Pyronium Injection 200mcgml

Country: Malaysia

Language: English

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

Active ingredient:

GLYCOPYRROLATE

Available from:

IMEKS PHARMA SDN. BHD.

INN (International Name):

GLYCOPYRROLATE

Units in package:

10Units Units

Manufactured by:

SM PHARMACEUTICALS SDN. BHD.

Patient Information leaflet

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Summary of Product characteristics

PRESENTATION
Clear, colourless, sterile solution presented in 1 ml clear glass
ampoule. Each 1 ml ampoule contains 200 micrograms of
Glycopyrrolate.
PROPERTIES
Glycopyrrolate is an anticholinergic (antimuscarinic) agent. It
inhibits the action of acetylcholine on structures innervated by
postganglionic cholinergic nerves and on smooth muscles
that respond to acetylcholine but lack cholinergic innervation.
These peripheral cholinergic receptors are present in the
autonomic effector cells of smooth muscle, cardiac muscle,
the sinoatrial node, the atrioventricular node, exocrine glands,
and to a limited degree, in the autonomic ganglia. Thus it
diminishes the volume and free acidity of gastric secretions
and controls excessive pharyngeal, tracheal, and bronchial
secretions. Glycopyrrolate also antagonises muscarinic symp-
toms induced by cholinergic drugs such as the anticholinest-
erases.
The highly polar quaternary ammonium group of glycopyrro-
late limits its passage across lipid membranes, such as the
blood-brain barrier.
Glycopyrrolate has a specific effect on salivary and sweat
gland activity with little effect on pupil size, visual accommo-
dation or heart rate. Following a dose of 0.2 mg intramuscular-
ly, sweat gland activity and salivation are markedly inhibited
for over 6 hours.
Absorption from the intramuscular site of administration is
almost complete and as rapid as that following intravenous
administration. As would be anticipated from a quaternary
compound, oral absorption is poor and erratic.
Glycopyrrolate
is
a
superior
drug
when
compared
with
atropine. A dose of 0.4 mg I.M. inhibits salivation by over 90%
and produces only slight slowing of the heart rate. Atropine
has been shown in doses of 2.0 mg I.M. to inhibit salivation by
approximately 80% but produces a rise in heart rate of greater
than 80%.
Studies
involving
radio-labelled
glycopyrrolate
(200
mcg
intravenously)
show
that
the
initial
distribution
phase
is
extremely rapid, approximately 90% of the radioactivity disap-
peared from plasma wit