Femoston 1/5
Femoston 1/5: 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. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 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 1/5
ATX code: G03FA14
Active ingredient: dydrogesterone + estradiol (Dydrogesterone + Estradiol)
Manufacturer: Solvay Pharmaceuticals (Netherlands)
Description and photo update: 2018-27-07
Prices in pharmacies: from 1086 rubles.
Buy
Femoston 1/5 is a combined estrogen-progestin agent.
Release form and composition
Dosage form Femoston 1/5 - film-coated tablets: round, biconvex, orange-pink, engraved on one side "379", on the other - the letter "S" above the number "7" (28 pcs. In a blister, in a cardboard box 1 or 3 blisters).
Active ingredients in 1 tablet:
- dydrogesterone - 5 mg;
- estradiol - 1 mg.
Additional components of the tablets: corn starch, methyl hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, colloidal anhydrous silica, yellow and red iron oxide (E172), Opadry Y 8734 orange [macrogol 400, titanium dioxide (E171)].
Pharmacological properties
Pharmacodynamics
Femoston 1/5 is a drug for hormone replacement therapy (HRT) with a low-dose content of hormones: estradiol as an estrogenic component and dydrogesterone as a gestagenic component. These substances determine the action of the drug.
Estradiol is identical to endogenous estradiol. It compensates for the estrogen deficiency in a woman's body after menopause. Eliminates psychoemotional and vegetative climacteric syndromes, such as increased sweating, hot flashes, increased nervous excitability, sleep disturbances, headache, dizziness, involution of the skin and mucous membranes, especially the genitourinary system, which is manifested by dryness and irritation of the vaginal mucosa, soreness during intercourse.
Femoston 1/5 also prevents bone loss in the postmenopausal period. Risk factors for osteoporosis in postmenopausal women are the early onset of menopause, smoking, and long-term use of glucocorticosteroids in the recent past.
The drug changes the lipid profile: reduces the level of total cholesterol and low density lipoproteins, while increasing the content of high density lipoproteins.
Dydrogesterone is a progestogen effective when taken orally. It ensures the onset of the secretion phase in the endometrium, and also reduces the risk of developing endometrial hyperplasia and / or carcinogenesis, increased by estrogen. Does not possess glucocorticoid, anabolic, estrogenic and androgenic activity.
To achieve the maximum preventive effect, HRT is recommended to start immediately after the onset of menopause. The action of Femoston 1/5 is manifested during the entire period of its administration (there is reliable information on the use of estrogens for up to 10 years, in later periods the data are limited).
Pharmacokinetics
Estradiol is readily absorbed after oral administration. The metabolic process takes place in the liver, resulting in the formation of metabolites estrone and estrone sulfate (also undergoing hepatic biotransformation). The glucuronides estrone and estradiol are excreted mainly in the urine.
Dydrogesterone after oral administration is rapidly absorbed from the gastrointestinal tract. It is completely metabolized, its main metabolite is 20-dihydrodidrogesterone, which is present in the urine mainly in the form of a glucuronic acid conjugate. The half-life of dydrogesterone is 5-7 hours, and its main metabolite is 14-17 hours. It takes 72 hours to completely remove the substance.
Indications for use
- hormone replacement therapy for disorders caused by estrogen deficiency in postmenopausal women;
- prevention of postmenopausal osteoporosis.
Contraindications
- vaginal bleeding of unknown etiology;
- endometrial cancer or other hormone-dependent neoplasms;
- diagnosed or suspected breast cancer, history of breast cancer;
- acute or chronic liver diseases, including in history (before the normalization of laboratory parameters of liver function);
- disorders of cerebral circulation;
- a history of confirmed acute deep vein thrombosis or pulmonary embolism;
- established or suspected pregnancy;
- lactation period;
- hypersensitivity to any component of the drug.
With caution and under the supervision of a physician, Femoston 1/5 should be used if the following diseases / conditions are present or have a history:
- benign liver tumor;
- impaired renal function;
- cholelithiasis;
- hemoglobinopathy;
- diabetes mellitus with vascular complications;
- systemic lupus erythematosus;
- otosclerosis;
- porphyria;
- migraine or intense headache;
- epilepsy;
- multiple sclerosis;
- history of thrombosis and their risk factors;
- bronchial asthma;
- arterial hypertension;
- a history of endometrial hyperplasia;
- endometriosis;
- uterine leiomyoma;
- the presence of risk factors for the development of estrogen-dependent tumors (for example, breast cancer in the patient's mother).
Instructions for use of Femoston 1/5: method and dosage
Femoston 1/5 should be taken orally. Food intake does not affect the effectiveness of the drug.
For the prevention of osteoporosis and during HRT, 1 tablet is prescribed 1 time per day, preferably at the same time of the day. The duration of therapy is individual and is determined by the balance of benefits and risks, as well as the severity of estrogen deficiency.
For the prevention of postmenopausal osteoporosis, the advisability of prescribing the drug is determined individually depending on its tolerability, as well as on the possible effect on bone mass, which is dose-dependent.
