Femostone conti, 28 pcs.

Pharmacodynamics

Estradiol, as part of the drug and identical to endogenous estradiol, replenishes estrogen deficiency in the female body after menopause.

Estradiol provides effective treatment of psycho-emotional and vegetative menopausal symptoms: “hot flashes”, increased sweating, sleep disorders, increased nervous excitability, dizziness, headache, involution of skin and mucous membranes, especially of urogenital system (dryness and irritation of vaginal mucosa, painfulness during sexual intercourse). Hormone replacement therapy (HRT) with Femostone 1/5 prevents loss of bone mass in the postmenopausal period. Risk factors for osteoporosis in postmenopause include early menopause, long-term use of GCS in the recent past, and smoking.

Pemostone 1/5 changes the lipid profile: It lowers total cholesterol, LDL, and increases HDL.

Didrogesterone is a progestagen that is effective when taken orally and brings about the secreting phase in the endometrium. Didrogesterone reduces the risk of endometrial hyperplasia and/or carcinogenesis increased by estrogen. Didrogesterone has no estrogenic, androgenic, anabolic or glucocorticoid activity.

In order to achieve the maximum prophylactic effect ZGT should be started immediately after the onset of menopause. The effect is evident for the duration of treatment (information on the use of estrogen for more than 10 years is limited).

Pharmacokinetics

Micronized estradiol is easily absorbed after oral administration. It is metabolized in the liver to estrone and estrone sulfate, which also undergoes hepatic biotransformation. Glucuronides of estrone and estradiol are excreted mainly with the urine.

Dydrogesterone is rapidly absorbed from the gastrointestinal tract after oral administration. It is completely metabolized, the main metabolite being 20-dihydrodihydrogesterone (DDH), present mainly as a glucuronic acid conjugate in the urine. T_1/2 is 5-7 hours, DHD is 14-17 hours. Complete excretion occurs after 72 hours.

Indications

Climax, Osteoporosis

• Hormone replacement therapy for disorders due to estrogen deficiency in postmenopausal women (not earlier than 12 months after the last menstruation);
• prevention of osteoporosis in postmenopausal women at high risk of fractures with intolerance or contraindications to the use of other drugs

Active ingredient

Dydrogesterone, Estradiol

Composition

1 tablet contains:

acting ingredients:

estradiol 1 mg,

didrogesterone 5 mg;

excipients:

lactose monohydrate,

methylhydroxypropylcellulose,

corn starch,

silicon dioxide colloidal anhydrous,

magnesium stearate,

macrogol 400,

titanium dioxide (E171),

iron oxide yellow and red (E172),

Opadry orange (Y-8734).

How to take, the dosage

For the purpose of MHT and prevention of osteoporosis: orally in a continuous regime on 1 tablet a day (preferably at the same time of the day) irrespective of meal. Duration of therapy is determined by the ratio of benefits to risks for a woman’s health and the degree of severity of estrogen deficiency.

Postmenopausal osteoporosis prophylaxis should be based on individual tolerance of the drug and possible effects on bone mass which are dose-dependent.

Interaction

The estrogenic effect of Femostone is reduced when concomitantly administered with drugs that are inducers of microsomal liver enzymes: anticonvulsants (barbiturates, phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate), antimicrobials (rifampicin, rifabutin, nevirapine,efavirenz); with herbal drugs containing Hypericum perforatum (Hypericum perforatum).

The estrogenic effect of the drug Femoston may be enhanced with concomitant use of drugs that inhibit microsomal liver enzymes (ritonavir, nelfinavir). Interactions of didrogesterone with other drugs are not known.

The patient should inform her physician of any medications she is taking at the time of ZGT or was taking prior to the prescription of Femostone.

Special Instructions

Before prescribing or renewing ZGT, a complete medical and family history should be taken, and a general and gynecologic exam should be performed to identify possible contraindications and conditions that require necessary precautions to be taken. During treatment with Femostone^® 1/5 women are recommended to be examined periodically (frequency and nature of examinations are determined individually).

Breast examinations and/or mammograms are performed according to accepted norms, taking into account clinical indications.

Femostone 1/5 is prescribed for women who have been in the postmenopause for at least 1 year.

Femostone 1/5 should be started at the end of the estrogen-progestogen phase without interruption of the pills when switching from another estrogen-progestogen drug for MHT.

The use of estrogens can affect the results of the following laboratory tests: glucose tolerance test, thyroid and liver function tests.

