Tri-sekvens - instructions for use, reviews, analogues and forms of release (tablets) drugs for hormone replacement therapy for menopause (estrogen deficiency) and prevention of postmenopausal osteoporosis in women. Composition and side effect

In this article, you can read the instructions for using the drug Tricequence. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Triesquens in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Triekwens with available structural analogues.Use for hormone replacement therapy in menopause (estrogen deficiency) and prevention of postmenopausal osteoporosis in women. Composition and side effect of the drug.

Tricequence - a combined preparation containing estrogen and progestogen, for successive hormone replacement therapy (HRT).

Estradiol (the first active substance of the drug Trisekvens) - synthetic 17 Β-estradiol, chemically and biologically identical to human endogenous estradiol. Eliminates estrogen deficiency in postmenopausal women and alleviates menopause symptoms, and also prevents bone loss during menopause or oophorectomy.

Since estrogens stimulate the growth of the endometrium, the use of exclusively estrogens increases the risk of endometrial hyperplasia and endometrial cancer. The addition of progestogen (norethisterone, the second active ingredient in the Tricequens preparation) significantly reduces the estrogen-induced risk of endometrial hyperplasia in women who have not undergone hysterectomy.

Attenuation of the symptoms of menopause occurs within the first few weeks of treatment.The termination of regular menstrual bleeding occurs in 93% of women with an average duration of 3-4 days.

Deficiency of estrogen during the menopause is associated with an increase in the rate of bone tissue renewal and a decrease in bone mineral density. The effect of estrogens on the mineral density of bones depends on the dose. It is believed that this effect persists as long as the treatment continues. After the termination of HRT, the decrease in bone mass occurs in the same degree as in women who have not undergone treatment. Various studies and their meta-analyzes show that the widespread use of HRT alone estrogen or in combination with progestogen, prescribed mainly to healthy women, reduces the risk of fractures of the hip joint, spine and other fractures due to osteoporosis. HRT can also prevent fractures in women with low bone mineral density and / or with diagnosed cases of osteoporosis, but the evidence supporting this assumption is limited.

Studies based on the measurement of bone mineral density indicate that Trisequens is effective as a drug that prevents osteoporosis in postmenopausal women.After 2 years of treatment, the mineral density of the bone mass of the spinal column increases by 5.14%, and the hip joint by 3.12%.

Composition

Estradiol (in the form of estradiol hemihydrate) 2 mg + excipients (blue tablets).

Estradiol (in the form of estradiol hemihydrate) 2 mg + Norethisterone 1 mg + excipients (white tablets).

Estradiol (in the form of estradiol hemihydrate) 1 mg + excipients (tablets of red color).

Pharmacokinetics

After oral administration of Trisequens, 17 Β-estradiol is rapidly absorbed into the gastrointestinal tract. It circulates in the blood as a complex with globulin (37%), binding sex hormones (SHGG), and albumin (61%), and only 1-2% remains unbound. Metabolism 17 Β-estradiol occurs mainly in the liver and intestines. Norethisterone quickly enters the bloodstream, where 36% of it binds to SHBG, and 61% to albumin. Norethisterone undergoes presystemic metabolism in the liver and intestines. In elderly people, pharmacokinetic studies have not been conducted.

Indications

• hormone replacement therapy (HRT) in women with symptoms of estrogen deficiency (with menopause);
• prevention of postmenopausal osteoporosis in women in the presence of a high risk of fractures, including those patients who do not tolerate or which are contraindicated in other drugs intended for the prevention of osteoporosis.

Forms of release

Tablets coated with a film sheath of 28 pieces (12 blue, 10 white, 6 red) in a plastic calendar disk.

Instructions for use and dosing regimen

Trisequence is a drug for permanent, consistent use for HRT. Take 1 tablet orally 1 time per day, without interruption, preferably at the same time each day.

Begin with the reception of tablets containing estradiol (blue tablets) - 12 days. The next 10 days are white tablets (estradiol / norethisterone). Then within 6 days should be treated with estradiol (tablets of red color). During the action phase of the red tablets, the functional layer of the endometrium is regularly separated. After taking the last tablets of red, the treatment is continued, taking the first tablet of the blue color from the new package the next day.

Women with amenorrhea who do not take HRT drugs, or women with irregular bleeding, or women who are transferred with continuous therapy with combined HRT drugs, can start treatment with Triesquens on any convenient day. Women switching from a different regimen of HRT, or women still following a course of consistent HRT, should be treated with Triesquens on day 5 of the cycle.

The appointment of a higher dose of Tricequence may be indicated if the response to taking the drug for three months is unsatisfactory.

If the patient forgot to take one pill, then the forgotten pill should not be taken. Bypassing the drug may increase the likelihood of resumption of uterine bleeding and the appearance of smearing vaginal discharge.

