Femoston conty 15 N28 film coated pills
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Active ingredients
Didrogesterone + Estradiol
Release form
Pills
Composition
1 tablet contains: Active substance: estradiol hemihydrate 1.03 mg, which corresponds to the estradiol content of 1 mg, didrogesterone 5 mg.; Excipients: lactose monohydrate - 114.7 mg, hypromellose - 2.8 mg, corn starch - 14.4 mg, colloidal silicon dioxide - 1.4 mg , magnesium stearate - 0.7 mg.; Film coating composition: OY-8734 opadry orange (hypromellose - 2.844 mg, macrogol 400 - 0.284 mg, titanium dioxide (E171) - 0.8 mg, iron dye yellow oxide (E172) - 0.048 mg, dye iron oxide red (E172) - 0.024 mg) - 4 mg .;
Pharmacological effect
Estradiol, which is part of the drug Femoston; 1/5 conti, identical to human endogenous estradiol, which is the most active estrogen. Estradiol compensates for the lack of estrogen in the female body after menopause and provides effective treatment of psycho-emotional, vegetative and urogenital menopausal symptoms. Replacement hormone therapy (HRT) with Femoston; 1/5 of the conty prevents bone loss in the postmenopausal period.; Femoston; 1/5 of the contiti leads to a change in the lipid profile in the direction of lowering total cholesterol and LDL cholesterol and increasing HDL.; Didrogesteron is a progestogen, effective when taken orally. It does not have estrogenic, androgenic, anabolic, or glucocorticoid activity.; When performing HRT, the inclusion of didrogesterone provides a complete secretory transformation of the endometrium, thereby reducing the risk of developing hyperplasia and / or endometrial cancer under the influence of estrogen.
Pharmacokinetics
After ingestion, micronized estradiol is easily absorbed. It is metabolized in the liver to estrone and estrone sulfate, which also undergoes hepatic biotransformation. Estrone and estradiol glucuronides are mainly excreted in the urine. After oral administration, didprogesterone is rapidly absorbed from the gastrointestinal tract. It is fully metabolized, the main metabolite is 20-dihydrodrodester-testerone (DHD), which is present in the urine, mainly as a conjugate of glucuronic acid. T1 / 2 - 5–7 h, DGD - 14–17 h. Complete elimination occurs after 72 hours.
Indications
- hormone replacement therapy for disorders caused by estrogen deficiency in postmenopausal women; - prevention of postmenopausal osteoporosis in women with a high risk of fractures with intolerance or contraindications to the use of other drugs.
Contraindications
- established or suspected pregnancy; - lactation period; - diagnosed or suspected breast cancer, a history of breast cancer; - diagnosed or suspected progestogen-dependent neoplasms; - diagnosed or suspected estrogen-dependent malignant neoplasms, including endometrial cancer, including in the anamnesis; - bleeding from the vagina of unknown etiology; - thromboembolic disease at present or in history (for example, myocardial infarction, deep vein thrombosis, pulmonary embolism); - violation of cerebral circulation; - acute or chronic liver disease in the present or in history (before normalization of laboratory parameters of liver function); - untreated endometrial hyperplasia; - porphyria; - galactose intolerance, lactase deficiency, glucose / galactose malabsorption syndrome; - Hypersensitivity to the components of the drug. With care, postmenopausal hormone replacement is prescribed to women if they are currently diagnosed or have a history of: - uterine leiomyoma, endometriosis; - the presence of risk factors for the emergence of estrogen-dependent tumors (for example, I degree of heredity of breast cancer); - liver adenoma; - cholelithiasis; - migraine or intense headache; - renal failure; - bronchial asthma; - Endometrial hyperplasia in history; - epilepsy; - otosclerosis; - multiple sclerosis; - hemoglobinopathies; - risk factors for the development of thromboembolic states, incl. angina pectoris, prolonged immobilization, severe obesity (body mass index of more than 30 kg / m2); - arterial hypertension; - diabetes mellitus, both in the presence of vascular complications, and in cases of their absence; - Systemic lupus erythematosus.
Use during pregnancy and lactation
The drug is contraindicated during pregnancy and during breastfeeding. If pregnancy occurs during treatment with the drug Femoston; 1/5 Conty, therapy should be immediately discontinued.
Dosage and administration
For the purpose of HRT and the prevention of osteoporosis, the drug is taken orally in a continuous mode for 1 tab. / Day (preferably at the same time of day), regardless of the meal. ; Prevention of postmenopausal osteoporosis should be carried out taking into account the individual tolerance of the drug and the possible impact on bone mass,which are dose dependent.
Side effects
From the nervous system: often - headache, migraine; infrequently - dizziness; very rarely - chorea. On the part of the psyche: infrequently - depression, changes in libido, nervousness.; On the part of the cardiovascular system: very rarely - increased blood pressure, venous thromboembolism, stroke, myocardial infarction.; On the part of the digestive system: often - nausea , pain in the abdomen, flatulence; infrequently - cholecystitis; rarely, liver dysfunction, sometimes in combination with asthenia, malaise and abdominal pain, jaundice (cholestatic); very rarely - vomiting.; From the reproductive system and mammary glands: often - tension / tenderness of the mammary glands, metrorrhagia in the first months of treatment, spotting from the vagina, pain in the lower abdomen; infrequently - a change in the cervical epithelium during cervical erosion, a change in cervical secretion, dysmenorrhea, an increase in the size of leiomyoma, candidiasis of the vagina; rarely - an increase in the mammary glands, premenstrual syndrome; Hereditary disorders: very rarely - clinical manifestations of previously undiagnosed porphyria. From the hematopoietic system: very rarely - hemolytic anemia. From the musculoskeletal system: often - cramps in the muscles of the lower extremities; infrequently - pain in the back (lower back) .; From the immune system: rarely - allergic reactions such as urticaria, skin rash and itching; very rarely - angioedema, hypersensitivity reactions.; Dermatological reactions: very rarely - chloasma and / or melasma that may persist after stopping the drug, erythema multiforme, erythema nodosum, vascular purpura.; From the whole body: often asthenia, increase or decrease in body weight; infrequently - peripheral edema.; Other: rarely - intolerance to contact lenses, increased curvature of the cornea.
