Visanne tabs 2mg #28

Visanne instruction

Reed more and buy Visanne on this page

Composition

One tablet of the pharmaceutical preparation contains:
    micronized dienogest (the main 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 of issue

In pharmacy kiosks, the drug is supplied in the form of tablets of white or close to white color of 2 mg, which are packaged in blisters (contoured cell packs) of PVC or aluminum foil, designed for 14 pieces. Tablets of round shape with a flat surface and bevelled edges. Each is engraved on one side in the form of the letter "B". The cardboard box contains 2, 6 or 12 plates.

pharmachologic effect

Dienogest, the main active component of the Visanne tablets, is a chemical derivative of nortestosterone, that is, it is characterized by a strong anti-androgenic activity. The active substance has a relative affinity with progesterone by 10%, which is manifested in a powerful progestagen effect.
Dienogest binds to receptors for progesterone in the woman's womb, after which it shows its therapeutic effects. Thus, in endometriosis, the endogenous production of estradiol is reduced, as a result of which its trophic influences are suppressed both at the ectopic and ectopic levels. Later, with continuous treatment with tablets, the active ingredient, creating a specific endocrine environment, causes the initial stage of decidualization of the endometrial tissue, that is, layer-by-layer exfoliation of the affected integument. The next stage is the atrophy of endometroids, the elimination of the pathophysiological cause of this nosological unit.
It should not be forgotten that the biological effects of Dienogest also include immunological and anti-angiogenic. These properties of the active ingredient of the pharmaceutical preparation for women make it possible to significantly inhibit the proliferation of cells, their maturation and the germination of vessels into newly formed integuments. Thus, the tendency of endometriosis to spread is suppressed.

Pharmacodynamics and pharmacokinetics

The drug is used for oral administration, after which it is quickly and completely absorbed from the gastrointestinal tract. The maximum serum concentration (47 ng / ml) is reached after 1.5 hours after a single dose of the tablets of Byzantine. Bioavailability of biologically active components makes up an unprecedented 91%. It should also be noted that within certain limits (single dose of 1 to 8 mg), the pharmacokinetic ability of the drug is dose-dependent.
Getting into the blood, the main active ingredient is associated non-specifically with albumin (about 90%), the remaining 10% are in the form of a free serum steroid. The drug has weak cumulative abilities - after daily use of tablets Visanne, the concentration of the active component increases by 1.24 times. The equilibrium amount of the drug in the main bloodstream is observed after 4 days of the course of conservative therapy.
Metabolized Dienogest by hydroxylation with the formation of inactive exchange products. The main enzyme that participates in the metabolic pathways of the active component is CYP3A4, which is important in determining clinical interactions with various kinds of pharmaceutical preparations. The metabolic products are quickly removed from the body through the kidneys and intestines - the clearance rate from the blood serum is 64 ml / min. The half-life of the drug is 9-10 hours. It is interesting that the elimination of the drug takes place in two stages. First of all, during the first 24 hours, the main part of a single dose is allocated by the kidneys, after which during 6 days the basic amount of taken and absorbed tablets is given.

Indications for use

Endometriosis is a gynecological nosological unit that develops in women of reproductive age. From the point of view of pathophysiology, the disease is an intensive proliferation of endometrial cells (the inner layer of tissue covering the uterine wall) beyond the boundaries of typical localization. Intensively proliferating tissue has specific receptors for female hormones, that is, newly formed cells are subject to the menstrual cycle. As a result of this sequence of changes, monthly hemorrhages lead to inflammation, since blood can not normally be released from the uterine wall.
The main symptoms of the disease:
    pelvic pain of a cyclic nature;
    lengthening of menstrual bleeding;
    an increase in the sex organs in volume;
    infertility;
    dyspareunia - soreness in sexual intercourse;
    at the fourth stage of development, evacuation of the intestine or bladder also causes intense pain.

Contraindications

    increased individual sensitivity to the components of the pharmaceutical product;
    intolerance of hereditary or acquired biologically active substances of the drug;
    acute thrombophlebitis;
    venous thromboembolism;
    bleeding from the vagina with an unclear cause and pathogenesis;
    diabetes mellitus (especially in the presence of vascular complications);
    atherosclerotic vascular lesions;
    heart disease (in particular ischemic heart disease, stroke or transient ischemic attacks);
    pathology of the liver, changing the indicators of functional tests;
    cholestatic jaundice of pregnant women in anamnesis;
    benign and malignant neoplasms of the liver;
    disorders of carbohydrate metabolism - galactose intolerance, glucose-galactose malabsorption, lactase deficiency;
    hormone-dependent malignant neoplasms (in particular, adenoma of the breast);
    children and adolescents up to the age of 18.
Use the medicine with caution (it is recommended that a conservative therapeutic course be performed in a specialized hospital under the supervision of qualified medical personnel) should be followed when:
    depression;
    ectopic pregnancy (or presence of the given pathology in the anamnesis);
    arterial hypertension;
    chronic heart failure;
    Clinically confirmed migraine with aura;
    hyperlipidemia.

