CP Pharma Diphenhydramine Expectorant

Land: Malaysia

Sprog: engelsk

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

Aktiv bestanddel:

DIPHENHYDRAMINE HYDROCHLORIDE; AMMONIUM CHLORIDE; SODIUM CITRATE/TRISODIUM CITRATE

Tilgængelig fra:

HOVID BERHAD

INN (International Name):

DIPHENHYDRAMINE HYDROCHLORIDE; AMMONIUM CHLORIDE; SODIUM CITRATE/TRISODIUM CITRATE

Enheder i pakken:

100ml ml; 120ml ml; 100ml mL; 120ml mL

Fremstillet af:

HOVID BERHAD

Indlægsseddel

Not Applicable

Produktets egenskaber

VIHOV12-var
CP PHARMA DIPHENHYDRAMINE EXPECTORANT
DESCRIPTION
Brown, viscous liquid with raspberry flavour
COMPOSITION
Each 5 ml contains:
Diphenhydramine Hydrochloride
14.0 mg
Ammonium Chloride
135.0 mg
Sodium Citrate
57.0 mg
ACTIONS AND PHARMACOLOGY
Diphenhydramine, an antihistamine, acts by competing
with histamine for H1-receptor sites on effector cells. Its
muscarinic actions provide a drying effect on the nasal
mucosa. It also suppresses the cough reflex by a direct
effect on the cough center in the medulla of the brain. Both
ammonium chloride and sodium citrate are useful ingredients
in expectorants. It is readily absorbed orally, metabolised in
the liver and excreted in the urine.
PHARMACOKINETICS
•
ABSORPTION:
Diphenhydramine
and
sodium
citrate
is
readily absorbed after oral administration. When taken
orally, ammonium chloride is rapidly absorbed from the
gastrointestinal tract.
•
BLOOD CONCENTRATION: After an oral dose of 50 mg of the
hydrochloride as a solution, plasma concentrations of 50
to 54 ng/ml are attained at 1 hour; at 2 hours, the
respective plasma concentrations are 64 to 70 ng/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 bloodstream and extracellular fluids causes a
metabolic acidosis and decreases the pH of the urine.
Sodium citrate is oxidised in the tissues and is partly
excreted as carbon dioxide.
•
EXCRETION: 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 appear to be diphenylmethoxyacetic acid in
free or conjugated form.
Ammonium c