Visanne (Vizanna) tabs 2mg #28

User manual for Visanne

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Visanne is a gestagen.

Release form and composition

Dosage form - tablets: almost white or white, round flat shape, with beveled edges, engraved "B" on one side (14 pcs. In a blister, in a cardboard box 2, 6 or 12 blisters and instructions for use by Visanne ).
1 tablet contains:
    active substance: dienogest (micronized) - 2 mg;
    auxiliary components: microcrystalline cellulose, crospovidone, lactose monohydrate, povidone K25, potato starch, magnesium stearate, talc.

Pharmacodynamics

The active ingredient of Visanne is dienogest, a derivative of nortestosterone, characterized by antiandrogenic activity (makes up about a third of the activity of cyproterone acetate).
Dienogest binds to progesterone receptors in the uterus. It has a low affinity for progesterone receptors (about 10%), however, in vivo it has a powerful progestogenic effect. Does not have significant glucocorticoid and mineralocorticoid activity in vivo.
The effect of the drug on endometriosis occurs due to the suppression of trophic effects in relation to the ectopic and eutopic endometrium as a result of a decrease in the production of estrogens in the ovaries and a decrease in their plasma concentration.
With prolonged regular intake, Visanne promotes the initial decidualization of the endometrial tissue, and subsequently causes atrophy of endometrioid foci. Such additional effects of the drug as antiangiogenic and immunological, presumably explain its suppressive effect on cell proliferation.
The advantage of Visanne over placebo for pelvic pain due to endometriosis was demonstrated in 102 patients in a 3-month clinical study. Pain intensity was assessed using a visual analogue scale (VAS with a ruler from 0 to 100 mm). After three months of drug treatment, a statistically significant difference was shown compared with the placebo group (Δ = 12.3 mm; 95% confidence interval - 6.4-18.1; p <0.0001) and a clinically significant decrease in pelvic pain in comparison with baseline values ​​(mean value 27.4 mm ± 22.9).
After the end of therapy, 37.3% of women showed a decrease in pain intensity by 50% or more, while the dose of anesthetic taken simultaneously did not increase (in the placebo group, this indicator was 19.8%); in 18.6% of women, the intensity of pain decreased by 75% or more, while the dose of anesthetic taken simultaneously did not increase (in the placebo group, this indicator was 7.3%).
In the extended open phase of this placebo-controlled study, there was a persistent decrease in pelvic pain due to endometriosis during treatment for up to 15 months (the average decrease in pain intensity at the end of therapy with Visanne was 43.2 ± 21.7 mm).
The efficacy of Visanne for pelvic pain associated with endometriosis was also demonstrated in a six-month comparative study of dienogest and leuprorelin acetate (LA), a gonadotropin-releasing hormone (GnRH) agonist. 120 women received Visanne. Pain intensity was assessed by VAS (0–100 mm). In both groups, there was a clinically significant reduction in pain compared to baseline (Visanne - 47.5 ± 28.8 mm; LA - 46 ± 24.8 mm). The efficacy of dienogest was comparable to that of LA (p <0.0001), with a predetermined limit of least efficacy of 15 mm.
A total of 252 women participated in the three studies. They received Visanne in a daily dose of 2 mg. After 6 months of treatment, a significant decrease in endometriotic foci was revealed.
The pharmacodynamic effects of four daily doses of dienogest (0.5 mg, 1 mg, 2 mg and 3 mg) were studied in parallel groups (n = 20–23 per dose group) in a randomized, double-blind study of up to 72 days. Ovulation occurred in 14% and 4% of the groups receiving dienogest at a dose of 0.5 mg and 1 mg, respectively. In women from the groups receiving the drug at a dose of 2 mg and 3 mg, ovulation was absent. In 80% of patients from the group taking dienogest 2 mg, ovulation was observed 5 weeks after the end of the course of therapy. In larger studies, the contraceptive effect of Visanne has not been studied.
The study, lasting 12 months, involved 111 adolescent girls aged 12–18 years (after menarche). Visanne has been shown to be effective in endometriosis for symptoms such as pelvic pain, dyspareunia and dysmenorrhea.
In the course of therapy, there was no decrease in the average bone mineral density (BMT), which was assessed in 21 adult patients before the start of Visanne and 6 months after the end of the therapeutic course.
The study, lasting 12 months, involved 103 adolescent girls. In this group, there was a decrease in the BMD of the lumbar spine (L2–4 vertebrae) by an average of 1.2% compared with the initial values. 6 months after the end of therapy, within the framework of the period of continued observation, it was found that the indicators returned to normal.
When Visanne was used for a period of up to 15 months, there was no significant effect on standard laboratory parameters, including blood chemistry, hematology, glycosylated hemoglobin, lipids and liver enzymes.
In the course of standard studies of the pharmacological safety of dienogest, its toxicity with repeated administration, genotoxicity, carcinogenicity and toxicity to the human reproductive system, preclinical data were obtained that did not indicate the presence of specific risks. However, it must be borne in mind that sex hormones can stimulate the growth of some hormone-dependent tissues and tumors.