In all cases, at least once a year, a thorough assessment of the risk-benefit ratio of HRT by Triesquens should be carried out and continued only as long as the benefits from the use of the drug exceed the risk of associated side effects.

Instructions for using the calendar disk

Rotate the inner disc and set the day of the week opposite the small plastic tab. Break off the plastic tab and, tilting the box, remove the first tablet. Every day, just rotate the transparent disc clockwise one step (in the direction of the arrow on the disk). Tilting the box, remove each next tablet.

A transparent disc can be rotated only after the tablet is removed from the hole.

Side effect

• disorders of the menstrual cycle, including menorrhagia (severe blood loss during menstruation (more than 150 ml), the duration of which also exceeds the physiological norm);
• pain or pain in the mammary glands;
• insomnia, anxiety;
• change in libido;
• dizziness;
• impaired cerebral circulation;
• visual impairment;
• aggravation of arterial hypertension;
• myocardial infarction;
• dyspepsia, vomiting;
• cholecystitis (inflammation of the gallbladder);
• cholelithiasis, exacerbation of cholelithiasis;
• seborrhea, rash, angioedema;
• vulvovaginal itching;
• decreased body weight;
• benign and malignant neoplasms of the mammary gland and genital organs, including cysts and polyps.

Contraindications

• breast cancer (established, history, and suspicion of it);
• established or suspected estrogen-dependent tumor (including endometrial cancer);
• pathological hemorrhages from the genitals of unclear etiology;
• untreated endometrial hyperplasia;
• recent or in active phase venous thromboembolic diseases (deep vein thrombosis, pulmonary embolism);
• recently transferred or in the active phase arterial thromboembolic diseases (including angina pectoris, myocardial infarction);
• acute liver disease or liver disease in an anamnesis, in which the liver function was not normalized;
• congenital lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
• hypersensitivity to the active substance or other components included in the preparation;
• porphyria (almost always a hereditary impairment of pigment metabolism with an increased content of porphyrins in the blood and tissues and enhanced excretion in urine and feces).

Application in pregnancy and lactation

The drug Trisequens is not indicated during pregnancy. If pregnancy occurs against the background of treatment with Tricequence, then treatment should be immediately stopped.

The analysis of the outcomes of pregnancies, during which the patients took hormonal preparations, testifies to the adverse effect of norethisterone on the fetus. At doses exceeding those commonly used in HRT, masculinization of female fetuses was observed.

The results of most of the studies carried out to date on the unintentional effects on the fetus of combined estrogen and progestogen compositions indicate a teratogenic and fetotoxic effect.

The drug Trisequens is not indicated during breastfeeding.

Use in children

The drug Triksekvens in pediatric practice is not used.

Application in elderly patients

The experience of using Trisequens in women over the age of 65 is limited.

special instructions

When deciding whether HRT requires Triksevens for the treatment of postmenopausal symptoms, it should only be started if there are symptoms that reduce the patient's quality of life.The frequency of medical examinations is individual, but at least 1 time in 6 months - to assess the need for further HRT. In all cases, HRT should at least continue until the benefits of using the drug exceed the risk of associated side effects.

Before starting or resuming HRT, the patient's medical history and family history should be studied. In this case, a checkup (including pelvic organs and mammary glands) should be taken and contraindications and special precautions should be taken into account when applying Trisequens.

During the treatment it is recommended to conduct periodic examinations of the patient, the frequency and volume of which must be selected individually.

Women should be advised to report to the doctor about the changes in the mammary gland that they noticed, so that he promptly prescribes a test, including a mammogram.

Treatment with Trisequens should be interrupted if contraindications are found in the following situations: jaundice or liver dysfunction, significant increase in blood pressure, migraine headache attacks, pregnancy.

The risk of developing hyperplasia and endometrial cancer increases when a woman takes estrogen alone for a long time. The addition of progestogen to women who have not undergone hysterectomy significantly reduces this risk. The development of bleeding and the appearance of spotting can occur during the first months of treatment. If this occurs some time after the start of treatment or continues after the cessation of treatment, you should find out the reason for the endometrial biopsy to exclude malignant formation.

A randomized placebo-controlled study with the WHI (Women's Health Initiative study), as well as epidemiological studies, including MWS (Million Women Study), showed that there is an increased risk of breast cancer in women taking estrogens, estrogen-progestagen combinations as HRT over the several years. This risk returns to baseline for several years (maximum five) after discontinuation of treatment.

HRT is associated with a higher risk of venous thromboembolism (VTE), namely, vein thrombosis and pulmonary embolism.In one randomized controlled trial and in epidemiological studies, there was an increased risk for patients using HRT compared to those who did not receive such treatment.

