Alendronate-GA

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Alendronate sodium

Available from:

Actavis Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

Alendronate-GA CMI v4 100501 

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_ _
_ALENDRONATE-GA _
_70 mg Once Weekly _
_Alendronate sodium_

Consumer Medicine Information 

WHAT IS IN THIS LEAFLET 
This leaflet answers some common 
questions about _ALENDRONATE-_
_GA_. 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 
_ALENDRONATE-GA_ 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-GA_ 
IS USED FOR 
_ALENDRONATE-GA_ is used to 
treat osteoporosis.It is also used to 
treat or prevent osteoporosis in 
people who are receiving 
corticosteroid medicines, such as 
prednisone and dexamethasone. 
In addition, _ALENDRONATE-GA_ is 
used to prevent osteoporosis in 
postmenopausal women who have 
low bone mass. 
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 replaced. In women, after 
menopause, hormonal changes 
cause bone loss at a

Summary of Product characteristics

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ALENDRONATE-GA 
 (ALENDRONATE 70 MG TABLETS) 

NAME OF THE MEDICINE 

Alendronate sodium 

_CAS Number_:_ _129318-43-0. 

DESCRIPTION 

ALENDRONATE-GA tablets contain alendronate
sodium anhydrous, which is described chemically 
as: (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt.
The molecular formula of 
Alendronate sodium anhydrous is C
4
H
12
NO
7
P
2
Na and molecular weight is 271.1. Alendronate 
sodium anhydrous is a
white or almost white, crystalline, nonhygroscopic powder. It
is soluble in 
water, very slightly soluble
in alcohol, and practically insoluble in
chloroform. Bisphosphonates are 
synthetic analogs of pyrophosphate that bind to the
hydroxyapatite found in bone. Alendronate is a 
bisphosphonate that acts as a potent,
specific inhibitor of osteoclast-mediated bone resorption.  

STRUCTURAL FORMULA OF ALENDRONATE  

Each tablet of ALENDRONATE-GA
contains 76.188 mg of alendronate sodium anhydrous, which 
is the molar equivalent to 70 mg of alendronic acid. 

ALENDRONATE-GA tablets contain the
following inactive ingredients: Mannitol, Croscarmellose 
Sodium, Magnesium stearate, Purified Talc, Colloidal Anhydrous
Silica. 

PHARMACOLOGY 

•  PHARMACODYNAMIC PROPERTIES 

Alendronate is a bisphosphonate that, in animal studies,
localizes preferentially to sites of bone 
resorption, specifically under osteoclasts, and inhibits
osteoclastic bone resorption with no direct 
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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. Following 
exposure to alendronate, normal bone
is formed that incorporates alendronate into its matrix where 
it is pharmacologically i