Pharmacokinetics

Once in the gastrointestinal tract, dienogest is rapidly and almost completely absorbed. The maximum serum concentration is 47 ng / ml and is reached within about 1.5 hours after a single dose of Visanne. Bioavailability is about 91%. The pharmacological kinetics of dienogest in the dose range of 1–8 mg is dose-dependent.
Approximately 90% of dienogest binds nonspecifically to serum albumin, 10% of the drug in serum is in the form of a free steroid. The substance does not bind to corticosteroid-binding globulin (CSG) and sex hormone-binding globulin (SHBG).
The apparent volume of distribution (Vd) is 40 liters.
With daily intake of Visanne, the serum concentration of dienogest increases by about 1.24 times. Equilibrium concentration is reached after 4 days. The pharmacokinetics of the drug with repeated use is similar to that with a single dose.
Dienogest is almost completely metabolized, mainly by hydroxylation, as a result of which several almost inactive metabolites are formed.
In in vitro and in vivo studies, it was found that dienogest is metabolized mainly with the participation of the CYP3A4 isoenzyme. Metabolites are quickly excreted from the body; therefore, unchanged dienogest prevails in the blood plasma. The metabolic clearance rate from blood serum is 64 ml / min.
The decrease in serum concentration of the drug occurs in two phases. The half-life in the terminal phase is about 9-10 hours. After taking Visanne at a dose of 0.1 mg / kg, dienogest is excreted as metabolites through the kidneys and intestines in an approximate ratio of 3: 1. The half-life of metabolites by the kidneys is 14 hours. About 86% of the drug dose is excreted within 6 days, with most of it in the first day, mainly by the kidneys.

Indications for use

The use of Visanne is indicated for the treatment of endometriosis.

Contraindications

    pathologies of the heart and arteries caused by atherosclerotic vascular damage: ischemic heart disease, transient ischemic attack, stroke, myocardial infarction (including anamnesis);
    venous thromboembolism at present, acute thrombophlebitis;
    diabetes mellitus with vascular complications;
    vaginal bleeding of unknown origin;
    breast cancer and other hormone-dependent malignant neoplasms, including if they are suspected;
    benign and malignant liver tumors (including anamnesis);
    severe liver diseases (including anamnesis) – in the absence of positive dynamics in the results of liver tests;
    indication in the anamnesis of cholestatic jaundice of pregnant women;
    lactase deficiency, galactose intolerance, glucose-galactose malabsorption syndrome;
    pregnancy;
    breastfeeding;
    hypersensitivity to the components of the drug.
Caution should be exercised when prescribing Visanne to women with a history of depression, arterial hypertension, chronic heart failure, diabetes mellitus without vascular complications, hyperlipidemia, migraines with aura, a history of deep vein thrombophlebitis, venous thromboembolism and/or ectopic pregnancy.
In pediatrics, Visanne is not used in patients before the onset of menarche (children under 12 years of age).
In the event of the appearance of these pathologies against the background of the use of tablets, their reception should be immediately canceled.

Visanne, instructions for use: method and dosage

Visanne tablets are taken orally, washed down with any liquid.
The use of tablets is continued for six months, the expediency of further therapy is determined by the doctor on the basis of the patient's clinical condition.
You can start treatment on any day of the menstrual cycle.
Recommended dosage: 1 pc. 1 time a day, preferably at one time. The therapeutic effect is achieved by continuous use of the drug, including during bleeding from the vagina, so you can not allow a break in taking Visanne.
The effect of the drug may decrease with accidental skipping and the development of vomiting and / or diarrhea in the first 3-4 hours after taking the next dose. Therefore, the missed tablet should be taken as soon as possible, after being remembered, and not absorbed due to vomiting or diarrhea, it is necessary to compensate by taking an additional dose of Visanne. Further, the drug is continued at the set time of the day.

