Promethiol Syrup

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CARBOCISTEINE(METHYL); PROMETHAZINE HYDROCHLORIDE

Boleh didapati daripada:

Y.S.P. INDUSTRIES (M) SDN. BHD.

INN (Nama Antarabangsa):

CARBOCISTEINE(METHYL); PROMETHAZINE HYDROCHLORIDE

Unit dalam pakej:

100ml ml; 60ml ml; 90ml ml

Dikeluarkan oleh:

Y.S.P. INDUSTRIES (M) SDN. BHD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
PROMETHIOL SYRUP
Carbocisteine 20mg/ml, Promethazine Hydrochloride 0.5mg/ml
WHAT IS IN THIS LEAFLET
1.
What Promethiol Syrup is used for
2.
How Promethiol Syrup works
3.
Before you use Promethiol Syrup
4.
How to use Promethiol Syrup
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Promethiol
Syrup
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT PROMETHIOL SYRUP IS USED FOR
Promethiol Syrup is used for
symptomatic treatment of troublesome,
non-productive cough, particularly
occurring at night.
HOW PROMETHIOL SYRUP WORKS
Promethazine is a sedating antihistamine.
It blocks the effects of the naturally
occurring chemical histamine in the
body. It provides a drying effect on the
nasal and oral mucosa. It is commonly
used in the preparation for symptomatic
treatment of coughs and the common
cold.
Carbocisteine is used to dissolve or
breakdown mucus in respiratory
disorders associated with productive
cough.
BEFORE YOU USE PROMETHIOL SYRUP
-
_When you must not use it _
This medicines is contraindicated in the
following cases:
1.
History of hypersensitivity to one of
the components (particularly to
promethazine HCl, carbocisteine, to
any other phenothiazine medications
or parabens)
2.
Infants under two years of age
3.
Because of the presence of
promethazine hydrochloride:
-
Hypersensitivity to
antihistamines,
-
History of agranulocytosis,
-
Risk of urine retention related to
urethral or prostate disorders,
-
Risk of angle-closure glaucoma
Use of this medicine is generally
inadvisable in combination with
sultopride.
_ _
_Pregnancy and lactation _
Do not take Promethiol Syrup if you are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not take Promethiol Syrup if you are
breast-feeding. Ask your doctor or
pharmacist for advice before taking any
medicine.
_ _
-
_Before you start to use it _
Tell your doctor if you are allergic to any
medicines or if you have any other
medical condition. Info

Ciri produk

ATTACHMENT 1
260 x 110mm
PROMETHIOL
SYRUP
INGREDIENT(S):
Each ml contains:
Carbocisteine
................................................................................................................................................................
20mg
Promethazine Hydrochloride
........................................................................................................................................
0.5mg
Methyl Paraben(as preservative)
.................................................................................................................................
1.8mg
Propyl Paraben(as preservative)
..................................................................................................................................
0.2mg
PHARMACOLOGY (SUMMARY OF PHARMACODYNAMIC AND PHARMACOKINETIC):
PHARMACODYNAMIC:
1.
Promethazine: H1 antihistamine, phenothiazine with an aliphatic side
chain, characterized by:
-
A marked sedative effect at standard doses as a result of
histaminergic and adrenolytic activity.
-
An anticholinergic effect causing peripheral adverse effects.
-
A peripheral adrenolytic effect, possibly affecting hemodynamics (risk
of postural hypotension).
2.
All antihistamines are opposed to the effects of histamines,
particularly on the skin, bronchi, intestine and blood
vessels, through more or less reversible competitive antagonism.
3.
Most have an antitussive effect, which is mild in itself but
potentiates the effects of central morphine antitussivesas
well as those of other bronchodilators such as sympathomimetic amines,
with which they are often combined.
PHARMACOKINETIC:
1.
Orally administered carbocisteine is rapidly absorbed; peak plasma
concentration is reached within two hours.
Bioavailability is low (less than 10% of the dose administered),
probably because of intraluminal metabolism and a
marked hepatic first-pass effect. Elimination half-life is
approximately two hours. Carbocisteine and its metabolites
are eliminated primarily in the urine.
2.
Promethazine bioavailabilit