

Muscular apparatus in the backs in the bones

Muscle spasms

Pain in the limbs

Feeling of gravity in the limbs

Urinary system of urinary tract (including cystitis)

Reproductive system and milk irondsophobe in lactic glands (including an increase in the mammary glands and pain in lactic glands)

Gestagens, including dienogest, metabolized mainly with the participation of the P450 3A4 cytochrome system (CYP3A4), located both in the intestinal mucosa and in the liver. Consequently, inductors or CYP3A4 inhibitors can affect the metabolism of gestagenic preparations.

Increased warents of sex hormones, due to induction of enzymes, can lead to a decrease. therapeutic effect Preparation of Byzanne, as well as cause side effects, for example, changing the nature of the uterine bleeding.

Reducing the clearance of sex hormones due to inhibition of enzymes can increase the exposure of dienethest and cause side effects.

Substances that can induce enzymes

There may be interaction with drugs induced by microsomal enzymes (for example, cytochrome P450 systems), as a result of which the clearance of sex hormones may increase (such drugs include phenytoin, barbiturates, prison, carbamazepine, rifampicin, and possibly oxarbazepine, topiramate, falevbamate , nevirapine, griseofullvin, as well as preparations containing St. John's wort).

The maximum induction of enzymes, as a rule, is noted no earlier than in 2-3 weeks, but then it can be maintained for at least 4 weeks after the termination of therapy.

The effect of the CYP3A4 inductor Rifampicin was studied in healthy women in postmenopausal. With simultaneous reception of rifampicin with estradiol / dienenest pills, a significant decrease in the equilibrium concentration and systemic exposure of dienethest was noted. The system exposure of dienethest with an equilibrium concentration, determined by the largest AUC (0-24 h), was reduced by 83%.

Substances that can inhibit enzymes

Famous CYP3A4 inhibitors, such as Azole antifungal drugs (for example, ketoconazole, itraconazole, fluconazole), cimetidine, verapamil, macrolides (for example, erythromycin, clarithromycin and roxitromycin), diltiazem, protease inhibitors (for example, ritonavir, sanitary, indinavir, orefinavir), antidepressants (for example, nefazodon, fluvoxamine, fluoxetine ) And grapefruit juice, can increase the concentration of gestagennes in blood plasma and cause side effects.

In one study, in the process of which the effect of CYP3A4 inhibitors (ketoconazole, erythromycin), the concentration of estradiol of valeret and dienogest in blood plasma was increased with an equilibrium concentration. When simultaneous reception With a powerful inhibitor by ketoconazole, the value of AUC (0-24 hours) at equilibrium concentration in dionethest increased by 186%. With simultaneous use with a moderate inhibitor CYP3A4 erythromycin, the value of AUC (0-24 h) in dienethest at equilibrium concentration increased by 62%. The clinical significance of these interactions is not clarified.

The effect of dienogest on other medicinal substances

Based on these inhibiting data in vitro, the clinically significant interaction of the drug for wiser with the mediated enzymes of the cytochrome system P450 metabolism of others medicinal substances Unlikely.

Note: To identify possible interactions, you should familiarize yourself with the instructions of the accompanying drugs.

Food interaction

Eating with a high fat content did not affect the bioavailability of the preparation of Visagna.

Other types of interaction

Gestagen can influence the results of some laboratory studies, including the biochemical parameters of the liver function, thyroid gland, adrenal glands and kidneys, plasma concentrations of proteins (s), for example, lipid / lipoprotein fractions, carbohydrate parameters and coagulation parameters.

Contraindications:

The drug Visan should not be applied if there are any of the states listed below, some of which is common to all drugs containing only a gestagne component. If any of these states will develop against the background of the preparation of the preparation of Visan, the use of the drug should be immediately terminated.

Acute thrombophlebitis, venous thromboembolism at present;

Children's and adolescent age up to 18 years old (efficiency and safety of adolescents are not installed).

Application with caution

Depression in history, ectopic pregnancy in history, arterial hypertension, chronic heart failure, migraine with aura, diabetes Without vascular complications, hyperlipidemia, thrombophlebitis deep veins in history, venous thromboembolism in history (see section "Special instructions").

Pregnancy

Data on the use of the drug Byzanne in pregnant women are limited. The data obtained in animal studies and data on the use of dienogest in women during pregnancy did not reveal specific risks for pregnancy, the development of the fetus, childbirth and the development of the child after birth. The drug Byzanne should not be prescribed to pregnant women due to the lack of the need to treat endometriosis during pregnancy.

Period breastfeeding

Reception of the drug Byzanne during breastfeeding period is not recommended, since animal studies indicate the allocation of dienethest breast milk. Decision on the cessation of breastfeeding or refusal to receive the wiser is made on the basis of an assessment of the ratio of benefit breastfeeding for a child and the benefits of treatment for a woman.

Overdose:

About serious disorders in overdose was not reported. Symptoms that may be celebrated in overdose: nausea, vomiting, oscillations bloody issues or metrragia. No specific antidote, symptomatic treatment should be carried out.

Storage conditions:

Store at a temperature not higher than 30 ° C. Keep out of the reach of children. Shelf life is 5 years. Do not use after the expiration date!

Leave terms:

On prescription

Packaging:

Pills; 14 tablets in a blister from PVC / PVDX and aluminum foil. 2, 6 or 12 blisters together with the instructions for use are inserted into the cardboard box.

Manufacturer:

Bayer Healthcare Pharmaceuticals (Bayer Helsiker Pharmaceutical) Germany.

All information is provided for informational purposes and is not a reason to independently appoint or replace medication.

Latin name:Visanne.
ATH code: G03D B08.
Active substance: Dienogest.
Manufacturer:Bayer Weimar (FRG)
Pharmacy vacation condition: On prescription

Byzanna - hormonal drugused in gynecology to eliminate excessive growth of endometrial (fabric lining the uterus) by suppressing increased production of genital hormones responsible for its state.

Indications for use

The drug is intended for endometriosis therapy.

The composition of the drug

  • Active component: micronized dienethest - 2 mg
  • Other components: Lactose monohydrate, starch from potatoes, MDC, polyvinylpyrrolidone, talc, crosspovidone, E572.

Medical properties

The therapeutic effect of the medical process is obliged to the properties of its main component - a dieneth. The substance refers to the group of Northestosterone derivatives. Its antagandrogen action is one third of the ciproterone acetate.

The body associates with a progestron hormone receptors in a small amount - only about 10%. But despite this, it has a strong progestogenic effect.

The substance suppresses the development of the disease by oppressing the trophic effects of estrogen on the endometrial tissue, which, in turn, is achieved due to a decrease in the production of hormone in the ovaries and, therefore, to reduce their blood concentration.

With long-term therapy, the dienogest facilitates the initial transformation of the endometrium and the subsequent suppression of its foci. At the same time, the substance has an immunological and angiogenic effect.

After oral medication, its main component is absorbed almost in full at high speed. Peak values \u200b\u200bof the blood concentration after a single dose reach an average after an hour and a half. Bioavailability exceeds 90%.

The dienogest is transformed in the body almost completely, the proportion of inactive metabolites is negligible. The main enzyme involved in the hydroxylation process is CYP3A4. Metabolites are derived from the body at a short period of time at a rate of about 64 ml per minute.

Forms of release

The drug is produced in tablets - white or whitish pills with a chamfer. One of the surfaces is marked with the letter "B". The agent is fusing 14 pieces in blisters. In the package - 2/6/12 plates, manual for use.

Mode of application

Before therapeutic course, cancel the reception of oral hormonal contraceptives. To drink tablets of Visagna instructions for use permits regardless of the month of the monthly cycle.

Average price: (28 pcs.) - 3244 rub., (84 pcs.) - 8671 rub., (168 pcs.) - 14011 rub.

To achieve the therapeutic effect, the tablet takes a despite of vaginal bleeding. Reception is carried out continuously all over the course - no breaks after the end of one package and the next next are not observed.

  • What to do if the tablet is missing

If the patient for some reason was not able to drink a medicine in time, the missed pill is accepted at the first opportunity, and the next one is the next time in the usual time.

  • Vomiting or diarrhea

If, after receiving, vomiting (for 3-4 hours) has developed vomiting or diarrhea, then the dienogest is learned in incomplete quantity, which will negatively affect its ability to suppress the growth of endometrial tissue. To fill its missing content in the body, you should quickly take another tablet, and the next one is to drink in the usual mode.

During pregnancy and breastfeeding

Studies conducted on laboratory animals did not reveal a negative impact on the development of the fetus both during the therapeutic course and after its end. Information obtained as a result of observations of women who received a dienogest also did not record cases side effects Hp. Despite this, the drug Vizanna is not recommended to be prescribed to pregnant women, since the experience of its use is extremely skuded, and doctors cannot vouch for its safety for the child.

