Alovell Tablets 70 mg

Država: Malezija

Jezik: angleščina

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

Aktivna sestavina:

ALENDRONATE MONOSODIUM SALT TRIHYDRATE

Dostopno od:

CELESTEMAL PHARMA SDN. BHD.

INN (mednarodno ime):

ALENDRONATE MONOSODIUM SALT TRIHYDRATE

Enote v paketu:

4tablet Tablets

Izdeluje:

PT NOVELL PHARMACEUTICAL LABORATORIES.

Navodilo za uporabo

ALOVELL TABLET 70MG
®
Alendronate (70mg)
_Consumer Medication Information Leaflet (RiMUP)_
_ _
_ _
WHAT IS IN THIS LEAFLET
1.
What Alovell is used for
2.
How Alovell works
3.
Before you use Alovell
4.
How to use Alovell
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Alovell
Product Description
8.
Manufacturer and Product
Registration Holder
9.
Date of revision
WHAT ALOVELL IS USED FOR
Alovell
is
used
to
treat
osteoporosis
(brittle bones), that is thinning of bone
tissues
and
loss
of
bone
density
in
postmenopausal
women.
Osteoporosis
can lead to fractures, usually of the hip,
backbone and wrist.
Alovell is also used for the treatment of
osteoporosis in men to prevent fractures.
HOW ALOVELL WORKS
Alovell
contains
alendronate
which
belongs
to
a
group
of
medicines
that
prevent bone loss from the body.
Alendronate helps to build up bone mass
which
may
have
been
lost
due
to
osteoporosis thus can reduce the risk of
fracture.
BEFORE YOU USE ALOVELL
-
_When you must not use it_
_ _
Do not take Alovell
•
If you are allergic to alendronate and
any ingredients of Alovell
•
If you have low blood levels of
calcium.
•
If you are suffering from delayed
esophageal emptying.
•
If you could not sit or stand in upright
position for 30 minutes.
_Pregnancy and lactation_
_ _
Do not take Alovell if you are pregnant,
trying to get pregnant or think you may
be pregnant.
Do not take Alovell if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
-
_Before you start use it_
_ _
Inform the doctor if you have active
upper
gastro-intestinal
problems,
e.g
difficulty
swallowing,
esophageal
disease, gastritis, duodenitis, or ulcers.
Low blood levels of calcium must be
corrected.
Other
disorders
affecting
mineral metabolism (such as vitamin D
deficiency
and
low
activity
of
parathyroid) should also be effectively
treated.
-
_Taking other medicines_
_ _
Tell your doctor if you are taking any
other
medicines,
including
any
that
you buy without a prescription from a
pharmacy, sup

Lastnosti izdelka

LFT/01/1126
ALOVELL TABLET 70 mg
Alendronate 70 mg
PRODUCT DESCRIPTION
White, round uncoated tablet, shallow convex, blank on side I and II.
COMPOSITION
Each tablet contains Alendronate monosodium trihydrate equivalent to
70 mg
of Alendronate.
PHARMACODYNAMICS
Alendronate sodium, a synthetic bisphosphonate analog of pyrophosphate
is an
inhibitor
of
osteoclast-mediated
bone
resorption.
Alendronate
is
resistant
to
enzymatic hydrolysis by phosphatases.
Alendronate appears to inhibit bone resorption in a dose-dependent
manner and is
100-1000 times more potent than etidronate in this effect. In
addition, alendronate
is a highly selective inhibitor of bone resorption; data from animals
indicate that the
dose of alendronate that inhibits bone mineralization is up to 6000
times greater
than the dose that inhibits resorption. Alendronate is incorporated
into bone and
has an estimated terminal elimination half-life of at least 10 years
in humans;
however, while incorporated into bone matrix, the drug is not
pharmacologically
active.
PHARMACOKINETICS
Like
other
biphosphonates,
alendronate
is
poorly
absorbed
following
oral
administration. Absorption is decreased by food, especially by
products containing
calcium or other polyvalent cations. Bioavailibility is about 0.4%
when administered
half an hour before food, reduced from 0.7% in the fasting state;
absorption is
negligible when taken up to 2 hours after a meal. In vitro and in vivo
studies have
shown that biphosphonates are absorbed from the gastrointestinal tract
via
paracellular transport. About half of the absorbed portion is excreted
in the urine;
the remainder is sequestered to bone for a prolonged period.
Biphosphonates do
not appear to be metabolized.
Systemically available biphosphonates disappear very rapidly from
plasma, and are
partly taken up by the bone and partly excreted by the kidney.
Concentrations of the
drug in plasma following therapeutic oral doses are too low for
analytical detection
(less than 5 ng/mL). Protein binding in human plasma is approximat