ATROVENT N METERED DOSE INHALER 20MCGPUFF

Country: Մալայզիա

language: անգլերեն

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

active_ingredient:

IPRATROPIUM BROMIDE

MAH:

BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.

INN:

IPRATROPIUM BROMIDE

units_in_package:

10ml mL

manufactured_by:

BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG

SPC

ATROVENT
®
ABCD
COMPOSITION
For
ATROVENT
®
20
mcg/puff Metered Dose Inhaler
1 metered dose (puff) contains 21 mcg (8r)-3

-hydroxy-8-isopropyl-1

H,5

H-tropanium bromide (

)-tropate monohydrate
(= ipratropium bromide monohydrate) corresponding to 20mcg ipratropium
bromide anhydrous.
Excipients
Propellant: 1,1,1,2-Tetrafluoroethane (HFA [hydrofluoralkane] 134a)
Other excipients: citric acid anhydrous, water purified, ethanol
anhydrous, nitrogen (inert gas)
For ATROVENT
®
0.025 % Nebuliser Solution
1 mL (20 drops) nebuliser solution contains 261mcg (8r)-3

-hydroxy-8-isopropyl-1

H,5

H-tropanium bromide (

)-tropate
monohydrate (= ipratropium bromide monohydrate) corresponding to 250
mcg ipratropium bromide anhydrous
Excipients: benzalkonium chloride, disodium edetate dihydrate, sodium
chloride, hydrochloric acid, purified water
DESCRIPTION
For
ATROVENT
®
20
mcg/puff Metered Dose Inhaler
Clear, colourless liquid, free from suspended particles
For ATROVENT
®
0.025 % Nebuliser Solution
Clear, colourless or almost colourless liquid, free from suspended
particles
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Anticholinergics
ATC Code : R03BB01
Mode of action
ATROVENT
®
(ipratropium bromide) is a quaternary ammonium compound with
anticholinergic (parasympatholytic)
properties. In non-clinical studies, it appears to inhibit vagally
mediated reflexes by antagonizing 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 ATROVENT
®
(ipratropium bromide) is primarily local and site specific to
the lung and not systemic in nature.
Non-clinical and clinical evidence suggest no deleterious effect of
ATROVENT
®
(ipr