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Visanne is a derivative of nortestosterone, which does not have androgenic activity, but has a largely anti-androgenic effect, which is about one-third of cyproterone acetate activity.
Dienogest binds to progesterone receptors in the human uterus, with only 10% of the relative affinity of progesterone. Despite its low affinity for progesterone receptors, dienogest has a powerful progestogenic effect in vivo.
Dienogest does not have significant androgenic, mineralocorticoid or glucocorticoid activity in vivo.
Dienogest affects endometriosis, reducing endogenous production of estradiol and thereby, suppressing its trophic effects on both eutopic and ectopic endometrium. With continuous use, dienogest creates a hypoestrogenic, hyperhestagenic endocrine environment, causing an initial decidualization of the endometrial tissue with subsequent atrophy of endometriotic foci.
Additional properties of dienogest, such as immunological and anti-angiogenic effects, obviously, contribute to its overwhelming effect on cell proliferation.
One tablet contains: Dienogest 2 mg.
Excipients: lactose monohydrate, potato starch, microcrystalline cellulose, Povidone K25, talc, crospovidone, magnesium stearate.
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Dosage and Administration
For oral administration. Taking the pills can be started on any day of the menstrual cycle. Take one tablet per day without a break, preferably at the same time every day, if necessary, with a liquid. pills must be taken continuously, regardless of vaginal bleeding. After completing one pack, start taking the next one without interruption in taking the pills. The effectiveness of Visanne may decrease when skipping pills, vomiting and / or diarrhea (if it occurs within 3-4 hours after taking the pill). If one or several pills are missed, a woman should take only one pill as soon as she remembers, and then continue taking pills at the usual time the next day. A pill that is not absorbed due to vomiting or diarrhea should be replaced by an additional intake of one pill. There is no appropriate indication for the use of Visanne in elderly patients. There is no data indicating the need for dose adjustment in patients with renal insufficiency.
Side effects often occur in the first months of taking Visanne and their frequency decreases in the course of drug treatment.
The following side effects were noted in women while receiving the Visanne.
The most frequent side effects in the process of treatment of Visanne, which, at least, were considered as possibly related to taking the drug, include: headache (9.0%), discomfort in the mammary glands (5.4%), decrease in mood ( 5.1%) and acne (5.1%).
The following are undesirable drug reactions, divided into organ system classes according to MedDRA - Medical Dictionary for Regulatory Activities.
Side effects in each frequency group are presented in decreasing order of frequency. Frequency rates are based on pooled data from four clinical trials involving 332 patients (100%).
Often (≥1 / 100 and Infrequently (≥1 / 1000 to
Visanne® should not be used if there are any of the conditions listed below, which are partially taken from information on other drugs that contain only the progestin component. If any of these conditions develops on the background of the reception of Visanne, the use of the drug should be stopped immediately.
- active venous thromboembolic states;
- diseases of the heart and blood vessels (for example, myocardial infarction, stroke, coronary heart disease) now or in the past;
- diabetes with vascular complications;
- severe liver disease in the present or in the past, as long as indicators of hepatic function do not return to normal;
- liver tumors (benign and malignant) now or in the past;
- identified or suspected malignant tumors, dependent on sex steroids;
- vaginal bleeding of unknown origin;
- hypersensitivity to the active substance or to any of the excipients.
Individual inducers or inhibitors of enzymes (CYP3A isoenzyme):
Progestins, including dienogest, are metabolized predominantly with the participation of the cytochrome P450 3A4 (CYP3A4) system, which is localized both in the intestinal mucosa and in the liver. Therefore, inducers or inhibitors of CYP3A4 can affect the metabolism of progestin drugs. Increased clearance of sex hormones, due to the induction of enzymes, can lead to a decrease in the therapeutic effect of Visanne, 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 dienogest, which can lead to the development of side effects.
