APO-Risedronate

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

Risedronate sodium; Risedronate sodium hemipentahydrate

Pieejams no:

Apotex Pty Ltd

Klase:

Medicine Registered

Lietošanas instrukcija

APO-RISEDRONATE
TABLETS

_Contains the active ingredient risedronate sodium (as
hemipentahydrate)_
CONSUMER MEDICINE INFORMATION

_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_

WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE. ASK YOUR
DOCTOR OR PHARMACIST IF YOU DO NOT
UNDERSTAND ANYTHING OR ARE
WORRIED ABOUT TAKING YOUR
MEDICINE.
This leaflet answers some common
questions about risedronate.
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. Some more recent
information on your medicine may
be available. Speak to your
pharmacist or doctor 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.
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 APO-
Risedronate. It contains the active
ingredient, risedronate sodium.
This medicine is used to:
•
Treat osteoporosis (brittle or
fragile bones that may fracture
easily)
•
Treat osteoporosis caused by
taking steroids
It is also used to preserve bone
mineral density in patients on long
term steroid therapy
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
UNDERSTANDING BONE
Bone is a living tissue consisting of
calcium and other minerals.
Throughout life, old bone is
constantly broken down and replaced
with new bone. After the age of 35,
bone loss may occur faster than your
body can replace it. If you lose too
much bone then they become weaker
and are more likely to break.
OSTEOPOROSIS
Osteoporosis (brittle bone disease) is
a disease that causes bones to
become

Produkta apraksts

Product Information – Australia 
APO-Risedronate tablets 
Page 1 
APO-RISEDRONATE TABLETS 

NAME OF THE MEDICINE 
Risedronate sodium hemipentahydrate. 

Chemical Name: 
[1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid], monosodium salt, 
hemipentahydrate 

Structural Formula: 

Molecular Formula: 
C
7
H
10
NO
7
P
2
Na · 2½ H
2
O 

Molecular Weight: 
350.132 

CAS Registry Number:  329003-65-8 

DESCRIPTION 
Risedronate sodium hemipentahydrate is a fine, white to off-white, odourless, crystalline powder. It is 
soluble in water and in aqueous solutions and essentially insoluble in common organic solvents. It is 
also soluble in pH 7.0 potassium phosphate
dibasic solution, 0.1N sodium hydroxide solution, very 
slightly soluble in
0.1N hydrochloric acid, practically insoluble in ethanol and
insoluble in isopropanol. 

PHARMACOLOGY 
PHARMACOKINETICS 
Absorption: 
Risedronate is relatively rapidly absorbed (t
max
  ~  1  hour) throughout the upper gastrointestinal (GI) 
tract.  Absorption is independent of dose over the range studied
(single dose study, 2.5 to 30  mg; 
multiple dose studies, 2.5 to 5 mg daily  and up
to 150  mg  once-a-month).  In a 13-week 
pharmacokinetic study with 5 mg daily and 35 mg or  50
mg once-a-week  dosing (n ~ 19/group), a 
comparison of the average serum concentration for 35
mg  once-a-week and 5 mg/day was not 
statistically significantly different.
 Steady-state conditions in the serum are observed within 57
days of 
daily dosing. 

Mean oral bioavailability of the tablet is 0.63% and
is decreased when risedronate is administered with 
food. Bioavailability was similar in men and women. 

Although administration of risedronate either 30 minutes prior to
breakfast or 2 hours after dinner 
reduces absorption of risedronate by 55% compared to
administ