Instructions for use FEMOSTON® 2/10 (FEMOSTON® 2/10)
Before prescribing or resuming HRT, it is necessary to collect a complete medical and family history, conduct a general and gynecological examination in order to identify possible contraindications and conditions requiring precautions. During treatment with Femoston® 2/10, it is recommended to conduct periodic examinations (the frequency and nature of the examinations are determined individually). In addition, it is advisable to conduct breast examination (including mammography) in accordance with accepted standards, taking into account clinical indications.
Risk factors for thrombosis and thromboembolism during HRT are a history of thromboembolic complications, severe forms of obesity (body mass index more than 30 kg/m2) and systemic lupus erythematosus. There is no generally accepted opinion regarding the role of varicose veins in the development of thromboembolism.
The risk of developing deep vein thrombosis of the lower extremities may temporarily increase with prolonged immobilization, major trauma, or surgery. In cases where prolonged immobilization is necessary after surgery, temporary cessation of HRT should be considered 4-6 weeks before surgery.
When deciding on HRT in patients with recurrent deep vein thrombosis or thromboembolism receiving anticoagulant treatment, the benefits and risks of HRT must be carefully assessed.
If thrombosis develops after starting HRT, Femoston® 2/10 should be discontinued.
The patient should be informed of the need to consult a doctor if the following symptoms occur:
- painful swelling of the lower extremities, sudden loss of consciousness, dyspnea, blurred vision.
After consultation with the doctor, the patient should stop taking the drug if jaundice appears or deterioration of liver function, a pronounced increase in blood pressure, a newly diagnosed migraine-like attack, pregnancy, or the manifestation of any contraindication.
There is research data demonstrating a slight increase in the incidence of breast cancer detection in women receiving HRT for a long time (more than 10 years). The likelihood of being diagnosed with breast cancer increases with the duration of treatment and returns to normal 5 years after stopping HRT.
Patients who have previously received HRT using only estrogen drugs should be especially carefully examined before starting treatment with Femoston® 2/10 in order to identify possible endometrial hyperstimulation.
Breakthrough uterine bleeding and mild menstrual-like bleeding may occur in the first months of treatment with the drug. If, despite dose adjustment, such bleeding does not stop, the drug should be discontinued until the cause of the bleeding is determined. If bleeding recurs after a period of amenorrhea or continues after discontinuation of treatment, its etiology should be determined. This may require an endometrial biopsy.
The patient should inform the doctor about the medications she is currently taking or was taking before prescribing Femoston® 2/10.
The use of estrogens may affect the results of the following laboratory tests:
- determination of glucose tolerance, study of thyroid and liver functions.
To treat symptoms of estrogen deficiency in postmenopausal women, HRT is prescribed only if symptoms of estrogen deficiency negatively affect quality of life. A thorough assessment of the benefits and disadvantages of HRT should be carried out regularly, at least once a year, and treatment should only be continued if the benefits of therapy outweigh the disadvantages.
Femoston® 2/10 is not a contraceptive. Perimenopausal patients are advised to use non-hormonal contraceptives.
Impact on the ability to drive vehicles and operate machinery
Femoston® 2/10 does not have or has an insignificant effect on the ability to drive vehicles and operate machinery.
Pharmacological properties of the drug Femoston
Pharmacodynamics. combined estrogen-progestin drug. Estradiol Estradiol is chemically and biologically identical to the natural human sex hormone estradiol. Among ovarian hormones, it has the highest activity. Estradiol causes cyclic changes in the uterus, cervix and vagina and ensures the maintenance of tone and elasticity of the genitourinary tract. Estradiol also plays an important role in the preservation of bone tissue, ensuring the prevention of osteoporosis and fractures. Oral intake of estrogens has a positive effect on lipid metabolism, has a beneficial effect on the autonomic nervous system and an indirect positive effect on the psycho-emotional sphere. Dydrogesterone Dydrogesterone is an orally effective progestogen whose effects are comparable to those of parenterally administered progesterone. In the context of hormone replacement therapy, dydrogesterone promotes complete secretory transformation of the uterine endometrium, thus preventing the risk of developing estrogen-induced endometrial hyperplasia and/or carcinoma, without