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Femoston is a combined medicinal product containing progestogens and estrogens. It is available in the form of tablets (orange-pink, double-convex, round). They are coated and packaged in blister packs. In a 5 mg tablet, there is 1 mg of the active ingredient.
Active ingredients: estradiol and dydrogesterone. The combination of dydrogesterone and estradiol is complementary—neither component diminishes the beneficial effect of the other.
Hormone replacement therapy is used for disorders associated with the onset of menopause (whether naturally or as a result of surgical intervention), provided that the uterus is preserved, and for the prevention of postmenopausal osteoporosis.
Femoston 1/10 – Indications for Use
- Climacteric complaints in women
- Postmenopausal osteoporosis
Clinical Pharmacology
Pharmacodynamics
Estradiol – the estrogen included in Femoston is identical to endogenous human estradiol. It replenishes the estrogen deficiency in the female body after menopause and effectively treats the psycho-emotional and vasomotor climacteric symptoms such as hot flashes, increased sweating, sleep disturbances, heightened nervous excitability, dizziness, headache, and involution of the skin and mucous membranes (especially of the urogenital tract, where it counteracts vaginal dryness, irritation, and painful sexual intercourse). Hormone replacement therapy with Femoston prevents the loss of bone mass in the postmenopausal period that is caused by estrogen deficiency. Administration of Femoston also favorably alters the lipid profile by reducing total cholesterol and LDL levels while increasing HDL.
Dydrogesterone is a progestogen that is effective when taken orally. It fully induces the secretory phase in the endometrium, thereby reducing the risk of developing endometrial hyperplasia and/or carcinogenesis that may be promoted by estrogen. Dydrogesterone does not have estrogenic, androgenic, anabolic, or glucocorticoid activity.
The combination of 1 mg of estradiol with dydrogesterone represents a modern, low-dose HRT regimen.
Pharmacokinetics
After oral administration, micronized estradiol is readily absorbed. It is metabolized in the liver to estrone and estrone sulfate, which in turn undergo further hepatic biotransformation. The glucuronides of estrone and estradiol are excreted predominantly in the urine.
Dydrogesterone is rapidly absorbed from the gastrointestinal tract after oral administration. It is completely metabolized; its main metabolite is 20-dihydrodydrogesterone, which appears in the urine mainly as a glucuronic acid conjugate. Complete elimination of dydrogesterone occurs within 72 hours.
Dosage Form and Composition
White Tablets:
• Round, double-convex, with an “S” embossed above the “dlt” symbol on one side and “379” on the other side (14 tablets per blister pack).
• Each tablet contains:
– Active ingredient: estradiol 1 mg
– Excipients: lactose monohydrate, hypromellose, corn starch, colloidal silicon dioxide, magnesium stearate
– Coating: Opadry OY-1-7000 white
Gray Tablets:
• Round, double-convex, with an “S” embossed above the “dlt” symbol on one side and “379” on the other side; the tablet core is white (14 tablets per blister pack).
• Each tablet contains:
– Active ingredients: estradiol 1 mg, dydrogesterone 10 mg
– Excipients: lactose monohydrate, hypromellose, corn starch, colloidal silicon dioxide, magnesium stearate
– Coating: Opadry OY-8243 gray
• Available as 28 tablets in a calendar pack, with 1, 3, or 10 blister packs per carton box.
Special Instructions
Femoston 1/10 is not a contraceptive and does not prevent pregnancy. Its use may reduce the effectiveness of medications used for high blood pressure and anti-diabetic drugs. (The text suggests that the efficacy of Femoston 1/10 may also be reduced by additional factors which are not detailed in this excerpt.)
Interactions
- Medications that induce hepatic microsomal enzymes (barbiturates, phenytoin, rifampicin, rifabutin, carbamazepine) may weaken the estrogenic effect of Femoston.
- Ritonavir and nelfinavir, although known as inhibitors of microsomal metabolism, may act as inducers when taken concurrently with steroid hormones.
- Herbal products containing St. John’s wort may stimulate the metabolism of estrogens and progestogens.
No interactions have been noted between dydrogesterone and other medications.
Patients should inform their physician about any medications they are currently taking or have taken before starting Femoston.
Overdose
Symptoms: nausea, vomiting, drowsiness, dizziness.
Treatment: symptomatic.
Dosage and Administration, Course of Treatment
Take one tablet daily by mouth, preferably at the same time each day and regardless of meals, without interruption. The recommended scheme for Femoston 1/10 is as follows:
• During the first 14 days of a 28-day cycle, take one white tablet daily (from the half-pack marked with an arrow and the number “1”), which contains 1 mg of estradiol.
