DYNAPHAN SYRUP

País: Malásia

Língua: inglês

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

Ingredientes ativos:

DEXTROMETHORPHAN HYDROBROMIDE

Disponível em:

DYNAPHARM (M) SDN BHD

DCI (Denominação Comum Internacional):

DEXTROMETHORPHAN HYDROBROMIDE

Unidades em pacote:

100 ml mL; 60 ml mL; 120 ml mL

Fabricado por:

DYNAPHARM (M) SDN BHD

Folheto informativo - Bula

Consumer Medication Information Leaflet (RiMUP)
DYNAPHAN SYRUP
Dextromethorphan Hydrobromide (15mg/5ml)
Page 1 of 2
What is in this leaflet
1.
What DYNAPHAN SYRUP is
used for
2.
How DYNAPHAN SYRUP works
3.
Before you use DYNAPHAN
SYRUP
4.
How to use DYNAPHAN SYRUP
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
DYNAPHAN SYRUP
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
What DYNAPHAN SYRUP is used
for
DYNAPHAN SYRUP is used for the
symptomatic relief of unproductive
cough caused by minor throat and
airway irritation occurring with colds
or inhaled irritants.
How DYNAPHAN SYRUP works
Dextromethorphan suppresses the
cough reflex by a direct central action,
probably located in the brain.
Before you use DYNAPHAN
SYRUP
- When you must not use it
Do not use DYNAPHAN SYRUP if
you are taking monoamine oxidase
inhibitors (MAOI) for depression.
It should not be taken for persistent or
chronic coughs or when coughing is
accompanied by excessive secretions.
Pregnancy and lactation
Tell your doctor if you are pregnant,
think you may be pregnant or planning
to get pregnant or if you are
breastfeeding. Use of DYNAPHAN
SYRUP during breastfeeding should
be avoided. Ask your doctor for advice
before taking DYNAPHAN SYRUP.
- Before you start to use it
Tell your doctor or pharmacist if you
have any of the following conditions:
-
Liver disease
-
Asthma
-
Persistent or chronic cough
-
Cough accompanied by excessive
secretions.
- Taking other medicines
Tell your doctor if you are taking any
other medicines, including any that
you buy without a prescription from a
pharmacy, supermarket or health food
shop.
How to use DYNAPHAN SYRUP
- How much to use
Follow all directions given to you by
your doctor and pharmacist carefully.
They may differ from the information
contained in this leaflet. If you do not
understand the instructions on the
label, ask your doctor or pharmacist
for help.
Adults:
1 to 2 teaspoonfuls (5 ml to 10 ml).
Not to exceed 8 teaspoonfuls (40 ml)
daily.
C

Características técnicas

DYNAPHAN SYRUP
MAL19910825AZ
DESCRIPTION:
Orange in colour syrupy solution, clear with orange flavour.
EACH 5 ML CONTAINS:
Dextromethorphan HBr .............................. 15 mg
PRESERVATIVES: Methyl Paraben 0.1% w/v, Propyl Paraben 0.01% w/v &
Sodium Benzoate 0.1% w/v.
PHARMACODYNAMICS:
Dextromethorphan suppresses the cough reflex by a direct central
action, probably in the medulla or pons.
PHARMACOKINETICS:
Dextromethorphan HBr is absorbed after oral administration. After an
oral dose of 30 mg, 10, 25 and 10% of the dose
is detectable in the blood at 1, 2.5, and 6 hours respectively after
administration. It is metabolised by N-
Demethylation and O-Demethylation followed by Sulphate or Glucuronic
Acid conjugation; the major metabolite is (+)-
3-hydroxy-N-methylmorphinan
and
the
other
metabolites
are
(+)-3-hydroxymorphinan
and
possibly
(+)-3-
methoxymorphinan and their respective conjugates. Up to 56% of a dose
is excreted in the urine, about 8% being
excreted unchanged in 6 hours, in rats, Dextromethorphan is excreted
in the bile and twice as much may be
detectable in the faeces as in the urine.
INDICATION:
Symptomatic relief of unproductive cough caused by minor throat and
bronchial irritation occurring with colds or
inhaled irritants.
RECOMMENDED DOSE:
Adults
: 1 to 2 teaspoonfuls (5 ml to 10 ml). Not to exceed 8 teaspoonfuls
(40 ml) daily.
Children
: 7 - 12 years : ½ to 1 teaspoonfuls (2.5 ml to 5 ml). Not to exceed
4 teaspoonfuls (20 ml) daily.
2 - 6 years
: ½ teaspoonfuls (2.5 ml). Not to exceed 2 teaspoonfuls (10 ml)
daily.
All to be taken 1 to 4 times daily.
WARNING (When Used For Treatment of Cough and Cold):
1.
Not to be used in children less than 2 years of age.
2.
To be used with caution and doctor’s advice in children 2 to 6 years
of age.
CONTRAINDICATION:
It is contraindicated in patients receiving monoamine oxidase
inhibitor (MAOI).
WARNING AND PRECAUTIONS:
It should be administered with caution to patients with liver disease
and to asthmatic patients. It should not be taken
for persistent o