AMSOLVAN ORAL SOLUTION 30mg5ml

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Ambroxol Hydrochloride

Boleh didapati daripada:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

INN (Nama Antarabangsa):

Ambroxol Hydrochloride

Unit dalam pakej:

100 ml

Dikeluarkan oleh:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
AMSOLVAN ORAL SOLUTION
Ambroxol Hydrochloride 30mg/5ml
1
WHAT IS IN THIS LEAFLET:
1.
What is Amsolvan used for
2.
How Amsolvan works
3.
Before you use Amsolvan
4.
How to use Amsolvan
5.
While you are using Amsolvan
6.
Side effects
7.
Storage and disposal of Amsolvan
8.
Product description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
WHAT IS AMSOLVAN USED FOR
Amsolvan clears the airway by thinning the
thick mucus in the respiratory tract and
facilitates expectoration.
HOW AMSOLVAN WORKS
Amsolvan is a mucolytic agent that alters
the
thick
mucus
becoming
thinner,
less
viscous and thus makes it easier to spitting
up from airway.
BEFORE YOU USE AMSOLVAN
_When you must not to use it _
Do not use Amsolvan if you:

are
allergic
to
Ambroxol
Hydrochloride.
_ _

have
rare
hereditary
fructose
intolerance as this product containing
sorbitol.
_ _
_ _
_Before you start to use it _
Tell your doctor or pharmacist if you:

are pregnant or breast-feeding.
_ _

have kidney failure.
_ _
_ _
_Taking other medicines _

Tell your doctor or pharmacist if you
are taking or have recently taken any
other
medicines.
This
includes
any
medicines
which
you
have
bought
without a prescription.
HOW TO USE AMSOLVAN
_How much to use _
Adults and
children over 12
years old
10ml 2 times daily
Children 6-12
years old
5ml 2-3 times daily
Children 2-5
years old
2.5ml 3 times daily
Amsolvan is not recommended for children
under 2 years of age without medical advice.
_When to use it _
Use only when necessary. Can be taken with
or without food.
_How long to use it _

Follow the recommendation from your
doctor or pharmacist.

Ask your doctor or pharmacist before
prolong using Amsolvan.
_If you forget to use it _
In case you miss a dose, do not double the
dose the next time you take it. Double the
dose may lead to overdose.
_If you use too much (overdose) _
No
specific
overdosage
symptoms
have
been reported. You may experience some
known side effects, as stated in

Ciri produk

AMSOLVAN
ORAL SOLUTION 30MG/5ML
COMPOSITION
Each 5ml contains Ambroxol Hydrochloride 30mg.
Benzoic Acid 0.15%w/v as preservative.
PHARMACODYNAMICS
Ambroxol hydrochloride is a mucolytic that alters the structure of
mucus to decrease its
viscosity thereby facilitating its removal by ciliary action or
expectoration.
PHARMACOKINETICS
Absorption
Absorption of ambroxol hydrochloride is rapid and complete, with dose
linearity in the
therapeutic range. Maximum plasma levels are reached within 1-2.5
hours following oral
administration.
Distribution
In
the
therapeutic
range,
plasma
protein-binding
was
found
to
be
approximately
90%.Distribution of ambroxol hydrochloride from blood to tissue is
rapid and pronounced,
with
the
highest
concentration
of
the
active
substance
found
in
the
lungs.
The volume of distribution following oral administration was estimated
to be 552 L.
Metabolism
About 30% of an orally administered dose is eliminated via first-pass
metabolism. Studies
in human liver microsomes have shown that CYP3A4 is responsible for
the metabolism of
ambroxol hydrochloride to dibromanthranilic acid. Ambroxol
hydrochloride is primarily
metabolized in the liver by glucuronidation and some cleavage to
dibromanthranilic acid
(approximately 10% of dose) aside from some minor metabolites.
Elimination
Ambroxol hydrochloride is eliminated with a terminal elimination
half-life of
approximately 10 hours. Total clearance is in the range of 660 ml/min,
with renal clearance
accounting for approximately 83% of the total clearance.
_ _
_Special Populations:_
In patients with hepatic dysfunction, elimination of ambroxol
hydrochloride is reduced, resulting in approximately 1.3 to 2-fold
higher plasma levels.
Due to the high therapeutic range of ambroxol hydrochloride, dose
adjustments are not
necessary.
_Others:_
Age and gender were not found to affect the pharmacokinetics of
ambroxol
hydrochloride to a clinically relevant extent and thus, there is no
necessity for adjustment
of dosage regimens.
Food was not found to influence the bioav