NOPHALAC SOLUTION 670mgml

Land: Malaysia

Språk: engelska

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

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Ladda ner Produktens egenskaper (SPC)
03-10-2023

Aktiva substanser:

Lactulose

Tillgänglig från:

Noripharma Sdn. Bhd.

INN (International namn):

Lactulose

Enheter i paketet:

120ml mL; 100ml mL; 60ml mL; 200ml mL; 500ml mL

Tillverkad av:

Noripharma Sdn. Bhd.

Produktens egenskaper

                                NOPHALAC SOLUTION 670MG/ML
DESCRIPTION:
Clear, viscous liquid, colourless or pale brownish-yellow with a sweet
taste.
COMPOSITION:
Each ml of solution contains 670mg Lactulose
PHARMACODYNAMIC:
Lactulose,
a
synthetic
disaccharide
which
is
the
active
ingredient
of
NOPHALAC
is
metabolized in the colon by the sacchrolytic bacteria producing low
molecular weight organic
acid mainly lactic acid via bacterial degradation. This lowers the pH
of the colon contents
with stimulation of peristalsis by promoting the retention of water by
an osmotic effect.
In portal systemic encephalopathy (PSE) or (pre)coma hepaticum, the
effect has been
attributed to suppression of proteolytic bacteria by an increase of
acidophilic bacteria (e.g.
lactobacillus), trapping of ammonia in the ionic form by acidification
of the colonic contents,
catharsis due to the low pH in the colon as well as an osmotic effect,
and alteration of the
bacterial nitrogen metabolism by stimulating the bacteria to utilize
ammonia for bacterial
protein synthesis.
PHARMACOKINETICS
:
Lactulose is minimally absorbed after oral administration. It reaches
the colon unchanged,
where it is metabolized by the colonic bacteria flora. Metabolism is
completed at 20-50g or
40-75ml; at higher dosages, a proportion may be excreted unchanged.
INDICATIONS:
Constipation: Regulation of the physiological rhythm of the colon.
Portal
systemic
encephalopathy
(PSE):
Treatment
and
prevention
of
hepatic
coma
or
precoma.
Where a soft stool is considered of medical benefit (haemorrhoids,
after colon/anal surgery)
DOSAGE & ADMINISTRATION:
Lactulose can be taken as a single daily dose or in two divided doses.
Dose need to be taken
in one swallow. It should not be held in the mouth for length of time.
Dosage will be adjusted to individual needs. NOPHALAC is best taken at
the same time each
day, preferably at breakfast time.
Nophalac can be taken diluted or undiluted.
ROUTE OF ADMINISTRATION:
Oral administration
DOSING IN CONSTIPATION OR WHERE SOFT STOOL IS CONSIDERED OF MEDICAL
BENEFIT
Adults

                                
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