Byzanne
Vizanne: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Visanne
ATX code: G03D
Active ingredient: dienogest (dienogest)
Manufacturer: Bayer Weimar (Germany)
Description and photo updated: 2019-27-08
Prices in pharmacies: from 2949 rubles.
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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.
Pharmacological properties
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 use, Visanne promotes the initial decidualization of the endometrial tissue, and subsequently causes atrophy of endometrioid foci. Such additional effects of the drug, as anti-angiogenic 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 at a daily dose of 2 mg. After 6 months of treatment, a significant decrease in endometrioid 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). The efficacy of Visanne in endometriosis has been confirmed for symptoms such as pelvic pain, dyspareunia and dysmenorrhea.
During 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 continued observation period, 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 concentration in serum is 47 ng / ml and is reached within approximately 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 (V d) is 40 liters.
With a 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 excreted from the body quickly, therefore unchanged dienogest prevails in the blood plasma. The metabolic clearance rate from blood serum is 64 ml / min.
The decrease in the 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 in the form of 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 lesions: ischemic heart disease, transient ischemic attack, stroke, myocardial infarction (including history);
- 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 history);
- severe liver disease (including anamnesis) - in the absence of positive dynamics in the results of liver tests;
- an indication of a history of cholestatic jaundice of pregnant women;
- lactase deficiency, galactose intolerance, glucose-galactose malabsorption syndrome;
- pregnancy;
- breast-feeding;
- hypersensitivity to the components of the drug.
Care should be taken when prescribing Visanne to women with a history of depression, arterial hypertension, chronic heart failure, diabetes mellitus without vascular complications, hyperlipidemia, migraine 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 intake should be immediately canceled.
Byzanne, instructions for use: method and dosage
Visanne tablets are taken orally with any liquid.
The use of tablets continues for six months, the physician determines the appropriateness of further therapy based on the patient's clinical condition.
You can start treatment on any day of the menstrual cycle.
Recommended dosage: 1 pc. Once a day, preferably at the same time. The therapeutic effect is achieved by continuous administration of the drug, including during the period of bleeding from the vagina, therefore, a break in taking Visanne should not be allowed.
The effect of the drug may decrease if you accidentally skip and develop vomiting and / or diarrhea in the first 3-4 hours after taking the next dose. Therefore, the missed pill must be taken as soon as possible after remembering, and not absorbed due to vomiting or diarrhea must be compensated by taking an additional dose of Visanne. Further, taking the drug is continued at the set time of day.
Side effects
- from the hematopoietic system: infrequently - anemia;
- on the part of the reproductive system: often - discomfort in the mammary glands (including their enlargement and / or pain), a feeling of heat against the background of flushing 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 - pain in the pelvic region, vaginal discharge, vaginal candidiasis, dryness in the vulvovaginal region, atrophic vulvovaginitis, breast induration, fibrocystic mastopathy;
- alimentary pathologies and metabolism: often - an increase in body weight; infrequently - weight loss, increased appetite;
- from the nervous system: often - headache, low mood, nervousness, sleep disturbance, insomnia, loss of libido, mood changes, migraine; infrequently - anxiety, imbalance of the peripheral nervous system, impaired attention, mood swings, depression;
- from the digestive system: often - flatulence, nausea, vomiting, pain in the abdomen (including in the lower abdomen and epigastrium), a feeling of bloating; infrequently - abdominal discomfort, diarrhea, constipation, gingivitis, inflammatory pathologies of the gastrointestinal tract;
- from the organ of hearing: infrequently - ringing in the ears;
- on the part of the organ of vision: infrequently - a feeling of dry eyes;
- on the part of the cardiovascular system: infrequently - unspecified circulatory disorders, arterial hypotension, palpitations;
- from the musculoskeletal system: often - back pain; infrequently - muscle cramps, bone pain, pain and / or a feeling of heaviness in the limbs;
- from the respiratory system: infrequently - shortness of breath;
- from the urinary system: infrequently - cystitis and other urinary tract infections;
- on the part of the skin: often - alopecia, acne; infrequently - itching, dry skin, hair growth abnormalities (including hirsutism and hypertrichosis), hyperhidrosis, onychoclasia, dermatitis, pigmentation disorders, photosensitivity reactions, dandruff;
- others: often - asthenic state (including malaise, fatigue, asthenia), irritability; infrequently - edema (including the face).
Overdose
Cases of development of serious disorders in overdose have not been reported.
Possible symptoms: nausea and vomiting, metrorrhagia or spotting spotting. There is no specific antidote for dienogest. Treatment is symptomatic.
special instructions
Treatment with the drug can be started only after physical and gynecological examinations, excluding pregnancy, and a detailed study of the medical history. Measurement of blood pressure (BP), cytological examination of the epithelium of the cervix, assessment of the condition of other pelvic organs, abdominal cavity, mammary glands should be carried out at least once every 3–6 months.
While taking Visanne, women should use non-hormonal contraception, including the barrier method.
Despite the fact that Visanne is not a contraceptive, the action of the drug in most cases causes suppression of ovulation.
The physiological cycle of menstrual bleeding is restored within two months after discontinuation of therapy.