Side effects

    from the hematopoietic system: infrequently-anemia;
    from the genital system: often – discomfort in the mammary glands (including their enlargement and/or pain), a feeling of heat against the background of blood flushes to the face, bleeding from the vagina or uterine bleeding (in the form of spotting, menorrhagia, metrorrhagia, irregular bleeding), amenorrhea, ovarian cyst (including hemorrhagic cyst); infrequently – pelvic pain, vaginal discharge, vaginal candidiasis, dryness in the vulvovaginal region, atrophic vulvovaginitis, breast compaction, fibrocystic mastopathy;
    alimentary pathologies and metabolism: often-an increase in body weight; infrequently-a decrease in body weight, an increase in appetite;
    from the nervous system: often-headache, low mood, nervousness, sleep disorders, insomnia, loss of libido, mood changes, migraine; infrequently-anxiety, imbalance of the peripheral nervous system, attention disorders, mood fluctuations, depression;
    from the digestive system: often-flatulence, nausea, vomiting, abdominal pain (including in the lower abdomen and epigastrium), a feeling of abdominal distension; infrequently-abdominal discomfort, diarrhea, constipation, gingivitis, inflammatory pathologies of the gastrointestinal tract;
    from the side of the hearing organ: infrequently-ringing in the ears;
    from the side of the organ of vision: infrequently-a feeling of dry eyes;
    from the cardiovascular system: infrequently-unspecified circulatory disorders, arterial hypotension, palpitations;
    from the musculoskeletal system: often-back pain; infrequently-muscle spasms, bone pain, pain and / or a feeling of heaviness in the extremities;
    from the respiratory system: infrequently-shortness of breath;
    from the urinary system: infrequently-cystitis and other urinary tract infections;
    from the skin: often-alopecia, acne; infrequently-itching, dry skin, hair growth abnormalities (including hirsutism and hypertrichosis), hyperhidrosis, onychoclasia, dermatitis, pigmentation disorders, photosensitivity reactions, dandruff;
    other: often-asthenic condition (including malaise, fatigue, asthenia), irritability; infrequently-edema (including the face).

Overdose

There have been no reports of cases of serious disorders in overdose.
Possible symptoms: nausea and vomiting, metrorrhagia or spotting spotting. There is no specific antidote of dienogest. The treatment is symptomatic.

Special instructions

Treatment with the drug can be started only after physical and gynecological examinations, excluding the presence of pregnancy, a detailed study of the medical history. Measurement of blood pressure( BP), cytological examination of the cervical epithelium, assessment of the condition of other pelvic organs, abdominal cavity, mammary glands should be carried out at least once every 3-6 months.
During the period of taking Visanne, women should use non-hormonal contraceptives, including the barrier method.
Despite the fact that Visanne is not a contraceptive, the effect of the drug in most cases causes the suppression of ovulation.
The physiological cycle of menstrual bleeding is restored within two months after the discontinuation of therapy.
The expediency of using Visanne in case of a violation of the function of the fallopian tubes or an ectopic pregnancy in the anamnesis is decided individually, based on an assessment of the ratio of possible risk and expected benefit from therapy.
Risk factors for the development of venous thromboembolism (VTE) are: family history (the presence of VTE in parents at a young age, brother, sister), obesity, age, prolonged immobilization, serious injury or extensive surgery.
The risk of developing cardiovascular pathologies and disorders of cerebral circulation increases in women with arterial hypertension, smoking or increasing age. The probability of developing a stroke with arterial hypertension against the background of using drugs containing only progestogen may increase, but only slightly.
In case of planned surgery, it is recommended to stop taking pills no later than four weeks before the date of the procedure and resume treatment with the drug after full recovery of motor ability two weeks later.
When prescribing Visanne, the possibility of developing thromboembolism in the postpartum period should be taken into account.
If you suspect or the first symptoms of arterial or venous thrombosis appear, taking the pills should be canceled immediately.
In rare cases, the use of hormonal drugs containing progestogen causes benign or malignant neoplasms of the liver, accompanied, in some cases, by intra-abdominal bleeding. Therefore, in the differential diagnosis of severe pain in the upper abdomen in women with an enlarged liver or with signs of intra-abdominal bleeding, the possibility of a liver tumor should not be excluded.
Taking pills can increase uterine bleeding, including in women with leiomyoma or uterine adenomyosis, therefore, with the development of anemia against the background of heavy and prolonged bleeding, the abolition of Visanne is required.
If severe depression or cholestatic jaundice and/or cholestatic itching recurs against the background of taking Visanne (first developed during previous use of sex steroids or during pregnancy), clinically significant persistent arterial hypertension occurs, the drug should be discontinued.
Due to the insignificant effect on glucose tolerance and peripheral insulin resistance, it is necessary to monitor the condition of patients with diabetes mellitus, especially if there is a history of diabetes mellitus in pregnant women.
If there is a tendency to develop chloasma, it is recommended to avoid exposure to direct sunlight and ultraviolet radiation during the treatment period.
Visanne can cause the development of functional ovarian cysts, in most cases the follicles are asymptomatic, sometimes they can be accompanied by pain in the pelvic area.
The content of lactose monohydrate in 1 tablet of Visanne is 63 mg.