Use Visagna undesirable and lactating women, as it is found that the dienogest penetrates the maternal milk. If it is impossible to replace the hormonal facility with a different LAN, it is recommended to refrain from lactation during its application.

Contraindications

The hormonal agent cannot be applied if there is:

  • Thrombophlebitis B. acute form, veins thromboembolia at the time of appointment
  • Heart disease and vessels accompanied by atherosclerotic lesions of vessels (including them, stroke, ischemia, etc.) - already available or in history
  • Diabetes mellifying vessel damage
  • Heavy liver pathologies (at the time of destination and in history)
  • Malignant or benign neoplasms liver (now or in the past)
  • Available or alleged hormone-dependent oncological education (including breast cancer)
  • Vaginal bleeding of unexplained origin
  • Cholestatic hepatosis of pregnant women (history)
  • Individual hypersensitivity to the components of LS
  • Congenital immunity of lactose, genetic lactase deficiency, glucose-galactose malabsorption
  • Pregnancy, Lactation
  • Children's age under 12 years old (before the onset of the first menstruation).

This recommendation on the features of the application is based on the descriptions of drugs containing only the dienogest. If the patient during the course of the Course was concluded at least one mentioned contraindication, the medicine should be canceled and immediately visited the doctor.

Precautions

Before applying hormonal tablets, it is necessary to make sure in the absence of pregnancy. During therapy to use non-corporal means protection.

Typically, the welcome is not reflected on the ability to manage transport and working with hazardous mechanisms. But if the pills provoked a deterioration in care, scattered, then from such species of classes should be refrained.

  • Byzanne and alcohol: Is it possible to combine?

When treating hormonal means, alcohol should be excluded. Moreover, the dry law applies to pharmaceuticals containing alcohol. The prohibition is due to the ability of ethanol to unpredictably affect biochemical reactions in the body, which can lead to the sad consequences and ineffectiveness of treatment. In addition, it is necessary to remember that the action of the mobby is aimed at normalizing the hormonal background, and ethanol can reduce the result achieved, and provoke the relapse of endometriosis.

Therefore, at the time of therapy should be abstained from drugs with ethanol (tinctures, extracts), pick up other medical preparations with a similar effect.

Cross drug interactions

The receiving tablets of the Visan should be carried out with possible reactions With substances of other medical preparations:

Progesterogens (including dienogest) are transformed with the participation of the CYP3A4 enzyme. Reception of other drugs affecting its functioning (reinforcing production or overwhelming education) may affect the therapeutic effect of the mobble, which will lead to the development of side effects and will affect the nature of menstruation.

When combined with phenythine, barbiturates, rifampicin, felbamat, drugs with the substances of the Hypericum and some other drugs, should be remembered that they increase the clearance of sex hormones. Increasing the content of enzymes can occur throughout several days after one or two days of treatment and persist within a month after the next therapeutic course is completed.

With a parallel reception of HIV and NNITIV protease inhibitors with sex hormones and hepatitis causative inhibitors, change (increase / decrease) of the plasma content of progestin. In some cases, this can significantly affect the results of treatment.

The combination of powerful CYP3A4 inhibitors contributes to an increase in the content of dienethest in the body.

The main component of the wiser is capable of changing the results of some laboratory tests (indicators of the condition of the liver, thyroid gland, kidneys, etc.), carbohydrate metabolic rate, blood coagulation. But, as a rule, oscillations do not go beyond the norm.

Side effects

Unwanted consequences of therapy hormonal pills usually appear at first treatment, but then the number side manifestations Gradually decreases. The most common side effects are bleeding of various types (Including oscillates), the failure of the menstrual cycle, disconnecting sensations in lactic glands, oppressed mood, depression, etc.). In addition, the exchange rate of the wiser can provoke disorders internal organs and systems:

  • Anemia
  • Ns: scalp, frequent migraines, vegetative dysfunction, reducing care, sleep impairment, increased nervousness and anxiety, mood lability, inhibition of sexual entry
  • Metabolism: increase / decrease body weight, appetite disruption
  • Vision and rumor: dry eye, Tinnitus
  • CSS: Failure in the blood circulation system, rapid heartbeat, height hell
  • Respiratory System: Difficult Breathing, Apnea
  • Digestive organs: nausea, uncomfortable sensations or abdominal pain (in the lower and epigastric area), flatulence, attacks of vomiting, violation of the chair (diarrhea / constipation), inflammation of the mucous tissues of the gastrointestinal tract, gingivit
  • Locomotor system: back pain, bones, limbs, muscle spasms, gravity in hand and legs
  • Urinary Ways: infections of various etiology
  • Sexual system: uncomfortable sensations and changes in breast (increasing glands, soreness, occurrence of seals), tides, bleeding of different intensity, mastopathy, oily tumor formations (cysts), amenorrhea, vaginal candidiasis, dryness of mucous tissues, pain in the pelvic area, etc.
  • Others sideflines: Fast fatigue, asthenia, irritability, female swelling.

With a worsening of well-being due to the admission of Byzanne, drugs should be canceled and obtaining a consultation of the doctor about further therapy.

Overdose

Information about the development of sharp states due to the reception too large number There are no tablets. In the case of taking a medical preparation in a dosage greater than daily rate Several times, the occurrence of nausea, attacks of vomiting, separating bleeding, as well as uterine bleeding, not related to menstruation. Since there is no certain antidote yet, the therapy to eliminate overdose is carried out depending on the nature of the symptoms manifested.

Conditions and shelf life

The drug can be used for 5 years after the release. Keep branded packaging, temperatures during storage should not exceed 30 ° C.

Analogs

Given that the pathology of endometrial tissue is one of the most common diseases in women, many drugs with various active ingredients have been developed for eliminating it. Each of them has its own characteristics, so it is better to decide: Differelin, Silhouette, Byzanne, or Zhanin, should determine only a specialist, based on the totality of testimony and individual state of the patient. Alone to apply hormonal agents Without proper knowledge, extremely undesirable.

Bayer (FRG)

Cost: (21 DRAGE) - 993 rubles, (63 dr.) - 2421 rubles.

The medical preparation is a hormonal contraceptive. Blocks the ripening of follicles, inhibits ovulation, increases the density of the vaginal secret, which eliminates the possibility of passing into the spermatozooid uterus. In addition, used for androgenization therapy (excess hair growth or alopecia on male type), eels, etc.

In addition to the dienethest contains the second active component - ethinyl estradiol. Hormonal substance has a beneficial effect on the female sex system: Applied to uterine bleeding, therapy of some forms of oncology of the mammary glands.

The contraceptive agent is made in the form of dragee, which is recommended to take one thing daily at one time. After the 7-day break is followed, and then the reception is renewed.

The result of the reception is not only contraceptive effect, but also normalization of the menstrual cycle (regularity and intensity of bleeding), normalization of the state of endometrial tissue.

Apply Zhinin against endometriosis preferably to young women (25-35 years old), who do not want to acquire offspring. In this case, several tasks are solved at the same time: unplanned pregnancy is warned, the foci of endometriosis is eliminated, normalized monthly cycle. For older women (35-45 years), the risk of natural conception is reduced, so it will be better helped by Vizann.

Pros:

  • Double Effect (contraceptive and therapeutic)
  • Menstruation without pain
  • Improving hair condition.

Disadvantages:

  • High price
  • Sorerity of Ven.
  • Reduced sexual attraction.

Gedeon Richter (Hungary)

Average cost: (21 pcs.) - 644 rub., (63 rubles) - 1447 rubles.

Hormonal LAN to prevent pregnancy, eliminate endometriosis. The action is provided by ethinyl estardiol and dienogest.

The drug is produced in tablets. The instruction prescribes drinking them daily at one time. After completing the 21-day course, the next bundle is allowed to receive after a weekly break, during which bleeding occurs like this menstrual. It is usually developing on 2 or 3 days a break and can be saved until the next tablet reception cycle. Some time after the start of the course, the bleeding stops.

Pros:

  • Strong action
  • Warns unwanted pregnancy
  • Normalizes the monthly cycle.

Disadvantages:

  • Many side effects and contraindications
  • High price.

The dienogest is a derivative of Northestosterone, characterizing the antagandrogenic activity that makes up about one third of the activity of ciproterone acetate. The dienogest is associated with progesterone receptors in the man's uterus, possessing only 10% of the relative affinity of progesterone. Despite the low affinity for progesterone receptors, the dienogest is characterized by a powerful progestogenic effect in vivo. The dienogest does not have a substantial mineralocorticoid or glucocorticoid activity in vivo.

The dienogest acts on endometriosis by suppressing the trophic effects of estrogen with respect to the euteopic and ectopic endometrium, due to the reduction of estrogen products in the ovaries and reduce their concentration in plasma.

