Riik: Indoneesia
keel: indoneesia
Allikas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 1 BOTOL PLASTIK @ 120 TABLET
2023-01-31
1 PRODUCT NAME ZYTIGA® (abiraterone acetate) DOSAGE FORMS AND STRENGTHS 250 mg uncoated Tablet ZYTIGA uncoated tablets contain 250 mg of abiraterone acetate White to off-white, oval tablets, debossed with AA250 on one side. 500 mg film-coated tablets ZYTIGA film-coated tablets contain 500 mg of abiraterone acetate Purple, oval-shaped, film-coated tablets, debossed with “AA” on one side and “500” on the other. For excipients, see _Pharmaceutical Information_ - List of Excipients. PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES PHARMACOTHERAPEUTIC GROUP: Other hormone antagonists and related agents, ATC CODE: L02BX03 _ _ _MECHANISM OF ACTION _ Abiraterone acetate (ZYTIGA) is converted _ in vivo_ to abiraterone, an androgen biosynthesis inhibitor. Specifically, abiraterone selectively inhibits the enzyme 17α-hydroxylase/C17,20-lyase (CYP17). This enzyme is expressed in and is required for androgen biosynthesis in testicular, adrenal and prostatic tumor tissues. It catalyzes the conversion of pregnenolone and progesterone into testosterone precursors, DHEA and androstenedione, respectively, by 17α hydroxylation and cleavage of the C17,20 bond. CYP17 inhibition also results in increased mineralocorticoid production by the adrenals (see _Warnings _ _and _ _Precautions _ _- _ _Hypertension, _ _hypokalemia _ _and _ _fluid _ _retention _ _due _ _to _ _mineralocorticoid excess_). Androgen-sensitive prostatic carcinoma responds to treatment that decreases androgen levels. Androgen deprivation therapies, such as treatment with LHRH agonists or orchiectomy, decrease androgen production in the testes but do not affect androgen production by the adrenals or in the tumor. Treatment with ZYTIGA decreases serum testosterone to undetectable levels (using commercial assays) when given with LHRH agonists (or orchiectomy). _PHARMACODYNAMIC EFFECTS _ ZYTIGA decreases serum testosterone and other androgens to levels lower than those achieved by the use of LHRH agonists alone or by orchiectomy. This results from the sele Lugege kogu dokumenti