YAZ

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

DROSPIRENONE; ETHINYLESTRADIOL

Tersedia dari:

BAYER INDONESIA - Indonesia

INN (Nama Internasional):

DROSPIRENONE; ETHINYLESTRADIOL

Dosis:

3/0.02 MG

Bentuk farmasi:

TABLET SALUT SELAPUT

Unit dalam paket:

DUS, 1 BLISTER @ 28 TABLET SALUT SELAPUT

Diproduksi oleh:

BAYER WEIMAR GMBH UND CO. KG - GERMANY

Tanggal Otorisasi:

2018-03-22

Karakteristik produk

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,