Hovid Alendronate 70mg Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ALENDRONATE MONOSODIUM SALT TRIHYDRATE

Boleh didapati daripada:

HOVID BERHAD

INN (Nama Antarabangsa):

ALENDRONATE MONOSODIUM SALT TRIHYDRATE

Unit dalam pakej:

1 x 4'stablet Tablets

Dikeluarkan oleh:

HOVID BERHAD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
HOVID ALENDRONATE 70 MG TABLET
Alendronate Sodium USP (70 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Hovid Alendronate 70 mg
Tablet is used for
2.
How Hovid Alendronate 70 mg
Tablet works
3.
Before you use Hovid Alendronate
70 mg Tablet
4.
How to use Hovid Alendronate 70
mg Tablet
5.
While
you
are
using
Hovid
Alendronate 70 mg Tablet
6.
Side effects
7.
After using Hovid Alendronate 70
mg Tablet
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
WHAT
HOVID
ALENDRONATE
70
MG
TABLET IS USED FOR
This
medicine
contains
the
active
ingredient alendronate sodium.
It is used to treat and / or prevent
Post-menopausal
osteoporosis,
corticosteroid-induced osteoporosis
and reduces the risk of
vertebral
and hip fractures
metastases and hypercalcaemia of
malignancy.
HOW
HOVID
ALENDRONATE
70
MG
TABLET WORKS
Alendronate sodium belongs to a group
of
non-hormonal
medicines
called
biphosphonates.
This medicine slows down the removal
of
old
bones
to
allow
bone-forming
cells enough time to build new bones.
BEFORE YOU
USE
HOVID
ALENDRONATE
70 MG TABLET
_- When you must not use it _
_ _
Do not take this medicine if:
you
are
allergic
to
alendronate
sodium or any of the excipients, or
other
substances
including
food,
preservatives or dyes
you have problems with your food
pipe (oesophagus)
you cannot stand or sit upright for
at least 30 minutes
you have low level of blood
calcium
you are pregnant or breastfeeding.
_- Before you start to use it _
_ _
Tell your doctor if:
you plan to become pregnant or
breastfeed
you have swallowing or digestive
problems such as ulcers
you have kidney problems
you have dental or jaw bone
problems
you currently smoke or used to be
a smoker in the past
_- Taking other medicines _
_ _
Talk to your doctor or pharmacist if you
are taking any other medicines in any
form
including
any
that
you
buy
or
obtained without a prescription.
Some
medicines
interfere
with
alendronate sodium. You must wait at
least 30 minutes after taking Osteomax
before taking

Ciri produk

VIALE06-var (MY)2
ALENDRONATE 70 MG TABLET
DESCRIPTION
Oval, white uncoated tablet; shallow
convex
with
‘HD’
and
break
bar
embossed on one face.
COMPOSITION
Each
tablet
contains
Sodium
Alendronate
Trihydrate
91.4mg
equivalent to 70 mg Alendronic Acid.
ACTIONS AND
PHARMACOLOGY
The
active
ingredient
of
Hovid
Alendronate 70 mg Tablet, alendronate
sodium trihydrate, is a bisphosphonate
that
inhibits
osteoclastic
bone
resorption with no direct effect on bone
formation.
Preclinical
studies
have
shown
preferential
localisation
of
alendronate
to
sites
of
active
resorption.
Activity
of
osteoclasts
is
inhibited, but recruitment or attachment
of osteoclasts is not affected. The bone
formed
during
treatment
with
alendronate is of normal quality.
Alendronate
is
given
in
the
management
of
osteoporosis
either
alone or with Vitamin D.
PHARMACOKINETICS
ABSORPTION
Alendronate is poorly absorbed after
oral doses. Absorption is decreased by
food, especially by products containing
calcium or other polyvalent cations.
Relative to an intravenous reference
dose, the oral mean 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.
Bioavailability
was
decreased
similarly
to
an
estimated
0.46% and 0.39% when alendronate
was administered one hour or half an
hour before a standardised breakfast.
In
osteoporosis
studies,
alendronate
was
effective
when
administered
at
least 30 minutes before the first food or
beverage of the day.
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 healthy subjects, oral prednisone (20
mg three times daily for five days) did
not
produce
a
clinically
meaningful
change
in
oral
bioavailability
of
alendronate (a mean increase ranging
from 20% to 44%).
DISTRIBUTION
The
mean
steady-state
volume
of
distributi