Presmedic Expectorant

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
29-12-2022
Ciri produk Ciri produk (SPC)
03-01-2023

Bahan aktif:

SODIUM CITRATE DIHYDRATE; AMMONIUM CHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE

Boleh didapati daripada:

Hovid Pharmacy Sdn. Bhd.

INN (Nama Antarabangsa):

SODIUM CITRATE DIHYDRATE; AMMONIUM CHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE

Unit dalam pakej:

120 ml

Dikeluarkan oleh:

HOVID BERHAD

Risalah maklumat

                                PRESMEDIC EXPECTORANT
Diphenhydramine HCl (14mg/5ml), Ammonium Chloride (135mg/5ml), Sodium
Citrate Dihydrate (57mg/5ml)
1
_CONSUMER MEDICATION INFORMATION _
_LEAFLET (RIMUP)_
_CONSUMER MEDICATION INFORMATION _
_LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Presmedic Expectorant is used
for
2.
How Presmedic Expectorant works
3.
Before you use Presmedic
Expectorant
4.
How to use Presmedic Expectorant
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Presmedic
Expectorant
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT PRESMEDIC EXPECTORANT
IS USED
FOR
Presmedic Expectorant is used as an
expectorant for control of cough due to
cold or allergy.
HOW PRESMEDIC EXPECTORANT WORKS
Diphenhydramine suppresses the cough
reflex by a direct effect on the cough
centre in the brain. It also works by
blocking a certain natural substance
(histamine) that your body makes during
an allergic reaction.
The action of antihistamine provides a
drying effect in the nose lining. It
diminished vestibular stimulation (the
process of sending specific electric
messages to a nerve in the ear that
maintains balance) and depress
labyrinthine function (hearing and
balance). An action on the brain trigger
zone may also be involved in the
antiemetic (vomiting and nausea) effect.
Ammonium Chloride has irritant action
on the gastric lining and may contribute
expectorant action (to loosen and clear
mucus from the airways).
Sodium Citrate when used together with
Ammonium Chloride in oral preparation
may enhance the expectorant action.
BEFORE YOU USE PRESMEDIC EXPECTORANT
-
_When you must not use it _
This preparation should not be used in
newborn or premature infants and in
nursing mother.
It should not be used to treat lower
respiratory tract symptoms including
asthma.
It is also not to be used in cases of
hypersensitivity to Diphenhydramine,
other similar antihistamine or other
ingredients listed at the end of this
leaflet.
Not to be used in children less than 2

                                
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Ciri produk

                                VIEXPxx-0
DESCRIPTION
Brown liquid with raspberry flavor
COMPOSITION
Each 5 ml contains: Diphenhydramine Hydrochloride
14.0 mg
Ammonium Chloride
135.0 mg
Sodium Citrate Dihydrate
57.0 mg
PHARMACODYNAMICS
DIPHENHYDRAMINE HYDROCHLORIDE
Antihistaminic
Diphenhydramine which is used in the treatment of allergy act by
competing with histamine for H1-receptor sites on effector cells. It
thereby
prevents, but do not reverse, responses mediated by histamine alone.
The antimuscarinic actions of diphenhydramine provide a drying effect
on
the nasal mucosa.
Antitussive
Diphenhydramine suppresses the cough reflex by a direct effect on the
cough center in the medulla of the brain.
AMMONIUM CHLORIDE
Expectorant
The ammonium ion supposedly exerts an expectorant action. Its action
is doubtful as to whether its irritant action on the gastric mucous
membrane contributes to any expectorant action.
SODIUM CITRATE DIHYDRATE
Expectorant
Sodium citrate is used for its action in rendering mucous less
viscous, hence a useful ingredient in expectorant.
PHARMACOKINETICS
ABSORPTION
Diphenhydramine and sodium citrate is readily absorbed after oral
administration. When taken orally, ammonium chloride is rapidly
absorbed
from the gastro-intestinal tract.
BLOOD CONCENTRATION
After an oral dose of 50mg of the hydrochloride as a solution, plasma
concentrations of 50 to 54ng/ml are attained at 1 hour; at 2 hours,
the
respective plasma concentrations are 64 to 70ng/ml.
HALF-LIFE
The plasma half-life after an oral dose of diphenhydramine is 13 to 21
hours.
DISTRIBUTION
98% of diphenhydramine is bound to plasma proteins.
METABOLIC REACTIONS
Diphenhydramine is extensively metabolised. About 50% of an oral dose
is metabolised in the liver before reaching the general circulation.
Reactions include N-dealkylation and deamination.
The ammonium ion (from ammonium chloride) is converted into urea in
the liver; the anion thus liberated into the blood stream and
extracellular
fluids causes a metabolic acidosis and decreases the pH of the urine.
Sodium citrate i
                                
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Risalah maklumat Risalah maklumat Bahasa Melayu 29-12-2022