excluding androgenic side effects. Due to the fact that estrogens stimulate endometrial growth, estrogen monotherapy increases the risk of developing endometrial hyperplasia and cancer. The use of progestogen in therapy reduces the estrogen-induced risk of developing endometrial hyperplasia in women with a preserved uterus. Clinical trial data Reduction of symptoms of estrogen deficiency and improvement of bleeding profile Reduction in the severity of menopausal symptoms was achieved during the first weeks of treatment. Regular menstrual-like reactions (average duration 5 days) when using Femoston, which contains 2 mg estradiol and 10 mg dydrogesterone, were observed in approximately 90% of women. Menstruation usually began on the day of taking the last tablet of the progestogen phase. Breakthrough uterine bleeding and/or spotting was reported in approximately 10% of women. During the first year of therapy, amenorrhea (absence of bleeding or spotting) was observed in 5–15% of women per cycle. Regular menstrual-like reactions when using the drug Femoston, which contains 1 mg of estradiol and 10 mg of dydrogesterone, were observed in 75–80% of women. The day of the onset of menstruation, its duration, as well as the number of women with periodic menstrual-like reactions were the same as with the use of the drug Femoston, which contains 2 mg estradiol and 10 mg dydrogesterone, but there were more women with no menstruation (10–25% per 1 cycle). Prevention of osteoporosis Estrogen deficiency during menopause is associated with increased bone turnover and decreased bone mass. The effect of estrogens on bone mineral density is dose-dependent. The protective effect of estrogens only occurs during their use. After stopping hormone replacement therapy (HRT), the rate of bone loss is the same as in women who did not receive this therapy. Data from the WHI (Women's Health Initiative) study and objective analysis of studies suggest that current HRT, primarily in healthy women, either as monotherapy or in combination with a progestogen, reduces the risk of hip, vertebral and other types of fractures that occur due to osteoporosis. HRT may also prevent fractures in women with low bone density and/or known osteoporosis, but data on this are limited. After two years of treatment with Femoston, which contains 2 mg estradiol and 10 mg dydrogesterone, bone mineral density (BMD) in the lumbar spine increased by 6.7% ± 3.9%. During treatment, BMD in the lumbar spine increased or remained unchanged in 94.4% of women. In women who took the drug Femoston, which contains 1 mg of estradiol and 10 mg of dydrogesterone, BMD in the lumbar spine increased by 5.2% + 3.8%. BMD in the lumbar spine increased or remained unchanged during treatment in 93.0% of women. Femoston affects BMD of the femur. After two years of therapy with 1 mg estradiol, BMD of the femoral neck increased by 2.7% ± 4.2%, by 3.5% ± 5.0% in the trochanteric area and by 2.7% ± 6.7% in the Ward triangle . After two years of treatment with estradiol at a dose of 2 mg, these figures were 2.6% ± 5.0%; 4.6% ± 5.0% and 4.1% ± 7.4%, respectively. BMD in three areas of the femur increased or remained unchanged after treatment with estradiol at a dose of 1 and 2 mg in 67–78% and 71–88% of women, respectively. Pharmacokinetics. Estradiol After oral administration, micronized estradiol is rapidly absorbed and extensively metabolized. The main unconjugated and conjugated metabolites are estrone and estrone sulfate. These metabolites have estrogenic activity both directly and after their conversion to estradiol. Estrone sulfate may be subject to enterohepatic metabolism. The main compounds found in urine are the glucuronides of estrone and estradiol. Estrogens pass into breast milk. Dydrogesterone After oral administration, approximately 63% of dydrogesterone is excreted in the urine. The drug is completely eliminated after 72 hours. Dydrogesterone is completely metabolized in the body. The main metabolite of dydrogesterone is 20-α-dihydrodydrogesterone (DHD), which is found primarily in urine as a glucuronic acid conjugate. A common feature of all metabolites is that they retain the 4,6-dien-3-one configuration and the absence of hydroxylation reaction under the action of 17α-hydroxylase. This explains the lack of estrogenic and androgenic effects of dydrogesterone. After oral administration of dydrogesterone, the concentration of DHD in the blood plasma significantly exceeds the level of the parent substance. Dydrogesterone is rapidly absorbed. The time to reach maximum concentration for dydrogesterone and DGD varies between 0.5–2.5 hours. The half-lives for dydrogesterone and DGD are 5–7 and 14–17 hours, respectively. Unlike progesterone, dydrogesterone is not excreted in the urine in the form of pregnanediol. Thus, it remains possible to analyze the formation of endogenous progesterone based on the measurement of pregnanediol excretion.