Influence on the ability to drive vehicles and complex mechanisms

The ability to drive vehicles and mechanisms is not affected by Visanne.

Use during pregnancy and lactation

No reproductive toxicity, carcinogenicity and genotoxicity were detected in animal studies. The experience of using dienogest during pregnancy is limited. Visanne is not prescribed for pregnant women, since there is no need to treat endometriosis during this period.
In animal studies, it was found that dienogest is excreted in breast milk. In this regard, it is not recommended to use Visanne during lactation. If the treatment is clinically justified, breastfeeding should be discontinued.

Use in childhood

Visanne can be used in adolescence only in girls after menarche.

With impaired renal function

There is no need to adjust the dose of Visanne in patients with impaired renal function.

In case of liver function disorders

It is contraindicated to use Visanne tablets for severe liver diseases at the present time or in the anamnesis (until functional tests are normalized), as well as for benign and malignant liver tumors, including in the anamnesis.
In rare cases, patients receiving hormonal drugs are diagnosed with benign formations, even less often-malignant liver tumors, which can lead to the development of intra-abdominal bleeding, life-threatening. In this regard, in women receiving Visanne, if there is severe pain in the upper abdomen, an enlarged liver or there are signs of intra-abdominal bleeding during differential diagnosis, it is necessary to take into account the probability of having a liver tumor.

Use in the elderly

Visanne is not prescribed for postmenopausal women.

Drug interaction

With the simultaneous use of the Visanne:
    inducers of microsomal enzymes of the cytochrome P450 system: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, nevirapine, griseofulvin, drugs containing St. John's wort-increase the clearance of sex hormones and reduce the therapeutic effect of the drug;
    CYP3A4 inhibitors: azole antifungal agents (including itraconazole, ketoconazole, fluconazole), verapamil, cimetidine, macrolides (including erythromycin, roxithromycin, clarithromycin), protease inhibitors (such as ritonavir, indinavir, saquinavir, nelfinavir), diltiazem, antidepressants (including nefazodone, fluoxetine, fluvoxamine), grapefruit juice – contribute to an increase in the concentration of dienogest in the blood plasma and the risk of side effects.
During the treatment period, it is necessary to carefully study the instructions of any drug of concomitant therapy for interaction with the progestogen. This will avoid the development of undesirable phenomena, including changes in the nature of uterine bleeding.
The effect of Visanne distorts the results of such laboratory studies as the biochemical functional parameters of the liver, adrenal glands and kidneys, thyroid gland, blood clotting parameters, parameters of carbohydrate metabolism, plasma concentrations of proteins (including fractions of lipids, lipoproteins).

Terms and conditions of storage

Keep away from children.
Store at a temperature of up to 30 °C.
The shelf life is 5 years.

Reviews about Visanne

According to reviews, Visanne is an effective drug for the treatment of endometriosis. Women claim that it really helps with this disease and allows you to avoid surgical intervention. The main disadvantage of gestagen is a large list of side effects, but in most cases, according to patients, "the end justifies the means". Also, many women complain about the high cost of the drug.

Terms of sell

You can buy Visanne without a doctor's prescription.