With prolonged use, it causes initial decidualization of endometrial tissue with subsequent atrophy of endometrial foci. Additional properties of dienethest, such as immunological and anti-angiogenic effects, seem to contribute to its overwhelming effect on cell proliferation.

No decrease in the mineral density of bone tissue (IPC), as well as the substantial influence of the drug is wisered into standard laboratory parameters, including general and biochemical blood indicators, hepatic enzymes, lipids and HBA1c are not marked. The dienogest moderately reduces the production of estrogen in the ovaries.

Pharmacokinetics

Suction

After oral administration, the dienogest is quickly and almost completely absorbed. C MAX in serum, component of 47 ng / ml, is achieved by about 1.5 hours after one-time oral administration. Bioavailability is about 91%. Pharmacokinetics of dienogest in the dose range from 1 to 8 mg is characterized by dose-dependence.

Distribution

The dienogest is associated with serum albumin and does not associate with globulin connecting sex hormones (GSPG), as well as with corticosteroid-binding globulin (KSG). 10% of the total concentration of the substance in the blood serum is in the form of a free steroid, while about 90% is non-specific associated with albumin.

The apparent V D Dienethest is 40 liters.

Pharmacokinetics of dienogest does not depend on the level of the GSPG. The concentration of dienogest in serum after daily intake increases by about 1.24 times, reaching an equilibrium concentration after 4 days of reception. Pharmacokinetics of dienethest after repeated reception, the mobble can be predicted on the basis of pharmacokinetics after one-time reception.

Metabolism

The dienogest is almost completely metabolized mainly by hydroxylation with the formation of several practically inactive metabolites. Based on the results of research in vitro and in vivo, the main enzyme involved in the metabolism of dienogest is CYP3A4. Metabolites are derived very quickly, so that the prevailing fraction in the blood plasma is unchanged dienogest.

The velocity of metabolic clearance from serum is 64 ml / min.

Election

The concentration of serum dienethest is reduced by two-phase. T 1/2 in the terminal phase is approximately 9-10 hours. After testing in a dose of 0.1 mg / kg, the dienogest is derived in the form of metabolites that are allocated through the kidneys and intestines in the ratio of approximately 3: 1. T 1/2 of metabolites with their excretion of the kidneys is 14 hours. After oral administration, approximately 86% of the obtained dose is derived within 6 days, and the main part is derived for the first 24 hours, mainly by the kidneys.

Form release

White tablets or almost white color, Round, flat surface and beveled edges, with engraving "B" on one side.

1 tab.
dienoyst (micronized)2 mg

Auxiliary substances: Monohydrate lactose - 62.8 mg, Potato starch - 36 mg, microcrystalline cellulose - 18 mg, Povidone K25 - 8.1 mg, Talc - 4.05 mg, Crosspovidone - 2.7 mg, magnesium stearate - 1.35 mg.

14 pcs. - Blister (2) - cardboard boxes.
14 pcs. - Blister (6) - cardboard boxes.
14 pcs. - Blisters (12) - cardboard boxes.

Dosage

The drug Byzanne is appointed for 6 months. The decision on further therapy is made by a doctor, depending on the clinical picture.

Taking tablets can be started on any day of the menstrual cycle. Take 1 tab. / Sut without a break, preferably at the same time every day, if necessary, drinking water or other liquid. Tablets must be taken continuously regardless of the bleeding from the vagina. After the reception of the tablets from one package is started receiving tablets from the following, without making a break in the reception of the drug.

When the tablets are skipping and in case of vomiting and / or diarrhea (if it occurs within 3-4 hours after taking a tablet), the effectiveness of the Visan drug may decrease. In the case of passing one or more tablets, a woman should take 1 tablet as soon as she remembers about it, and then the next day to continue receiving tablets at normal time. Instead of a tablet, which was not absorbed due to vomiting or diarrhea, should also drink 1 tablet.

Overdose

About serious disorders in overdose was not reported. Symptoms that may be observed in overdose: nausea, vomiting, cargo bleeding or metrragia. No specific antidote, symptomatic treatment should be carried out.

Interaction

Separate inductors or enzyme inhibitors (CYP3A isoenzysis)

Gestagens, incl. Dienoyst, metabolized mainly with the participation of CYP3A4, located both in the intestinal mucosa and in the liver. Consequently, inductors or CYP3A4 inhibitors can affect the metabolism of gestagenic preparations.

Increased clearance of genital hormones, due to induction of enzymes, can lead to a decrease in the therapeutic effect of the preparation of Visan, as well as cause side effects, for example, a change in the nature of uterine bleeding.

Reducing the clearance of sex hormones due to inhibition of enzymes can increase the exposure of dienethest and cause side effects.

Substances that can induce enzymes

There may be interaction with drugs induced by microsomal enzymes (for example, cytochrome P450 systems), as a result of which the clearance of sex hormones may increase (such drugs include phenytoin, barbiturates, prison, carbamazepine, rifampicin, and possibly oxarbazepine, topiramate, falevbamate , nevirapine, griseofullvin, as well as preparations containing St. John's wort).

The maximum induction of enzymes, as a rule, is noted no earlier than in 2-3 weeks, but then it can be maintained for at least 4 weeks after the termination of therapy.

The effect of the CYP3A4 inductor Rifampicin was studied in healthy women in postmenopausal. With simultaneous reception of rifampicin with estradiol / dienenest pills, a significant decrease in the equilibrium concentration and systemic exposure of dienethest was noted. The system exposure of dienethest with an equilibrium concentration, determined by the largest AUC (0-24 h), was reduced by 83%.

Substances that can inhibit enzymes

Famous CYP3A4 inhibitors, such as azole antifungal drugs (for example, ketoconazole, itraconazole, fluconazole), cimetidine, verapamil, macrolides (eg, erythromycin, clarithromycin and roxitromycin), diltiazene, protease inhibitors (for example, rhythonavir, saquinavir, indinavir, orefinavir), Antidepressants (for example, nefazodon, fluvoxamine, fluoxetine) and grapefruit juice, can increase the concentration of gestagen in blood plasma and cause side effects.

In one study, in the process of which the effect of CYP3A4 inhibitors (ketoconazole, erythromycin), the concentration of estradiol of valeret and dienogest in blood plasma was increased with an equilibrium concentration. In the case of simultaneous reception with a powerful inhibitor by ketokonazole, the value of AUC (0-24 h) with an equilibrium concentration in dienethest increased by 186%. With simultaneous use with a moderate inhibitor CYP3A4 erythromycin, the value of AUC (0-24 h) in dienethest at equilibrium concentration increased by 62%. The clinical significance of these interactions is not clarified.

The effect of dienogest on other medicinal substances

Based on the in vitro inhibiting studies, the clinically significant interaction of the preparation of wisered with the mediated enzymes of the cytochrome P450 system of other medicinal substances is unlikely.

Note: To identify possible interactions, you should familiarize yourself with the instructions of the accompanying drugs.

Food interaction

Eating with a high fat content did not affect the bioavailability of the preparation of Visagna.

Other types of interaction

The reception of gestagens can affect the results of some laboratory studies, including the biochemical parameters of the liver function, thyroid gland, adrenal glands and kidneys, plasma concentrations of proteins (-News), for example, lipid / lipoprotein fractions, carbohydrate exchange parameters and coagulation parameters.

Side effects

Side effects occur more often in the first months of the reception of the drug of Byzanne, and over time, their number decreases. The most frequent side effects include: bleeding from the vagina (including carriage, metrragia, menorrhagia, irregular bleeding), headache, discomfort in lactic glands, decline in mood and acne.

Table 1 shows undesirable drug reactions (NLR) distributed by body system classes. Side effects in each frequency group are presented in descending order of frequency. Frequency is defined as often (from ≥1 / 100 to<1/10) и нечасто (от ≥1/1000 до <1/100).

