Fosamax Plus 70mg/5600I.U. Combination Tablet

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

ALENDRONATE SODIUM; Vitamin D3 100,000 I.U./g, Ph. Eur.

Boleh didapati daripada:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (Nama Antarabangsa):

ALENDRONATE SODIUM; Vitamin D3 100,000 I.U./g, Ph. Eur.

Unit dalam pakej:

4Tablet Tablets

Dikeluarkan oleh:

Rovi Pharma Industrial Services S.A

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
FOSAMAX
® PLUS
Alendronate Sodium/Cholecalciferol (70mg/2800I.U., 70mg/5600I.U.)
1
WHAT IS IN THIS LEAFLET
1.
What FOSAMAX PLUS is
used for
2.
How FOSAMAX PLUS
works
3.
Before you use FOSAMAX
PLUS
4.
How to use FOSAMAX
PLUS once weekly
5.
While you are using
FOSAMAX PLUS
6.
Side effects
7.
Storage and Disposal of
FOSAMAX PLUS
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT FOSAMAX PLUS IS
USED FOR
_WHY HAS MY DOCTOR PRESCRIBED _
_FOSAMAX PLUS? _
Your doctor has prescribed
FOSAMAX PLUS to treat your
osteoporosis and to help make
sure you get enough vitamin D.
This will help prevent you from
developing fractures.
absorb calcium properly unless
you have enough vitamin D.
Too little vitamin D may lead to
bone loss and osteoporosis, and
severe vitamin D deficiency
may cause muscle weakness
which can lead to falls, and
greater risk of fracture.
_WHAT SHOULD I KNOW ABOUT _
_VITAMIN D? _
Vitamin D is an essential
nutrient, required for calcium
absorption and healthy bones.
The main source of Vitamin D is
through exposure to summer
sunlight, which makes vitamin
D in our skin. Clothing or sun
block can prevent from getting
enough sunlight. In addition, as
people age, their skin becomes
less able to make vitamin D.
Very few foods are natural
sources of vitamin D.
Too little vitamin D leads to
inadequate calcium absorption
and low phosphate – the
minerals that make bones strong.
Even if you are eating a diet rich
in calcium or taking a calcium
supplement, your body cannot
HOW IS NORMAL BONE
MAINTAINED?
Bone undergoes a normal
process of rebuilding that occurs
continuously throughout your
skeleton. First, old bone is
removed (resorbed), then new
bone is laid down (formed). This
balanced process of resorbing
and forming bone keeps your
skeleton healthy and strong.
WHAT IS OSTEOPOROSIS AND WHY
SHOULD IT BE TREATED?
Osteoporosis is thinning and
weakening of the bones. It is
common in women after
menopause and may also occur
in

Ciri produk

1
FOSAMAX PLUS
LPC-MK0217A-T-052015c-Malaysia
(alendronate sodium/cholecalciferol, MSD)
LOCAL PRODUCT CIRCULAR
FOSAMAX PLUS
®
70/2800
(alendronate sodium 70 mg/cholecalciferol 2800 IU)
FOSAMAX PLUS
®
70/5600
(alendronate sodium 70 mg/cholecalciferol 5600 IU)
I. THERAPEUTIC CLASS
FOSAMAX PLUS contains alendronate sodium and cholecalciferol (vitamin
D
3
).
Alendronate Sodium
Alendronate sodium is a bisphosphonate that acts as a potent, specific
inhibitor of osteoclast-
mediated bone resorption. Bisphosphonates are synthetic analogs of
pyrophosphate that bind to
the hydroxyapatite found in bone.
Cholecalciferol
Cholecalciferol (vitamin D
3
) is a secosterol that is the natural precursor of the
calcium-regulating
hormone calcitriol (1,25-dihydroxyvitamin D
3
)
II. INDICATIONS
FOSAMAX PLUS is indicated
•
For the treatment of osteoporosis in postmenopausal women to increase
bone mass,
prevent fractures, including those of the hip and spine (vertebral
compression fractures).
Osteoporosis may be confirmed by the finding of low bone mass or by
the presence or
history of osteoporotic fracture.
•
Treatment of osteoporosis in men to prevent fractures.
2
III. CLINICAL PHARMACOLOGY
IIIa. Mechanism of Action
Alendronate Sodium
Animal studies have indicated the following mode of action. At the
cellular level, alendronate shows
preferential localization to sites of bone resorption specifically
under osteoclasts. The osteoclasts
adhere normally to the bone surface but lack the ruffled border that
is indicative of active
resorption. Alendronate does not interfere with osteoclast recruitment
or attachment, but it does
inhibit osteoclast activity. Studies in mice on the localization of
radioactive [
3
H] alendronate in bone
showed about 10-fold higher uptake on osteoclast surfaces than on
osteoblast surfaces. Bones
examined 6 and 49 days after [
3
H] alendronate administration in rats and mice, respectively,
showed that normal bone was formed on top of the alendronate, which
was incorporated inside the
matrix, where it is no lo