The drug Femoston is an effective means of hormone replacement therapy. Why is femoston prescribed and how to take it When to take femoston 1 10
- Instructions for use Femoston ® 1/10
- Composition of the drug Femoston ® 1/10
- Indications of the drug Femoston ® 1/10
- Storage conditions for the drug Femoston ® 1/10
- Shelf life of the drug Femoston ® 1/10
ATX code: Genitourinary system and sex hormones (G) > Sex hormones and modulators of the reproductive system (G03) > Progestogens in combination with estrogens (G03F) > Progestogens in combination with estrogens (combinations for sequential use) (G03FB) > Dydrogesterone and estrogen (G03FB08)
Release form, composition and packaging
tab., cover casing, two types: 28 pcs. in the box; tab. white 1 mg: 14 pcs., tab. gray 1 mg+10 mg: 14 pcs.Reg. No.: 6405/03/06/08/09/11/13 dated 06/17/2013 - Valid
Film-coated tablets , two types.
White film-coated tablets, round, biconvex, embossed with “S” above the “∇” symbol on one side, “379” on the other (14 pcs. per blister).
Excipients:
Shell composition: opadry OY-1-7000 white.
Gray film-coated tablets, round, biconvex, embossed with "S" above the "∇" symbol on one side, "379" on the other; white tablet core (14 pieces in a blister).
Excipients: lactose monohydrate, hypromellose, corn starch, colloidal silicon dioxide, magnesium stearate.
Shell composition: opadry OY-8243 gray.
28 pcs. - blisters (1) - cardboard boxes.
Description of the drug FEMOSTON ® 1/10 based on officially approved instructions for use of the drug and made in 2011. Update date: 05/25/2012
A combined drug for hormone replacement therapy, contains estradiol, identical to endogenous human estradiol, and the gestagen dydrogesterone.
Estradiol replenishes the deficiency of estrogen in the female body after menopause and provides effective relief of psycho-emotional and vegetative menopausal symptoms:
- hot flashes, increased sweating, sleep disturbances, increased nervous excitability, dizziness, headache, involution of the skin and mucous membranes, especially the genitourinary system (dryness and irritation of the vaginal mucosa, pain during sexual intercourse).
HRT with Femoston ® 1/10 prevents bone loss in the postmenopausal period caused by estrogen deficiency.
Taking Femoston ® 1/10 leads to a change in the lipid profile towards a decrease in the level of total cholesterol and LDL and an increase in HDL.
Dydrogesterone is a gestagen, effective when taken orally, which completely ensures the onset of the secretion phase in the endometrium, thereby reducing the risk of developing endometrial hyperplasia and/or carcinogenesis (increased with the use of estrogens). Dydrogesterone does not have estrogenic, androgenic, anabolic or glucocorticoid activity.
The combination of 1 mg estradiol with dydrogesterone is a modern low-dose HRT regimen.
Estradiol
Suction
After taking the drug orally, micronized estradiol is easily absorbed.
Metabolism and excretion
Estradiol is metabolized in the liver to form estrone and estrone sulfate. Estrone sulfate undergoes intrahepatic metabolism.
Glucuronides of estrone and estradiol are excreted primarily in the urine.
Dydrogesterone
Suction
In the human body, dydrogesterone is rapidly absorbed from the gastrointestinal tract.
Metabolism
Metabolized completely. The main metabolite of dydrogesterone is 20-dihydrodydrogesterone, present in urine mainly as a glucuronic acid conjugate.
Removal
Complete elimination of dydrogesterone occurs after 72 hours.
- hormone replacement therapy for disorders caused by natural menopause or menopause resulting from surgical intervention;
- prevention of postmenopausal osteoporosis with a high risk of fractures in case of intolerance or in the presence of contraindications to the use of other drugs for the prevention of osteoporosis. Experience in treating women over 65 years of age is limited.
Femoston ® 1/10 is taken 1 tablet/day (preferably at the same time of day) without interruption, regardless of food intake.
In the first 14 days of a 28-day cycle, take 1 tablet daily. white (from half a package with an arrow marked "1") containing 1 mg of estradiol, and in the remaining 14 days - 1 tablet daily. gray (from half a package with an arrow marked "2") containing 1 mg of estradiol and 10 mg of dydrogesterone.
Patients whose menstruation has not stopped are recommended to begin treatment on the first day of the menstrual cycle. For patients with irregular menstrual cycles, it is advisable to begin treatment after 10-14 days of progestogen monotherapy (“chemical curettage”).
Patients whose last menstruation was observed more than 1 year ago can begin treatment at any time.
For the treatment of symptoms associated with postmenopause, it is recommended to prescribe the drug in the minimum effective dose with a minimum duration of therapy.
In order to prevent osteoporosis during HRT in the postmenopausal period, it is necessary to take into account the expected effects on bone mass, which are dose-dependent, as well as the individual tolerance of the treatment.
If a pill is missed, it is recommended to take the missed pill as soon as possible. If the missed dose is more than 12 hours, it is recommended to continue treatment by taking the next tablet without taking the missed tablet. If you miss a pill, you are more likely to experience severe bleeding or spotting.
From the reproductive system: breast tenderness, breakthrough bleeding, pain in the pelvic area;
From the digestive system: nausea, flatulence, abdominal pain;
From the side of the central nervous system: headache, migraine (1-10%);
From the cardiovascular system: uncommon - venous thromboembolism;
From the hematopoietic system: very rarely (<0.01%) - гемолитическая анемия.
From the musculoskeletal system: cramps in the muscles of the lower extremities, back pain.
From the side of metabolism: changes in body weight;
Dermatological reactions: uncommon - rash, itching;
Allergic reactions: infrequently - urticaria;
Other: infrequently - peripheral edema;
- established or suspected pregnancy;
- lactation period (breastfeeding);
- diagnosed or suspected breast cancer, history of breast cancer;
- diagnosed or suspected estrogen-dependent malignancies;
- untreated endometrial hyperplasia;
- vaginal bleeding of unknown etiology;
- previous idiopathic or confirmed venous thromboembolism (deep vein thrombosis, pulmonary embolism);
- active or recent arterial thromboembolism;
- acute liver diseases, as well as a history of liver diseases (until normalization of laboratory parameters of liver function);
- porphyria;
- galactose intolerance, lactase deficiency, lapp lactase deficiency syndrome, glucose/galactose malabsorption;
- hypersensitivity to the components of the drug.
- uterine leiomyoma, endometriosis;
- history of thrombosis and their risk factors;
- in the presence of risk factors for estrogen-dependent tumors (for example, breast cancer in the patient’s mother);
- arterial hypertension;
- benign liver tumor;
- diabetes;
- cholelithiasis;
- epilepsy;
- migraine or intense headache;
- history of endometrial hyperplasia;
- systemic lupus erythematosus;
- bronchial asthma;
- renal failure;
- otosclerosis.