• During the remaining 14 days, take one gray tablet daily (from the half-pack marked with an arrow and the number “2”), which contains 1 mg of estradiol and 10 mg of dydrogesterone.
For patients whose menstruation has not ceased, it is recommended to begin treatment on the first day of the menstrual cycle (the first day of menstruation). For patients with irregular menstrual cycles, starting treatment after 10–14 days of progestogen monotherapy is advisable. Patients whose last menstruation occurred more than a year ago may start treatment at any time.
Contraindications
• Established or suspected pregnancy
• Breastfeeding
• Diagnosed or suspected breast cancer; history of breast cancer
• Diagnosed or suspected estrogen-dependent malignant tumors
• Unexplained vaginal bleeding
• History of idiopathic or confirmed venous thromboembolism (deep vein thrombosis, pulmonary embolism)
• Active or recent (acute) arterial thromboembolism
• Acute liver diseases or a history of liver disease (until liver function test results normalize)
• Untreated endometrial hyperplasia
• Increased sensitivity to any of the components of the product
• Porphyria
Use with Caution – Patients receiving HRT who currently or previously had the following conditions should be closely monitored by a physician:
• Uterine leiomyoma, endometriosis
• History of thrombosis or presence of risk factors for thrombosis
• Risk factors for estrogen-dependent tumors (e.g., breast cancer in the patient’s mother)
• Arterial hypertension
• Benign liver tumor
• Diabetes mellitus
• Cholelithiasis
• Epilepsy
• Migraine or severe headaches
• History of endometrial hyperplasia
• Systemic lupus erythematosus
• Bronchial asthma
• Renal insufficiency
• Otosclerosis
After consulting with a physician, treatment should be discontinued if any of the following occur:
• The appearance of jaundice or deterioration of liver function
• Significant increase in blood pressure
• A first-time migraine-like attack
• Pregnancy
• Manifestation of any contraindication
Special Instructions
Before starting or resuming HRT, a complete medical and family history should be obtained, and a general as well as gynecological examination should be performed to detect any potential contraindications or conditions warranting caution. During treatment, periodic examinations are recommended (with frequency and scope determined individually). Breast examinations and/or mammography should be performed in accordance with accepted medical standards and clinical indications. The use of estrogens may influence certain laboratory test results (such as glucose tolerance, thyroid, and liver function tests).
Recognized risk factors for thrombosis and thromboembolism in association with HRT include a history of thromboembolic complications, severe obesity (body mass index over 30 kg/m²), and systemic lupus erythematosus. There is no universally accepted position regarding the role of varicose veins in the development of thromboembolism.
The risk of developing deep vein thrombosis in the lower extremities may temporarily increase with prolonged immobilization, extensive trauma, or surgical interventions. In cases where prolonged immobilization is necessary following surgery, temporary discontinuation of HRT 4–6 weeks before the procedure should be considered.
When considering HRT for patients with recurrent deep vein thrombosis or thromboembolism who are on anticoagulant therapy, the benefits and risks of HRT must be carefully assessed.
If thrombosis develops after initiating HRT, the medication should be discontinued. The patient should be informed to seek immediate medical attention if they experience symptoms such as painful swelling of the lower limbs, sudden loss of consciousness, difficulty breathing, or vision disturbances.
There is evidence indicating a slight increase in the detection frequency of breast cancer in women who have received HRT for an extended period (more than 10 years). The likelihood of diagnosing breast cancer increases with the duration of treatment and returns to normal approximately 5 years after discontinuing HRT.
Patients who have previously undergone HRT with estrogen-only preparations should be carefully examined before starting treatment to rule out potential endometrial hyperstimulation. Breakthrough uterine bleeding and mild menstrual-like bleeding may occur during the initial months of treatment. If such bleeding persists despite dose adjustments, the medication should be suspended until the cause of the bleeding is determined. Should bleeding recur after a period of amenorrhea or continue following treatment discontinuation, its etiology should be established, potentially requiring an endometrial biopsy.
Femoston is not a contraceptive. Patients in the perimenopausal stage are advised to use non-hormonal contraceptive methods.
It does not affect the ability to drive or operate machinery.
Do Not Use If:
• There is increased sensitivity to Femoston 1/10
• There is impaired liver function
• There are tumors of the uterus, ovaries, or breast
• Thrombophlebitis
• Uterine bleeding
Femoston 1/10 – Indications for Use
HRT for disorders caused by natural or surgically induced menopause; prophylaxis of postmenopausal osteoporosis.
