Femoston 1/10
Femoston 1/10: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. For violations of liver function
- 11. Use in the elderly
- 12. Drug interactions
- 13. Analogs
- 14. Terms and conditions of storage
- 15. Terms of dispensing from pharmacies
- 16. Reviews
- 17. Price in pharmacies
Latin name: Femoston
ATX code: G03FB08
Active ingredient: dydrogesterone (dydrogesteronum), estradiol (oestradiolum)
Producer: Solvay Pharmaceuticals (Netherlands), Abbott Laboratories SA (USA)
Description and photo update: 2018-26-10
Femoston 1/10 is a combined estrogen-progestogenic anti-climacteric drug.
Release form and composition
Femoston 1/10 is available in the form of film-coated tablets: round, biconvex, engraved on one side "379", the core of the tablet is white 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 box 1, 3 or 10 blisters).
Content of active ingredients in 1 tablet:
- white tablet: estradiol hemihydrate - 1.03 mg, which is equivalent to 1 mg of estradiol;
- gray tablet: estradiol hemihydrate - 1.03 mg, which is equivalent to 1 mg of estradiol; dydrogesterone - 10 mg.
Auxiliary components: lactose monohydrate, hypromellose, starch, colloidal silicon dioxide, magnesium stearate.
Shell composition:
- white tablet: white opadry Y-1-7000 [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 combined drug intended for hormone replacement therapy (HRT) to prevent bone loss in the postmenopausal period and after ovariectomy. The identity of estradiol hemihydrate with human endogenous estradiol, which is the most active estrogen, makes it possible to compensate for the estrogen deficiency in the body of a woman in menopausal age and reduces menopause symptoms during the first weeks of using the drug. The therapeutic efficacy of dydrogesterone (progestogen) is similar in activity to that of parenteral progesterone. Dydrogesterone during HRT provides a full secretory transformation of the endometrium. Its presence in the drug reduces the risk of endometrial hyperplasia, which is increased by the action of estrogens.
Pharmacokinetics
After taking Femoston 1/10 inside, there is a rapid and complete absorption of micronized estradiol and dydrogesterone from the gastrointestinal tract. The bioavailability of dydrogesterone is 28%, the maximum concentration in the blood plasma occurs in 0.5–2.5 hours.
Plasma protein binding: 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 an inherent intestinal-hepatic recirculation ability.
Dydrogesterone is completely metabolized, its main metabolite is 20-a-dihydrodidrogesterone (DHD), the maximum concentration in blood plasma is reached approximately 1.5 hours after taking Femoston 1/10. The plasma concentration of DHD significantly exceeds the initial concentration of dydrogesterone.
The absence of estrogenic and androgenic activity determines the characteristic feature of all dydrogesterone metabolites to maintain the configuration of the 4,6-diene-3-one of the parent substance and the absence of 17alpha-hydroxylation.
The half-life for dydrogesterone is 5-7 hours (DHD - 14-17 hours), estrone and estradiol - 10-16 hours.
Estrogens pass into breast milk.
Estrone and estradiol in a state conjugated with glucuronic acid are excreted mainly through the kidneys.
Approximately 63% of the dose of dydrogesterone taken is excreted by the kidneys; its complete excretion occurs only after 72 hours. Its total plasma clearance is 6.4 l / min. DHD is determined in urine mainly in the form of glucuronic acid conjugate.
With a 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 in postmenopausal women, as hormone replacement therapy for conditions that are caused by a deficiency in the body of estrogen.
In addition, the drug is prescribed for the prevention of postmenopausal osteoporosis with 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 history);
- thromboembolism, including hemorrhagic or ischemic cerebrovascular disorders, pulmonary embolism, myocardial infarction (including history);
- severe 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 valvular apparatus of the heart, 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 m 2);
- malignant liver tumors;
- acute or chronic liver disease (including history);
- porphyria;
- lactase deficiency, galactose intolerance, glucose-galactose malabsorption syndrome;
- period of pregnancy;
- breast-feeding;
- hypersensitivity to the components of the drug.