WITH caution and under the supervision of a physician, use in patients receiving HRT and having the following diseases and conditions (currently or in history):
The drug should be discontinued if jaundice or deterioration of liver function occurs, a strong increase in blood pressure, a newly diagnosed migraine-like attack, pregnancy, or any contraindication.
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 ® 1/10, 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 ® 1/10 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 ® 1/10 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 ® 1/10.
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 ® 1/10 is not a contraceptive. Perimenopausal patients are advised to use non-hormonal contraceptives.
Impact on the ability to drive vehicles and operate machinery
Femoston ® 1/10 does not affect the ability to drive vehicles and operate machinery.
(Swiss Confederation) 
Representative office of JSC "Abbott Laboratories S.A." in the Republic of Belarus
- Instructions for use Femoston ® 1/10
- Composition of the drug Femoston ® 1/10
- Indications of the drug Femoston ® 1/10
- Storage conditions for the drug Femoston ® 1/10
- Shelf life of the drug Femoston ® 1/10
ATX code: Genitourinary system and sex hormones (G) > Sex hormones and modulators of the reproductive system (G03) > Progestogens in combination with estrogens (G03F) > Progestogens in combination with estrogens (combinations for sequential use) (G03FB) > Dydrogesterone and estrogen (G03FB08)
Release form, composition and packaging
tab., cover film casing, two types: 28 pcs. per package, 1 package per pack, including:; tab. white 1 mg: 14 pcs.; tab. gray 1 mg+10 mg: 14 pcs.Reg. No.: RK-LS-5-No. 010043 dated 06/26/2012 - Valid
Film-coated tablets, two types.
White film-coated tablets
Excipients: lactose monohydrate, hypromellose, corn starch, colloidal anhydrous silicon dioxide, magnesium stearate.
Shell composition: Opadry ® Y-1-7000-white (hypromellose, titanium dioxide (E171), macrogol 400).
Gray film-coated tablets, round, biconvex, marked "379" on one side and 7 mm in diameter (14 pieces per pack).
Excipients: lactose monohydrate, hypromellose (HPMC 2910), corn starch, colloidal anhydrous silicon dioxide, magnesium stearate.
Shell composition: Opadry ® II Gray 85F27664 (polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171), iron (III) oxide black (E172)).
28 pcs. - contour cellular packaging (1) - cardboard packs.
Description of the drug FEMOSTON ® 1/10 based on officially approved instructions for use of the drug and made in 2013. Update date: 04/23/2013
A combined hormonal drug for sequential use containing estrogen and progestogen.
Estradiol. The active substance 17-β estradiol is chemically and biologically identical to endogenous human estradiol. It replaces lost estrogen production in menopausal women and relieves symptoms of estrogen deficiency. Estrogens prevent bone loss due to menopause or oophorectomy.
Dydrogesterone. The activity of dydrogesterone when taken orally is comparable to the activity of parenterally administered progesterone. Because Estrogens promote endometrial growth; taking estrogens without adding progestogens increases the risk of endometrial hyperplasia and cancer. The addition of progestogens significantly reduces the risk of estrogen-mediated endometrial hyperplasia in women with a nonremoved uterus.
The effectiveness of Femoston is 1/10 in the treatment of symptoms of estrogen deficiency and dysfunctional uterine bleeding (according to the results of clinical studies)
Regular withdrawal bleeding lasting an average of 5 days was observed in 76% of women. Withdrawal bleeding usually began on average on the 28th day of the cycle. Breakthrough bleeding and/or spotting were reported in 23% of women during the first 3 months of therapy and in 15% of women during 10-12 months of therapy. During the first year of therapy, amenorrhea (no bleeding or spotting) was observed in 21% of cycles. A reduction in the severity of menopausal symptoms was achieved during the first weeks of treatment.
Prevention of osteoporosis
Estrogen deficiency in menopause is associated with accelerated bone turnover and decreased bone mass. The effect of estrogens on bone mineral density is dose dependent. The protection is valid throughout the entire course of therapy. After stopping HRT, bone mass decreases at a rate similar to the rate of bone loss in women not undergoing treatment. Clinical trial results suggest that current use of HRT (alone or in combination with a progestogen, given primarily to healthy women) reduces the risk of hip, vertebral and other osteoporotic fractures. HRT may also prevent fractures in women with low bone density and/or established osteoporosis, but data on this are limited.
After taking Femoston 1/10 for 2 years, bone mineral density (BMD) of the lumbar spine increased by 5.8% ± 3.8% (mean ± standard deviation). During treatment, in 93% of women taking Femoston ® 1/10, lumbar BMD remained at the same level or increased. Femoston ® 1/10 also affects BMD of the femur. After taking Femoston 1/10 for 2 years, BMD increased by 2.7% ± 4.2% in the femoral neck, by 3.5% ± 5.0% in the trochanter of the femur and by 2.7% ± 6.7% in Ward’s triangle. In 67-78% of women after treatment with Femoston, 1/10 BMD in the indicated 3 femoral sections remained unchanged or increased.
Estradiol
Absorption . The absorption of estradiol depends on the particle size: unlike crystalline estradiol, which is poorly absorbed, micronized estradiol is easily absorbed from the gastrointestinal tract. Below is a table with the average values of the pharmacokinetic parameters of estradiol (E2), estrone (E1) and estrone sulfate (E1S) for a dose of estradiol 1 mg after multiple doses:
Estradiol 1 mg
Distribution. Estrogens bind weakly to plasma albumin by nonspecific binding or bind specifically with high affinity to sex hormone binding globulin (SHBG). The percentage of binding to SHBG varies from 9-37% in perimenopausal women to 23-53% in postmenopausal women receiving conjugated estrogens.
Metabolism. After taking the drug orally, estradiol is rapidly metabolized. The main unconjugated and conjugated metabolites are estrone and estrone sulfate. These metabolites can exhibit estrogenic activity both themselves and after conversion to estradiol. Estrone sulfate undergoes intrahepatic metabolism.
Elimination. Estrone and estradiol are excreted in the urine, mainly in the form of glucuronides. The half-life is 10-16 hours. Estrogens are excreted in the milk of nursing mothers.
Dose and time dependence. When taking Femoston tablets 1/10 orally daily, a stable concentration of estradiol is achieved after 5 days of administration, most often by 8-11 days.
Dydrogesterone
Absorption.After oral administration, it is quickly absorbed from the gastrointestinal tract. Time to reach maximum concentration (Tmax) from 0.5 to 2.5 hours. The absolute bioavailability of dydrogesterone at a dose of 20 mg orally (compared with 7.8 mg intravenously) is 28%
The table shows the average values of the pharmacokinetic parameters of dydrogesterone (D) and dihydrodydrogesterone (DHD) after repeated oral administration of dydrogesterone at a dose of 10 mg.
Dydrogesterone 10 mg
Distribution. At a stable concentration of dydrogesterone when administered intravenously, the volume of distribution is about 1400 l. Dydrogesterone and DHD are more than 90% bound to plasma proteins.