Side Effects
• Breast tenderness
• Headache, dizziness
• Nausea, vomiting, changes in libido, bloody discharges
Brief Summary of Indications
Hormone replacement therapy.
Active ingredients: estradiol and dydrogesterone. The combination of dydrogesterone and estradiol is complementary—neither component diminishes the beneficial effect of the other.
Hormone replacement therapy is used for disorders associated with the onset of menopause (whether naturally or as a result of surgical intervention), provided that the uterus is preserved, and for the prevention of postmenopausal osteoporosis.
Femoston 1/10 – Indications for Use
- Climacteric complaints in women
- Postmenopausal osteoporosis
Clinical Pharmacology
Pharmacodynamics
Estradiol – the estrogen included in Femoston is identical to endogenous human estradiol. It replenishes the estrogen deficiency in the female body after menopause and effectively treats the psycho-emotional and vasomotor climacteric symptoms such as hot flashes, increased sweating, sleep disturbances, heightened nervous excitability, dizziness, headache, and involution of the skin and mucous membranes (especially of the urogenital tract, where it counteracts vaginal dryness, irritation, and painful sexual intercourse). Hormone replacement therapy with Femoston prevents the loss of bone mass in the postmenopausal period that is caused by estrogen deficiency. Administration of Femoston also favorably alters the lipid profile by reducing total cholesterol and LDL levels while increasing HDL.
Dydrogesterone is a progestogen that is effective when taken orally. It fully induces the secretory phase in the endometrium, thereby reducing the risk of developing endometrial hyperplasia and/or carcinogenesis that may be promoted by estrogen. Dydrogesterone does not have estrogenic, androgenic, anabolic, or glucocorticoid activity.
The combination of 1 mg of estradiol with dydrogesterone represents a modern, low-dose HRT regimen.
Pharmacokinetics
After oral administration, micronized estradiol is readily absorbed. It is metabolized in the liver to estrone and estrone sulfate, which in turn undergo further hepatic biotransformation. The glucuronides of estrone and estradiol are excreted predominantly in the urine.
Dydrogesterone is rapidly absorbed from the gastrointestinal tract after oral administration. It is completely metabolized; its main metabolite is 20-dihydrodydrogesterone, which appears in the urine mainly as a glucuronic acid conjugate. Complete elimination of dydrogesterone occurs within 72 hours.
Dosage Form and Composition
White Tablets:
• Round, double-convex, with an “S” embossed above the “dlt” symbol on one side and “379” on the other side (14 tablets per blister pack).
• Each tablet contains:
– Active ingredient: estradiol 1 mg
– Excipients: lactose monohydrate, hypromellose, corn starch, colloidal silicon dioxide, magnesium stearate
– Coating: Opadry OY-1-7000 white
Gray Tablets:
• Round, double-convex, with an “S” embossed above the “dlt” symbol on one side and “379” on the other side; the tablet core is white (14 tablets per blister pack).
• Each tablet contains:
– Active ingredients: estradiol 1 mg, dydrogesterone 10 mg
– Excipients: lactose monohydrate, hypromellose, corn starch, colloidal silicon dioxide, magnesium stearate
– Coating: Opadry OY-8243 gray
• Available as 28 tablets in a calendar pack, with 1, 3, or 10 blister packs per carton box.
Special Instructions
Femoston 1/10 is not a contraceptive and does not prevent pregnancy. Its use may reduce the effectiveness of medications used for high blood pressure and anti-diabetic drugs. (The text suggests that the efficacy of Femoston 1/10 may also be reduced by additional factors which are not detailed in this excerpt.)
Interactions
- Medications that induce hepatic microsomal enzymes (barbiturates, phenytoin, rifampicin, rifabutin, carbamazepine) may weaken the estrogenic effect of Femoston.
- Ritonavir and nelfinavir, although known as inhibitors of microsomal metabolism, may act as inducers when taken concurrently with steroid hormones.
- Herbal products containing St. John’s wort may stimulate the metabolism of estrogens and progestogens.
No interactions have been noted between dydrogesterone and other medications.
Patients should inform their physician about any medications they are currently taking or have taken before starting Femoston.
Overdose
Symptoms: nausea, vomiting, drowsiness, dizziness.
Treatment: symptomatic.
Dosage and Administration, Course of Treatment
Take one tablet daily by mouth, preferably at the same time each day and regardless of meals, without interruption. The recommended scheme for Femoston 1/10 is as follows:
• During the first 14 days of a 28-day cycle, take one white tablet daily (from the half-pack marked with an arrow and the number “1”), which contains 1 mg of estradiol.
