Femoston 2/10
Femoston 2/10: 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. In case of impaired renal function
- 11. For violations of liver function
- 12. Use in the elderly
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Femoston 2/10
ATX code: G03FB08
Active ingredient: estradiol (oestradiolum), dydrogesterone (dydrogesteronum)
Producer: Solvay Pharmaceuticals (Netherlands), Abbott Laboratories SA (USA)
Description and photo update: 2018-26-10
Femoston 2/10 is an anti-climacteric combined estrogen-progestin drug.
Release form and composition
Femoston 2/10 is available in the form of film-coated tablets of two types - pink and light yellow: round, biconvex, engraved with "379" on one side, at break - the core of a white tablet with a rough structure (28 pcs.. in a blister - 14 pink tablets and 14 light yellow tablets; in a cardboard box 1, 3 or 10 blisters).
Content of active ingredients in 1 tablet:
- pink tablet: estradiol hemihydrate - 2.06 mg, which is equivalent to 2 mg of estradiol;
- light yellow tablet: estradiol hemihydrate - 2.06 mg, which is equivalent to 2 mg of estradiol; dydrogesterone - 10 mg.
Auxiliary components: lactose monohydrate, colloidal silicon dioxide, hypromellose, magnesium stearate, corn starch.
Shell composition:
- pink tablet: opadry OY-6957 pink - macrogol 400, hypromellose, titanium dioxide (E171), iron oxide red, iron oxide yellow, iron oxide black, talc;
- light yellow tablet: opadry OY-02B22764 yellow - macrogol 400, hypromellose, yellow iron oxide, titanium dioxide (E 171), talc.
Pharmacological properties
Pharmacodynamics
Femoston 2/10 is an anti-climacteric drug, the therapeutic effect of which is provided by a combination of two hormones. It is used as hormone replacement therapy (HRT) to prevent bone loss in the postmenopausal period and after ovariectomy.
Estradiol is an estrogen identical to endogenous estradiol, the main and most active sex hormone in women. Taking estradiol allows you to compensate for the estrogen deficiency in women at the onset of menopause and to reduce the symptoms of menopause at the beginning of treatment.
Dydrogesterone is a progestogen, its pharmacological efficacy when taken orally is similar to that of progesterone. The presence of dydrogesterone in the tablet helps to ensure a full secretory transformation of the endometrium, reducing the risk of endometrial hyperplasia, increased by the action of estrogens, during HRT.
Pharmacokinetics
After oral administration, absorption of Femoston 2/10 occurs in the gastrointestinal tract, where micronized estradiol and dydrogesterone are easily and quickly absorbed. The bioavailability of dydrogesterone is 28%.
Estrogen is found bound and free. Plasma protein binding: estradiol - up to 99% of the dose, of which with albumin - from 30 to 52%, with sex hormone binding globulin (SHBG) - from 46 to 69%; dydrogesterone and its metabolite - more than 90%.
In the liver, estradiol is metabolized to estrone and estrone sulfate. Both metabolites have estrogenic activity; intestinal-hepatic recirculation is characteristic of estrone sulfate.
The main metabolite of dydrogesterone is 20alpha-dihydrodidrogesterone (DHD), its maximum concentration in the blood plasma after taking the pill occurs after about 1.5 hours. The plasma concentration of DHD is significantly higher than the initial concentration of dydrogesterone. The absence of estrogenic and androgenic action determines the characteristic feature of all dydrogesterone metabolites - to preserve the configuration of the 4,6-dien-3-one of the initial substance and the absence of 17alpha-hydroxylation.
Estradiol passes into breast milk.
Excretion of estradiol and its metabolites is mainly carried out by the kidneys in a state conjugated with glucuronic acid.
About 63% of the dose of dydrogesterone taken is excreted by the kidneys. Its total plasma clearance is 6.4 l / min. In urine, DHD is determined to a greater extent in the form of a glucuronic acid conjugate.
Half-life: estradiol - 10-16 hours, dydrogesterone - 5-7 hours, DHD - 14-17 hours.
Dydrogesterone is completely excreted after 72 hours.
With a daily intake of Femoston 2/10, the equilibrium concentration in the blood plasma of estradiol occurs after about 5 days, of dydrogesterone - after 3 days.
Reception of multiple doses does not affect the pharmacokinetic properties of dydrogesterone and its main metabolite.