OftenInfrequently
From the hematopoietic system
Anemia
Metabolism and Alimentary Violations
Increase body weightReducing body weight
Raising Appetitis
From the CNS
Headache
Migraine
Reduced mood
Sleep disorder (including insomnia)
Nervousness
Loss of libido
Changing mood
Imbalance peripheral nervous system
Violation of attention
Anxiety
Depression
Mood oscillations
From the authority of sight
Feeling dry eye
From the hearing body
Tinnitus
From the cardiovascular system
Uncomfortable circulatory disorder
Heartbeat
Arterial hypotension
From the respiratory system
Dyspnea
From the digestive system
Nausea
Pain in the abdomen (including pain at the bottom of the abdomen and pain in the epigastrics)
Flatulence
Sensation of abdominal cutting
Vomot
Diarrhea
Constipation
Discomfort in the abdomen
Inflammatory diseases of the tract
Gingivitis
From the side of the skin
Acne
Alopecia
Dry skin
Hypergidrosis
Itch
Hair growth anomalies, incl. Girsutism and hypertrichosis
Onichoklasia
Dandruff
Dermatitis
Reactions photosensitivity
Pigmentation disorder
From the bone-muscular system
Back painPain in Kostya
Muscle spasms
Pain in the limbs
Feeling of gravity in the limbs
From the urinary system
Urinary tract infection (including cystitis)
From the gender system
Discomfort in lactic glands (including an increase in the mammary glands and pain in the milk glands)
Ovarian cyst (including hemorrhagic cyst)
Fear of heat
Uterine bleeding / bleeding from the vagina (including separating selection, metrragia, menorrhagia, irregular bleeding)
Amenorrhea
Candidiasis vagina
Dryness in the vulvovaginal region (including dry mucous membranes)
Selection of genital organs (including the allocations from the vagina)
Pain in the pelvic region
Atrophic vulvovaginite
Fibrozno-cystic mastopathy
Seal of mammary glands
Others
Asthenic condition (including fatigue, asthenia and malaise)
Irritability
Edema (including swelling of the face)

Indications

  • treatment of endometriosis.

Contraindications

The drug Visan should not be applied if there are any of the states listed below, some of which is common to all drugs containing only a gestagne component. If any of these states will develop against the background of the preparation of the drug Byzanne, the use of the drug should be immediately discontinued:

  • acute thrombophlebitis, venous thromboembolism at present;
  • heart disease and arteries, based on atherosclerotic damage to vessels (including IBS, myocardial infarction, stroke and transient ischemic attack) or in history;
  • sugar diabetes with vascular complications;
  • severe liver diseases are currently or a history (in the absence of normalization of functional samples of the liver);
  • liver tumors (benign and malignant) currently or history;
  • revealed or suspected hormone-dependent malignant tumors, incl. mammary cancer;
  • bleeding from the vagina of unclear genes;
  • cholestatic jaundice of pregnant women in history;
  • the intolerance to galactose, lactase deficiency, glucose-galactose malabsorption;
  • children's and adolescent age up to 18 years old (the efficiency and safety of applications in adolescents are not installed);
  • increased sensitivity to active substances or any of the auxiliary substances.

With caution: history depression, ectopic pregnancy in history, arterial hypertension, chronic heart failure, migraine with aura, diabetes mellitus without vascular complications, hyperlipidemia, thrombophlebitis of deep veins in history, venous thromboembolism in history.

Features of application

Application in pregnancy and breastfeeding

Data on the use of the drug Byzanne in pregnant women are limited. The data obtained in animal studies and data on the use of dienogest in women during pregnancy did not reveal a specific risk for pregnancy, the development of the fetus, childbirth and the development of the child after birth. The drug Byzanne should not be prescribed to pregnant women due to the lack of the need to treat endometriosis during pregnancy.

Reception of the drug Visagna during breastfeeding is not recommended, because Animal research indicates the release of dienogest with breast milk.

The decision to stop breastfeeding or the refusal of the welcome is made, based on the assessment of the beneficiation ratio for the child and the benefits of treatment for a woman.

Application with violations of liver function

Contraindicated: severe liver diseases at present or a history of (in the absence of normalization of functional samples of the liver); Liver tumors (benign and malignant) at present or in history. In rare cases, against the background of using hormonal substances similar to the one that is contained in the preparation of Byzanne, benign, and even less often -caluable liver tumors. In some cases, these tumors led to a pose a threat to life intra-abdominal bleeding. If a woman who takes the preparation of Byzanne, there are severe pains in the top of the abdomen, the liver is increased or there are signs of intra-abdominal bleeding, then the probability of the presence of a hepatic tumor should be taken into account in differential diagnostics.

Application with violations of the kidney function

Application in children

Contraindicated in children's and adolescent age up to 18 years (efficiency and safety of adolescents have not been established).

Application in elderly patients

Not applied in women in postmenopausal.

special instructions

Before receiving the preparation of Vizanna, it is necessary to exclude pregnancy. During the reception of the preparation of Byzanne, if necessary, contraceptive patients, it is recommended to use non-flame contraceptive methods (for example, barrier).

Fertility

According to reports, during the reception of the drug, the majority of patients is suppressed by ovulation. However, Vizanna is not a contraceptive.

According to reports, the physiological menstrual cycle is restored within 2 months after the cessation of the preparation of the preparation of Byzanne.

The question of the use of the preparation of Visaran in women with ectopic pregnancy in history or disruption of the uterine pipe function should be solved only after a thorough assessment of the ratio of expected benefits and possible risk.

Since the preparation is only a drug with a gestagne component, it can be assumed that special warnings and precautions when using other drugs of this type are valid and against the preparation of Byzanne, although not all of them are confirmed in the process of clinical studies of the drug Visan.

In the presence or exacerbation of any of the states listed below or risk factors, before starting or continuing to receive the preparation of the Visan drug, it is necessary to conduct an individual assessment of the ratio of benefit and risk.

Circulatory disorders

In the process of epidemiological studies, insufficient facts were obtained confirming the existence of the connection between the use of drugs only with the gestagne component and an increased risk of myocardial infarction or brain vessel thromboembolism. The risk of cardiovascular episodes and violations of cerebral circulation is associated, rather, with an increase in age, arterial hypertension and smoking. The risk of stroke in women with arterial hypertension can be slightly increased against the background of drugs only with a gestagne component.

Epidemiological studies indicate the possibility of a statistically not significant increase in the risk of venous thromboembolism (deep vein thrombosis, pulmonary artery embolism) due to the use of drugs only with the gestagne component. Commonly recognized factors of the risk of development of venous thromboembolism (VTE) include the corresponding family history (VTE at Brother, sisters, or one of the parents in relatively early age), age, obesity, long-term immobilization, extensive surgical intervention or massive injury. In the case of long-term immobilization, it is recommended to stop the reception of the drug of Byzanne (with a planned operation, at least four weeks before it) and resume the use of the drug only two weeks after the complete restoration of motor ability.

An increased risk of thromboembolism in the postpartum period should be taken into account.

When developing or suspected of the development of arterial or venous thrombosis, the drug should be discontinued immediately.

The meta-analysis of 54 epidemiological studies revealed a slight increase in relative risk (OR \u003d 1.24) of the development of breast cancer in women who used oral contraceptives (PCs) at the time of study (PC), mainly estrogen-gestagenic drugs. This increased risk gradually disappears within 10 years after the termination of the use of combined oral contraceptives. Since breast cancer is rarely found in women younger than 40 years old, a slight increase in the number of similar diagnoses in women who take combined oral contraceptives at the present moment or used combined oral contraceptives earlier, it is small in relation to the overall risk of breast cancer. The risk of breast cancer detection in women using hormonal contraceptives only with a gestagne component may be similar in magnitude with the appropriate risk due to the use of combined oral contraceptives. However, the facts relating to drugs only with the gestagne component are based on much smaller populations using their women and therefore less convincing than data on combined oral contraceptives. To establish causal relationships based on these studies is not possible. The identified pattern of risk increases can be caused by an earlier diagnosis of breast cancer in women taking PCs, biological effects of a PC or a combination of both factors. Malignant breast tumors that are diagnosed in women ever used PCs are usually clinically less pronounced than women who have never used hormonal contraception.

In rare cases, against the background of the use of hormonal substances similar to that contained in the preparation of Byzanne, benign, and even less often - malignant liver tumors. In some cases, these tumors led to a pose a threat to life intra-abdominal bleeding. If a woman who takes the preparation of Byzanne, there are severe pains in the top of the abdomen, the liver is increased or there are signs of intra-abdominal bleeding, then the probability of the presence of a hepatic tumor should be taken into account in differential diagnostics.

Changing the nature of bleeding

Most women have a welding of Visan drug affects the nature of menstrual bleeding.

Against the background of the use of the preparation of Byzanne, uterine bleeding can be enhanced, for example, in women with adenomyosis or leomyoma of the uterus. Abundant and prolonged bleeding can lead to anemia (in some cases heavy). In such cases, consider the abolition of the drug Byzanne.

Other states

Patients with depressions in history need careful observation. If depression recurrences in a serious form, the drug should be canceled.

In general, Visagna, apparently, does not affect hell in women with normal blood pressure. However, if a resistant clinically significant arterial hypertension occurs on the background of the preparation of Byzann, it is recommended to cancel the drug and prescribe antihypertensive treatment.

With a recurrence of cholestatic jaundice and / or cholestatic itch, first arising against the background of pregnancy or preceding the use of germ steroids, the preparation of the wiser must be canceled.

Byzann can have a slight effect on peripheral insulin resistance and glucose tolerance. Women suffering from diabetes, especially in the presence of diabetes of pregnant women in history, during the reception of the preparation of Visann need careful observation.

