Estramon (estradiol) 50 transdermal patch 4 mg. №6

Description

Estramon Storage
active substance: estradiol;

1 patch of 20 cm2 with an average rate of estradiol release of 50 μg per day contains estradiol 4 mg;

Excipients: d-a-tocopherol concentrate, acrylate copolymer, Pegoterat substrate.

Estramon Dosage form
The patch is transdermal.

Main physical and chemical properties: ellipsoidal matte colorless patch fixed on a colorless protective film.

Pharmacotherapeutic group
Gonadal hormones and drugs used in pathology of the genital area. ATX code G03C A03.

Pharmacological properties

Pharmacodynamics.

The transdermal system contains estradiol (17ß-estradiol), which is chemically and biologically similar to endogenous human estradiol. Estradiol replaces the loss of estrogen production in menopausal women and relieves menopausal symptoms. Estrogens prevent bone loss after menopause or ovariectomy.

Clinical trial data

Improving the symptoms caused by estrogen deficiency and the effect on bleeding. Relief of menopausal symptoms is achieved during the first weeks of treatment.

Prevention of osteoporosis.

Estrogen deficiency in menopause is accompanied by increased bone metabolism and bone loss.
The effect of estrogen on bone density depends on the dose. Obviously, protection is provided while treatment continues. After completion of HRT (hormone replacement therapy), bone loss is comparable to bone loss in untreated women.
The results of a study by the Women’s Health Initiative (WHI) and meta-analyzes in other studies suggest that current use of HRT, alone or in combination with a progestogen, in predominantly healthy women reduces the risk of fractures of the femur, spine or other osteoporotic fractures. HRT may also prevent fractures in women with low bone density and / or confirmed osteoporosis, however, there is limited information on this.

Estramon Indication
Hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women.

HRT to eliminate the symptoms caused by estrogen deficiency in women in the menopausal period not earlier than 12 months after the last menstrual period.

Prevention of osteoporosis in postmenopausal women at high risk of fractures in case of intolerance or contraindications for the use of other drugs intended for the prevention of osteoporosis.

Experience in the treatment of women over 65 years of age is limited.

Contraindication
Diagnosed, predicted breast cancer or a history of breast cancer;
diagnosed in the past or suspected estrogen-dependent malignancies (eg endometrial cancer);
vaginal bleeding of unknown origin;
untreated endometrial hyperplasia;
existing venous thromboembolism (deep vein thrombosis, thromboembolism legene arteries) or venous thromboembolism in the past;
known thrombophilic disorders (eg deficiency of protein C, protein S or antithrombin, see section “Features”);
arterial thromboembolic diseases currently or in the anamnesis (for example, ischemic heart disease, stroke);
acute liver disease, as well as the presence of liver disease in the past, if liver function tests are not normalized;
known hypersensitivity to the active substances or to any of the components of the drug;
porphyria.