Overdose
Estradiol and didrogesteron - substances with low toxicity. No cases of overdose have been registered.; Symptoms: theoretically, in the case of overdose, symptoms such as nausea, vomiting, drowsiness, dizziness may occur; Treatment: conducting symptomatic therapy.
Interaction with other drugs
Estrogenic effect of the drug Femoston; 1/5 conti is reduced when taken simultaneously with microsomal liver enzyme inducer drugs: anticonvulsant (barbiturates, carbamazepine, phenytoin, oxcarbazepine, topiramate, felbamate), antimicrobial drugs (rifampicin, rifabutin, nevirapine, efavirenz, nefiraprene, efavirenz). with herbal preparations containing St. John's wort (Hypericum perforatum); possibly enhancing the estrogenic action of the drug Femoston; 1/5 of the conti when taken concomitantly with drugs that are inhibitors of microsomal liver enzymes (ritonavir, nelfinavir); the interaction of didprogesterone with other drugs is not known.
special instructions
The drug is prescribed in postmenopausal women only if there are symptoms that adversely affect the quality of life: "hot flashes", increased sweating, sleep disturbance, increased nervous irritability, dizziness, headache, involution of the skin and mucous membranes, especially mucous membranes of the urogenital system (dryness and irritation of the vaginal mucosa, pain during intercourse). Therapy should continue as long as the benefits of taking the drug outweigh the risk of side effects, and you should strive to prescribe the minimum therapeutically effective doses of the drug. You should strive to achieve the shortest duration of treatment. Experience in the use of the drug in women over 65 is limited.; Medical examination; Before prescribing or resuming HRT, a full medical and family history should be collected and a general and gynecological examination of the patient should be conducted in order to identify possible contraindications and precautionary measures. During treatment with drug Femoston; 1/5 years, it is recommended to conduct periodic surveys, the frequency and nature of which is determined individually, but not less than 1 time per year, based on the collected history, clinical and laboratory parameters. It is advisable to conduct a study of the mammary glands, incl. mammography. Women should be informed about the possible changes in the mammary glands, which are required to inform the doctor. The use of estrogens can affect the results of the following laboratory tests: determination of glucose tolerance, examination of the thyroid gland and liver.; Endometrial hyperplasia; For the purpose of timely diagnosis appropriate ultrasound screening,if necessary, a histological (cytological) study.; Spotting; In the first months of drug treatment, breakthrough bleeding and / or acyclic menstrual-like bloody discharge from the vagina may occur. If such bleeding occurs some time after the start of therapy or continues after stopping treatment, their cause should be established. It is possible to conduct a biopsy of the endometrium in order to exclude a malignant neoplasm.; Venous thromboembolism; If there is a thromboembolism in the patient's history (including familial), as well as in the case of recurrent miscarriage, a history of hemostasis is necessary. Until a thorough assessment of the factors for the possible development of thromboembolism or the onset of anticoagulant therapy, HRT is not used; the risk of thrombosis of the deep veins of the lower extremities may temporarily increase with prolonged immobilization, extensive injuries or surgical interventions. If necessary, long-term immobilization after surgical interventions should stop HRT for 4-6 weeks. before surgery, the resumption of the drug is possible after the full restoration of the woman's motor activity. If thrombosis develops after initiation of therapy, HRT should be canceled.; You should contact your doctor if any of the symptoms indicate possible thromboembolism (pain or swelling of the lower limbs, sudden chest pain, dyspnea, visual impairment); Breast cancer and ovarian cancer; In women who received long-term HRT, increases the frequency of diagnosis of breast cancer, which returns to the initial level within 5 years after discontinuation of therapy.; Against the background of HRT, an increase in the density of breast tissue during mammography, which can make it difficult to diagnose breast cancer.; There is no increase in the risk of ovarian cancer when using estrogen-progestin drugs for HRT.; Other conditions; Estrogens can cause fluid retention, which can adversely affect the state in patients with impaired cardiac and renal function. In very rare cases, women with triglyceridemia with HRT may experience a significant increase in t plasma blood glucoserides, which contributes to the development of pancreatitis.; Estrogens increase the content of thyroid-binding globulin,which leads to a general increase in the concentration of circulating thyroid hormones (concentrations of free hormones T3 and T4 usually do not change). Levels of other serum binding proteins (corticoid binding globulin, sex hormone binding globulin) may also increase, leading to an increase in the concentration of circulating corticosteroids and sex hormones. Concentrations of free or biologically active hormones do not change. It is possible to increase the concentration of other plasma proteins (substrate angiotensinogen / renin, -l-antitrypsin, ceruloplasmin); the administration of the drug Femoston; 1/5 of the contti should be stopped if contraindications are detected and / or when the following conditions occur: - jaundice and / or abnormal liver function; - A significant increase in blood pressure; - appearance on the background of HRT migraine attack; - in case of recurrence or aggravation of the severity of the above diseases or conditions. Femoston; 1/5 conti is not a contraceptive. The patient should inform the physician about the medications she takes during HRT or before taking the drug Femoston; 1/5 conti.; Influence on ability to drive motor vehicles and control mechanisms; Femoston; 1/5 of the conty does not affect the ability to drive vehicles and machinery.