EXEMEST exemestane 25mg tablet blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

exemestane, Quantity: 25 mg

Disponível em:

Accord Healthcare Pty Ltd

DCI (Denominação Comum Internacional):

Exemestane

Forma farmacêutica:

Tablet, film coated

Composição:

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

Via de administração:

Oral

Unidades em pacote:

30 Tablets, 15 Tablets, 90 Tablets

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

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.

Resumo do produto:

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

Status de autorização:

Licence status A

Data de autorização:

2017-02-09

Folheto informativo - Bula

Exemest (Exemestane film-coated tablets 25mg)
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2017
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PRODUCT INFORMATION
EXEMEST
(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.
Exemest are white to off-white, round, biconvex film-
coated tablets debossed with ‘E25’
on one side and plain on the other.
Exemest
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
Exemest (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 inactivation. Such type of i
nactivation 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 body
aromatisation was reduced by 98%.
Exem