Indications for use
According to the instructions, Femoston 2/10 is indicated as HRT for conditions that are caused by estrogen deficiency in perimenopausal women (no earlier than six months after the last menstrual bleeding) and postmenopausal women.
In addition, the drug can be prescribed for the prevention of postmenopausal osteoporosis in women with a high risk of bone fractures, for whom the use of other drugs is contraindicated or if they are intolerant.
Contraindications
- untreated endometrial hyperplasia;
- vaginal bleeding of unknown etiology;
- breast cancer, including suspected;
- meningioma and other progestogen-dependent tumors, including presumed ones;
- endometrial cancer and other estrogen-dependent malignant tumors, including presumed ones;
- thrombosis (venous and arterial), including deep vein thrombosis (including history);
- thromboembolism, myocardial infarction, pulmonary thromboembolism, cerebrovascular disorders of hemorrhagic and ischemic origin (including anamnesis);
- the presence of pronounced or multiple factors of venous or arterial thrombosis due to a hereditary or acquired predisposition, including antithrombin III deficiency, protein C or S deficiency, the presence of lupus anticoagulant or antibodies to cardiolipin, prolonged immobilization, severe obesity (body weight index above 30 kg / m 2), diseases of the coronary arteries or cerebral vessels, angina pectoris, transient ischemic attacks, atrial fibrillation, complicated lesions of the valvular apparatus of the heart;
- malignant neoplasms of the liver;
- porphyria;
- acute or chronic form of liver disease, until the normalization of the functional parameters of liver samples (including history);
- lactase deficiency, glucose-galactose malabsorption syndrome, galactose intolerance;
- period of pregnancy;
- breast-feeding;
- individual intolerance to the components of the drug.
Continuation of Femoston 2/10 is contraindicated in case of liver dysfunction, jaundice, uncontrolled arterial hypertension, migraine-like headache that first appeared during HRT.
With caution, it is recommended to prescribe Femoston 2/10 to women with or with a history of the following diseases and conditions: arterial hypertension, endometriosis, uterine leiomyoma, risk factors for the occurrence of estrogen-dependent neoplasms (including close relatives with breast cancer), liver tumors of benign etiology, epilepsy, diabetes mellitus with or without vascular complications, systemic lupus erythematosus, cholelithiasis, bronchial asthma, severe headache, migraine, otosclerosis, endometrial hyperplasia.
Instructions for use of Femoston 2/10: method and dosage
Femoston 2/10 tablets are taken orally, regardless of food intake, preferably always at the same time of day, convenient for the woman.
Recommended dosage: 1 pc. Once a day.
It is necessary to start taking the drug from the blister with pink tablets (marked with the number 1). After 14 days of taking pills containing only estradiol (2 mg), light yellow pills (marked with the number 2) should be used, which contain estradiol (2 mg) and dydrogesterone (10 mg). After 28 days, after the end of taking all the tablets from the current blister, the therapy is continued by taking pink tablets from the new blister. HRT involves continuous administration of the drug.
If you miss taking the next dose of Femoston 2/10 at the set time, the missed pill can be taken immediately, as soon as you remember, if the delay does not exceed 12 hours or the period from taking the previous pill is not more than 36 hours. Otherwise, it must be taken at the usual time the next day. Skipping the next dose of the drug increases the risk of developing breakthrough uterine bleeding.
Usually HRT begins with the appointment of Femoston 1/10, if the therapeutic effect is insufficient due to estrogen deficiency, the dose of estradiol is increased using Femoston 2/10. In this case, namely when switching from a continuous combination therapy regimen, you can start taking a new drug on any day.
When switching from another drug with a continuous sequential or cyclic treatment regimen, you must first complete the current cycle, and only then start taking Femoston 2/10.
