Nazione: Indonesia
Lingua: indonesiano
Fonte: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DROSPIRENONE; ETHINYLESTRADIOL
BAYER INDONESIA - Indonesia
DROSPIRENONE; ETHINYLESTRADIOL
3/0.02 MG
TABLET SALUT SELAPUT
DUS, 1 BLISTER @ 28 TABLET SALUT SELAPUT
BAYER WEIMAR GMBH UND CO. KG - GERMANY
2018-03-22
Name of Product/Active ingredient/Dosage form/Version/Date of approval YAZ/Drospirenone 3 mg+Ethinylestradiol 0.02 mg/Film coated tablets/ BEC: 10645-CCDS #18-Shelf life deletion 1 YAZ ® FILM-COATED TABLET Important information, please read carefully! COMPOSITION 24 hormone-containing light pink film-coated tablets: Each film-coated tablet contains 0.020 mg ethinylestradiol (as betadex clathrate), 3 mg drospirenone 4 hormone-free white film - coated tablets. PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES The contraceptive effect of COCs is based on the interaction of various factors, the most important of which are seen as the inhibition of ovulation and the changes in the cervical secretion. As well as protection against pregnancy, COCs have several positive properties which, next to the negative properties (see ‘Warnings’, ‘Undesirable effects’), can be useful in deciding on the method of birth control. The cycle is more regular and the menstruation is often less painful and bleeding is lighter. The latter may result in a decrease in the occurrence of iron deficiency. Drospirenone has antimineralocorticoid activity, counteracting estrogen-related sodium retention. In combination with ethinylestradiol, drospirenone displays a favorable lipid profile with an increase in HDL. Drospirenone exerts antiandrogenic activity. Drospirenone does not counteract the ethinylestradiol-related SHBG (sex hormone binding globulin) increase which is useful for binding and inactivating the endogenous androgens. Drospirenone is devoid of any androgenic, estrogenic, glucocorticoid and antiglucocorticoid activity. This, in combination with the antimineralocorticoid and antiandrogenic properties, gives drospirenone a biochemical and pharmacological profile closely resembling the natural hormone progesterone. Apart from this, there is evidence of a reduced risk of endometrial cancer and ovarian cancer. Furthermore, the higher dosed COCs (0.05 mg ethinylestradiol) have been shown to reduce the incidence of ovarian cysts, Leggi il documento completo