ALENDRONATE AN alendronic acid (as sodium alendronate) 70mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

alendronate sodium

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

alendronate sodium

Authorization status:

Registered

Patient Information leaflet

_Alendronate AN tablets – Consumer Medicine Information _
_Doc ID: 37.AN.2.0 _
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_Page 1 _
ALENDRONATE AN
_alendronate (as sodium) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
ALENDRONATE
AN.
It
is
particularly
important
that
you
read the sections “When to take
it” and “How to take it” before you
take
this
medicine.
This
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
ALENDRONATE AN 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
ALENDRONATE
AN
IS USED FOR
ALENDRONATE AN is used to
treat osteoporosis.
This
condition
is
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 replaced. In
women,
after
menopause,
hormonal
changes
cause
bone
loss at an even faster rate. When
bone
loss
is
excessive,
bones
can become thinner and weaker,
and therefore are more likely to
break.
_OSTEOPOROSIS _
“Osteo”
means
bone,
and
“porosis” means something that
has holes in it, like a sponge.
Therefore,
osteoporosis
is
a
disease which causes bones to
become more porous, gradually
making them weaker, more brittle
and likely to break.
Osteoporosis
is
common
in
postmenopausal
women.
The
menopause
occurs
when
the
ovaries
virtually
stop

Summary of Product characteristics

_Alendronate AN tablets Product Information _
_ _
_ _
_ Amneal PharmaAustra.liaPty Ltd _
Doc ID: 37.AN.P.2.0
Page 1
ALENDRONATE AN
_ _
_(ALENDRONATE SODIUM TABLETS) _
_ _
PRODUCT INFORMATION
_ _
NAME OF THE MEDICINE
The name of the medicine is alendronic acid as alendronate sodium.
H
2
N
OH
P
O
O NA
OH
P
OH
OH
O
. 3H
2
O
CHEMICAL NAME: (4-amino-1-hydroxybutylidene)-bisphosphonic acid
monosodium salt,
trihydrate
MOLECULAR FORMULA: C
4
H
12
NNaO
7
P
2
. 3H
2
O
MOLECULAR WEIGHT: 325.1
CAS REGISTRY NUMBER: _[121268-17-5]_
DESCRIPTION
Sodium alendronate is a white or almost white, crystalline powder. It
is sparingly soluble in
water, practically insoluble in methanol and methylene chloride.
INACTIVE: Microcrystalline cellulose , maize starch, sodium starch
glycollate type A, Povidone &
magnesium stearate.
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Alendronate is a bisphosphonate that, in animal studies, localises
preferentially to sites of bone
resorption, specifically under osteoclasts, and inhibits osteoclastic
bone resorption with no direct
effect on bone formation. Since bone formation and bone resorption are
coupled, bone formation
is also reduced, but less so than resorption, leading to progressive
gains in bone mass (see
_Alendronate AN tablets Product Information _
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_ Amneal PharmaAustra.liaPty Ltd _
Doc ID: 37.AN.P.2.0
Page 2
Clinical Trials section for details). Following exposure to
alendronate, normal bone is formed that
incorporates alendronate into its matrix where it is pharmacologically
inactive.
The relative inhibitory activities on bone resorption and
mineralisation of alendronate and
etidronate were compared in growing rats. The lowest dose of
alendronate that interfered with
bone
mineralisation
(leading
to
osteomalacia)
was
6000-fold
the
antiresorptive
dose.
The
corresponding safety margin for etidronate was one to one. These data
indicate that, unlike
etidronate,
alendronate
administered
in
therapeutic
doses
is
highly
unlikely
to
induce
osteomalacia.
OSTEOPOROSIS
WHO utilises the definition of