Metabolism. After oral administration, dydrogesterone is rapidly metabolized to DGD. Concentrations of the major metabolite 20-α-dihydrodydrogesterone (DHD) peak approximately 1.5 hours after dosing. The concentration of DHD in blood plasma is significantly higher than that of dydrogesterone. The AUC (area under the curve) and C max (maximum concentration) ratios of DHD and dydrogesterone are approximately 40 and 25, respectively. The half-lives of dydrogesterone and DHD average 5–7 hours and 14–17 hours, respectively. A common feature of all metabolites is that the configuration of the parent compound 4,6 dien-3-one remains unchanged and the absence of 17-alpha-hydroxylation. This explains the lack of estrogenic and androgenic effects of dydrogesterone.
Elimination. After oral administration of labeled dydrogesterone, an average of 63% of the dose is excreted in the urine. Total plasma clearance 6.4 l/min. Complete elimination of dydrogesterone occurs after 72 hours. DHD is excreted in urine primarily in the form of a glucuronic acid conjugate.
Dose and time dependence. Pharmacokinetics are linear for both single and multiple dosing in the range from 2.5 to 10 mg. Comparison of the kinetics of single and multiple doses shows that the pharmacokinetics of D and DHD do not change as a result of repeated dosing. Stable concentration is achieved after 3 days of treatment
- hormone replacement therapy for symptoms of estrogen deficiency in women during menopause no earlier than 6 months after the last menstruation (symptoms of estrogen deficiency in women are individual and may include: hot flashes, increased night sweats, sleep disturbances, vaginal dryness and urinary disorders);
- prevention of osteoporosis in postmenopausal women with a high risk of fractures with intolerance or contraindications to drugs intended for the treatment of osteoporosis.
Femoston ® 1/10 is taken orally regardless of food intake.
The estrogen contained in Femoston ® 1/10 is intended for continuous use. Progestogen is added during the last 14 days of each 28-day cycle for sequential use.
Treatment should begin by taking 1 white tablet daily for the first 14 days of the cycle, then continue treatment by taking 1 gray tablet daily for the next 14 days, according to the directions on the package for 28 calendar days. Femoston ® 1/10 should be taken continuously, without taking breaks between packs.
As a rule, sequential combined HRT begins with the drug Femoston ® 1/10. In the future, the dose of hormones can be adjusted individually, in accordance with the clinical results of treatment.
To switch from another drug for continuous or cyclic therapy, you should complete a 28-day cycle and then switch to Femoston ® 1/10.
When switching from a drug to continuous combination therapy, you should start taking this drug on any day.
If a woman forgot to take the pill on time, it should be taken within 12 hours from the time of proper administration. If more than 12 hours have passed, then the “forgotten” tablet must be destroyed and the next tablet taken at the usual time. Do not take a double dose to make up for a missed dose. Skipping a pill may increase the chance of breakthrough bleeding.
Treatment experience elderly women over 65 years of age limited.
There are no indications for the use of Femoston 1/10 children and teenagers.
- diagnosed or suspected breast cancer;
- diagnosed or suspected estrogen-dependent malignant tumors (for example, endometrial cancer or others);
- diagnosed or suspected progestogen-dependent neoplasms (including meningioma);
- bleeding from the genital tract of unknown etiology;
- untreated endometrial hyperplasia;
- deep vein thrombosis or pulmonary embolism in history or currently;
- diagnosed thrombophilic disorders (protein C, protein S or antithrombin deficiency);
- arterial thromboembolism currently or in the recent past (including ischemic heart disease, myocardial infarction, ischemic stroke);
- active or history of liver disease, until liver tests normalize;
- porphyria;
- established or suspected pregnancy;
- lactation period (breastfeeding);
- children and adolescents up to 18 years of age;
- hypersensitivity to the components of the drug.
Use during pregnancy and breastfeeding
The use of Femoston ® 1/10 is contraindicated during established or suspected pregnancy and during lactation (breastfeeding).
Estrogens promote fluid retention, so patients with renal failure need careful monitoring. Patients with end-stage renal failure should be carefully monitored because the concentration of the active ingredients of the drug Femoston 1/10 will be increased.
HRT is prescribed in cases where menopausal symptoms significantly affect a woman's quality of life. In all cases, a thorough assessment of the risks and benefits is necessary at least once a year. Femoston 1/10 is continued when the expected benefits significantly exceed the possible risks.
Data are limited regarding the risks associated with HRT in the treatment of premature menopause. However, due to the low absolute risk in younger women, the benefit-risk ratio may be more favorable for them than for older women.
Medical examination and observation
A complete medical and family history should be obtained before starting or resuming HRT. A medical examination (including examination of the mammary glands and pelvic organs) is carried out to identify possible contraindications and conditions requiring precautions. During treatment with Femoston ® 1/10, dynamic monitoring is recommended (the frequency and nature of studies are determined individually). Patients should know that they should immediately report any changes in the mammary glands to their doctor. Special studies, including mammography, are carried out in accordance with accepted screening standards, taking into account clinical indications.
Conditions requiring observation
During treatment with Femoston 1/10, patients should be under close medical supervision if they have or have had in the past the following conditions:
- uterine fibroids or endometriosis, thromboembolism or risk factors for its development;
- risk factors for estrogen-dependent tumors, for example, breast cancer in 1st degree relatives;
- arterial hypertension;
- liver disease (hepatocellular adenoma), diabetes mellitus with or without angiopathy, cholelithiasis, migraine or (severe) headache, systemic lupus erythematosus, history of endometrial hyperplasia, epilepsy, bronchial asthma, otosclerosis.
This also applies to those patients in whom the severity of these conditions has increased during pregnancy or previous hormonal treatment. It must be taken into account that when treated with Femoston 1/10, these conditions may recur or become more pronounced.
Reasons for immediate discontinuation of therapy
Taking Femoston 1/10 should be stopped if contraindications are identified and in the following situations:
- jaundice or liver dysfunction;
- significant increase in blood pressure;
- the appearance of a migraine-like headache;
- pregnancy.
Hyperplasia and endometrial cancer
The risk of endometrial hyperplasia and cancer increases with long-term estrogen use. Women treated with estrogen-only HRT have a 2- to 12-fold increased risk of endometrial cancer compared with patients who have not received such therapy, depending on the duration of treatment and the dose of estrogen. After stopping estrogen, the risk remains elevated for 10 years. Adding progestogens for at least 12 days of a 28-day cycle significantly reduces this risk in women with a non-removed uterus.
Breakthrough bleeding and spotting bleeding are sometimes observed in the first few months of treatment. In case of breakthrough bleeding or spotting bleeding while taking Femoston 1/10 or after stopping treatment, it is necessary to conduct an examination to identify the cause. This may include an endometrial biopsy to rule out malignancy.