Side effects

Side effects are manifested, as a rule, at the beginning of the course of conservative therapy and as the treatment continues, their number and strength is significantly reduced. The adverse consequences of sanitation are conveniently divided into systems and the frequency of manifestations (the pharmaceutical literature establishes the following norms for side effects - often from 1/1000 to 1/10, and infrequently from 1/1000 to 1/100):
    From the hemopoietic system: infrequently anemia.
    Alimentary and metabolic disorders: often - weight gain; infrequently, weight loss or increased appetite.
    Digestive system: often - nausea, vomiting, pain in the epigastric region or in the lower abdomen, flatulence and a feeling of raspiraniya abdominal cavity; infrequently - constipation or diarrhea, inflammatory diseases of the gastrointestinal tract, gingivitis.
    From the skin: often - acne (acne with sebaceous glands), alopecia (hair loss); infrequent dry skin, hyperhidrosis (excessive accumulation and discharge of fluid), itching, hirsutism (excessive terminal hair growth by male type), hypertrichosis, onychoclasis (fragility of nail plates), dandruff, dermatitis with various pathogens, pigmentation disorders, photosensitivity reactions .
    Sexual system: often - breast enlargement, breast tenderness, cystic ovarian failure, irregular uterine bleeding, amenorrhea; infrequently - candidiasis of the vagina, dryness of the mucous membranes of the vulvovaginal area, pain in the pelvic region, atrophic vulvovaginitis, secretions from the genitals, fibrocystic mastopathy, or thickening of the mammary glands of another origin.
    Central nervous system: often - headache, migraines, disturbed sleep and wakefulness, decreased libido, frequent mood changes; infrequent imbalance of the peripheral nervous system, depression, attention disorders, anxiety.
    From the senses: infrequent - the sensation of dry eyeballs, ringing in the ears.
    Cardiovascular system: infrequent - blood circulation disorder of unknown origin, rapid heart rate, arterial hypotension.
    From the musculoskeletal system: often - pains that are localized at the bottom of the back; infrequently - bone pain, especially in the limbs, short-term muscle spasms, "unattainable limbs" (unpleasant sensation of heaviness in the hands and feet).
    Urinary system: infrequently - infection of the urinary tract and bladder.
    Others: often - asthenia (increased fatigue, malaise and irritability); infrequently - puffiness.
Byzantine, instructions for use (Method and dosage)
Tablets are intended for oral administration. You can start a conservative course of treatment on any day of the menstrual cycle. Dosage is 1 tablet per day. Pharmaceutical preparation should be used regularly, every day, at the same time. This fact is due to fluctuations in the hormonal background during the day, that is, the therapeutic effect of the drug will be much higher if the instruction for Visanne will be performed as correctly as possible.
If the package is over, then the next should be immediately purchased within the duration of the course of conservative therapy. If one or more procedures are missed, further treatment continues with the same dosage (one tablet per day) from the nearest possible time, but such a break adversely affects the outcome of the sanation (the course may be longer than originally thought). If, after taking the pharmaceutical preparation for 3-4 hours, there is profuse vomiting or diarrhea, then instead of unabsorbed tablets you should drink another to maintain a constant concentration of the biologically active components of the drug.

Overdose

When using an excessive concentration of the drug, the following symptoms can be observed: nausea and vomiting, metrorrhagia and macular bleeding from the genitals. Specific antidote for an overdose of Visanne drug among pharmaceutical products does not exist at the moment, therefore, with the above adverse effects, further therapy and symptomatic treatment should be discontinued.

Interaction

The metabolism of the active components of the preparation of Visanne is closely related to the system of biological catalysts of the CYP3A isoenzyme (microsomal enzymes of the cytochrome P 450 system), respectively, a group of drugs that in one way or another influence the biochemical properties of this metabolic link exhibit a clinically significant interaction.

Typical inducers of the enzymatic system

Medicines that increase the activity of biological catalysts of the cytochrome system indirectly contribute to increased clearance of sex hormones. Since the main active component of Byzantine is a derivative of a hormone-like substance, the metabolism of tablets also undergoes certain changes. First of all, this leads to a significant decrease in the therapeutic effect (biologically active substances circulate not long enough in the main bloodstream). Also, such clinical interaction can cause side effects, for example, a change in the character of uterine bleeding (quantity, consistency, soreness, etc.).
The drugs that work in this manner include: Phenytoin, antibiotics Carbamazepine and Rifampicin, barbiturates, Primidone, Felbamate, Griseofulvinum, used in the fight against pathogenic fungi, as well as drugs based on medicinal St. John's wort.
The maximum influence of inductive character on enzymes is not observed immediately, but only after 2-3 weeks, however, this pharmaceutical effect persists for at least 4 weeks after discontinuation of the combined therapy until the normal metabolic pathway is restored.