In some cases, there may have a chloa, especially in women with pregnant women in history. Women prone to the development of chloasma, during the reception of the drug Visann, the impact of the sun or ultraviolet radiation should be avoided.

During the use of the drug, the ovarian persistent follicles may occur (often referred to as ovarian functional cysts). Most of these follicles are asymptomatic, although some may be accompanied by pain in the pelvis area.

In 1 tablet, the preparation of the Vesanna contains 63 mg of monohydrate lactose. Located on a lactose-free diet to patients with rare hereditary disorders, such as the intolerance of galactose, lactase deficiency Lapp or glucose-galactose macabsorption, the volume of lactose contained in the preparation is mounted.

Women in postmenopausal

This category of patients does not apply.

Patients with renal failure

There is no data indicating the need to adjust the dose in patients with kidney disease.

Medical examination

Before you begin or resume the admission of Visan drug, you should familiarize yourself with the history of the patient's disease and conduct physical and gynecological examination. The frequency and nature of such surveys should be based on existing health practices with the necessary accounting of individual characteristics of each patient (but at least 1 time in 3-6 months) and should include the measurement of blood pressure, assessing the state of the mammary glands, abdominal cavity and pelvic organs, including Cytological examination of the epithelium of the cervix.

Use in pediatrics

Byzanne is contraindicated for children and adolescents up to 18 years old (the effectiveness and safety of applications in adolescents are not installed).

Impact on the ability to driving vehicles and control mechanisms

As a rule, the Preparation of Byzanne does not affect the ability to control the car and work with the mechanisms, however, patients who have disorders of the concentration of attention should be careful.

pharmachologic effect

The dienogest is a derivative of Northestosterone, characterizing the antagandrogenic activity that makes up about one third of the activity of ciproterone acetate. The dienogest is associated with progesterone receptors in the man's uterus, possessing only 10% of the relative affinity of progesterone. Despite the low affinity for progesterone receptors, the dienogest is characterized by a powerful progestogenic effect in vivo. The dienogest does not have a substantial mineralocorticoid or glucocorticoid activity in vivo.

The dienogest acts on endometriosis by suppressing the trophic effects of estrogen with respect to the euteopic and ectopic endometrium, due to the reduction of estrogen products in the ovaries and reduce their concentration in plasma.

With prolonged use, it causes initial decidualization of endometrial tissue with subsequent atrophy of endometrial foci. Additional properties of dienethest, such as immunological and anti-angiogenic effects, seem to contribute to its overwhelming effect on cell proliferation.

No decrease in the mineral density of bone tissue (IPC), as well as the substantial influence of the drug is wisered into standard laboratory parameters, including general and biochemical blood indicators, hepatic enzymes, lipids and HBA1c are not marked. The dienogest moderately reduces the production of estrogen in the ovaries.

Pharmacokinetics

Suction

After oral administration, the dienogest is quickly and almost completely absorbed. C MAX in serum, component of 47 ng / ml, is achieved by about 1.5 hours after one-time oral administration. Bioavailability is about 91%. Pharmacokinetics of dienogest in the dose range from 1 to 8 mg is characterized by dose-dependence.

Distribution

The dienogest is associated with serum albumin and does not associate with globulin connecting sex hormones (GSPG), as well as with corticosteroid-binding globulin (KSG). 10% of the total concentration of the substance in the blood serum is in the form of a free steroid, while about 90% is non-specific associated with albumin.

The apparent V D Dienethest is 40 liters.

Pharmacokinetics of dienogest does not depend on the level of the GSPG. The concentration of dienogest in serum after daily intake increases by about 1.24 times, reaching an equilibrium concentration after 4 days of reception. Pharmacokinetics of dienethest after repeated reception, the mobble can be predicted on the basis of pharmacokinetics after one-time reception.

Metabolism

The dienogest is almost completely metabolized mainly by hydroxylation with the formation of several practically inactive metabolites. Based on the results of research in vitro and in vivo, the main enzyme involved in the metabolism of dienogest is CYP3A4. Metabolites are derived very quickly, so that the prevailing fraction in the blood plasma is unchanged dienogest.

The velocity of metabolic clearance from serum is 64 ml / min.

Election

The concentration of serum dienethest is reduced by two-phase. T 1/2 in the terminal phase is approximately 9-10 hours. After testing in a dose of 0.1 mg / kg, the dienogest is derived in the form of metabolites that are allocated through the kidneys and intestines in the ratio of approximately 3: 1. T 1/2 of metabolites with their excretion of the kidneys is 14 hours. After oral administration, approximately 86% of the obtained dose is derived within 6 days, and the main part is derived for the first 24 hours, mainly by the kidneys.

Indications

- Treatment of endometriosis.

Dosing mode

The drug Byzanne is appointed for 6 months. The decision on further therapy is made by a doctor, depending on the clinical picture.

Taking tablets can be started on any day of the menstrual cycle. Take 1 tab. / Sut without a break, preferably at the same time every day, if necessary, drinking water or other liquid. Tablets must be taken continuously regardless of the bleeding from the vagina. After the reception of the tablets from one package is started receiving tablets from the following, without making a break in the reception of the drug.

When the tablets are skipping and in case of vomiting and / or diarrhea (if it occurs within 3-4 hours after taking a tablet), the effectiveness of the Visan drug may decrease. In the case of passing one or more tablets, a woman should take 1 tablet as soon as she remembers about it, and then the next day to continue receiving tablets at normal time. Instead of a tablet, which was not absorbed due to vomiting or diarrhea, should also drink 1 tablet.

Side effect

Side effects occur more often in the first months of the reception of the drug of Byzanne, and over time, their number decreases. The most frequent side effects include: bleeding from the vagina (including oscillations, metrragia, menorgia, irregular bleeding), headache, discomfort in lactic glands, reduced mood and acne.

Table 1 shows undesirable drug reactions (NLR) distributed by body system classes. Side effects in each frequency group are presented in descending order of frequency. Frequency is defined as often (from ≥1 / 100 to<1/10) и нечасто (от ≥1/1000 до <1/100).

Often Infrequently
From the hematopoietic system
Anemia
Metabolism and Alimentary Violations
Increase body weightReducing body weight
Raising Appetitis
From the CNS
Headache
Migraine
Reduced mood
Sleep disorder (including insomnia)
Nervousness
Loss of libido
Changing mood
Imbalance peripheral nervous system
Violation of attention
Anxiety
Depression
Mood oscillations
From the authority of sight
Feeling dry eye
From the hearing body
Tinnitus
From the cardiovascular system
Uncomfortable circulatory disorder
Heartbeat
Arterial hypotension
From the respiratory system
Dyspnea
From the digestive system
Nausea
Pain in the abdomen (including pain at the bottom of the abdomen and pain in the epigastrics)
Flatulence
Sensation of abdominal cutting
Vomot
Diarrhea
Constipation
Discomfort in the abdomen
Inflammatory diseases of the tract
Gingivitis
From the side of the skin
Acne
Alopecia
Dry skin
Hypergidrosis
Itch
Hair growth anomalies, incl. Girsutism and hypertrichosis
Onichoklasia
Dandruff
Dermatitis
Reactions photosensitivity
Pigmentation disorder
From the bone-muscular system
Back painPain in Kostya
Muscle spasms
Pain in the limbs
Feeling of gravity in the limbs
From the urinary system
Urinary tract infection (including cystitis)
From the gender system
Discomfort in lactic glands (including an increase in the mammary glands and pain in the milk glands)
Ovarian cyst (including hemorrhagic cyst)
Fear of heat
Uterine bleeding / bleeding from the vagina (including separating selection, metrragia, menorrhagia, irregular bleeding)
Amenorrhea
Candidiasis vagina
Dryness in the vulvovaginal region (including dry mucous membranes)
Selection of genital organs (including the allocations from the vagina)
Pain in the pelvic region
Atrophic vulvovaginite
Fibrozno-cystic mastopathy
Seal of mammary glands
Others
Asthenic condition (including fatigue, asthenia and malaise)
Irritability
Edema (including swelling of the face)

Contraindications for use

The drug Visan should not be applied if there are any of the states listed below, some of which is common to all drugs containing only a gestagne component. If any of these states will develop against the background of the preparation of the drug Byzanne, the use of the drug should be immediately discontinued:

- acute thrombophlebitis, venous thromboembolism at present;

- diseases of the heart and arteries, which are based on atherosclerotic lesions of vessels (including IBS, myocardial infarction, stroke and transient ischemic attack) or in history;

- diabetes mellitus with vascular complications;

- severe liver diseases currently or history (in the absence of normalization of the functional samples of the liver);

- tumors of the liver (benign and malignant) at present or in history;

- identified or suspected hormone-dependent malignant tumors, incl. mammary cancer;

- bleeding from the vagina of unclear genes;

- cholestatic jaundice of pregnant women in history;

- intolerance to galactose, lactase deficiency, glucose-galactose malabsorption;

- Children and adolescent age up to 18 years old (the effectiveness and safety of applications in adolescents are not established);

- Increased sensitivity to active substances or to any of the auxiliary substances.