Mammary cancer
According to current data from clinical and epidemiological studies, women taking combination drugs for HRT and, possibly, monoestrogens, have an increased risk of breast cancer, and this value depends on the duration of therapy.
The randomized placebo-controlled WHI trial and pharmacoepidemiological studies showed an increased risk of breast cancer in women taking combination HRT drugs, which manifests itself 3 years after the start of treatment.
Monotherapy with estrogen-containing drugs. The WHI study did not find an increased risk of breast cancer in women with a hysterectomy who used estrogen-only products. Observational studies report a small increase in the risk of breast cancer, which is much lower than that observed in women receiving combination drugs.
Increased risk of breast cancer observed in the first few years of treatment , but returns to baseline within several years after cessation (maximum 5 years) of treatment. When taking combined drugs for HRT, the density of the mammographic image increases, which may have a negative impact on the X-ray diagnosis of breast cancer.
Ovarian cancer
The incidence of ovarian cancer is much less common than breast cancer. Long-term use (minimum 5-10 years) of a monoestrogen drug is associated with a small increase in the risk of ovarian cancer. Some studies, including the WHI, suggest that long-term use of combination HRT drugs may be associated with the same or slightly lower risk.
Venous thromboembolism
With HRT, the relative risk of developing venous thromboembolism (VTE) - deep vein thrombosis and pulmonary thromboembolism - increases by 1.3-3 times. The likelihood of such a complication is higher in the first years of treatment than in subsequent years.
Patients with a history of VTE or diagnosed thrombophilic conditions have an increased risk of VTE, and HRT may increase this risk. Therefore, HRT is contraindicated in such cases.
Risk factors for developing VTE include:
- taking estrogen, old age, major surgery, prolonged immobilization, severe obesity (BMI more than 30 kg/m2), pregnancy and the postpartum period, systemic lupus erythematosus and cancer. Currently, there is no consensus on the relationship of varicose veins to risk factors for VTE.
It is necessary to take measures to prevent VTE in patients in the postoperative period. In cases where long-term immobilization is expected after surgery, especially on abdominal organs or orthopedic operations on the lower extremities, you should stop taking Femoston 1/10, if possible, 4-6 weeks in advance. Resumption of treatment is possible only after complete restoration of motor activity.
Women who do not have a history of VTE but have a first-degree relative with a history of VTE at a young age should be evaluated for thrombophilia. In this case, the patient should be taken into account and warned that screening does not detect all types of blood coagulation pathologies. HRT is contraindicated if family members have a thrombophilic defect (eg, antithrombin, protein S or protein C deficiency, or a combination of defects). Patients in this risk group receiving anticoagulant therapy require a careful assessment of the balance of risks and benefits of prescribing HRT.
If VTE develops while taking Femoston 1/10, treatment should be suspended. When the first possible symptoms of VTE appear (painful swelling of the lower extremities, sudden chest pain, shortness of breath), the patient should immediately contact her doctor.
There is no evidence from randomized clinical trials that HRT (estrogens alone or in combination with progestogens) protects against myocardial infarction in women with or without coronary artery disease.
Combined preparations containing estrogen + progestogen. The relative risk of coronary heart disease during treatment with combined drugs for HRT increases slightly. Because The absolute risk of developing CHD largely depends on age; the incidence of additional cases of CHD in women receiving combined HRT is very low in the group of healthy women near the onset of menopause, and increases with age.
Monotherapy with estrogen-containing drugs. According to randomized studies, the risk of coronary heart disease in women with a removed uterus receiving estrogens in monotherapy does not increase.
Ischemic stroke
The risk of ischemic stroke in healthy women during HRT with combined HRT drugs increases by 1.5 times. The relative risk does not depend on age or duration of menopause. However, the risk of ischemic stroke is known to vary with age, so the risk of stroke in women receiving HRT increases with age.
Other states
Estrogens promote fluid retention, so patients with heart or kidney failure require careful medical monitoring.
Hypertriglyceridemia requires careful monitoring during HRT, because There are rare reports of a significant increase in plasma triglycerides, which led to the development of pancreatitis in women with a similar condition taking estrogens.
Estrogens increase levels of thyroid binding globulin, which leads to an increase in total circulating thyroid hormone levels, as measured by protein-bound iodine, T4 and T3. Free T4 or T3 levels do not change.
There may be increased levels of other binding proteins, such as corticoid binding globulin, sex hormone binding globulin, resulting in increased circulating levels of corticosteroid and sex hormones, respectively. The concentrations of free or biologically active hormones do not change. Levels of other plasma proteins (angiotensin/renin substrate, α-1-antitrypsin, ceruloplasmin) may also increase.
HRT does not improve cognitive function. There is a risk of possible dementia in women who start HRT over the age of 65.
Patients with rare hereditary galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption should not be prescribed Femoston ® 1/10.
Femoston ® 1/10 is not a contraceptive.
Impact on the ability to drive vehicles and operate machinery
During the period of use of the drug, patients should be careful when driving vehicles and moving mechanisms.
To date, there have been no reports of symptoms overdose of the drug Femoston ® 1/10. Estradiol and dydrogesterone have a low degree of toxicity. There may be increased side effects of the drug, such as nausea, vomiting, drowsiness and dizziness.
Treatment: carrying out symptomatic therapy. There is no specific antidote.
The doctor should find out what medications the woman is currently taking or was taking before prescribing Femoston 1/10.
Possible reduction in the effectiveness of estrogens and progestogens
The metabolism of estrogens can be increased with the simultaneous use of drugs that induce microsomal liver enzymes of the cytochrome P450 system, for example, CYP2B6, CYP3A4, CYP3A5, CYP3A7. These include anticonvulsants (phenobarbital, carbamazepine, phenytoin) and anti-infective (rifampicin, ribavirin, nevirapine, efavirenesis) drugs.
Ritonavir and nelfinavir, although known as potent inhibitors of CYP3A4, CYP3A5, CYP3A7, on the contrary, induce liver enzymes when used simultaneously with steroid hormones.
Herbal preparations containing the herb St. John's wort (Hypericum perforatum) increase estrogen metabolism by inhibiting CYP3A4.
An increase in the metabolism of estrogens and progestogens can be clinically manifested by a decrease in efficiency and a change in the nature of the menstrual-like reaction.
The effect of estrogens on the metabolism of other drugs
Estrogens are capable of inhibiting CYP450 isoenzymes involved in drug metabolism through a competitive mechanism. This is especially important when it is necessary to simultaneously use drugs with a narrow therapeutic range, such as tacrolimus and cyclosporine A (CYP3A4, CYP3A3), fentanyl (CYP3A4), theophylline (CYP1A2). This interaction may be clinically manifested by an increase in plasma concentrations of these drugs to toxic levels. Therefore, the condition of patients receiving estrogen preparations should be carefully and long-term monitored and, if necessary, the doses of tacrolimus, fentanyl, theophylline and cyclosporine A should be reduced.
