Hormone replacement therapy (HRT) to eliminate symptoms caused by estrogen deficiency in menopausal women no earlier than 6 months after the last menstruation. Prevention of osteoporosis in postmenopausal women with a high risk of fractures. Femoston should only be used in patients who are intolerant or have contraindications for the use of other medications for the prevention of osteoporosis (see the section “Features of use”). Experience in treating women over 65 yEars and Nose of age is limited.
Femoston Conti Composition
active ingredients: 1 tablet contains micronized estradiol hemihydrate, which is equivalent to estradiol 1 mg dydrogesterone micronized 5 mg
excipients: lactose monohydrate, hypromellose (HPMC 2910), corn starch, colloidal silicon dioxide, magnesium stearate
film coating: mixed film coating Orange I (polyethylene glycol 400, hypromellose (HPMC 2910), iron oxide yellow (E172), iron oxide red (E172), titanium dioxide (E 171)).
Femoston Conti Dosage form
Basic physical and chemical properties:
Femoston ContiPharmacological group
Drugs for the treatment of diseases of the genitourinary system and sex hormones. Progestogens in combination with estrogens. Dydrogesterone and estrogen. ATX code G03F A14.
Estrogens prevent bone loss after menopause or oophorectomy.
Dydrogesterone is an orally active progestogen with a comparable effect to parenteral progesterone.
Due to the fact that estrogens stimulate endometrial growth, if progestogen is not used, they increase the risk of endometrial hyperplasia and carcinoma. The addition of progestogen to therapy significantly reduces estrogen-induced risk in women with a preserved uterus.
Clinical trial data
Reducing the symptoms of estrogen deficiency and improving the bleeding profile.
A decrease in menopausal symptoms was observed during the first few weeks of treatment.
Amenorrhea (without bleeding and spotting) was observed in 88% of women within 10-12 months of treatment. Irregular bleeding and / or spotting appeared in 15% of women during the first 3 months of treatment and in 12% – in the 10-12th months of treatment.
Prevention of osteoporosis
Postmenopausal estrogen deficiency is associated with increased bone resorption and decreased bone mass. The effect of estrogen on bone density is dose-dependent. The protective effect of estrogens is effective only during their use. After discontinuation of hormone replacement therapy (HRT), the rate of bone loss is the same as in women who did not receive this therapy.
Data from the WHI (Women Health Initiative) study and a meta-analysis of other studies indicate that the use of HRT in predominantly healthy women in the form of estrogen alone or in combination with progestogen reduces the risk of hip, vertebral and other types of fractures resulting from osteoporosis. HRT may also prevent fractures in women with low bone density and / or diagnosed osteoporosis, but the evidence is limited.
The percentage of women who experienced maintenance or increases in bone density in these three sites of the femur after Femoston Conti treatment were 71%, 66% and 81%, respectively.
Previously diagnosed with present or suspected breast cancer
present or suspected estrogen-sensitive tumors (eg, endometrial cancer)
vaginal bleeding of unknown origin
untreated endometrial hyperplasia
active venous thromboembolism in the past (deep vein thrombosis, pulmonary embolism)
existing thrombophilic disorders (for example, a deficiency of protein C, protein S, or
active or recent arterial thromboembolic disease (eg
angina pectoris, myocardial infarction)
acute liver disease or past history of liver disease in which liver function tests have not returned to normal
known hypersensitivity to active ingredients or to any of the excipients
Interaction with other medicinal products and other types of interactions
Drug interaction studies have not been performed.
The effectiveness of estrogens and progestogens may be impaired.
The metabolism of estrogens (and progestogens) can be enhanced by the simultaneous use of substances with a known ability to induce enzymes involved in drug metabolism. This applies in particular to the P450 enzymes. These include anticonvulsants (phenobarbital, carbamazepine, phenytoin) and antibacterial / antivirals (eg rifampicin, rifabutin, nevirapine, efavirenz)
Although ritonavir and nelfinavir are known to be potent inhibitors, they actually have an inducing effect when used concomitantly with nonsteroidal hormones.
Herbal preparations, which include perforated St. John’s wort (Hypericum perforatum), can also increase the metabolism of estrogens (and progestogens).
Clinically increased metabolism of estrogens and progestogens may result in decreased efficacy and altered bleeding profile.