资料单张
FONAT
_contains the active ingredient alendronic acid_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Fonat.
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 benefits and
risks. Your doctor has weighed the
risks of you taking Fonat against the
benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT FONAT IS USED FOR
Fonat 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.
_HOW DOES FONAT WORK?_
Fonat belongs to a group of non-
hormonal medicines called
bisphosphonates.
In osteoporosis, Fonat works by
slowing down the process of old
bone being removed, which allows
the bone-forming cells time to
rebuild normal bone. Fonat not only
helps prevent the loss of bone but
actually helps to rebuild bone and
makes bone less likely to fracture.
Thus, Fonat prevents or reverses the
progression of osteoporosis.
Fonat starts working on the bone
cells immediately, but measurable
effects on bone mass may not be seen
for several months or more.
_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 c
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产品特点
FONAT
_Alendronic acid _
PRODUCT INFORMATION
NAME OF THE MEDICINE
Active ingredient:
Alendronate sodium
Chemical name:
(4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate
Structural formula:
Empirical formula:
C
4
H
12
NNaO
7
P
2
•3H
2
O
Molecular weight:
325.13
CAS Registry no:
121268-17-5
DESCRIPTION
Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Fonat
contains alendronate sodium which is a bisphosphonate that acts as a potent, specific inhibitor of osteoclast-
mediated bone resorption.
Alendronate is a white, crystalline, non-hygroscopic powder. It is soluble in water, very slightly soluble in
alcohol, and practically insoluble in chloroform.
Each tablet of Fonat contains 91.37 mg of alendronate sodium, which is the molar equivalent to 70 mg of
alendronic acid.
In addition to the active ingredient alendronate sodium, each Fonat tablet contains the following inactive
ingredients: lactose monohydrate, microcrystalline cellulose, povidone (K29-32), croscarmellose sodium and
magnesium stearate.
PHARMACOLOGY
PHARMACODYNAMIC
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 alendro
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