DENSATE 70 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:

Pharmacor Pty Ltd

INN (International Name):

alendronate sodium

Authorization status:

Registered

Patient Information leaflet

DENSATE 70
CONSUMER MEDICINE INFORMATION
Ver 1.0
Page 1 of 4
DENSATE 70
Alendronate (as alendronate sodium)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions
about
DENSATE.
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 DENSATE
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
DENSATE
IS
USED
FOR
DENSATE
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 producing the female
hormone, oestrogen, or are removed

Summary of Product characteristics

Product Information:
DENSATE (Alendronic Acid Tablets 70 mg)
Ver 1.1
Page 1 of 17
PRODUCT INFORMATION
DENSATE 70
(70 MG ALENDRONIC ACID AS ALENDRONATE SODIUM)
NAME OF 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
CHEMICALNAME:
(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:
Cellulose - microcrystalline (Avicel PH-101 & PH-102), starch-maize,
sodium starch
glycollate type A, Povidone & magnesium stearate.
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
osteoporosis and Paget’s
disease studies, alendronate was effective when administered at least
30 minutes before the first
food or beverage of the day.
Product Information:
DENSATE (Alendronic Acid Tablets 70 mg)
Ver 1.1
Page 2 of 17
Bioavailability was negligible whether alendronate was administered
with or up to two hours
after a standardised breakfast. Concomitant administration of
alendronate with coffee or orange
juice reduced bioavailability by approximately 60%.
In normal subjects, oral prednisone (20 mg three times daily for five
days) did not substantially
alter
the
oral
bioavailability
of
alendron