• During the remaining 14 days, take one gray tablet daily (from the half-pack marked with an arrow and the number “2”), which contains 1 mg of estradiol and 10 mg of dydrogesterone.
For patients whose menstruation has not ceased, it is recommended to begin treatment on the first day of the menstrual cycle (the first day of menstruation). For patients with irregular menstrual cycles, starting treatment after 10–14 days of progestogen monotherapy is advisable. Patients whose last menstruation occurred more than a year ago may start treatment at any time.
Contraindications
• Established or suspected pregnancy
• Breastfeeding
• Diagnosed or suspected breast cancer; history of breast cancer
• Diagnosed or suspected estrogen-dependent malignant tumors
• Unexplained vaginal bleeding
• History of idiopathic or confirmed venous thromboembolism (deep vein thrombosis, pulmonary embolism)
• Active or recent (acute) arterial thromboembolism
• Acute liver diseases or a history of liver disease (until liver function test results normalize)
• Untreated endometrial hyperplasia
• Increased sensitivity to any of the components of the product
• Porphyria
Use with Caution – Patients receiving HRT who currently or previously had the following conditions should be closely monitored by a physician:
• Uterine leiomyoma, endometriosis
• History of thrombosis or presence of risk factors for thrombosis
• Risk factors for estrogen-dependent tumors (e.g., breast cancer in the patient’s mother)
• Arterial hypertension
• Benign liver tumor
• Diabetes mellitus
• Cholelithiasis
• Epilepsy
• Migraine or severe headaches
• History of endometrial hyperplasia
• Systemic lupus erythematosus
• Bronchial asthma
• Renal insufficiency
• Otosclerosis
After consulting with a physician, treatment should be discontinued if any of the following occur:
• The appearance of jaundice or deterioration of liver function
• Significant increase in blood pressure
• A first-time migraine-like attack
• Pregnancy
• Manifestation of any contraindication
Special Instructions
Before starting or resuming HRT, a complete medical and family history should be obtained, and a general as well as gynecological examination should be performed to detect any potential contraindications or conditions warranting caution. During treatment, periodic examinations are recommended (with frequency and scope determined individually). Breast examinations and/or mammography should be performed in accordance with accepted medical standards and clinical indications. The use of estrogens may influence certain laboratory test results (such as glucose tolerance, thyroid, and liver function tests).
Recognized risk factors for thrombosis and thromboembolism in association with HRT include a history of thromboembolic complications, severe obesity (body mass index over 30 kg/m²), and systemic lupus erythematosus. There is no universally accepted position regarding the role of varicose veins in the development of thromboembolism.
The risk of developing deep vein thrombosis in the lower extremities may temporarily increase with prolonged immobilization, extensive trauma, or surgical interventions. In cases where prolonged immobilization is necessary following surgery, temporary discontinuation of HRT 4–6 weeks before the procedure should be considered.
When considering HRT for patients with recurrent deep vein thrombosis or thromboembolism who are on anticoagulant therapy, the benefits and risks of HRT must be carefully assessed.
If thrombosis develops after initiating HRT, the medication should be discontinued. The patient should be informed to seek immediate medical attention if they experience symptoms such as painful swelling of the lower limbs, sudden loss of consciousness, difficulty breathing, or vision disturbances.
There is evidence indicating a slight increase in the detection frequency of breast cancer in women who have received HRT for an extended period (more than 10 years). The likelihood of diagnosing breast cancer increases with the duration of treatment and returns to normal approximately 5 years after discontinuing HRT.
Patients who have previously undergone HRT with estrogen-only preparations should be carefully examined before starting treatment to rule out potential endometrial hyperstimulation. Breakthrough uterine bleeding and mild menstrual-like bleeding may occur during the initial months of treatment. If such bleeding persists despite dose adjustments, the medication should be suspended until the cause of the bleeding is determined. Should bleeding recur after a period of amenorrhea or continue following treatment discontinuation, its etiology should be established, potentially requiring an endometrial biopsy.
Femoston is not a contraceptive. Patients in the perimenopausal stage are advised to use non-hormonal contraceptive methods.
It does not affect the ability to drive or operate machinery.
Do Not Use If:
• There is increased sensitivity to Femoston 1/10
• There is impaired liver function
• There are tumors of the uterus, ovaries, or breast
• Thrombophlebitis
• Uterine bleeding
Femoston 1/10 – Indications for Use
HRT for disorders caused by natural or surgically induced menopause; prophylaxis of postmenopausal osteoporosis.
Side Effects
• Breast tenderness
• Headache, dizziness
• Nausea, vomiting, changes in libido, bloody discharges
Brief Summary of Indications
Hormone replacement therapy.