Femoston 1/10: instructions for use and reviews
Latin name: Femoston
ATX code: G03FB08
Active substance: dydrogesterone (dydrogesteronum), estradiol (oestradiolum)
Manufacturer: Solvay Pharmaceuticals (Netherlands), Abbott Laboratories S.A. (USA)
Updating the description and photo: 26.10.2018
Femoston 1/10 is a combined estrogen-progestin antimenopausal drug.
Release form and composition
Femoston 1/10 is available in the form of film-coated tablets: round, biconvex, engraved “379” on one side, white tablet core with a rough structure; in one blister there are two types of tablets - white and gray (28 tablets in a blister - 14 pieces of white and gray; in a cardboard pack there are 1, 3 or 10 blisters).
- white tablet: estradiol hemihydrate – 1.03 mg, which is equivalent to the content of 1 mg estradiol;
- gray tablet: estradiol hemihydrate – 1.03 mg, which is equivalent to the content of 1 mg estradiol; dydrogesterone – 10 mg.
Auxiliary components: lactose monohydrate, hypromellose, starch, colloidal silicon dioxide, magnesium stearate.
Shell composition:
- white tablet: opadry Y-1-7000 white [macrogol 400, titanium dioxide (E171), hypromellose];
- gray tablet: opadry II 85F27664 gray [macrogol 3350, polyvinyl alcohol, titanium dioxide (E171), iron (II) oxide black (E172), talc].
Pharmacological properties
Pharmacodynamics
Femoston 1/10 is a combination drug intended for hormone replacement therapy (HRT) to prevent bone loss in the postmenopausal period and after oophorectomy. The identity of estradiol hemihydrate to endogenous human estradiol, which is the most active estrogen, makes it possible to compensate for the deficiency of estrogen in the body of a woman at menopausal age and reduces the symptoms of menopause during the first weeks of using the drug. The therapeutic effectiveness of dydrogesterone (progestogen) is similar in activity to the action of progesterone for parenteral administration. Dydrogesterone during HRT ensures complete secretory transformation of the endometrium. Its presence in the drug reduces the risk of developing endometrial hyperplasia, which is increased by the action of estrogens.
Pharmacokinetics
After taking Femoston 1/10 orally, micronized estradiol and dydrogesterone are rapidly and completely absorbed from the gastrointestinal tract. The bioavailability of dydrogesterone is 28%, the maximum concentration in the blood plasma occurs after 0.5–2.5 hours.
Binding to blood plasma proteins: estradiol - approximately 98-99% (with albumin - 30-52%, with globulin - up to 69%), dydrogesterone - more than 90% of the dose taken.
In the liver, estradiol is metabolized to estrone and estrone sulfate, which have estrogenic activity. Estrone sulfate also has the ability of enterohepatic recirculation.
Dydrogesterone is completely metabolized, its main metabolite is 20-a-dihydrodydrogesterone (DHD), the maximum concentration in the blood plasma is reached approximately 1.5 hours after taking Femoston 1/10. The plasma concentration of DHD significantly exceeds the initial level of dydrogesterone concentration.
The lack of estrogenic and androgenic activity is determined by the characteristic feature of all dydrogesterone metabolites to retain the 4,6-dien-3-one configuration of the original substance and the absence of 17alpha-hydroxylation.
The half-life for dydrogesterone is 5–7 hours (DGD is 14–17 hours), estrone and estradiol is 10–16 hours.
Estrogens pass into breast milk.
Estrone and estradiol in a state conjugated with glucuronic acid are excreted primarily through the kidneys.
Approximately 63% of the dose of dydrogesterone is excreted by the kidneys; its complete elimination occurs only after 72 hours. Its total plasma clearance is 6.4 l/min. DHD is detected in urine primarily as a glucuronic acid conjugate.
With daily intake of Femoston 1/10, the equilibrium concentration of estradiol occurs after 5 days, dydrogesterone - after 3 days.
The pharmacokinetic properties of dydrogesterone and DHD do not change with repeated administration.
Indications for use
According to the instructions, Femoston 1/10 is indicated for women in perimenopause (only 6 months after the last menstruation) or postmenopause, as hormone replacement therapy for conditions that are caused by estrogen deficiency in the body.
In addition, the drug is prescribed for the prevention of postmenopausal osteoporosis at a high risk of fractures in women with intolerance or contraindications to other drugs.
Contraindications
Absolute:
- bleeding from the vagina of unknown etiology;
- breast cancer, including suspected;
- endometrial cancer and other estrogen-dependent malignant neoplasms, including if they are suspected;
- meningioma and other progestogen-dependent neoplasms, including if they are suspected;
- untreated endometrial hyperplasia;
- arterial and venous thrombosis, including deep vein thrombosis (including medical history);
- thromboembolism, including hemorrhagic or ischemic cerebrovascular disorders, pulmonary embolism, myocardial infarction (including medical history);
- pronounced or multiple risk factors for the development of venous or arterial thrombosis in patients with an acquired or hereditary predisposition, such as angina pectoris, cerebrovascular disease, transient ischemic attacks, atrial fibrillation, coronary artery disease, complicated lesions of the heart valve apparatus, antithrombin III deficiency, the presence of antibodies to phospholipids (lupus anticoagulant, antibodies to cardiolipin), protein C or S deficiency, prolonged immobilization, severe obesity (body weight index more than 30 kg per 1 m2);
- malignant liver tumors;
- acute or chronic liver disease (including medical history);
- porphyria;
- lactase deficiency, galactose intolerance, glucose-galactose malabsorption syndrome;
- pregnancy period;
- breast-feeding;
- hypersensitivity to the components of the drug.
It is recommended to be careful when prescribing Femoston 1/10 as HRT if you have or have a history of the following diseases and conditions: arterial hypertension, endometriosis, uterine leiomyoma, the presence of risk factors for the occurrence of estrogen-dependent tumors (including first-degree relatives with breast cancer) , bronchial asthma, diabetes mellitus (with and without vascular complications), benign liver tumors, cholelithiasis, severe headache, migraine, systemic lupus erythematosus, epilepsy, otosclerosis, history of endometrial hyperplasia.
Immediate discontinuation of Femoston 1/10 is required if liver dysfunction, jaundice, uncontrolled arterial hypertension, or migraine-like headaches appear during treatment.
Instructions for use of Femoston 1/10: method and dosage
Femoston 1/10 tablets are taken orally, regardless of meals, at a time convenient for the woman, but always at the same time of day.
Recommended dosage: 1 pc. 1 per day. The package is designed for 28 days; you should start taking tablets from the blister with white tablets (marked with the number 1), which contain 1 mg of estradiol. After 14 days, therapy is continued with gray tablets (marked with the number 2 in the blister), they contain 1 mg of estradiol and 10 mg of dydrogesterone. After finishing taking the tablets from the current blister, therapy is continued by taking white tablets from the new package. HRT involves regular, continuous use of the drug.