FROM caution: Depression in history, ectopic pregnancy in history, arterial hypertension, chronic heart failure, migraine with aura, diabetes mellitus without vascular complications, hyperlipidemia, thrombophlebitis of deep veins in history, venous thromboembolism in history.

Application in pregnancy and breastfeeding

Data on the use of the drug Byzanne in pregnant women are limited. The data obtained in animal studies and data on the use of dienogest in women during pregnancy did not reveal a specific risk for pregnancy, the development of the fetus, childbirth and the development of the child after birth. The drug Byzanne should not be prescribed to pregnant women due to the lack of the need to treat endometriosis during pregnancy.

Reception of the drug Visagna during breastfeeding is not recommended, because Animal research indicates the release of dienogest with breast milk.

The decision to stop breastfeeding or the refusal of the welcome is made, based on the assessment of the beneficiation ratio for the child and the benefits of treatment for a woman.

Application in children

Contraindicated in children's and adolescent age up to 18 years (efficiency and safety of adolescents have not been established).

Overdose

About serious disorders in overdose was not reported. Symptoms that may be observed in overdose: nausea, vomiting, cargo bleeding or metrragia. No specific antidote, symptomatic treatment should be carried out.

Medicinal interaction

Separate inductors or enzyme inhibitors (CYP3A isoenzysis)

Gestagens, incl. Dienoyst, metabolized mainly with the participation of CYP3A4, located both in the intestinal mucosa and in the liver. Consequently, inductors or CYP3A4 inhibitors can affect the metabolism of gestagenic preparations.

Increased clearance of genital hormones, due to induction of enzymes, can lead to a decrease in the therapeutic effect of the preparation of Visan, as well as cause side effects, for example, a change in the nature of uterine bleeding.

Reducing the clearance of sex hormones due to inhibition of enzymes can increase the exposure of dienethest and cause side effects.

Substances that can induce enzymes

There may be interaction with drugs induced by microsomal enzymes (for example, cytochrome P450 systems), as a result of which the clearance of sex hormones may increase (such drugs include phenytoin, barbiturates, prison, carbamazepine, rifampicin, and possibly oxarbazepine, topiramate, falevbamate , nevirapine, griseofullvin, as well as preparations containing St. John's wort).

The maximum induction of enzymes, as a rule, is noted no earlier than in 2-3 weeks, but then it can be maintained for at least 4 weeks after the termination of therapy.

The effect of the CYP3A4 inductor Rifampicin was studied in healthy women in postmenopausal. With simultaneous reception of rifampicin with estradiol / dienenest pills, a significant decrease in the equilibrium concentration and systemic exposure of dienethest was noted. The system exposure of dienethest with an equilibrium concentration, determined by the largest AUC (0-24 h), was reduced by 83%.

Substances that can inhibit enzymes

Famous CYP3A4 inhibitors, such as azole antifungal drugs (for example, ketoconazole, itraconazole, fluconazole), cimetidine, verapamil, macrolides (eg, erythromycin, clarithromycin and roxitromycin), diltiazene, protease inhibitors (for example, rhythonavir, saquinavir, indinavir, orefinavir), Antidepressants (for example, nefazodon, fluvoxamine, fluoxetine) and grapefruit juice, can increase the concentration of gestagen in blood plasma and cause side effects.

In one study, in the process of which the effect of CYP3A4 inhibitors (ketoconazole, erythromycin), the concentration of estradiol of valeret and dienogest in blood plasma was increased with an equilibrium concentration. In the case of simultaneous reception with a powerful inhibitor by ketokonazole, the value of AUC (0-24 h) with an equilibrium concentration in dienethest increased by 186%. With simultaneous use with a moderate inhibitor CYP3A4 erythromycin, the value of AUC (0-24 h) in dienethest at equilibrium concentration increased by 62%. The clinical significance of these interactions is not clarified.

The effect of dienogest on other medicinal substances

Based on the in vitro inhibiting studies, the clinically significant interaction of the preparation of wisered with the mediated enzymes of the cytochrome P450 system of other medicinal substances is unlikely.

Note: To identify possible interactions, you should familiarize yourself with the instructions of the accompanying drugs.

Food interaction

Eating with a high fat content did not affect the bioavailability of the preparation of Visagna.

Other types of interaction

The reception of gestagens can affect the results of some laboratory studies, including the biochemical parameters of the liver function, thyroid gland, adrenal glands and kidneys, plasma concentrations of proteins (-News), for example, lipid / lipoprotein fractions, carbohydrate exchange parameters and coagulation parameters.

Conditions of vacation from pharmacies

The drug is released by the prescription.

Terms and Storage Terms

The drug should be stored in an inaccessible place at temperatures not higher than 30 ° C. Shelf life is 5 years.

Application with violations of liver function

Contraindicated: severe liver diseases at present or a history of (in the absence of normalization of functional samples of the liver); Liver tumors (benign and malignant) at present or in history. In rare cases, against the background of using hormonal substances similar to the one that is contained in the preparation of Byzanne, benign, and even less often -caluable liver tumors. In some cases, these tumors led to a pose a threat to life intra-abdominal bleeding. If a woman who takes the preparation of Byzanne, there are severe pains in the top of the abdomen, the liver is increased or there are signs of intra-abdominal bleeding, then the probability of the presence of a hepatic tumor should be taken into account in differential diagnostics.

Application with violations of the kidney function

Application in elderly patients

Not applied in women in postmenopausal.

special instructions

Before receiving the preparation of Vizanna, it is necessary to exclude pregnancy. During the reception of the preparation of Byzanne, if necessary, contraceptive patients, it is recommended to use non-flame contraceptive methods (for example, barrier).

Fertility

According to reports, during the reception of the drug, the majority of patients is suppressed by ovulation. However, Vizanna is not a contraceptive.

According to reports, the physiological menstrual cycle is restored within 2 months after the cessation of the preparation of the preparation of Byzanne.

The question of the use of the preparation of Visaran in women with ectopic pregnancy in history or disruption of the uterine pipe function should be solved only after a thorough assessment of the ratio of expected benefits and possible risk.

Since the preparation is only a drug with a gestagne component, it can be assumed that special warnings and precautions when using other drugs of this type are valid and against the preparation of Byzanne, although not all of them are confirmed in the process of clinical studies of the drug Visan.

In the presence or exacerbation of any of the states listed below or risk factors, before starting or continuing to receive the preparation of the Visan drug, it is necessary to conduct an individual assessment of the ratio of benefit and risk.

Circulatory disorders

In the process of epidemiological studies, insufficient facts were obtained confirming the existence of the connection between the use of drugs only with the gestagne component and an increased risk of myocardial infarction or brain vessel thromboembolism. The risk of cardiovascular episodes and violations of cerebral circulation is associated, rather, with an increase in age, arterial hypertension and smoking. The risk of stroke in women with arterial hypertension can be slightly increased against the background of drugs only with a gestagne component.

Epidemiological studies indicate the possibility of a statistically not significant increase in the risk of venous thromboembolism (deep vein thrombosis, pulmonary artery embolism) due to the use of drugs only with the gestagne component. Commonly recognized factors of the risk of development of venous thromboembolism (VTE) include the corresponding family history (VTE at Brother, sisters, or one of the parents in relatively early age), age, obesity, long-term immobilization, extensive surgical intervention or massive injury. In the case of long-term immobilization, it is recommended to stop the reception of the drug of Byzanne (with a planned operation, at least four weeks before it) and resume the use of the drug only two weeks after the complete restoration of motor ability.

An increased risk of thromboembolism in the postpartum period should be taken into account.

When developing or suspected of the development of arterial or venous thrombosis, the drug should be discontinued immediately.

Tumors

The meta-analysis of 54 epidemiological studies revealed a slight increase in relative risk (OR \u003d 1.24) of the development of breast cancer in women who used oral contraceptives (PCs) at the time of study (PC), mainly estrogen-gestagenic drugs. This increased risk gradually disappears within 10 years after the termination of the use of combined oral contraceptives. Since breast cancer is rarely found in women younger than 40 years old, a slight increase in the number of similar diagnoses in women who take combined oral contraceptives at the present moment or used combined oral contraceptives earlier, it is small in relation to the overall risk of breast cancer. The risk of breast cancer detection in women using hormonal contraceptives only with a gestagne component may be similar in magnitude with the appropriate risk due to the use of combined oral contraceptives. However, the facts relating to drugs only with the gestagne component are based on much smaller populations using their women and therefore less convincing than data on combined oral contraceptives. To establish causal relationships based on these studies is not possible. The identified pattern of risk increases can be caused by an earlier diagnosis of breast cancer in women taking PCs, biological effects of a PC or a combination of both factors. Malignant breast tumors that are diagnosed in women ever used PCs are usually clinically less pronounced than women who have never used hormonal contraception.

