PHARMACOR ALENDRONATE 10 alendronic acid (as alendronate sodium) 10 mg tablet blister pack

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

alendronate sodium

Boleh didapati daripada:

Accord Healthcare Pty Ltd

INN (Nama Antarabangsa):

alendronate sodium

Status kebenaran:

Registered

Risalah maklumat

PHARMACOR ALENDRONATE 10 CONSUMER MEDICINE INFORMATION
VERSION 1.0
2010 - 1 -
PHARMACOR ALENDRONATE 10
ALENDRONATE SODIUM TABLETS 10 MG
CONSUMER MEDICINE INFORMATION (CMI)
_WHAT IS IN THIS LEAFLET _
This
leaflet
answers
some
common
questions
about
PHARMACOR ALENDRONATE.
It
is
particularly
important
that
you read the sections “When to
take
it”
and
“How
to
take
it”
before
you
take
this
medicine.
The leaflet does not contain all
the available information. It does
not take the place of talking to
your doctor or pharmacist.
All
medicines
have
risks
and
benefits.
Your
doctor
has
weighed the risks of you taking
PHARMACOR
ALENDRONATE
against the benefits they expect it
will have for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT TAKING THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again
.
_WHAT IS PHARMACOR _
_ALENDRONATE USED _
_FOR _
PHARMACOR
ALENDRONATE
is used to treat osteoporosis.
It
is
also
used
to
treat
and
prevent
osteoporosis
in
post
menopausal
women
who
are
receiving
corticosteroid
medicines,
such
as
prednisone
and dexamethasone, if they are
not receiving oestrogen.
In
addition,
PHARMACOR
ALENDRONATE is also indicated
for prevention of

Osteoporosis
in
post
menopausal women with low
bone
mass
(at
least
1
standard deviation below the
mean for young adults) not
receiving oestrogen.

Glucocorticoid-
induced
osteoporosis
in
those
patients
on
long
term
corticosteroid therapy
These conditions are caused by
changes
in
the
way
bone
is
normally maintained.
_UNDERSTANDING BONE _
Bone is living, growing tissue.
Throughout life, our bodies are
breaking
down
old
bone
and
rebuilding
new
bone
in
a
continuous cycle. Until our late
20s,
while
bones
are
still
developing,
we
gain
bone
by
building more than we lose. From
then
until
about
age
35
the
process is usually in balance, so
that the amount of bone lost is
about equal to the amount that is
replaced. After about age 35 this
balance is disturbed, with bone
loss occurring at a slightly faster
rate than it can be

Ciri produk

PRODUCT INFORMATION:
PHARMACOR ALENDRONATE 10 (Alendronate Sodium Tablets 10 mg) Ver.1.0
2010 - 1 -
PRODUCT INFORMATION
PHARMACOR ALENDRONATE 10
(ALENDRONATE SODIUM TABLETS 10MG )
NAME OF THE MEDICINE
Alendronate Sodium
Chemical name: (4-amino-1-hydroxybutylidene) bisphosphonic acid
monosodium salt
trihydrate.
Molecular formula: C
4
H
12
NNaO
7
P
2
•3H
2
O,
The molecular weight is 325.12
CAS Registry Number is: 121268-17-5
The structural formula is
DESCRIPTION
Alendronate sodium, is a bisphosphonate that acts as a potent,
specific inhibitor of
osteoclast-mediated
bone
resorption.
Bisphosphonates
are
synthetic
analogs
of
pyrophosphate that bind to the hydroxyapatite found in bone.
Alendronate is a white,
crystalline, nonhygroscopic powder. It is soluble in water, very
slightly soluble in
alcohol, and practically insoluble in chloroform.
PHARMACOR ALENDRONATE (Alendronate Sodium) is available as 10 mg oral
uncoated tablets. Each tablet of PHARMACOR ALENDRONATE 10 contains
13.05
mg of alendronate sodium, which is the molar equivalent to 10 mg of
alendronic acid.
In
addition
to
the
active
ingredient
alendronate
sodium,
each
PHARMACOR
ALENDRONATE 10 mg tablet contains the following inactive ingredients:
Cellulose-
microcrystalline,
lactose
anhydrous,
croscarmellose
sodium
and
magnesium
stearate.
PRODUCT INFORMATION:
PHARMACOR ALENDRONATE 10 (Alendronate Sodium Tablets 10 mg) Ver.1.0
2010 - 2 -
PHARMACOLOGY
PHARMACOKINETIC PROPERTIES
Absorption
Relative to an intravenous (IV) reference dose, the mean oral
bioavailability of
alendronate
in
women
was
0.64%
for
doses
ranging
from
5
to
70
mg
when
administered after an overnight fast and two hours before a
standardised breakfast.
There was substantial variability both within and between patients,
coefficient of
variation 63% and 77%, respectively. Oral bioavailability in men
(0.6%) was similar to
that in women.
Bioavailability was decreased similarly (by approximately 40%) whether
alendronate
was
administered
one
or
one-half
hour
before
a
standardised
breakfast.
In
osteop