If you accidentally miss taking the next dose of Femoston 1/10, the tablet should be taken as soon as you remember, if the period of delay does not exceed 12 hours (the period from taking the previous dose to 36 hours). If the delay is more than 12 hours, then the missed tablet should not be taken, and the next day take the usual dose at the prescribed time. If you miss the next dose of the drug, the risk of spotting or breakthrough uterine bleeding increases.
When switching from the use of another hormonal drug (cyclic or continuous sequential regimen), you must end the current cycle and start taking Femoston 1/10. When switching from a continuous combination therapy regimen, you can start treatment with Femoston 1/10 on any day.
If the clinical effectiveness of the drug is insufficient due to estrogen deficiency, the dosage can be adjusted by prescribing Femoston 2/10.
Side effects
- from the reproductive system and mammary glands: very often - tension or soreness of the mammary glands; often - metrorrhagia, impaired vaginal secretion, minor bleeding in postmenopause, pain in the lower abdomen, heavy menstrual-like bleeding, acyclic bleeding, absence or scant menstrual bleeding, painful menstrual-like bleeding, vaginal candidiasis; uncommon – enlarged mammary glands, increased size of leiomyoma, premenstrual-like syndrome;
- from the nervous system: very often – headache; often – dizziness, migraine;
- from the cardiovascular system: infrequently - increased blood pressure, venous thromboembolism; rarely - myocardial infarction;
- mental disorders: often – nervousness, depression; infrequently – libido disturbance;
- from the gastrointestinal tract: very often – abdominal pain; often – flatulence, nausea, vomiting;
- from the hepatobiliary system: infrequently - impaired liver function, including in combination with abdominal pain, jaundice, malaise, asthenia; gallbladder pathology;
- from the skeletal muscles and connective tissue: very often – back pain (lumbar pain);
- on the part of the immune system: infrequently – hypersensitivity to the components of the drug;
- dermatological reactions: often - allergic reactions, including urticaria, skin rash, itching; rarely – angioedema, vascular purpura;
- general disorders: often - peripheral edema, asthenic conditions (malaise, weakness, fatigue);
- infectious diseases: infrequently – cystitis;
- other reactions: often - increase in body weight; infrequently – loss of body weight.
In addition, during combination therapy with estrogen and progestogen (including estradiol and dydrogesterone), the following undesirable effects may develop:
- from the body as a whole: neoplasms of benign, malignant and unspecified etiology (including ovarian cancer, endometrial cancer, meningioma);
- from the cardiovascular system: arterial thromboembolism;
- from the hematopoietic system: hemolytic anemia;
- from the nervous system: provoking attacks of epilepsy, chorea, risk of developing dementia against the background of hormone replacement therapy started over the age of 65 years;
- from the immune system: systemic lupus erythematosus;
- from the reproductive system and mammary glands: cervical erosion, fibrocystic mastopathy;
- from the organs of vision: increased curvature of the cornea, intolerance to contact lenses;
- from the skeletal muscles and connective tissue: cramps in the muscles of the lower extremities;
- from the genitourinary system: urinary incontinence;
- from the side of metabolism: hypertriglyceridemia;
- from the gastrointestinal tract: with hypertriglyceridemia - pancreatitis;
- diagnostic studies: increased levels of thyroid hormones;
- dermatological reactions: erythema nodosum, erythema multiforme, chloasma and/or melasma;
- other reactions: with porphyria – worsening of the disease.
Overdose
Symptoms: abdominal pain, nausea, vomiting, dizziness, drowsiness, weakness, withdrawal bleeding, breast tension.
Treatment: use of symptomatic therapy as indicated.
special instructions
The prescription of Femoston 1/10 is indicated only in the presence of symptoms that have an adverse effect on the quality of life. HRT is recommended until the risk of side effects exceeds the benefits of taking the drug. The limited clinical experience with the drug in women over 65 years of age should be taken into account.
In younger women, the absolute risk from using the drug is much lower than in older women.
To identify possible contraindications, the doctor should prescribe Femoston 1/10 based on a complete medical and family history and after a general gynecological examination of the patient, including mammography. The doctor should inform the woman about those changes in the mammary glands, the appearance of which requires consultation with a doctor. The use of the drug requires mandatory periodic examinations, at least once every 6 months. The doctor determines their nature and frequency individually.
The use of estrogens significantly increases the risk of developing endometrial cancer and hyperplasia, the degree of risk depends on the dose of the drug and the period of HRT. The combined composition of Femoston 1/10, namely cyclic administration of progestogen, reduces the risk of endometrial hyperplasia and cancer caused by estrogens. For timely diagnosis of these pathologies, it is advisable to conduct ultrasound screening, and, if necessary, histological examination. Bloody vaginal discharge, including breakthrough bleeding, may occur during the first months of therapy. If such bleeding occurs at later stages of treatment or occurs after discontinuation of the drug, it is necessary to diagnose their cause. To exclude malignancy, an endometrial biopsy is recommended.
The risk of developing deep vein thrombosis and pulmonary embolism during HRT increases several times, to a greater extent during the first 12 months of drug use. Patients whose first-degree relatives had thromboembolic complications at a young age, or with a history of spontaneous abortion, require a hemostasis study before prescribing the drug. With concomitant anticoagulant therapy, it is necessary to carefully evaluate the feasibility of prescribing Femoston 1/10. For planned surgery followed by long-term immobilization, it is recommended to discontinue HRT 1–1.5 months in advance and resume it only after the patient’s mobility has been completely restored. A woman should be informed about the symptoms of thromboembolism, such as shortness of breath, swelling or tenderness of the lower extremities, sudden chest pain, and the need to immediately consult a doctor if they occur.
The risk of developing breast cancer during combined estrogen-progestogen HRT, which lasts for more than 5 years, increases by 2 times. Breast engorgement caused by the drug may make it difficult to diagnose breast cancer in a timely manner.
There is a risk of developing ovarian cancer, but to a much lesser extent than breast cancer.
Combination therapy with estrogen and progestogen causes an increase in the relative risk of ischemic stroke, which is independent of the patient's age or duration of therapy. It should be borne in mind that the older the patient is at which she begins HRT, the higher the initial risk of ischemic stroke. Femoston 1/10 does not affect the occurrence of hemorrhagic stroke. The risk of developing coronary heart disease increases with age, but this can occur for objective and subjective reasons.
Femoston 1/10 is not a contraceptive.
In patients with impaired renal and cardiac function, their condition may be aggravated by the ability of estrogens to cause fluid retention.
In case of hypertriglyceridemia, HRT in very rare cases can contribute to the development of pancreatitis due to a significant increase in the level of triglyceride concentration in the blood plasma.
The use of the drug does not improve the patient’s cognitive functions. When starting HRT after the age of 65, women have an increased risk of developing dementia.
Impact on the ability to drive vehicles and complex mechanisms
Due to the risk of unwanted reactions from the nervous system, it is recommended to exercise caution when operating complex machinery and vehicles.