Side effects
- general disorders: often - fatigue, malaise, weakness, peripheral edema;
- from the nervous system: very often - headache; often - dizziness, migraine;
- from the reproductive system and mammary glands: very often - breast tension or soreness; often - metrorrhagia, a violation of vaginal secretion, bloody (smearing) discharge in postmenopausal women, lower abdominal pain, vaginal candidiasis, profuse menstrual bleeding, acyclic bleeding, scanty or no menstrual bleeding, painful menstrual discharge; infrequently - premenstrual-like syndrome, an increase in the mammary glands, an increase in the size of a leiomyoma;
- on the part of the cardiovascular system: infrequently - increased blood pressure, venous thromboembolism; rarely - myocardial infarction;
- from the hepatobiliary system: infrequently - pathology of the gallbladder, abnormal liver function, including in combination with malaise, abdominal pain, asthenia, jaundice;
- from the gastrointestinal tract: very often - abdominal pain; often - flatulence, nausea, vomiting;
- from the immune system: infrequently - hypersensitivity to estradiol and / or dydrogesterone;
- on the part of skeletal muscles and connective tissue: very often - pain in the lumbar back;
- dermatological reactions: often - allergic reactions, in the form of skin rash, itching, urticaria; rarely - angioedema, vascular purpura;
- mental disorders: often - nervousness, depression; infrequently - impaired libido;
- infectious diseases: infrequently - cystitis;
- others: often - an increase in body weight; infrequently - a decrease in body weight.
In addition, against the background of combined estrogen-gestagen therapy with the use of Femoston 2/10, the following undesirable effects may develop:
- on the part of the organism as a whole: ovarian cancer, endometrial cancer, meningioma and other neoplasms of malignant, benign or unspecified etiology;
- on the part of the reproductive system and mammary glands: cervical erosion, fibrocystic breast disease;
- on the part of the cardiovascular system: arterial thromboembolism;
- from the gastrointestinal tract: with hypertriglyceridemia - pancreatitis;
- from the nervous system: chorea, provoking epileptic seizures, the risk of dementia in women who start hormone replacement therapy over the age of 65;
- from the hematopoietic system: hemolytic anemia;
- from the immune system: systemic lupus erythematosus;
- on the part of the organs of vision: an increase in the curvature of the cornea, hypersensitivity to contact lenses;
- on the part of connective tissue and skeletal muscles: cramps in the muscles of the lower extremities;
- from the genitourinary system: urinary incontinence;
- laboratory indicators: an increase in the level of thyroid hormones;
- dermatological reactions: erythema nodosum, erythema multiforme, chloasma and / or melasma;
- from the side of metabolism: hypertriglyceridemia;
- others: in patients with porphyria - worsening of the course of the disease.
Overdose
Symptoms: abdominal pain, dizziness, nausea, vomiting, weakness, drowsiness, withdrawal bleeding, breast tension.
Treatment: symptomatic therapy.
special instructions
Femoston 2/10 should be prescribed only to women with symptoms that cause a significant deterioration in their quality of life, and continue HRT until the risk of side effects outweighs the benefits of treatment. Particular caution should be exercised in patients over 65 years of age, since the experience of using the drug at this age is limited.
The most common adverse events occurring against the background of a combination of estradiol and dydrogesterone include tension and tenderness of the mammary glands, abdominal pain, headache, back pain.
Before starting or resuming therapy, a woman needs to undergo a general and gynecological examination, mammography. To take into account possible contraindications and conditions, the appointment of Femoston 2/10 should be carried out on the basis of data on the patient's complete medical and family history. Based on the clinical picture, the doctor should inform the woman about all the risks associated with hormonal therapy and about those changes in the mammary glands for which it is necessary to see a doctor.
Since HRT has been carried out for a long time, it is recommended to conduct examinations during treatment. The doctor determines their frequency and nature for each patient individually, but the frequency of examinations should not be less than once every six months.
It should take into account the effect of estrogens on the results of laboratory tests to determine glucose tolerance, the study of liver and thyroid function.
Compared with women who do not receive estrogen monotherapy, when using it, patients increase the risk of developing endometrial hyperplasia or cancer from 2 to 12 times, depending on the duration and dose of the drug. Moreover, it remains elevated for another 10 years after the abolition of estrogen. Cyclic use of progestogen lowers the risk of hyperplasia and endometrial cancer increased by estrogen. For the timely diagnosis of these diseases, it is advisable to use ultrasound screening and histological examination. At the beginning of treatment, breakthrough or spotting bleeding from the vagina may appear. If such bleeding occurs after several months of therapy or after the cancellation of Femoston 2/10, in order to exclude a malignant neoplasm, their cause must be diagnosed,including with an endometrial biopsy.
