DYNADRYL SYRUP

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DIPHENHYDRAMINE HYDROCHLORIDE; AMMONIUM CHLORIDE; SODIUM CITRATE

Boleh didapati daripada:

DYNAPHARM (M) SDN BHD

INN (Nama Antarabangsa):

DIPHENHYDRAMINE HYDROCHLORIDE; AMMONIUM CHLORIDE; SODIUM CITRATE

Unit dalam pakej:

100 ml; 100 ml

Dikeluarkan oleh:

DYNAPHARM (M) SDN BHD

Risalah maklumat

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

Ciri produk

DYNADRYL SYRUP
MAL19910827AZ
DESCRIPTION:
SYRUP
Colour
:
Dark Brown
Flavour
:
Blended flavour of Raspberry and Plum
EACH 5 ML CONTAINS:
Diphenhydramine HCl ............................. 14 mg
Ammonium Chloride ............................. 135 mg
Sodium Citrate ..................................... 57 mg
PRESERVATIVES: Sodium Benzoate 0.1% w/v, Methyl Paraben 0.1% w/v,
Propyl Paraben 0.01% w/v.
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 is
converted into urea in the liver. The
anion thus is liberated into the blood stream and ext