SINARDRYL SYRUP

国: マレーシア

言語: 英語

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

有効成分:

SODIUM CITRATE; DIPHENHYDRAMINE HYDROCHLORIDE; AMMONIUM CHLORIDE

から入手可能:

DYNAPHARM MARKETING (M) SDN BHD

INN（国際名）:

SODIUM CITRATE; DIPHENHYDRAMINE HYDROCHLORIDE; AMMONIUM CHLORIDE

パッケージ内のユニット:

100 ml

製:

DYNAPHARM (M) SDN BHD

情報リーフレット

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
SINARDRYL SYRUP
Diphenhydramine hydrochloride/Ammonium chloride/Sodium citrate
(14mg/135mg/57mg per 5 ml)
1
WHAT IS IN THIS LEAFLET
1.
What SINARDRYL SYRUP_ _is used
for
2.
How SINARDRYL SYRUP_ _works
3.
Before you use SINARDRYL
SYRUP
4.
How to use SINARDRYL SYRUP
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
SINARDRYL SYRUP
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT SINARDRYL SYRUP IS USED
FOR
It is indicated for irritating coughs,
nasal stuffiness and airway congestion
associated with common cold and
allergy.
HOW SINARDRYL SYRUP 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
diminishes 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 SINARDRYL SYRUP
-
_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
years of age. To be used with caution
and doctor’s / pharmacist’s advice in
children 2 to 6 years of ag

製品の特徴

SINARDRYL SYRUP
MAL23086011ACZ
DESCRIPTION:
SYRUP
Colour
:
Dark Brown
Flavour
:
Raspberry and Plum
EACH 5 ML CONTAINS:
Diphenhydramine HCl
.....................................................................
14 mg
Ammonium Chloride
.....................................................................
135 mg
Sodium Citrate
.................................................................................
57 mg
PRESERVATIVES: Sodium Benzoate 5 mg, Methyl Paraben 5 mg, Propyl
Paraben 0.5 mg
PHARMACODYNAMICS:
Diphenhydramine suppresses the cough reflex by a direct effect on the
cough centre in the medulla of the brain. Its antihistaminic action is
by competing with histamine
for H1-receptor sites on effector cells. The antimuscarinic actions of
antihistamine provides a drying effect on the nasal mucosa. It
diminishes vestibular stimulation and
depress labyrinthine function. An action on the medullary
chemoreceptive trigger zone may also be involved in the antiemetic
effect.
Ammonium Chloride has irritant action on the gastric mucous membrane
and may contribute expectorant action.
Sodium Citrate when used together with Ammonium Chloride in oral
preparation may enhance the expectorant action.
PHARMACOKINETICS:
Diphenhydramine is readily absorbed from the GIT. It is metabolised in
the liver and excreted mainly as metabolites in the urine. After an
oral dose of 50 mg of
Diphenhydramine HCl, plasma concentrations of 50 to 54 ng/ml are
attained at 1 hour; at 2 hours, plasma concentration is 64 to 70
ng/ml. The plasma half-life after an
oral dose is 13 to 21 hours. 98% is bound to plasma proteins. About
50% of an oral dose is metabolised in the liver before reaching the
general circulation. Reactions
include N-deakylation and deamination. In the urine, up to 3% of a
dose is excreted unchanged, up to 13% as basic amines and up to 65% as
diphenylmethane
metabolites. The major urinary metabolite appears to be
diphenylmethoxyacetic acid in free or conjugated form.
Ammonium Chloride is rapidly absorbed from the GIT. The Ammonium