HRT increases the risk of deep vein thrombosis and pulmonary embolism by almost 3 times, especially during the first year of hormone use. Women whose close relatives (mother, father) had thromboembolic complications at a young age, or with a history of recurrent miscarriage, should be tested for hemostasis. With anticoagulant therapy, the appointment of Femoston 2/10 is possible only if the benefits of HRT outweigh the potential risk of thromboembolism.
The use of HRT should be discontinued 1–1.5 months before planned surgery followed by long-term subsequent immobilization. Hormone therapy can be resumed only after the woman's mobility is fully restored.
The symptoms of venous thromboembolism include swelling of the lower extremities, their soreness, shortness of breath, sudden chest pain. If they develop against the background of Femoston 2/10, you should immediately consult a doctor and stop taking the drug.
Increasing with the use of monotherapy with estrogens or a combination of estrogen and progestogen, the frequency of diagnosing breast cancer after discontinuation of therapy returns to the initial level within 5 years. The risk of developing breast cancer depends on the duration of therapy and may double after 5 years of combined estrogen-progestogen HRT. Timely diagnosis of breast cancer can make it difficult to engorge the mammary glands with HRT.
There is a risk of developing ovarian cancer, but it is significantly lower than the risk of developing breast cancer.
The use of Femoston 2/10 increases the risk of ischemic stroke by 1.5 times, treatment does not affect the occurrence of hemorrhagic stroke.
Since estrogens can retain fluid in the body, this can worsen the condition in patients with impaired renal and cardiac function.
With hypertriglyceridemia that occurs while taking Femoston 2/10, the risk of developing pancreatitis increases.
HRT does not improve cognitive function. The increased risk of dementia should be taken into account when prescribing the drug to women over the age of 65 years.
Femoston 2/10 does not have contraceptive properties.
Influence on the ability to drive vehicles and complex mechanisms
It is recommended to be careful when working with complex mechanisms and driving vehicles, since the drug can cause dizziness, drowsiness and other side effects that affect the speed of psychomotor reactions.
Application during pregnancy and lactation
The appointment of Femoston 2/10 is contraindicated during pregnancy and lactation.
When conceiving against the background of the use of a hormonal drug, treatment should be canceled immediately.
With impaired renal function
Since estrogens can retain fluid in the body, it can worsen if the patient's kidney function is impaired.
For violations of liver function
The use of Femoston 2/10 is contraindicated in patients with malignant neoplasms of the liver, with a chronic or acute form of liver dysfunction (including history), and porphyria.
It is recommended to prescribe HRT with caution in benign liver neoplasms.
Use in the elderly
The experience of using Femoston 2/10 in women over the age of 65 is limited.
Drug interactions
Simultaneous use of Femoston 2/10 with other medicinal substances / preparations:
- anticonvulsants (carbamazepine, phenobarbital, phenytoin), antimicrobial agents (nevirapine, rifabutin, rifampicin, efavirenz), ritonavir, nelfinavir, Hypericum perforatum drugs (St. from the vagina;
- fentanyl, tacrolimus, theophylline, cyclosporine: can significantly increase their plasma levels.
Analogs
The analogues of Femoston 2/10 are: Femoston 1/5 Conti, Femoston 1/10, Femoston Mini, Klimonorm, Trissequens, Divina, Cliogest.
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 2/10
Reviews about Femoston 2/10 are quite contradictory. Women, whom the drug helped to normalize hormones and become pregnant after many years of lack of conception and disappointing predictions of doctors, describe the effectiveness of the drug using words only in superlatives. With HRT therapy significantly improves the general condition, women forget about frequent hot flashes and “wadded” legs. Patients recommend taking pills before bedtime, which will reduce the unpleasant effects of the drug in the form of nausea and headaches, as well as undergo regular medical examinations.
Negative reviews about Femoston 2/10 are given by women who, after 6 months of combination therapy, were diagnosed with the development of a hormone-dependent breast tumor. One of the patients describes that the use of the drug for polycystic ovaries normalized the menstrual cycle, without causing noticeable side effects for 3 years, but after discontinuation of therapy, menstruation stopped. And the consequence of taking hormonal pills was a significant increase in weight and swelling.
Doctors give a positive assessment of the effectiveness of Femoston 2/10 when used for the treatment and prevention of conditions that have arisen with premature ovarian depletion.
Price for Femoston 2/10 in pharmacies
The price for Femoston 2/10 per pack can be from 1121 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!