In rare cases, against the background of the use of hormonal substances similar to that contained in the preparation of Byzanne, benign, and even less often - malignant liver tumors. In some cases, these tumors led to a pose a threat to life intra-abdominal bleeding. If a woman who takes the preparation of Byzanne, there are severe pains in the top of the abdomen, the liver is increased or there are signs of intra-abdominal bleeding, then the probability of the presence of a hepatic tumor should be taken into account in differential diagnostics.

Changing the nature of bleeding

Most women have a welding of Visan drug affects the nature of menstrual bleeding.

Against the background of the use of the preparation of Byzanne, uterine bleeding can be enhanced, for example, in women with adenomyosis or leomyoma of the uterus. Abundant and prolonged bleeding can lead to anemia (in some cases heavy). In such cases, consider the abolition of the drug Byzanne.

Other states

Patients with depressions in history need careful observation. If depression recurrences in a serious form, the drug should be canceled.

In general, Visagna, apparently, does not affect hell in women with normal blood pressure. However, if a resistant clinically significant arterial hypertension occurs on the background of the preparation of Byzann, it is recommended to cancel the drug and prescribe antihypertensive treatment.

With a recurrence of cholestatic jaundice and / or cholestatic itch, first arising against the background of pregnancy or preceding the use of germ steroids, the preparation of the wiser must be canceled.

Byzann can have a slight effect on peripheral insulin resistance and glucose tolerance. Women suffering from diabetes, especially in the presence of diabetes of pregnant women in history, during the reception of the preparation of Visann need careful observation.

In some cases, there may have a chloa, especially in women with pregnant women in history. Women prone to the development of chloasma, during the reception of the drug Visann, the impact of the sun or ultraviolet radiation should be avoided.

During the use of the drug, the ovarian persistent follicles may occur (often referred to as ovarian functional cysts). Most of these follicles are asymptomatic, although some may be accompanied by pain in the pelvis area.

Lactose

In 1 tablet, the preparation of the Vesanna contains 63 mg of monohydrate lactose. Located on a lactose-free diet to patients with rare hereditary disorders, such as the intolerance of galactose, lactase deficiency Lapp or glucose-galactose macabsorption, the volume of lactose contained in the preparation is mounted.

Women in postmenopausal

This category of patients does not apply.

Patients with renal failure

There is no data indicating the need to adjust the dose in patients with kidney disease.

Medical examination

Before you begin or resume the admission of Visan drug, you should familiarize yourself with the history of the patient's disease and conduct physical and gynecological examination. The frequency and nature of such surveys should be based on existing health practices with the necessary accounting of individual characteristics of each patient (but at least 1 time in 3-6 months) and should include the measurement of blood pressure, assessing the state of the mammary glands, abdominal cavity and pelvic organs, including Cytological examination of the epithelium of the cervix.

Use in pediatrics

Byzanna contraindicated children and adolescents under 18 (The efficiency and safety of applications in adolescents are not installed).

Impact on the ability to driving vehicles and control mechanisms

As a rule, the Preparation of Byzanne does not affect the ability to control the car and work with the mechanisms, however, patients who have disorders of the concentration of attention should be careful.

One pharmaceutical preparation tablet contains:

  • micronized (basic biologically active component) - 2 mg;
  • lactose monohydrate - 62.8 mg;
  • potato starch - 36 mg;
  • microcrystalline cellulose (MCC) - 18 mg;
  • povidone to 25 - 8.1 mg;
  • talc - 4.05 mg;
  • crospovidone - 2.7 mg;
  • magnesium stearate - 1.35 mg.

Form release

In the pharmaceutical kiosks, the drug is supplied as tablet white or white-close to white 2 mg, which are packaged in blisters (contour cellular packaging) from PVC or aluminum foil, designed for 14 pieces. Tablets round shape with a flat surface and beveled edges. Each has engraving on one side in the form of the letter "B". The cardboard box contains 2, 6 or 12 plates.

pharmachologic effect

Dienogest , the main operating component of the pill tablets is a chemical derivative northestosterone that is, characterized by a strong antandrogenic activity . The active substance has relative affinity with progesterone by 10%, which manifests itself in a powerful progestogen effect.

The dienogest is associated with receptors designed for progesterone, in a woman's uterus, after which it shows its therapeutic effects. So, as Endogenous Development decreases , as a result, its trophic influences and on an ektopic, and in the ectopic levels are suppressed. In the future, with continuous treatment with tablets, a valid component, creating specific endocrine medium , causes the initial stage of dezidalization of endometrial tissues, that is, layered peeling of the affected cover. The next stage is endometroid foci, eliminating the pathophysiological cause of this nosological unit.

We should not forget that the biological effects of dienethest also include immunological and antiangiogenic . These properties of the active component of the pharmaceutical preparation for women make it possible to largely slow down the proliferation of cells, their maturation and germination of vessels into newly formed coverings. Thus, endometriosis addiction is suppressed.

Pharmacodynamics and pharmacokinetics

Drug is used for oral reception, after which it is fast and fully absorbed from the gastrointestinal tract. The maximum serum concentration (47 ng / ml) is achieved after 1.5 hours after one-time reception of Visan tablets. Bioavailability biologically active components is invisible 91%. It should also be noted that under certain framework (single dosage from 1 to 8 mg), pharmacokinetic abilities of the drug dose-dependent .

Falling into the blood, the main acting component is nonspecific manner associated with (about 90%), the remaining 10% are in the form of free serum steroid . The drug has weak cumulative abilities - After the daily use of the tablets, the concentration of the active component increases 1.24 times. The equilibrium amount of drug in the main blood flow is observed after 4 days of conservative therapy.

Metabolized Dienenogest by hydroxylation with the formation of inactive exchange products. The main enzyme that participates in the metabolic paths of the active component is CYP3A4. What is important in determining clinical interactions from a different kind of pharmaceutical preparations. Food exchange products fast enough displays from the body through kidney and intestine - Clearance rate from serum is 64 ml / min. The half-life of the medication is 9-10 hours. Interestingly, the elimination of the drug takes place in two stages. First of all, in the first 24 hours, the kidneys highlighted the main part of a single dose, after which within 6 days the main number of accepted and suiced tablets.

Indications for use

- This is a gynecological nosological unit that develops in women of reproductive age. From the point of view of pathophysiology, the disease is intensive generation of endometrial cells (The inner layer of covering the walls of the tissue uterus) outside the boundaries of typical localization. Intensively proliferating fabric has specific receptors to female hormones, that is, newly formed cells are subject to menstrual cycle. As a result of this sequence of changes monthly hemorrhagia lead to inflammation Since the blood cannot normally stand out from the wall of the uterus.

Maintenance symptoms diseases:

  • patus cyclic nature;
  • lengthening menstrual bleeding;
  • increase in genital organs in volume;
  • dISSAREUTION - soreness with sexual intercourse;
  • at the fourth stage of development, the emptying of the intestine or bladder also causes intensive pain.

Contraindications

  • increased individual sensitivity to the components of the pharmaceutical preparation;
  • intolerance hereditary or acquired biologically active substances of the drug;
  • acute ;
  • venous thromboembolism;
  • bleeding from the vagina with an unexplained cause and pathogenesis;
  • (especially in the presence of vascular complications);
  • damage to the vascular bed;
  • diseases of the heart (in particular coronary artery disease , or transient ischemic attacks);
  • liver pathologies that change the indicators of functional samples;
  • cholestatic jaundice pregnant women in history;
  • benign and malignant liver neoplasms;
  • violations of carbohydrate exchange - intolerance to galactose, glucose-galactose malabsorption, lactase deficiency;
  • hormone-dependent malignant neoplasms (in particular breast);
  • children's and adolescent age until the age of 18.

Use medicine carefully (It is recommended to pass a conservative therapeutic course in a specialized hospital under the supervision of qualified medical personnel) follows at:

  • (or the presence of this pathology in history);
  • chronic heart failure;
  • clinically confirmed with aura;
  • hyperlipidemia .