Substances capable of inducing enzymes:
The use of drugs that induce liver microsomal enzymes (for example, cytochrome P450 enzymes) can lead to an increase in the clearance of sex hormones. Such drugs include: phenytoin, barbiturates, primidone, carbamazepine and rifampicin; There are also suggestions regarding oxcarbazepine, topiramate, felbamate, ritonavir and griseofulvin, nevirapine, and preparations containing St. John's wort.The maximum induction of enzymes, as a rule, is noted not earlier than in 2-3 weeks, however, then it can be maintained for at least 4 weeks after cessation of therapy.
Substances capable of inhibiting enzymes:
Known inhibitors of CYP3A4, such as azole antifungals (e.g., ketoconazole, itraconazole, fluconazole), cimetidine, verapamil, macrolides (e.g., erythromycin, clarithromycin and roxithromycin), diltiazem, protease inhibitors (e.g., ritonavir, saquinavir, indinavir, nelfinavir), antidepressants (for example, nefazodone, fluvoxamine, fluoxetine) and grapefruit juice, can increase the concentration of gestagens in the blood plasma and lead to the development of side effects.
Effect of dienogest on other medicinal substances:
Based on data from in vitro inhibition studies, the development of a clinically significant interaction of Vizanne with the metabolism of other drugs with the participation of cytochrome P450 enzymes is unlikely.
Standardized high-fat food intake did not affect the bioavailability of Visanne.
Other types of interaction:
Acceptance of gestagens may affect the results of some laboratory tests, including the biochemical parameters of the liver, thyroid, adrenal glands and kidneys, plasma concentrations of proteins, for example, lipid / lipoprotein fractions, carbohydrate metabolism parameters and clotting parameters. Changes usually do not go beyond the normal range.
Before starting the reception of Visanne it is necessary to exclude pregnancy. During the reception of Visanne, if necessary, contraception patients are recommended to use non-hormonal contraceptive methods (for example, the barrier method).
When pregnancy has arisen in women who use contraceptive drugs with only the gestagen component (for example, minipily), there is a greater likelihood of its ectopic localization, compared with pregnancy that occurred while taking combined oral contraceptives. Therefore, the question of the application of Visanne in women with an ectopic pregnancy in history or with impaired function of the fallopian tubes should be resolved only after a thorough assessment of the balance of benefits and risks.
Since Visanne is a drug with only a gestagen component, it can be assumed that special precautions and precautions for using other drugs with a gestagen component are also applicable for Visanne, although not all precautions and precautions are based on the relevant results of the Visanne clinical studies. .
If any of the conditions or risk factors listed below are present or aggravated, an individual assessment of the risk / benefit ratio should be carried out before starting or continuing to take the Visanne.
- Brand name: Visanne®
- Active ingredient: Dienogest
- Dosage form: Pills
- Manufacturer: Bayer Pharma AG
- Country of Origin: Germany
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- Pharmacokinetic study of a continuous-combined estradiol valerate(2mg) /dienogest (3mg) product after single and repeated oral administrations in sixteen post-menopausal healthy women: V. Gualano1, A. Renoux1, T. Duvauchelle2, H. Zimmermann3, G. Kaufmann3 1. CEPHAC - Av. du Haut de Chaume 86281 - Saint Benoit Cedex, FRANCE 2. ASTER, 3–5 rue Eugéne Millon - 75015 PARIS, FRANCE 3. JENAPHARM, Otto-Schott-Strasse 15, D-07745 JENA, GERMANY
- Pharmacokinetic study of an association of 0.03 mg ethinylestradiol and 2 mg dienogest after single and repeated oral administrations in sixteen normal healthy young volunteers: A. Renoux1, V. Gualarlo, T. Duvauchelle2, H. Zimmermann, G. Kaufmann3 1. CEPHAC - Av. du Haut de Chaume 86281 - Saint Benoit Cedex, FRANCE 2. ASTER, 3–5 rue Eugéne Millon - 75015 PARIS, FRANCE 3. JENAPHARM, Otto-Schott-Strasse 15, D-07745 JENA, GERMANY
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- Effects of an oral contraceptive containing 30 mcg ethinyl estradiol and 2 mg dienogest on thyroid hormones and androgen parameters: conventional vs. extended-cycle use
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