Patients receiving HRT who have the following conditions (current or past) should be closely monitored by a physician: uterine leiomyoma, endometriosis, history of thrombosis or their risk factors, arterial hypertension, renal dysfunction, diabetes mellitus with vascular complications, bronchial asthma, porphyria, hemoglobinopathy, cholelithiasis, epilepsy, otosclerosis, multiple sclerosis, migraine or intense headache.

Publicly recognized risk factors for thrombosis and thromboembolism on ZGT are a history of thromboembolic complications, severe obesity (body mass index over 30 kg/m ²) and systemic lupus erythematosus. There is no generally accepted opinion about the role of varicose veins in the development of thromboembolisms.

The risk of developing deep vein thrombosis of the lower extremities may temporarily increase with prolonged immobilization, extensive trauma or surgery. If prolonged immobilization is necessary after surgery, consideration should be given to temporarily discontinuing MHT 4 to 6 weeks before surgery.

The benefits and risks of MHT in patients with recurrent deep vein thrombosis or thromboembolism treated with anticoagulants should be carefully evaluated when deciding whether to stop MHT.

If thrombosis develops after initiation of ZGT, Femostone1/5 should be discontinued. Patients should be advised to consult a physician if they experience the following symptoms: painful swelling of the lower extremities, sudden loss of consciousness, dyspnea, visual disturbances.

There is evidence showing a slight increase in the rate of detection of breast cancer in women who have received long-term (more than 10 years) hormone replacement therapy. The detection of breast cancer may be related to early diagnosis, to the biological effects of hormone replacement therapy, or to a combination of both. The likelihood of being diagnosed with breast cancer increases with the duration of treatment and returns to normal 5 years after discontinuing MHT.

Patients who were previously on estrogen-only ZGT should be particularly closely monitored before starting Femostone^® 1/5 for possible endometrial hyperstimulation.

In the first months of treatment with Femostone, breakthrough uterine bleeding and menstrual-like bleeding may occur. If, despite dosage adjustment, such bleeding does not stop, the drug should be stopped until the cause of bleeding is determined. If bleeding recurs after a period of amenorrhea or continues after treatment withdrawal, its etiology should be established. This may require an endometrial biopsy.

Femostone 1/5 is not a contraceptive. Non-hormonal contraceptives are recommended for perimenopausal patients.

The effect on the ability to drive or operate machinery is unknown.

Synopsis

Orange-pink film-coated tablets, round, biconvex, engraved “379” on one side of the tablet.

Contraindications

• pregnancy and breastfeeding;
• diagnosed or suspected breast cancer;
• diagnosed or suspected progestagen-dependent neoplasms (e.g., meningioma);
• vaginal bleeding of unclear etiology;
• untreated endometrial hyperplasia;
• thrombosis (arterial and venous) and thromboembolism, current or anamnesis (including thrombosis, deep vein thrombosis; pulmonary embolism, myocardial infarction, ischemic or hemorrhagic cerebrovascular disorders);
• Multiple or pronounced factors of arterial or venous thrombosis associated with congenital or acquired predisposition, such as protein C deficiency, protein S deficiency, antithrombin III deficiency, presence of antibodies to phospholipids (cardiolipin antibodies, lupus anticoagulant antibodies), angina pectoris, prolonged immobilization, severe forms of obesity (body mass index greater than 30 kg/m2), diseases of cerebral or coronary arteries, transient ischemic attacks, complicated valvular heart disease, atrial fibrillation;
• acute or chronic liver disease at present or in the anamnesis (until normalization of liver function tests), including malignant liver tumors;
• porphyria;
• high sensitivity to the components of the drug;
• Galactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.

Phemostone® therapy should be discontinued if contraindications are identified and/or if the following conditions occur: jaundice and/or liver dysfunction; uncontrolled arterial hypertension; migraine-like headache first observed during the use of ZGT drugs.

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Side effects

• Headache, migraine, dizziness;
• depression, nervousness;
• stomach pain, nausea, vomiting, flatulence;
• back (lower back) pain;
• allergic reactions such as hives, skin rashes and itching;
asthenic conditions (weakness, malaise, fatigue), peripheral edema;
• increased body weight.

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Overdose

There have been no reports of overdose symptoms so far.

Symptoms: there may be an increase in the side effects of the drug.

Treatment: symptomatic, no specific antidote.

Pregnancy use

The drug is contraindicated in pregnancy and during breastfeeding. If pregnancy occurs during treatment with Femostone® therapy should be stopped immediately.

Similarities

Femoston 1/10, Femoston 2/10, Femoston mini