Side effects

Side effects manifest usually at the beginning of the course conservative therapy and as they continue the treatment, their number and force significantly decreases. The adverse effects of the resentment for convenience are divided into systems and the frequency of manifestations (pharmaceutical literature establishes the following norms of manifestation of side effects - often from 1/1000 to 1/10, and infrequently from 1/1000 to 1/100):

  • From side hooping system : infrequently - anemia .
  • Alimentary and metabolic Violations: often - an increase in body weight; Infrequently - a decrease in body weight or an increase in appetite.
  • Digestive system : often - nausea , vomot , pain in the field of epigastria or lower abdomen, and a feeling of cutting the abdominal cavity; Infirmly - or, inflammatory diseases of the gastrointestinal tract, gingivitis.
  • From side skin Pokrov : often - (acne with a lesion of the sebaceous glands), (hair loss); Infrequently dry skin cover, (excessive accumulation and release of liquid), (excess terminal hair growth on male type), hypertrichosis, onichoklasia (Litness of nail plates), with different pathogens, violation, reaction photo sensitivity.
  • Sex system : often - the increase in the mammary glands, breast pain , cystic lesion of ovarian, irregular uterine bleeding ,; infrequently - vagina, dryness of the mucous membranes of the vulvovaginal region, pain in the pelvic region, atrophic vulvovaginite , separation from genital organs, fibrous-cystic or seals of the mammary glands of other origin.
  • central nervous system : often -, violation of the mode of sleep and wakefulness, reducing libido , frequent change of mood; Infrequently - imbalance of the peripheral nervous system, depression, disorders , anxiety.
  • From side sense organs : Infrequently - a feeling of dry eyeballs, ringing in the ears.
  • The cardiovascular system : infrequently - a violation of the blood circulation of an unexplained genesis, heart palpitations , arterial hypotension.
  • From side bone-muscular system : often - pain which are localized at the bottom of the back; Infrequently - bone pain, especially in the limbs, short-term muscle spasms, " unappropriate limbs "(Unpleasant feeling of gravity in hand and legs).
  • urinary system : infrequently - infection urinary tract and bladder.
  • Others: often - asthenization (increased fatigue, malaise and irritability); Infrequently - swelling.

Byzanna, instructions for use (method and dosage)

Tablets are designed for reception inside . You can begin a conservative treatment course on any day of the menstrual cycle. Dosage It is 1 tablet per day. The pharmaceutical preparation should be used regularly, every day, at the same time. This fact is explained hormonal vibrations During the day, that is, the therapeutic effect of the drug will be much higher, if the instruction on the wiser will be performed as correct as possible.

If a packaging is over then it is necessary to immediately acquire the following within the duration of the course of conservative therapy. When pass one or several receptions further treatment continues the same dosage (one tablet per day) from the nearest possible moment, but this break adversely affects the outcome of the sanation (the rate may turn out to be longer than was originally assumed). If after receiving the pharmaceutical preparation for 3-4 hours there is a rich vomot or, instead of a non-Absorbed tablet, you should drink another to maintain a constant concentration of biologically active drug components.

Overdose

When using excessive drug concentrations, the following may be observed. symptoms : nausea and vomiting, metrragia and bloody separation of a separating character from genitals. Specific antidote from the overdose of Visanne drug among pharmaceutical products at the moment does not exist, because when the above adverse effects should be further therapy and conduct symptomatic treatment .

Interaction

The active components of the drug Visan is closely related to the system of biological catalysts of the IP3A isoenzyme (microsomal systems cytochrome p 450. ), respectively, clinically significant interaction exhibit groups of medicines that in one way or another affect the biochemical properties of this metabolic link.

Typical inducers of the enzymatic system

Drugs that increase the activity of biological catalysts of the cytochrome system indirectly contribute enhance the clearance of sex hormones . Since the main acting component is messenger - a derivative of the hormone-like substance, respectively, the metabolism of the tablets also undergo certain changes. First of all, it leads to a significant reducing therapeutic effect (Biologically active substances circulate not enough long in the main blood flow). Also such clinical interaction can cause side effects , for example, a change in the nature of the uterine bleeding (quantity, consistency, soreness, and so on).

To medicines that act in a similar way include: Phenytoin , antibiotics and, barbiturates , Prindonon, Felbamat used in the fight against pathogenic fungi, as well as drugs based on medicinal ZHERBOYU. .

The maximum influence of inductive nature on enzymes is not immediately noted, but only after 2-3 weeks However, this pharmaceutical effect is preserved continuously - it takes at least 4 weeks after the cessation of combined therapy before restoring the usual metabolic pathway speed.

Substances that are able to brake enzyme action

Inhibitors of enzyme systems with a joint sanitation with a significant extent increase the concentration of gestagennes in the plasma component of blood, and accordingly cause Heavy side effects From the list specified above. Such actions have the following groups of drugs:

  • antifungal funds - , ;
  • macrolids -, roxitromycin;
  • protez inhibitors - Ritonavir, Indinavir, Savicinavir;
  • antidepressants – , , Nefazodon;
  • preparations of other groups - cimetidine ,.

Compatibility of the drug with food

Meal high fat Does not affect the pharmacokinetic abilities of components components and the therapeutic effects provided by them, that is, when the course of conservative therapy does not require a special diet. However, from the diet should be excluded grapefruit juice Since it contains trace elements acting as inhibitors of the enzymatic cytochrome system (see above possible adverse effects).

Illegal types of interaction

Active valid components of Visan tablets can several customize the results of clinical analyzes . For example, the influences of the pharmaceutical preparation should be taken into account with biochemical functional probes of the liver, thyroid gland, adrenal glands and kidneys. Fractional parameters are changed, for example, protein concentrations (including specific carrier transporters), lipids and lipoproteins, hemochaguing constants, carbohydrate metabolism.

Terms of sale

Medicine is released only on certified receptor forms.

Storage conditions

Visanne tablets should be stored in an inaccessible place for children of younger at a constant temperature mode not higher than 30 degrees Celsius.

Shelf life

special instructions

Byzanna - the drug, which includes hormonal component . This means that after a conservative course of therapy with a drug, the body undergo certain changes at the level of biological hormones, especially since the reception of the medication was preceded by such serious gynecological pathology as endometriosis. As a consequence, during the passage of the course of therapy by oral pills, the temporary (suppression of ovulation processes) is noted.

However, one should not once again set panic. Monthly after the Byzannes begin not immediately, but for one to two or three months, which is the norm, with the return of natural menstrual cycle The possibilities of the reproductive system of the female organism are restored. Of course, immediately at the end of the course of the pharmaceutical preparation, you should take advice from a qualified specialist.

Visa Analogs

Coincidences on the ATX 4 level code:

As such analogues of the drug for Vizanne at the moment there are no on the pharmaceutical market. This is the optimal means for the treatment of such pathology as endometriosis . At times in the sluggish disease and the corresponding indications, this product can be replaced by other hormonal means that do not have proven reliability and a clinically confirmed effect with this nosological unit.

So, for example, the analogues of the Visan drug are often presented drugs or " + Dienogest ", In fact, are the same pharmaceutical name (the first name is used for commercial purposes, because it is more common on the shelves of pharmaceutical kiosks, and the second is an international non-proprietary name).

A huge number of women on thematic pharmaceutical forums and Internet resources are asked, so it's better - Zhanin or Vizann, and what positive properties in therapeutic practice is preferable to choose in the treatment of endometriosis .

First of all, it should be understood that the zane is classified as monophasic contraceptive Pharmaceutical preparation. That is, this medicinal product is Based on hormonal components. This is nothing but the main purpose of the appointment of this medicine.

Of course, on the Internet, you can find information on which Zhanina clinical trials were carried out as a means to combat endometriosis. However, the components of the pharmaceutical preparation also include ethylene Estradiol and a large number of excipients that significantly expand the list of adverse effects and side effects of the therapeutic course.

Accordingly, the question of Byzanna or Zhanin during endometriosis is not correct in essence. Quite definitely choose pills Visanna Since this pharmaceutical preparation has been specially created to combat gynecological pathology. The auxiliaries were chosen in order to maximize the active component, minimize the risk of side effects and significantly reduce the duration of the conservative retention course.

Children

The pharmaceutical preparation is not used in pediatric practice, since the influence of biologically active components included in the tablets, on a young, unformed organism is not sufficiently studied.

Compatible with alcohol

During the course of conservative treatment of endometriosis, alcohol can be used, but in extremely limited quantities. A non-toxic dose is considered 150 ml of dry wine or 70 ml of fastened.

During pregnancy (and lactation)

The study of the influence of the drug Byzanne on pregnant women and developing fruits was carried out exclusively on animals. The data obtained during clinical studies indicate that the drug does not affect does not bear risk for the future child. You should not use tablets to this critical period for a woman period only with the lack of need to undergo a therapeutic course during endometriosis. It should also be noted that the pregnancy after the Byzanne passes as smoothly as without prior sanitation with a drug.

Use tablets from endometriosis during lactation () not recommended Since clinical studies on animals revealed the propensity of dienethest, the main active component of the pharmaceutical preparation, stand out with breast milk. With an absolute medical need for admission, the selection should be addressed to the cessation of feeding with their own milk with a qualified specialist (the ratio of natural feeding for the child and therapeutic effects for a woman).

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