Substances that can inhibit the action of enzymes

Inhibitors of enzyme systems when combined with Visanne significantly increase the concentration of progestogens in the plasma component of the blood, and consequently cause severe side effects from the list indicated above. The following groups of medicinal products have this effect:
    antifungal agents - ketoconazole, Itraconazole, Fluconazole;
    macrolides - Erythromycin, Clarithromycin, Roxithromycin;
    protease inhibitors - ritonavir, indinavir, saquinavir;
    antidepressants - fluoxetine, fluvoxamine, nefazodone;
    preparations of other groups - Cimetidine, Verapamil, Diltiazem.

Compatibility of the preparation with food products

Eating high in fat does not affect the pharmacokinetic ability of the constituent components and the therapeutic effect they exert, that is, when taking a course of conservative therapy, a special diet is not required. However, grapefruit juice should be excluded from the diet, as it contains trace elements acting as inhibitors of the enzymatic cytochrome system (see the possible adverse effects above).

Non-drug interactions

Active active ingredients of the Visanne tablets may somewhat distort the results of clinical analyzes. So, for example, the effects of a pharmaceutical preparation should be taken into account in biochemical functional tests of the liver, thyroid, adrenal and kidney. Fractional parameters are also changing, for example, the concentration of proteins (including specific transporter carriers), lipids and lipoproteins, hemocoagulation constants, and carbohydrate metabolism.

Storage conditions

Visanne tablets should be stored in a place inaccessible to young children at a constant temperature regime of no higher than 30 degrees Celsius.
Shelf life - 5 years

special instructions

Visanne is a drug in which there is a hormonal component. This means that after a conservative course of therapy with the drug, the body undergoes certain changes at the level of biological hormones, especially since the intake of the medication was preceded by such a serious gynecological pathology as endometriosis. As a consequence, during the course of therapy with oral tablets, temporary fertility is noted (suppression of ovulation processes).
However, do not panic again. The months after Byzantine do not begin immediately, but within one to two or three months, which is the norm, with the return of the natural menstrual cycle, the possibilities of the reproductive system of the female body are restored. Of course, immediately after the end of the course of the pharmaceutical preparation, you should consult a qualified specialist.

Children

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

Compatibility with alcohol

During the course of conservative treatment of endometriosis with the drug Visanne you can drink alcohol, however in extremely limited quantities. A non-toxic dose is 150 ml of dry wine or 70 ml of fortified wine.

During pregnancy (and lactation)

The study of the influence of the drug Visanne on pregnant women and developing fetuses was carried out exclusively on animals. The data obtained during clinical trials indicate that the drug does not affect pregnancy, does not carry a risk for the child's future. Do not use tablets in this critical period for a woman only with no need to undergo a therapeutic course for endometriosis. It should also be noted that the pregnancy after Byzantium is as smooth as without a previous sanitation with a drug.
The use of tablets from endometriosis during lactation (breastfeeding) is not recommended, as clinical studies in animals have revealed a tendency of Dienogest, the main active ingredient of a pharmaceutical preparation, to excrete with breast milk. With the absolute medical need for the reception of Byzantium, the question of stopping feeding by own milk with a qualified specialist (the relationship between the benefits of natural feeding for a child and the therapeutic effects for a woman) should be addressed.

Reviews about Visanne

The pharmaceutical drug enjoys a good reputation, despite all the negative features. Of course, responses to forums are sometimes even angry, since the drug has a very wide range of various side effects and adverse effects of treatment. However, with the task set, the pills cope with a bang, reviews about Byzantine in endometriosis allow us to assert that the drug can eliminate such a complex gynecological problem, which in itself is a good indicator.
Separately it is necessary to note reviews of gynecologists about Visanne, since these qualified specialists understand the whole pathophysiological mechanism of the disease and the pharmacokinetics of the therapeutic effect of the active components of the drug. From the point of view of medical personnel, the drug should be used without any "buts" in endometriosis, especially the use of tablets in the initial stages of nosological unit development, when not all genital organs are covered with pathology, and the hormonal background of a woman is close to the initial one.
Doctors especially insist on unquestioning adherence to instructions and dosages, because in this way a constant concentration of hormonal means is created, which makes it possible to effectively combat gynecological disease. It has been clinically proven that patients who had the slightest fluctuations in the concentration of active constituents of elements were treated conservatively several times longer.
It should also be emphasized that, like the menstrual cycle, pregnancy after taking a course of conservative treatment with this pharmaceutical product is possible and proceeds without any specific phenomena. Most advanced gynecologists before planning a future child are recommended to undergo an examination for endometriosis and other common pathologies of the female reproductive organism in order to avoid problems with conception and fetal bearing.