The risk of VTE may temporarily increase with prolonged immobilization, extensive trauma or radical surgical intervention. In the postoperative period, special attention should be paid to the prevention of VTE development. If the planned operation entails a state of prolonged immobilization, in particular, it may occur with abdominal intervention or orthopedic surgery of the lower extremities, it is necessary to consider temporarily suspending HRT 4-6 weeks before surgery. Treatment should not be resumed until the woman regains full mobility.

If VTE develops after the start of treatment with Trisex, the medication should be discontinued. Immediately, as soon as the patient noticed signs of thromboembolism (painful swelling of the lower limb, sudden chest pain, shortness of breath), she should inform her doctor about it.

Two large clinical studies have shown the possibility of an increased risk of cardiovascular disease in the first year of use of Triesquens.

A large randomized clinical trial revealed, as a secondary result, an increased risk of developing ischemic stroke in healthy women who underwent a continuous HRT course with Trisequens.

Prolonged use (at least for 5-10 years) of only estrogen preparations for HRT in women with a distant uterus is associated in some epidemiological studies with an increased risk of developing ovarian cancer. It remains unclear whether prolonged use of combined HRT drugs increases the risk of ovarian cancer, compared with the risk associated with the use of only estrogen-containing drugs.

Estrogens can lead to fluid retention in the body, and therefore patients with cardiovascular or renal dysfunction should be closely monitored, especially patients with terminal renal failure.

Women with hypertriglyceridemia in a history should be carefully examined in the HRT process.

Estrogens increase the concentration of thyroxine-binding globulin, which leads to an increase in the total concentration of circulating thyroid hormones. May increase concentrations of other binding proteins of blood serum, including kortikoidsvyazyvayuschego globulin binding globulin sex hormones, which leads to increased blood concentrations of sex hormones and corticosteroids.

There is some evidence in the WHI study of the risk of possible dementia in women who, after age 65, have begun to take the Trisequens combination drug continuously. It is not known whether this applies to women at a younger age in the postmenopausal state.

Trisequens does not have a contraceptive effect.

Drug Interactions

Metabolism of estrogen and progestogen can be increased while using inducers drug metabolism isoenzymes, in particular isoenzymes of cytochrome P450, such as antiepileptic drugs (e.g., phenobarbital, phenytoin, carbamazepine) and antibiotics (e.g., rifampicin, rifabutin, nevirapine, efavirenz).

Antiviral drugs that are active against HIV (ritonavir and nelfinavir), when combined with steroid hormones, stimulate the metabolism of estrogens and progestogens.

Herbal preparations containing St. John's wort (Hypericum perforatum) can also stimulate the metabolism of estrogens and progestogens.

Ketoconazole may increase the concentration of active substances of the drug Trisequens.

Analogues of the drug Triesquens

Structural analogs for the active substance:

• Pausogest;
• Triaclim;
• Revmelid.

Analogues of the drug Trisequens on the pharmacological group (estrogens, gestagens, their homologues and antagonists in combinations):

• Anabella;
• Angeletta;
• Angelique;
• Antotevin;
• Belara;
• Benidette;
• Bonade;
• Vesantra;
• Vidor;
• Gestarella;
• Gynodian Depot;
• Gynoflor E;
• Delsia;
• Demulen;
• Jess;
• Diane 35;
• Divina;
• Divertrain;
• Dicycylene;
• Dimia;
• Evra;
• Janine;
• Genetten;
• Zoeli;
• The individual;
• Clira;
• Klimen;
• Klimodien;
• Clinonorm;
• Cliogest;
• Colposseptin;
• Lei;
• Lindineth;
• Marvelon;
• Melleva;
• Mersilon;
• Midian;
• Microinon;
• Miniziston;
• NovaRing;
• Novinet;
• Non-Ovlon;
• Ovidon;
• Oralcon;
• Pausogest;
• Rigevidone;
• Silestus;
• Simicius;
• Triregol;
• Triaclim;
• Trigestrel;
• Trikwilar;
• Triogynal;
• Femiss;
• Femoden;
• Femoston;
• Tzimycycle;
• Evian;
• Egestenol;
• Yamera;
• Yarina.

Response of a gynecologist

And postmenopausal osteoporosis was and remains an actual problem of the female body. The drug Triksekvens - one of those that I appoint to women experiencing postmenopause. The most frequent side effect of hormone replacement therapy using this hormonal agent is spontaneous uterine bleeding, expressed to a greater or lesser extent. Especially often women face this problem in the first two to three months (sometimes up to six months) of taking Triesquens. But gradually these disorders go away: metrorrhagia become regular, ungrowth, coincide with the days of taking red tablets.

Similar medicines:

Other medicines: