LEBRETA FILM COATED TABLETS 2.5MG

Страна: Сингапур

Язык: английский

Источник: HSA (Health Sciences Authority)

Активный ингредиент:

Letrozole

Доступна с:

DUOPHARMA (SINGAPORE) PTE LTD

код АТС:

L02BG04

Фармацевтическая форма:

TABLET, FILM COATED

состав:

Letrozole 2.5 mg

Администрация маршрут:

ORAL

Тип рецепта:

Prescription Only

Производитель:

Duopharma HAPI Sdn Bhd

Статус Авторизация:

ACTIVE

Дата Авторизация:

2022-09-12

Характеристики продукта

Lebreta (Letrozole Tablets 2.5mg)
DESCRIPTION AND COMPOSITION:
Letrozole Tablets 2.5mg
Yellow coloured, round shaped tablets debossed with ‘LC’ on one
side and plain on other side.
_Excipients _
Sodium starch glycolate, lactose monohydrate, microcrystalline
cellulose, starch pregelatinized, colloidal silicon dioxide, magnesium
stearate,
Hypromellose, titanium dioxide, iron oxide yellow, macrogol and talc.
PHARMACODYNAMICS:
_Mechanism of action _
The elimination of estrogen-mediated stimulatory effects is a
prerequisite for tumor response in cases where the growth of tumor
tissue depends
on the presence of estrogens. In postmenopausal women, estrogens are
mainly derived from the action of the aromatase enzyme, which converts
adrenal androgens - primarily androstenedione and testosterone - to
estrone (E1) and estradiol (E2). The suppression of estrogen
biosynthesis in
peripheral tissues and the cancer tissue itself can therefore be
achieved by specifically inhibiting the aromatase enzyme.
Letrozole is a non-steroidal aromatase inhibitor. It inhibits the
aromatase enzyme by competitively binding to the hem of the cytochrome
P450
subunit of the enzyme, resulting in a reduction of estrogen
biosynthesis in all tissues.
_Pharmacodynamic effects _
In healthy postmenopausal women, single doses of 0.1 mg, 0.5 mg and
2.5 mg letrozole suppress serum oestrone and oestradiol by 75 to 78 %
and 78 % from baseline, respectively. Maximum suppression is achieved
in 48 to 78 hours.
In postmenopausal patients with advanced breast cancer, daily doses of
0.1 to 5 mg suppress plasma concentration of oestradiol, oestrone, and
oestrone sulphate by 75 to 95 % from baseline in all patients treated.
With doses of 0.5 mg and higher, many values of oestrone and oestrone
sulphate are below the limit of detection in the assays, indicating
that higher oestrogen suppression is achieved with these doses.
Oestrogen
suppression was maintained throughout treatment in all these patients.
Letrozole is highly specific in inhibiting aromatase activity