Side effects
- from the reproductive system: pain in the pelvic region, smearing bleeding from the vagina, acyclic menstrual bleeding in the first months of treatment, breast tenderness; sometimes - dysmenorrhea, changes in secretion, vaginal candidiasis, erosion of the cervix; rarely - premenstrual-like syndrome, changes in the mammary glands (enlargement, painful sensations and engorgement); in some cases - a change in libido;
- on the part of the hematopoietic system: very rarely - hemolytic anemia;
- from the central nervous system: headache, migraine; sometimes - nervousness, dizziness, depression; very rarely - chorea;
- from the digestive system: abdominal pain, flatulence, nausea; sometimes - cholecystitis; rarely - abnormal liver function, sometimes accompanied by abdominal pain, jaundice, asthenia, malaise; very rarely - vomiting;
- on the part of the cardiovascular system: sometimes - venous thromboembolism; very rarely - myocardial infarction;
- allergic and dermatological reactions; rash, itching, urticaria; very rarely - polymorphic or erythema nodosum, melasma, hemorrhagic purpura, chloasma; in some cases - angioedema;
- other reactions: change in body weight; sometimes - an increase in the size of leiomyoma, vaginal candidiasis, breast carcinoma; rarely - an increase in the curvature of the cornea, intolerance to contact lenses, peripheral edema; in some cases - exacerbation of porphyria.
Overdose
Overdose cases have not been reported to date. Presumably, side effects may increase.
Overdose treatment is symptomatic. The specific antidote is unknown.
special instructions
Femoston 1/5 is indicated for use by women who are postmenopausal for at least 1 year.
Before prescribing Femoston 1/5 or resuming its admission, the doctor must collect a complete medical and family history, conduct a general and gynecological examination in order to identify possible contraindications to taking the drug or conditions in which the necessary precautions will need to be taken.
Surveys are recommended to be repeated periodically during the entire period of HRT (the types of studies and the frequency of their conduct are determined individually).
Examination of the mammary glands and / or mammography is performed in accordance with accepted standards, taking into account clinical indications.
When transferring a patient from one estrogen-progestogen drug to Femoston 1/5 for HRT, the latter should be taken at the end of the estrogen-progestogen phase, without taking a break in therapy.
Women who are transferred to Femoston 1/5 with HRT, in which only estrogen drugs were used, should be carefully examined before starting treatment in order to identify possible endometrial hyperstimulation.
The main risk factors for the development of thrombosis and thromboembolism during HRT are considered to be thromboembolic complications in history, systemic lupus erythematosus and severe obesity (body mass index over 30 kg / m 2). As for the role of varicose veins in the development of thromboembolism, there is no generally accepted opinion on this matter.
The likelihood of deep vein thrombosis of the lower extremities may increase with extensive trauma, serious surgery, and prolonged immobilization. In cases where long-term immobilization is required after surgery, consideration should be given to temporarily discontinuing HRT 4–6 weeks before the intervention.
If it is necessary to prescribe HRT to women with thromboembolism or recurrent deep vein thrombosis who receive anticoagulants, the balance of benefits and risks should be carefully assessed.
If thrombosis develops after starting Femoston 1/5, therapy is discontinued. Each woman should be warned by the doctor that it is necessary to urgently contact him in case of dyspnea, painful swelling of the lower extremities, visual impairment and / or sudden loss of consciousness.
Estradiol can interfere with the results of some laboratory tests, such as examining thyroid and liver function, and determining glucose tolerance.
According to research data, women who receive HRT for more than 10 years have a slightly increased rate of breast cancer diagnostics. Detection of this disease may be due to early diagnosis, biological effects of hormone replacement therapy, or a combination of both. The likelihood of being diagnosed with cancer increases with the duration of treatment and returns to normal levels 5 years after completion of HRT.
In the first months of taking Femoston 1/5, not pronounced menstrual or breakthrough uterine bleeding may occur. If, even after adjusting the dose, the bleeding does not stop, the drug is canceled until the exact cause is established. In some cases, an endometrial biopsy is required.
Femoston 1/5 is not intended for use as contraception. Perimenopausal women should use non-hormonal contraception.
Influence on the ability to drive vehicles and complex mechanisms
The influence of Femoston 1/5 on the ability to drive transport and perform potentially hazardous activities has not been identified.
Application during pregnancy and lactation
Pregnancy (both established and prospective) and lactation are contraindications to the use of the drug.
Pediatric use
In childhood, Femoston 1/5 is not used.
With impaired renal function
The drug should be used with caution in patients with impaired renal function.
For violations of liver function
According to the instructions, Femoston 1/5 is contraindicated if you currently have or have a history of acute or chronic liver diseases until laboratory parameters of liver function are normalized.
The drug should be used with caution in patients with benign liver tumors.
Drug interactions
The estrogenic effect of Femoston 1/5 is reduced by herbal preparations containing St. carbamazepine, topiramate, phenytoin).
The estrogenic effect of Femoston 1/5 can be enhanced by drugs that are inhibitors of microsomal liver enzymes (for example, ritonavir and nelfinavir).
Possible interactions of dydrogesterone when used with other drugs are not known.
A woman should inform her doctor about any medications that she took or is taking while undergoing HRT.
Analogs
The analogue of Femoston 1/5 is Femoston Conti.
Terms and conditions of storage
The shelf life is 3 years.
Store in original packaging at temperatures up to 30 ° C. Do not freeze. Keep out of the reach of children.
Terms of dispensing from pharmacies
Dispensed by prescription.
Femoston reviews 1/5
Reviews of Femoston 1/5 are mostly positive. Women confirm that the drug really evens out hormonal levels and significantly improves overall well-being. However, there are also some negative reviews about this drug, in which patients indicate the development of serious side effects.
Price for Femoston 1/5 in pharmacies
The price of Femoston 1/5 is 850-970 rubles. per pack of 28 tablets.
Femoston 1/5: prices in online pharmacies
|
Drug name Price Pharmacy |
|
Femoston 1/5 conti tablets p.p. 28 pcs. 1086 RUB Buy |
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!