It is recommended to be careful when prescribing Femoston 1/10 as HRT in the presence or indication of 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 the first degree of relationship of relatives, with breast cancer), bronchial asthma, diabetes mellitus (with and without vascular complications), benign liver neoplasms, cholelithiasis, severe headache, migraine, systemic lupus erythematosus, epilepsy, otosclerosis, history of endometrial hyperplasia.
Requires immediate cancellation of Femoston 1/10 when liver dysfunctions, jaundice, uncontrolled arterial hypertension, migraine-like headache appear during the treatment period.
Instructions for use Femoston 1/10: method and dosage
Femoston 1/10 tablets are taken orally, regardless of food intake, at a convenient for a 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 the tablets from the blister with white tablets (marked with the number 1), which contain 1 mg of estradiol. After 14 days, therapy is continued by taking gray tablets (marked with the number 2 in the blister), they contain 1 mg of estradiol and 10 mg of dydrogesterone. After the end of taking the tablets from the current blister, the therapy is continued by taking white tablets from a new package. HRT involves regular continuous intake of the drug.
If you accidentally skip taking the next dose of Femoston 1/10, the pill 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 exceeds 12 hours, then the missed pill should not be taken, and the next day, take the usual dose at the prescribed time. On the background of skipping the next dose of the drug, the risk of "smearing" spotting or "breakthrough" uterine bleeding increases.
When switching from the use of another hormonal drug (cyclic or continuous sequential mode of administration), it is necessary to complete the current cycle and start taking Femoston 1/10. When switching from a continuous combination therapy regimen, treatment with Femoston 1/10 can be started on any day.
In case of insufficient clinical efficacy of the drug associated with 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 spotting in postmenopausal women, lower abdominal pain, profuse menstrual bleeding, acyclic spotting, absence or scanty menstrual bleeding, painful menstrual bleeding, vaginal candidiasis; infrequently - an increase in the mammary glands, an increase in the size of leiomyoma, premenstrual syndrome;
- from the nervous system: very often - headache; often - dizziness, migraine;
- on the part of the cardiovascular system: infrequently - increased blood pressure, venous thromboembolism; rarely - myocardial infarction;
- mental disorders: often - nervousness, depression; infrequently - impaired libido;
- from the gastrointestinal tract: very often - abdominal pain; often - flatulence, nausea, vomiting;
- from the hepatobiliary system: infrequently - abnormal liver function, including in combination with abdominal pain, jaundice, malaise, asthenia; pathology of the gallbladder;
- on the part of skeletal muscles and connective tissue: very often - back pain (low back pain);
- from 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 - an increase in body weight; infrequently - a decrease in body weight.
In addition, against the background of 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);
- on the part of the cardiovascular system: arterial thromboembolism;
- from the hematopoietic system: hemolytic anemia;
- from the nervous system: provoking seizures of epilepsy, chorea, the risk of dementia against the background of hormone replacement therapy, started at the age of over 65;
- from the immune system: systemic lupus erythematosus;
- on the part of the reproductive system and mammary glands: cervical erosion, fibrocystic breast disease;
- on the part of the organs of vision: an increase in the curvature of the cornea, intolerance to contact lenses;
- on the part of 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 tests: increased content of thyroid hormones;
- dermatological reactions: erythema nodosum, erythema multiforme, chloasma and / or melasma;
- other reactions: with porphyria - worsening of the course of the disease.
Overdose
Symptoms: abdominal pain, nausea, vomiting, dizziness, drowsiness, weakness, withdrawal bleeding, breast tension.
Treatment: the use of symptomatic therapy according to indications.
special instructions
The appointment of Femoston 1/10 is indicated only in the presence of symptoms that have an adverse effect on quality of life. HRT is recommended for as long as the risk of side effects does not exceed the benefits of taking the drug. Consideration should be given to the limited clinical experience with the drug in women over the age of 65 years.
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 on the basis of 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, when they appear, it is necessary to consult a doctor. The use of the drug requires mandatory periodic examinations, at least 1 time in 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 the cyclic intake of progestogen, reduces the risk of endometrial hyperplasia and cancer caused by estrogens. For the timely diagnosis of these pathologies, it is advisable to conduct ultrasound screening, and, if necessary, histological examination. Vaginal bleeding, including breakthrough bleeding, may appear during the first months of therapy. If such bleeding occurs at later stages of treatment or occurs after drug withdrawal, it is necessary to diagnose their cause. Endometrial biopsy is recommended to exclude malignant neoplasm.
