Ülke: Güney Afrika
Dil: İngilizce
Kaynak: South African Health Products Regulatory Authority (SAHPRA)
Donmed
SYNAPAUSE-E3® 2 mg (tablets) RU M 1720.061.013 SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): SYNAPAUSE-E3 ® 2 mg (tablets) COMPOSITION Each tablet contains 2 mg estriol PHARMACOLOGICAL CLASSIFICATION A/21.8/Female sex hormones PHARMACOLOGICAL ACTION Synapause-E3 2-mg tablets contain the natural female hormone estriol. Estriol induces the normalization of the vaginal epithelium and thus helps to restore the normal microflora and the physiological pH in the vagina. As a result, it increases the resistance of the vaginal epithelial cells to infection and inflammation. Estriol is short acting since it has only a short retention time in the nuclei of endometrial cells. Therefore, the risk for endometrial proliferation is low when the total recommended daily dose is taken at one time. Pharmacokinetics After oral administration estriol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma levels of unconjugated estriol are reached within 1 hour of administration. Nearly all (90%) estriol is bound to albumin in the plasma and estriol is hardly bound to sex hormone-binding globulin. The metabolism of estriol consists mainly of conjugation and deconjugation during enterohepatic circulation. Estriol, a metabolic end product, is mainly excreted via the urine in the conjugated form. Only a small fraction (± 2%) is excreted via the faeces, mainly as unconjugated estriol. INDICATIONS - Atrophy of the lower urogenital tract related to estrogen deficiency. - Pre- and postoperative therapy in postmenopausal women undergoing vaginal surgery. - Climacteric complaints such as hot flushes and night sweating. - diagnostic aid in case of a doubtful atrophic cervical smear. - Infertility due to cervical hostility. CONTRA-INDICATIONS - Pr Belgenin tamamını okuyun