ATROVENT N METERED DOSE INHALER 20 mcgpuff

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

IPRATROPIUM BROMIDE

Available from:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

ATC code:

R03BB01

Dosage:

20 mcg/dose

Pharmaceutical form:

AEROSOL, SPRAY

Composition:

IPRATROPIUM BROMIDE 20 mcg/dose

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

Prescription Only

Manufactured by:

BOEHRINGER INGELHEIM PHARMA GMBH & CO KG

Authorization status:

ACTIVE

Authorization date:

2002-06-26

Patient Information leaflet

0260-00 (MY & SG) 
20101223 
ATROVENT
®

ABCD

COMPOSITION 
ATROVENT
®
 N 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  
20 mcg 
ipratropium bromide anhydrous 
Propellant: 1,1,1,2-Tetrafluoroethane (HFA [hydrofluoralkane] 134a) 
Other
excipients: citric acid anhydrous, water purified , ethanol anhydrous, nitrogen (inert gas) 

ATROVENT
®
 0.025 % Solution for Inhalation 
1 ml (20 drops) solution for inhalation contains 261 mcg 
(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 
ATROVENT
®
 N 20 mcg/puff Metered Dose Inhaler 
Clear, colourless liquid, free from suspended particles  

ATROVENT
®
 0.025 % Solution for Inhalation 
Clear, colourless or
almost colourless liquid, free from suspended particles 

PROPERTIES  
Atrovent
®
  (ipratropium  bromide)  is  a  quaternary  ammonium  compound  with  anticholinergic  (parasympatholytic) 
properties.  In  preclinical  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 

Summary of Product characteristics

Date
: 17 March 2020
Country
: Brunei, Malaysia & Singapore
Drug substance
: Ipratropium
References
: CCDS 0260-02
Remarks
: Routine CCDS review, updates to sections – Instruction for use,
Pharmacokinetics, Warning &
Editorial changes
ATROVENT
®
ABCD
COMPOSITION
For
ATROVENT
®
20
mcg/puff Metered Dose Inhaler
1
metered
dose
(puff)
contains
21
mcg
(8r)-3
α
-hydroxy-8-isopropyl-1
α
H,5
α
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
α
-hydroxy-8-isopropyl-1
α
H,5
α
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
ATROVENT
®
(ipratropium bromide) is a quaternary ammonium compound with
anticholinergic (parasympatholytic)
properties. In nonclinical 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 follow