The risk of developing deep vein thrombosis and pulmonary embolism in the presence of HRT increases several times, to a greater extent during the first 12 months of using the drug. Patients whose first-degree relatives had thromboembolic complications at a young age, or with a history of spontaneous abortion, require a study of hemostasis before prescribing the drug. With concomitant anticoagulant therapy, it is necessary to carefully assess the feasibility of prescribing Femoston 1/10. In case of planned surgical intervention followed by prolonged immobilization, it is recommended to cancel HRT within 1–1.5 months and resume it only after the patient has fully recovered the mobility. The woman should be informed about the symptoms of thromboembolism such as shortness of breath, swelling or soreness of the lower extremities,sudden chest pain, and the need for immediate medical attention if they occur.
The risk of developing breast cancer on the background of combined estrogen-progestogen HRT, lasting for more than 5 years, increases 2 times. Breast engorgement caused by the drug can make it difficult to diagnose breast cancer early.
There is a risk of developing ovarian cancer, but to a much lesser extent than breast cancer.
Combination therapy with estrogen and progestogen increases the relative risk of ischemic stroke, which does not depend on the patient's age or the duration of therapy. It should be borne in mind that the older the patient is at which she starts HRT, the higher the initial risk of ischemic stroke. Femoston 1/10 does not affect the appearance 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 aggravate the property of estrogens to cause fluid retention.
With hypertriglyceridemia, HRT, in very rare cases, can contribute to the development of pancreatitis due to a significant increase in plasma triglyceride levels.
The use of the drug does not improve the patient's cognitive function. When starting HRT over the age of 65, women have an increased risk of developing dementia.
Influence on the ability to drive vehicles and complex mechanisms
Due to the risk of unwanted reactions from the nervous system, it is recommended to be careful when driving complex mechanisms and vehicles.
Application during pregnancy and lactation
The use of a combined hormonal drug during gestation and during breastfeeding is contraindicated.
For violations of liver function
The use of Femoston 1/10 is contraindicated in malignant liver tumors, acute or chronic liver dysfunction (including history) and porphyria.
It is recommended to prescribe the drug with caution to women with benign liver neoplasms.
Use in the elderly
In women over the age of 65, experience with the drug is limited.
Drug interactions
When used simultaneously with Femoston 1/10:
- carbamazepine, phenobarbital, phenytoin (anticonvulsants), rifabutin, nevirapine, rifampicin, efavirenz (antimicrobial agents), St.;
- tacrolimus, cyclosporine, theophylline, fentanyl: can significantly increase their plasma levels.
Analogs
The analogues of Femoston 1/10 are: Femoston Mini, Femoston 1/5 Conti, Femoston 2/10, Klimonorm, Kliogest, Trisekvens, Divina.
Terms and conditions of storage
Store at temperatures up to 30 ° C. Keep out of the reach of children.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Femoston reviews 1/10
Reviews about Femoston 1/10 are controversial. Many women give the drug a positive assessment. They indicate that it is quite effective when used to relieve the symptoms of menopause. Some of them, comparing the mild infrequent hot flashes during the use of Femoston 1/10 with the state of complete discomfort (severe hot flashes) after the drug was discontinued, decide to resume HRT. After 5–8 years of using combined hormone therapy, rare and minor side effects, improved quality of life, and general well-being are reported.
Negative reviews sound from those for whom the drug did not help; they argue their assessment by the lack of the desired clinical result, the development of severe side effects, severe edema, and a significant increase in body weight.
All women attribute the high cost of pills to the disadvantages of Femoston 1/10.
The doctors' comments, based on the results of clinical studies, indicate the high therapeutic efficacy of the drug and its good tolerance.
Price for Femoston 1/10 in pharmacies
The price of Femoston 1/10 for a package containing 28 tablets can range from 839 rubles.
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
