Zarthrimin Oral Powder 1.5g4.0g

Country: Malaysia

Language: English

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

Active ingredient:

Glucosamine Sulfate Potassium Chloride

Available from:

NOVA LABORATORIES SDN. BHD.

INN (International Name):

Glucosamine Sulfate Potassium Chloride

Units in package:

4.00gm0 mcg/mL

Manufactured by:

NOVA LABORATORIES SDN. BHD.

Summary of Product characteristics

STORAGE CONDITIONS
Store below 30
o
C.
Protect from light and moisture.
PHARMACODYNAMICS
Exogenous glucosamine is the preferred and essential substrate for the
biosynthesis of glycosaminoglycans (GAGs). Glucosamine sulphate also
enhanced proteoglycan biosynthesis. Glucosamine sulphate is an
essential
substrate in the biosynthesis of cartilage proteoglycan. The sulphate
esters
of the GAG side chains of proteoglycans are essential for the
elasticity and
water binding capacity in the cartilage matrix. Sulphates in GAGs also
contribute to the inhibition of cartilage-degrading enzymes.
PHARMACOKINETICS
Oral administration of Glucosamine sulphate potassium chloride was
well
absorbed (over 90%) in the gastrointestinal tract. Levels of
Glucosamine
sulphate potassium chloride incorporated in plasma proteins reached a
peak
after 8–10 hours and then declined, exhibiting a half-life of 68
hours. Following
oral administration, 10% was excreted via the urine; where as 11.3%
was found
in the faeces. The absolute bioavailability is 26% due to the
first-pass effect in
the
liver. With
intramuscular
and
intravenous
administration,
the
plasma
concentrations of Glucosamine sulphate potassium chloride were five
times
higher
than
those
following
oral
administration.
Studies
show
that
the
area-under-the-curve (AUC) achieved after oral administration was 26%
of that
achieved after parenteral administration.
SYMPTOMS AND TREATMENT OF OVERDOSE
No cases of accidental or intentional overdose are known. The animal
acute
and chronic toxicological studies indicate that toxic effects and
symptoms
of toxicity are not likely to occur, even after high doses.
PREGNANCY AND LACTATION
The
animal
studies
did
not
evidence
any
unfavorable
effects
on
the
reproductive functions or on lactation. In the absence of such studies
in
humans, the product during pregnancy and lactation should be used only
under medical control. Administration during the first three months of
pregnancy must be avoided.
Zarthrimin oral powder berasa masam manis dan berwarna putih.