The feasibility of using Visanne in case of dysfunction of the fallopian tubes or a history of ectopic pregnancy 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 (presence of VTE in young parents, brother, sister), obesity, age, prolonged immobilization, serious trauma or major surgery.
The risk of developing cardiovascular pathologies and cerebrovascular accidents increases in women with hypertension, smoking or increasing age. The likelihood of developing a stroke with arterial hypertension against the background of the use of drugs containing only gestagen may increase, but not significantly.
With a planned operation, it is recommended to stop taking the pills no later than four weeks before the date of the procedure and resume treatment with the drug after full restoration of motor ability after two weeks.
When prescribing Vizanne, one should take into account the possibility of thromboembolism in the postpartum period.
If you suspect or appear the first symptoms of arterial or venous thrombosis, taking the tablets should be stopped immediately.
In rare cases, the use of hormonal preparations containing a gestagen 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 having 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, if anemia develops against the background of heavy and prolonged bleeding, Visanne must be canceled.
If, while taking Visanne, depression in severe form or cholestatic jaundice and / or cholestatic pruritus (first developed during previous use of sex steroids or during pregnancy) recurs, 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 control the condition of patients with diabetes mellitus, especially if there is a history of diabetes mellitus in pregnant women.
If you have a tendency to develop chloasma, it is recommended to avoid exposure to direct sunlight and ultraviolet radiation during the treatment period.
Byzanne can cause the development of functional ovarian cysts, in most cases the follicles are asymptomatic, sometimes accompanied by pain in the pelvic region.
The content of lactose monohydrate in 1 tablet of Visanne is 63 mg.
Influence on the ability to drive vehicles and complex mechanisms
Visanne does not affect the ability to drive vehicles and mechanisms.
Application during pregnancy and lactation
In animal studies, reproductive toxicity, carcinogenicity and genotoxicity have not been identified. Experience with dienogest during pregnancy is limited. Visanne is not prescribed for pregnant women, since during this period there is no need to treat endometriosis.
In animal studies, it was found that dienogest is excreted in breast milk. In this regard, Vizanne is not recommended for use during lactation. If treatment is clinically justified, breastfeeding should be discontinued.
Pediatric use
Visanne can only be used in adolescence in girls after menarche.
With impaired renal function
No dose adjustment of Visanne is required for patients with impaired renal function.
For violations of liver function
It is contraindicated to use Visanne tablets in case of severe liver disease at present or in history (until functional tests are normalized), as well as in case of benign and malignant liver tumors, including a history.
In rare cases, patients receiving hormonal drugs are diagnosed with benign tumors, even less often with malignant liver tumors, which can lead to the development of life-threatening intra-abdominal bleeding. In this regard, in women receiving Visanne, with the appearance of severe pain in the upper abdomen, an enlarged liver or signs of intra-abdominal bleeding during differential diagnosis, it is necessary to take into account the likelihood of a liver tumor.
Use in the elderly
Byzanne is not prescribed for postmenopausal women.
Drug interactions
With the simultaneous use of Visanne:
- inducers of microsomal enzymes of the cytochrome P 450 system: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, nevirapine, griseofulvin, agents containing St. John's wort - increase the clearance of sex hormones and reduce the therapeutic effect of the drug;
- CYP3A4 inhibitors: azole antifungals (including itraconazole, ketoconazole, fluconazole), verapamil, cimetidine, macrolides (including erythromycin, roxithromycin, clarithromycin), protease inhibitors (such as ritonavir, indinavir, nel saquinavir) nefazodone, fluoxetine, fluvoxamine), grapefruit juice - increase the concentration of dienogest in blood plasma and the risk of side effects.
During the period of treatment, it is necessary to carefully study the instructions for any drug of concomitant therapy for interaction with a gestagen. This will avoid the development of undesirable phenomena, including changes in the nature of uterine bleeding.
Vizanne's action distorts the results of laboratory studies such as biochemical functional parameters of the liver, adrenal glands and kidneys, thyroid gland, blood coagulation parameters, carbohydrate metabolism parameters, plasma concentrations of proteins (including lipid and lipoprotein fractions).
Analogs
The analogues of Vizanne are: Dyufaston, Iprozhin, Crainon, Model Mam, Model 911, Nemestran, Norkolut, Oxyprogesterone Capronate, Orgametril, Prajisan, Progesterone, Utrozhestan.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 30 ° C.
The shelf life is 5 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Byzanne
According to reviews, Visanne is an effective drug for the treatment of endometriosis. Women claim that it really helps with this disease and avoids surgery. The main disadvantage of gestagen is called 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.
The price of Visanne in pharmacies
Approximate prices for Visanne (2 mg tablets): 3265–3371 rubles. per pack of 28 pcs., 7321-9332 rubles. per pack of 84 pcs.
Byzanne: prices in online pharmacies
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Drug name Price Pharmacy |
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Vizanna 2mg tablets 28 pcs. 2949 RUB Buy |
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Visanne 2 mg tablets 28 pcs. 2949 RUB Buy |
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Visanne 2 mg tablets 84 pcs. 8399 RUB Buy |
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Vizanna 2mg tablets 84 pcs. RUB 8494 Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
