ANASTROZOLE ACCORD anastrozole 1 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

anastrozole, Quantity: 1 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Anastrozole

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; povidone; magnesium stearate; sodium starch glycollate type A; hypromellose; titanium dioxide; macrogol 300

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Early breast cancer: . Adjuvant treatment of early breast cancer in postmenopausal women with oestrogen/progesterone-receptor-positive disease. . Advanced breast cancer :. First line treatment of advanced breast cancer in postmenopausal women with oestrogen/progesterone-receptor-positive disease. . Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with oestrogen-receptor-negative disease and patients who have not responded to previous tamoxifen therapy rarely respond to anastrozole.

Product summary:

Visual Identification: White to off white, round, biconvex, film-coated tablet debossed with "AHI" on one side and plain on other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-12-23

Summary of Product characteristics

Anastrozole Accord Version: 1.0
Page: 1 of 16
PRODUCT INFORMATION
ANASTROZOLE ACCORD
(ANASTROZOLE TABLETS 1 MG)
NAME OF THE MEDICINE
Anastrozole
Chemical name: α,α,α’,α’-Tetramethyl-5-(1
_H_
-1,2,4-triazol-1-ylmethyl)-
_m_
-
benzenediacetonitrile
Structural formula:
CAS number: 120511-73-1.
Molecular formula: C
17
H
19
N
5
Molecular weight: 293.4
DESCRIPTION
Anastrozole is a fine white to off-white powder. Anastrozole has very
slight aqueous
solubility (0.53 mg/mL at 25°C) which is dependent on pH from pH 1 to
4 but
independent of pH thereafter.
Solubility of anastrozole is independent of pH in the physiological
range. Anastrozole is
freely soluble in methanol, acetone, ethanol and tetrahydrofuran and
very soluble in
acetonitrile. It is also very soluble in chloroform and
dimethylformamide, freely soluble
in benzene and ethyl acetate and soluble in isopropyl alcohol and
toluene.
Anastrozole Accord tablets are white to off white, round, biconvex,
film-coated tablets
with “AHI” debossing on one side and plain on other side
containing 1 mg anastrozole
and includes the following excipients: lactose, povidone, sodium
starch glycollate type A,
magnesium stearate, hypromellose, macrogol 300 and titanium dioxide.
Anastrozole Accord Version: 1.0
Page: 2 of 16
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Anastrozole
is
a
potent
and
highly
selective
non-steroidal
aromatase
inhibitor.
It
significantly lowers serum oestradiol concentrations and has no
detectable effect on
formation of adrenal corticosteroids or aldosterone.
Many breast cancers have oestrogen receptors and growth of these
tumours can be
stimulated by oestrogen. In postmenopausal women, oestradiol is
produced primarily
from the conversion of androstenedione to oestrone through the
aromatase enzyme
complex in peripheral tissues. Oestrone is subsequently converted to
oestradiol. Many
breast cancers also contain aromatase; the importance of
tumour-generated oestrogens is
uncertain.
Reducing circulating oestradiol levels has been shown to produce a
benefici