APO-LETROZOLE letrozole 2.5mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

letrozole, Quantity: 2.5 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Letrozole

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; macrogol 8000; lactose monohydrate; iron oxide yellow; hyprolose; titanium dioxide; sodium starch glycollate; magnesium stearate; hypromellose

Administration route:

Oral

Units in package:

500, 100, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

? Treatment of postmenopausal women with hormone receptor positive early breast cancer (see Clinical Trials). ? The safety and efficacy of neoadjuvant use of letrozole has not been established. Letrozole is not indicated in hormone receptor negative disease.

Product summary:

Visual Identification: Dark yellow, round, biconvex, film coated tablets. Engraved "APO" on one side, "LET" over "2.5" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-01-20

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – APO-LETROZOLE
(LETROZOLE)
1
NAME OF THE MEDICINE
Letrozole
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Letrozole
is
a
white
to
yellowish
powder,
practically
odourless,
freely
soluble
in
dichloromethane, slightly soluble in ethanol, practically insoluble in
water and a melting
range
of
184°C
to
185°C.
The
partition
coefficient
log
P
is
2.5
and
the
pKa
1
(monoprotonated
form)
is
calculated
to
be
approximately
1.6.
According
to
the
Biopharmaceutics Classification Scheme (BCS), Letrozole is a BCS Class
I (high solubility,
high permeability) drug. The highest dose strength (2.5mg) solubility
volume is less than
250mL over a pH range 1 to 7.5.
Each tablet contains 2.5mg of letrozole, as the active ingredient.
In addition, each tablet contains the following inactive ingredients:
lactose monohydrate,
microcrystalline
cellulose,
sodium
starch
glycolate
type
A,
magnesium
stearate,
hypromellose, hyprolose, macrogol 8000, titanium dioxide and iron
oxide yellow.
2.5MG FILM COATED TABLETS:
Dark yellow, round, biconvex, film coated tablets. Engraved “APO”
on one side, “LET” over
“2.5” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of postmenopausal women with hormone receptor positive early
breast cancer
(see SECTION 5.1 PHARMACODYNAMIC PROPERTIES, CLINICAL TRIALS).
•
The safety and efficacy of neoadjuvant use of letrozole has not been
established.
Letrozole is not indicated in hormone receptor negative disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
The recommended dose of letrozole is one 2.5mg tablet daily.
Adjuvant treatment should continue for 5 years or until tumour relapse
occurs, whichever
comes first.
In extended adjuvant treatment, the optimal duration of treatment with
letrozole is not known
as data from studies planned for 5 years. However, at the time of
reported analysis, of the
2
median duration of treatment was 24 months, 25% of patients were
treated for at least three
years and less than