Chemmart Alendronate

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

Alendronate sodium

Доступна з:

Apotex Pty Ltd

Клас:

Medicine Registered

інформаційний буклет

CHEMMART ALENDRONATE
ONCE WEEKLY

_Contains the active ingredient, alendronate (as alendronate sodium)_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
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 answers some common
questions about alendronate. It does
not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
your medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Chemmart Alendronate Once
Weekly. It contains the active
ingredient, alendronate (as
alendronate sodium).
It is used to treat osteoporosis.
_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 20's, 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 we

Характеристики продукта

Product Information – Australia 
Chemmart Alendronate Once Weekly Tablets 
Page 1 
CHEMMART ALENDRONATE 

NAME OF THE MEDICINE 
Alendronate sodium. 

Chemical Name: 
(4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.  

Structural Formula: 

Alendronate sodium trihydrate 

Molecular Formula:  
C
4
H
12
NNa0
7
P
2
 3H
2
O 

Molecular Weight:  
325.12 

CAS Registry Number:   121268-17-5 

DESCRIPTION 
Alendronate is a white crystalline nonhygroscopic powder. It is soluble in water, very slightly soluble 
in alcohol and practically insoluble in chloroform. 

Bisphosphonates are synthetic analogues of pyrophosphate that bind to the hydroxyapatite found in 
bone. Alendronate (alendronate sodium) is a bisphosphonate that acts as a potent, specific inhibitor 
of osteoclast mediated bone resorption. 

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 CLINICAL TRIALS). 
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 anti-resorptive
dose. The corresponding safety margin for 
etidronate was one to one. These data indicate