Use of the drug Femoston
To initiate and maintain treatment of postmenopausal symptoms, the minimum effective dose should be prescribed for the minimum period of time. Femoston is taken daily in the first 14 days of a 28-day cycle, 1 tablet containing 1 or 2 mg of estradiol, and in the remaining 14 days - daily, 1 tablet containing 1 mg of estradiol and 10 mg of dydrogesterone or 2 mg of estradiol and 10 mg of dydrogesterone. After the end of the 28-day cycle, a new cycle should begin. Treatment must be continuous. The tablets should be taken in the order indicated on the package. Treatment of postmenopausal symptoms Usually begins with taking the drug Femoston, containing 1 mg of estradiol and 10 mg of dydrogesterone. Depending on the clinical effect, the dose is then selected individually. If the severity of symptoms associated with estrogen deficiency does not decrease, the dose can be increased by prescribing a drug that contains 2 mg of estradiol and 10 mg of dydrogesterone. Prevention of osteoporosis When hormone replacement therapy is used, it is necessary to take into account individual tolerance to treatment and that the expected effect of the drug on bone tissue is dose-dependent. Femoston Conti 1 tablet 1 time per day daily, without breaks, regardless of meals. Prevention of osteoporosis When hormone replacement therapy is used, it is necessary to take into account individual tolerance to treatment and that the expected effect of the drug on bone tissue is dose-dependent.
Contraindications to the use of Femoston
Hypersensitivity to the components of the drug; diagnosed or suspected breast cancer, endometrial carcinoma and other hormone-dependent tumors diagnosed or suspected; vaginal bleeding of unknown etiology; untreated endometrial hyperplasia; history of acute deep vein thrombosis, pulmonary embolism or idiopathic venous thromboembolism; arterial thromboembolism, including recent ones (for example, angina pectoris, myocardial infarction); acute and chronic liver diseases, as well as their history in the absence of normalization of functional state indicators; porphyria; established or suspected pregnancy.
Femoston price, where to buy
Price Femoston 1/5 in Russian pharmacies from 870 rubles. You can buy Femoston Conti 1/5 for an average of 900 rubles. Price Femoston 2/10 - from 790, Femoston 1/10 - from 795 rubles.
In Ukraine, the price of Femoston 1/10 is from 438 UAH, the price of Femoston 2/10 is from 520 UAH. The cost of the drug with a dosage of 1 mg + 5 mg is from 445 UAH.
- Online pharmacies in RussiaRussia
- Online pharmacies in UkraineUkraine
- Online pharmacies in KazakhstanKazakhstan
ZdravCity
- Femoston 1/5 conti tablets p.p.o.
28pcs Abbott Biologicals B.V. RUB 1,155 order - Femoston Mini tablets p.p.o. 2.5mg+0.5mg 28pcs Abbott Biologicals B.V.
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- Femoston 1 tab. p/o captivity. 1mg+10mg 28pcs Abbott Biologicals B.V. NL
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Pharmacy Dialogue
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- Femoston 1 tablet No. 28Abbot
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- Femoston mini tablets 2.5mg+0.5mg No. 28Abbot
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Pharmacy24
- Femoston Conti 1mg+5 mg No. 28 tablets Abbott Biologicals B.V., Netherlands
444 UAH.order - Femoston 1 mg/10 mg No. 56 tablets Abbott Biologicals B.V., Netherlands
816 UAH order
- Femoston Conti Mini 0.5 mg/2.5 mg No. 28 tablets Abbott Biologicals B.V., Netherlands
428 UAH. order
- Femoston 1mg+10mg No. 28 tablets Abbott Biologicals B.V., Netherlands
439 UAH. order
- Femoston 2 mg+10 mg No. 28 tablets Abbott Biologicals B.V., Netherlands
448 UAH order
PaniPharmacy
- Femoston tablets Femoston tablets 2mg+10mg No. 28 Netherlands, Solvay Biologicals
470 UAH. order
- Femoston conti tablets Femoston conti tablets 1mg+5mg No. 28 Netherlands, Solvay Biologicals
534 UAH. order
- Femoston tablets Femoston tablets 1mg+10mg No. 28 Netherlands, Abbott Biologicals
433 UAH order
- Femoston tablets Femoston tablets 1mg+10mg No. 56 Netherlands, Abbott Biologicals
795 UAH. order
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Interactions of the drug Femoston
The metabolism of estrogens can be enhanced when used simultaneously with substances that activate enzymes (cytochrome P450 systems) that are involved in the metabolism of drugs. These substances include anticonvulsants (eg, phenobarbital, carbamazepine, phenytoin) and antimicrobials (eg, rifampicin, rifabutin, nevirapine, efavirens). Ritonavir and nelvinavir, when used simultaneously with steroid hormones, activate the above enzymes. Herbal preparations, the component of which is St. John's wort (Hypericum perforatum), increase the metabolism of estrogens and progestogens, which can lead to a weakening of their effect and a change in the profile of uterine bleeding. There is no information on the interaction of dydrogesterone with other drugs.
