EXEDRAL 25 FILM-COATED TABLET 25MG

País: Singapur

Idioma: inglés

Fuente: HSA (Health Sciences Authority)

Ingredientes activos:

Exemestane

Disponible desde:

GOLDPLUS UNIVERSAL PTE LTD

Código ATC:

L02BG06

formulario farmacéutico:

TABLET, FILM COATED

Composición:

Exemestane 25.0mg

Vía de administración:

ORAL

tipo de receta:

Prescription Only

Fabricado por:

Remedica Ltd

Estado de Autorización:

ACTIVE

Fecha de autorización:

2022-11-22

Ficha técnica

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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
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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