EXEMESTANE INTAS exemestane 25mg tablet blister pack

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

exemestane, Quantity: 25 mg

Sẵn có từ:

Accord Healthcare Pty Ltd

INN (Tên quốc tế):

Exemestane

Dạng dược phẩm:

Tablet, film coated

Thành phần:

Excipient Ingredients: colloidal anhydrous silica; sodium starch glycollate type A; hypromellose; mannitol; microcrystalline cellulose; magnesium stearate; crospovidone; polysorbate 80; titanium dioxide; macrogol 400

Tuyến hành chính:

Oral

Các đơn vị trong gói:

30 Tablets, 15 Tablets, 90 Tablets

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

Exemestane is indicated for the sequential adjuvant treatment of oestrogen receptor-positive early breast cancer in post-menopausal women who have received prior adjuvant tamoxifen therapy. . Exemestane is indicated for the treatment of oestrogen receptor-positive advanced breast cancer in women with natural or induced postmenopausal status whose disease has progressed following anti-oestrogen therapy.

Tóm tắt sản phẩm:

Visual Identification: White to off-white, round, biconvex film-coated tablets debossed with 'E25' on one side and plain on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius

Tình trạng ủy quyền:

Licence status A

Ngày ủy quyền:

2017-02-09

Đặc tính sản phẩm

Exemestane Intas (Exemestane film-coated tablets 25mg)
Version: 1.1
2017
Page: 1 of 14
PRODUCT INFORMATION
EXEMESTANE INTAS
(EXEMESTANE FILM-COATED TABLETS 25 MG)
NAME OF THE MEDICINE
exemestane
Structural formula:
Chemical name: 6-methylenandrosta-1,4-diene-3,17-dione.
CAS number: CAS-107868-30-4
Exemestane has a molecular formula of C
20
H
24
O
2
and a molecular weight of 296.4.
DESCRIPTION
Exemestane is a white or yellowish-white powder, which is freely
soluble in N,N-
dimethylformamide, soluble in methanol and practically insoluble in
water. Due to the
very low solubility in water, the medicine is micronised.
Exemestane Intas are white to off-white, round, biconvex film-coated
tablets debossed
with ‘E25’ on one side and plain on the other.
Exemestane Intas tablets contain the following excipients:
Mannitol, Microcrystalline
cellulose, Crospovidone,
Sodium starch glycollate (Type A), Hypromellose, Polysorbate
80,
Colloidal anhydrous silica, Magnesium stearate and Opadry Complete
Film Coating
System 03B58900 White (Ingredient ID: 106176).
PHARMACOLOGY
PHARMACODYNAMICS
Exemestane is an irreversible, steroidal aromatase inactivator,
structurally related to the
natural substrate androstenedione. In post-menopausal women,
oestrogens are produced
Exemestane Intas (Exemestane film-coated tablets 25mg)
Version: 1.1
2017
Page: 2 of 14
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. Exemestane acts by binding irreversibly to the active site of
the enzyme causing
its i
nactivation. Such type of inactivation is also known as “suicidal
inhibition”. In
postmenopausal
women,
exemestane
significantly
lowered
serum
oestrogen
concentrations starting from a 5 mg dose, reaching maximal suppression
(80-90%) with a
dose of 10-25 mg.
In postmenopausal breast cancer patients treated with the 25 mg daily
dose, whole