Ipracip Respules 500mcg2mL

Land: Malaysia

Sprog: engelsk

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

Aktiv bestanddel:

IPRATROPIUM BROMIDE

Tilgængelig fra:

CIPLA MALAYSIA SDN BHD

INN (International Name):

IPRATROPIUM BROMIDE

Enheder i pakken:

20 Units

Fremstillet af:

Cipla Limited

Indlægsseddel

Not Applicable

Produktets egenskaber

_For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory only OR_
_for Specialist Use only_
NAME OF
PRO
DU
CT
Ipracip Respules 500mcg / 2mL
QUALITATIVE AND QUANTITATIVE
CO
M
PO
S
I
T
I
O
N
Each 2 ml contains:
Ipratropium Bromide (monohydrate) BP ………522 mcg
Equivalent to Ipratropium Bromide (Anhydrous) ……500 mcg
In an isotonic solution …………q.s
PHARMACEUTICAL
FOR
M
Solution for nebulization
PRODUCT
D
E
S
CR
I
PT
I
O
N
A clear, colourless solution filled in 2 ml FFS vial. On visual
inspection there is no sign
of physical damage or leakage.
PHARMACODYNAMIC/
PH
A
R
M
A
COK
I
N
ET
I
C
Pharmacodynamic
p
r
o
p
e
r
t
ies
:
Ipratropium is a quaternary ammonium compound with anticholinergic
(parasympatholytic)
properties., It appears to inhibit vagally mediated reflexes by
antagonising the action of
acetylcholine,
the
transmitter
agent released
from
the
vagus
nerve.
Anticholinergics
prevent the increase in intracellular concentration of Ca++ which is
caused by interaction
of acetylcholine with the muscarinic receptor on bronchial smooth
muscle. Ca++ release is
mediated by the second messenger system consisting of IP3 (inositol
triphosphate) and DAG
(diacylglycerol).
The bronchodilation following inhalation of Ipratropium Nebulizer
Solution is induced by
local drug concentrations sufficient for anticholinergic efficacy at
the bronchial smooth
muscle and not by systemic drug concentrations.
Pharmacokinetic
p
r
o
p
e
r
t
ies
:
Absorption
The therapeutic effect of Ipratropium is produced by a local action in
the
airways. Time courses of bronchodilation and systemic pharmacokinetics
do
not run in parallel.
Following inhalation, 10 to 30% of a dose is generally deposited in
the lungs,
depending on the formulation, device and inhalation technique. The
major part
of the dose is swallowed and passes through the gastro-intestinal
tract.
The portion of the dose deposited in the lungs reaches the circulation
rapidly
(within minutes).
Cumulative renal excretion (0-24 hrs) of parent compound is
ap