Use during pregnancy and lactation
The use of a combined hormonal drug during pregnancy and breastfeeding is contraindicated.
For liver dysfunction
The use of Femoston 1/10 is contraindicated in case of malignant liver tumors, acute or chronic forms of liver dysfunction (including medical history) and porphyria.
Use in old age
Women over 65 years of age have limited experience with the drug.
Drug interactions
When used simultaneously with Femoston 1/10:
- carbamazepine, phenobarbital, phenytoin (anticonvulsants), rifabutin, nevirapine, rifampicin, efavirenz (antimicrobials), St. John's wort, ritonavir, nelfinavir: increase the metabolism of the active components of the drug, which may result in a decrease in its therapeutic effect and a change in the intensity of vaginal bleeding ;
- tacrolimus, cyclosporine, theophylline, fentanyl: can significantly increase their plasma concentration levels.
Analogs
Analogues of Femoston 1/10 are: Femoston Mini, Femoston 1/5 Conti, Femoston 2/10, Klimonorm, Kliogest, Trisequens, Divina.
Terms and conditions of storage
Store at temperatures up to 30 °C. Keep away from children.
Shelf life – 3 years.
Latin name
Release form
Film-coated tablets
1 tablet contains:
Active ingredients: estradiol 1 mg, dydrogesterone 10 mg;
Excipients: lactose monohydrate, hypromellose, corn starch, colloidal silicon dioxide, magnesium stearate.
Package
pharmachologic effect
Femoston 1/10 is a combined two-phase drug for hormone replacement therapy, containing micronized 17-b-estradiol as an estrogenic component and dydrogesterone as a gestagenic component. Both components are chemically and biologically identical to the endogenous female sex hormones produced in the ovaries (estradiol and progesterone).
Estradiol replenishes the deficiency of estrogen in the female body after menopause and provides effective relief of psycho-emotional and vegetative menopausal symptoms, such as hot flashes, increased sweating, sleep disturbances, increased nervous excitability, dizziness, headache, involution of the skin and mucous membranes, especially the genitourinary system (dryness) and irritation of the vaginal mucosa, pain during sexual intercourse).
Hormone replacement therapy (HRT) with Femoston prevents bone loss in the postmenopausal period caused by estrogen deficiency.
Taking Femoston leads to a change in the lipid profile towards a decrease in the level of total cholesterol and LDL and an increase in HDL.
Dydrogesterone is a gestagen, effective when taken orally, which completely ensures the onset of the secretion phase in the endometrium, thereby reducing the risk of developing endometrial hyperplasia and/or carcinogenesis (increased with the use of estrogens). Dydrogesterone does not have estrogenic, androgenic, anabolic or glucocorticoid activity.
Indications
Hormone replacement therapy for disorders caused by natural or surgical menopause; prevention of osteoporosis in postmenopause.
Contraindications
- established or suspected pregnancy;
- lactation period (breastfeeding);
- diagnosed or suspected breast cancer; history of breast cancer;
- diagnosed or suspected estrogen-dependent malignancies;
- vaginal bleeding of unknown etiology;
- previous idiopathic or confirmed venous thromboembolism (deep vein thrombosis, pulmonary embolism);
- active or recent arterial thromboembolism;
- acute liver diseases, as well as a history of liver diseases (until normalization of laboratory parameters of liver function);
- untreated endometrial hyperplasia;
- porphyria;
- hypersensitivity to the components of the drug.
Use with caution and under the supervision of a physician in patients receiving HRT and having the following conditions (currently or in history): uterine leiomyoma, endometriosis, thrombosis and their risk factors in history, in the presence of risk factors for estrogen-dependent tumors (for example, breast cancer glands in the patient's mother), arterial hypertension, benign liver tumor, diabetes mellitus, cholelithiasis, epilepsy, migraine or intense headache, history of endometrial hyperplasia, systemic lupus erythematosus, bronchial asthma, renal failure, otosclerosis.
Use during pregnancy and breastfeeding
The drug is contraindicated for use during pregnancy and lactation (breastfeeding). If pregnancy occurs during treatment with Femoston, therapy should be stopped immediately.
Directions for use and doses
Femoston 1/10 is taken 1 tablet per day (preferably at the same time of day) without interruption.
In the first 14 days of a 28-day cycle, take 1 white tablet daily (from half the package with an arrow marked "1") containing 1 mg of estradiol, and in the remaining 14 days - 1 gray tablet daily (from half the package with an arrow marked "2") containing 1 mg of estradiol and 10 mg of dydrogesterone.
Side effects
From the reproductive system: possible soreness of the mammary glands, breakthrough bleeding, pain in the pelvic area; sometimes - changes in cervical erosion, changes in secretion, dysmenorrhea; rarely - enlarged mammary glands, premenstrual-like syndrome; in some cases - a change in libido.
From the digestive system: possible nausea, flatulence, abdominal pain; sometimes - cholecystitis; rarely (0.01-0.1%) - impaired liver function, in some cases accompanied by asthenia, malaise, jaundice or abdominal pain; very rarely - vomiting.
From the central nervous system: headache, migraine (1-10%); sometimes (0.1-1%) - dizziness, nervousness, depression; very rarely - chorea.
From the cardiovascular system: sometimes - venous thromboembolism; very rarely - myocardial infarction.
From the hematopoietic system: very rarely (less than 0.01%) - hemolytic anemia.
Dermatological reactions: sometimes - rash, itching; very rarely - chloasma, melasma, erythema multiforme, erythema nodosum, hemorrhagic purpura.
Allergic reactions: sometimes - urticaria; in some cases - angioedema.
Other: changes in body weight; sometimes - vaginal candidiasis, breast carcinoma, increase in the size of leiomyoma; rarely - peripheral edema, intolerance to contact lenses, increased corneal curvature; in some cases (less than 0.01%) - exacerbation of porphyria.
special instructions
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, 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.
Femoston 1/5 is prescribed to women who have been postmenopausal for at least 1 year.
When switching from another estrogen-progestogen drug for HRT, Femoston 1/5 should be taken at the end of the estrogen-progestogen phase without a break in taking the pills.
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.
Risk factors for thrombosis and thromboembolism while taking 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 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.
There is research data showing a slight increase in the likelihood of developing breast cancer in women who received 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 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.
Femoston is not a contraceptive. Perimenopausal patients are advised to use non-hormonal contraceptives.
The patient should inform the doctor about the medications she is currently taking or was taking before prescribing Femoston.
The use of estrogens may affect the results of the following laboratory tests: determination of glucose tolerance, study of thyroid and liver function.
Impact on the ability to drive vehicles and operate machinery
Femoston does not affect the ability to drive vehicles or operate machinery.
The instructions for use of Femoston indicate that this combination drug is used for the purpose of hormone replacement therapy in women upon the onset of menopause or in the treatment of disorders associated with removal of the ovaries. The use of the drug Femoston 1/10 and 2/10 allows you to eliminate disorders associated with deficiency of sex hormones, normalize the general condition and functioning of various organs and systems of the female body.
