Ország: Szingapúr
Nyelv: angol
Forrás: HSA (Health Sciences Authority)
Exemestane
GOLDPLUS UNIVERSAL PTE LTD
L02BG06
TABLET, FILM COATED
Exemestane 25.0mg
ORAL
Prescription Only
Remedica Ltd
ACTIVE
2022-11-22
sg-pi-exedral-fc-tabs-a4 Page 1 of 13 PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCT Exedral 25, 25 mg film-coated tablets 2. NAME AND STRENGTH OF THE ACTIVE SUBSTANCE Each film coated tablet contains 25 mg exemestane. 3. DESCRIPTION OF THE PRODUCT Film-coated tablet. White, round biconvex film-coated tablets. List of excipients: _Tablet Core: _ Silica, colloidal anhydrous Crospovidone Hypromellose 5cP Magnesium stearate Mannitol Microcrystalline cellulose Polysorbate 80 Sodium starch glycolate (Type A) _Film-coating: _ Hypromellose 5cP Macrogol Talc Titanium dioxide (E171) 4. PHARMACODYNAMICS / PHARMACOKINETICS PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: Enzyme therapy; Hormone antagonists and related agents, ATC code: L02BG06 Mechanism of action Exemestane is an irreversible, steroidal aromatase inhibitor, structurally related to the natural substrate androstenedione. In post-menopausal women, oestrogens are produced primarily from the conversion of androgens into oestrogens through the aromatase enzyme in peripheral tissues. Oestrogen deprivation through aromatase inhibition is an effective and selective treatment for hormone dependent breast cancer in postmenopausal women. In postmenopausal sg-pi-exedral-fc-tabs-a4 Page 2 of 13 women, exemestane p.o. significantly lowered serum oestrogen concentrations starting from a 5 mg dose, reaching maximal suppression (>90%) with a dose of 10-25 mg. In postmenopausal breast cancer patients treated with the 25 mg daily dose, whole body aromatization was reduced by 98%. Exemestane does not possess any progestogenic or oestrogenic activity. A slight androgenic activity, probably due to the 17-hydro derivative, has been observed mainly at high doses. In multiple daily doses trials, exemestane had no detectable effects on adrenal biosynthesis of cortisol or aldosterone, measured before or after ACTH challenge, thus demonstrating its selectivity with regard to the other enzymes involved in the steroidogenic pathway. Glucocorticoid or mineralocorticoid replacements Olvassa el a teljes dokumentumot