Foster Pressurised Inhalation Solution 100mcg6mcg per Actuation

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Beclometasone dipropionate anhydrous; Formoterol fumarate dihydrate

Available from:

ORIENT EUROPHARMA PTE LTD

ATC code:

R03AK07

Dosage:

0.100mg/ actuation

Pharmaceutical form:

AEROSOL, METERED

Composition:

Beclometasone dipropionate anhydrous 0.100mg/ actuation; Formoterol fumarate dihydrate 0.006mg/actuation

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

Prescription Only

Manufactured by:

Chiesi Farmaceutici SpA

Authorization status:

ACTIVE

Authorization date:

2011-03-15

Patient Information leaflet

1
FOSTER 100/6 MICROGRAMS PER ACTUATION 
pressurised inhalation solution 

Each metered dose (ex-valve) dose contains: 
100 micrograms of beclometasone dipropionate and 6 micrograms of
formoterol fumarate 
dihydrate. This is equivalent to a delivered dose (ex-actuator) of
84.6 micrograms of 
beclometasone dipropionate and 5
.
0 micrograms of formoterol fumarate dihydrate. 
Excipients: Norflurane (HFA-134a), Ethanol anhydrous, Hydrochloric
acid 

PHARMACODYNAMICS/PHARMACOKINETICS 
Pharmacotherapeutic group: Adrenergics and other drugs for obstructive
airway diseases.  
ATC-CODE: R03 AK07._ _
MECHANISMS OF ACTION AND PHARMACODYNAMIC EFFECTS 
Foster contains beclometasone dipropionate and formoterol, which have
different modes of 
action. In common with other inhaled corticosteroids and beta
2
-agonists combinations, additive 
effects are seen in terms of reduction of asthma exacerbations.  
BECLOMETASONE DIPROPIONATE_ _
Beclometasone dipropionate given by inhalation at recommended doses
has a glucocorticoid 
antiinflammatory action within the lungs, resulting in reduced
symptoms and exacerbations of 
asthma with less adverse effects than when corticosteroids are
administered systemically.  
FORMOTEROL  
Formoterol is a selective beta
2
-adrenergic agonist that produces relaxation of bronchial smooth 
muscle in patients with reversible airways obstruction. The
bronchodilating effect sets in rapidly, 
within 1-3 minutes after inhalation, and has a duration of 12 hours
after a single dose.  
FOSTER  
In clinical trials in adults, the addition of formoterol to
beclometasone dipropionate  improved 
asthma symptoms and lung function and reduced exacerbations.  
In a 24-week study the effect on lung function of Foster was at least
equal to that of the free 
combination of beclomeasone dipropionate and formoterol, and exceeded
that of beclometasone 
dipropionate alone.  
The systemic exposure to the active substances beclometasone
dipropionate and formoterol in 
t

Summary of Product characteristics

1
FOSTER 100/6 MICROGRAMS PER ACTUATION
pressurised inhalation solution
Each metered dose (ex-valve) dose contains:
100 micrograms of beclometasone dipropionate and 6 micrograms of
formoterol fumarate
dihydrate.
This
is
equivalent
to
a
delivered
dose
(ex-actuator)
of
84.6
micrograms
of
beclometasone dipropionate and 5.0 micrograms of formoterol fumarate
dihydrate.
Excipients: Norflurane (HFA-134a), Ethanol anhydrous, Hydrochloric
acid
PHARMACODYNAMICS/PHARMACOKINETICS
Pharmacotherapeutic group: Adrenergics and other drugs for obstructive
airway diseases.
ATC-CODE: R03 AK07.
MECHANISMS OF ACTION AND PHARMACODYNAMIC EFFECTS
Foster contains beclometasone dipropionate and formoterol, which have
different modes of
action. In common with other inhaled corticosteroids and beta
2
-agonists combinations, additive
effects are seen in terms of reduction of asthma exacerbations.
BECLOMETASONE DIPROPIONATE
Beclometasone dipropionate given by inhalation at recommended doses
has a glucocorticoid
antiinflammatory action within the lungs, resulting in reduced
symptoms and exacerbations of
asthma with less adverse effects than when corticosteroids are
administered systemically.
FORMOTEROL
Formoterol is a selective beta
2
-adrenergic agonist that produces relaxation of bronchial smooth
muscle in patients with reversible airways obstruction. The
bronchodilating effect sets in rapidly,
within 1-3 minutes after inhalation, and has a duration of 12 hours
after a single dose.
FOSTER
ASTHMA
CLINICAL EFFICACY FOR FOSTER MAINTENANCE THERAPY
In clinical trials in adults, the addition of formoterol to
beclometasone dipropionate improved
asthma symptoms and lung function and reduced exacerbations.
In a 24-week study the effect on lung function of Foster was at least
equal to that of the free
combination of beclomeasone dipropionate and formoterol, and exceeded
that of beclometasone
dipropionate alone.
CLINICAL EFFICACY FOR FOSTER MAINTENANCE AND RELIEVER THERAPY
In a 48-week parallel group study involving 1701 asthma patients, the
efficacy of