Femoston 1/10 and 2/10: description of the drug
Femoston is a combined two-phase drug containing analogues of female sex hormones (dydrogesterone and estradiol).
Estradiol is completely identical to the hormone estrogen, which is produced by a woman’s ovaries. During menopause, the functions of the ovaries fade away, and a deficiency of female hormones occurs, which is replenished by estradiol. Its action allows you to relieve menopausal symptoms - hot flashes, hyperhidrosis, increased nervousness and psycho-emotional excitability, negative changes in the genitourinary system, causing discomfort during sexual intercourse.
Dydrogesterone is an analogue of progesterone, responsible for the growth of the endometrium in the second half of the menstrual cycle. As part of the drug, this hormone is responsible for eliminating the risk of developing endometrial cancer or hyperplasia, which increases while taking estradiol.
The use of Femoston as a replacement therapy prevents bone loss (osteoporosis) during menopause and reduces the concentration of total cholesterol in the blood.
In what form is the drug released?
- Femoston is produced in the form of film-coated tablets.
- Femoston 1/5 Conti contains 1 mg estradiol and 5 mg dydrogesterone;
- Femoston 1/10 - tablet contains 1 mg of estradiol and 10 mg of dydrogesterone;
- Femoston 2/10 - in tablets the active components are contained in a concentration of 2:10.
When is Femoston prescribed?
Indications for use of all types of the drug are the same. Femoston, as a means of hormone replacement therapy, is intended to relieve menopausal changes caused by the onset of menopause or developed as a result of surgery to remove the ovaries. At the same time, tablets 1/5 can be prescribed only 12 months after the last menstruation, and Femoston 1/10 and 2/10 are approved for use six months after the onset of menopause.
Another indication for the use of the drug is the prevention of osteoporosis that develops during menopause.
Instructions for use
Femoston Conti is taken daily, preferably at the same time, regardless of meals. Treatment is carried out in a continuous mode, implying the use of 1 tablet per day. It is not advisable to skip the next dose, as the risk of breakthrough bleeding increases. If a woman forgets to take the drug at the usual time, then the tablet should be taken as soon as possible (if less than 12 hours have passed). Otherwise, take the missed tablet the next day at the usual time.
- Femoston 1/10. In the first two weeks of the menstrual cycle, take a white pill marked with the number “1” at the same time. For the remaining days of the 28-day cycle, you should take the gray pills marked with the number “2” every day.
- Femoston 2/10. In the first half of the cycle, for 2 weeks, you should take a pink tablet marked with the number “1” every day, in the remaining 2 weeks - light yellow tablets with the number “2”.
If a woman’s menstrual cycles have not yet stopped, treatment with the drug should begin on the first day of the cycle. For those who had their last menstruation a year ago, Femoston therapy can be started on any day.
Contraindications
Treatment with Femoston is contraindicated in the following conditions:
- endometrial cancer (detected or suspected);
- breast cancer (diagnosed or suspected);
- cerebrovascular accidents;
- porphyria;
- deep vein thrombosis (acute);
- pulmonary embolism (history);
- acute or chronic liver pathologies;
- vaginal bleeding of unknown etiology;
- and breastfeeding;
- individual intolerance to the components of the drug.
Hormone replacement therapy is administered with extreme caution to patients suffering from hypertension, migraine, renal failure, metabolic disorders (diabetes mellitus), endometriosis, cholelithiasis, with a tendency to epileptic seizures, and severe autoimmune diseases (systemic lupus erythematosus).
Adverse reactions
In general, the drug is well tolerated by patients, but in some cases, adverse reactions develop while taking Femoston.
- From the gastrointestinal tract, abdominal pain, flatulence occur, sometimes a woman is plagued by nausea and has bouts of vomiting.
- From the central nervous system - migraine attacks, dizziness, increased nervousness, depressive states.
Good to know: In rare cases, symptoms of hemolytic anemia, venous thromboembolism are observed, and peripheral edema occurs.
From the genitourinary system, breakthrough bleeding, changes in secretion, erosive lesions of the cervix, pain in the pelvis and lower back are noted. A woman may complain of painful swelling of the mammary glands, dysmenorrhea, symptoms of vaginal candidiasis, and weight gain.
With increased sensitivity to the components of the drug, allergic reactions develop - skin rashes, itching. In exceptional cases, angioedema is recorded. There have been cases of breast carcinoma and reactions leading to the inability to continue wearing contact lenses. In isolated cases, taking medication can provoke a stroke or myocardial infarction.
The active substances of Femoston are characterized by low toxicity, so exceeding the dosage of the drug can only provoke an increase in adverse reactions (nausea, vomiting, dizziness), which usually does not require symptomatic therapy.
Before prescribing hormone replacement therapy, the doctor must collect a complete medical history of the patient. In addition, it is necessary to conduct a full general and gynecological examination in order to identify possible contraindications and conditions that require special caution when prescribing Femoston. Additionally, before starting treatment, the patient is recommended to undergo an ultrasound or mammography of the mammary glands.
It should be taken into account that thromboembolic complications are possible while taking the drug. Other risk factors include metabolic disorders, obesity or chronic autoimmune diseases (lupus erythematosus). In patients with recurrent thrombosis and thromboembolism who are forced to take anticoagulant drugs, the possible risks should be carefully assessed before prescribing medication.
If, while taking Femoston, alarming symptoms such as swelling of the legs, blurred vision, dyspnea, jaundice of the skin, or fainting appear, you must stop taking the drug and consult a doctor about replacing it and adjusting the further treatment regimen.
In the first months of therapy, a woman may experience spotting or breakthrough bleeding. In this case, stop taking the pills and find out the cause of the bleeding. Patients receiving hormone replacement drugs should take into account that long-term use of Femoston (more than 10 years) increases the likelihood of developing breast cancer.
Analogs
Femoston 1/10 and Femoston 2/10 do not have structural analogues containing the same active ingredients. If necessary, this drug can be replaced by a number of medications with a similar therapeutic effect aimed at normalizing the condition of a woman during menopause. This list includes the following drugs:
- Artemis;
- Hormoplex;
- Inoclim;
- Klimadinon;
- Klymen;
- Microfollin;
- Ovestin;
- Remens;
- Triaclim;
- Estragelle.
If you are intolerant to the components of Femoston or if adverse reactions occur, your doctor can always select another medication with a similar therapeutic effect that will not cause negative reactions.
Price
The cost of the drug in the pharmacy chain depends on the manufacturer and the concentration of active substances. Thus, the average price of Femoston Conti 1/5 is 900 rubles, Femoston 1/10 - from 780 rubles, Femoston 2/10 - from 800 rubles.
Taking into account the fact that hormone replacement therapy is carried out over a long period, the final cost of treatment results in a rather impressive amount.