PULMICORT RESPULES NEBULISING SUSPENSION FOR INHALATION 0.5 mgml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

BUDESONIDE MICRONISED

Available from:

ASTRAZENECA SINGAPORE PTE LTD

ATC code:

R03BA02

Dosage:

1 mg/2 ml

Pharmaceutical form:

SOLUTION

Composition:

BUDESONIDE MICRONISED 1 mg/2 ml

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

Prescription Only

Manufactured by:

ASTRAZENECA PTY LTD

Authorization status:

ACTIVE

Authorization date:

1993-08-04

Patient Information leaflet

Pulmicort


Product Information (budesonide for oral inhalation) 
1 (10)

PULMICORT

 PRODUCT INFORMATION 
(budesonide nebuliser suspension for inhalation) 
NAME OF THE DRUG 
The active ingredient, budesonide, is
a non-halogenated glucocorticoid structurally 
related to 16

 hydroxyprednisolone. The chemical name is 16

, 17

-22R, 
S-propylmethylenedioxy-pregna-1, 4-diene-11ß,
21-diol-3, 20-dione; MW 430.5. 

CAS Number: 51333-22-3 
DESCRIPTION 
Budesonide  is  a  white  to  off-white  powder,  freely  soluble  in  chloroform,  sparingly 
soluble in ethanol and practically insoluble in water and heptane. Budesonide melts 
with decomposition between 224°C and 231.5°C. 

PULMICORT  RESPULES

  nebulising  suspension  for  inhalation  is  a  white  to  off-
white  suspension  in  plastic  single  dose  units.  PULMICORT  RESPULES  contain 
budesonide  0.5  mg/2  mL  or  1.0  mg/2  mL  as  the  active  ingredient  plus,  disodium 
edetate,  sodium  chloride,  polysorbate  80  (E  433)  citric  acid  -  anhydrous  (E  330), 
sodium citrate (E 331) and water for injections. 
PHARMACOLOGY 
PULMICORT is a corticosteroid for inhalation use in the treatment and prophylaxis of 
asthma. 

Studies in animals and humans have shown an advantageous ratio between topical 
anti-inflammatory activity and systemic glucocorticoid effect over a wide dose range. 
This is explained by the extensive first pass hepatic degradation of budesonide after 
systemic  absorption,  approximately  85-90%,  in  combination with the low potency of 
formed metabolites. 

Budesonide  is  approximately  twice  as  potent  as  beclomethasone  dipropionate  as 
shown  in  the  skin  blanching  test  for  anti-inflammatory  activity  of  

Summary of Product characteristics

1
PULMICORT
® RESPULES
®
(BUDESONIDE)
1.
NAME OF THE MEDICINAL PRODUCT
Budesonide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient, budesonide, is a non-halogenated glucocorticoid
structurally related to
16

hydroxyprednisolone.
The
chemical
name
is
16

,
17

-22R,
S-propylmethylenedioxy-pregna-1, 4-diene-11
ß
, 21-diol-3, 20-dione; MW 430.5.
CAS Number: 51333-22-3
Budesonide is a white to off-white powder, freely soluble in
chloroform, sparingly soluble in
ethanol and practically insoluble in water and heptane. Budesonide
melts with decomposition
between 224°C and 231.5°C.
PULMICORT RESPULES contain budesonide 0.5 mg/2 mL or 1.0 mg/2 mL as
the active
ingredient plus, disodium edetate, sodium chloride, polysorbate 80 (E
433) citric acid -
anhydrous (E 330), sodium citrate (E 331) and water for injections.
3.
PHARMACEUTICAL FORM
PULMICORT RESPULES nebulising suspension for inhalation is a white to
off-white
suspension in plastic single dose units.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of bronchial asthma.
PULMICORT may also be used when replacement or reduction in oral
steroid therapy is
desirable.
PULMICORT
RESPULES
provide
budesonide
in
a
nebulising
suspension
which
is
recommended when other modes of steroid therapy are unsuitable.
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
BRONCHIAL ASTHMA
PULMICORT RESPULES NEBULISING SUSPENSION
PULMICORT RESPULES should be administered from a suitable nebuliser.
The dose
delivered to the patient varies between 40-60% of the nominal dose
depending on the
nebulising equipment used. The nebulisation time and the dose
delivered is dependent on flow
rate, volume of nebuliser chamber and volume fill. A suitable fill for
most nebulisers is 2-4
mL.
Some sedimentation may occur during storage of PULMICORT RESPULES. If
this does not
readily resuspend completely upon shaking, the RESPULE should be
discarded.
_DOSAGE INITIALLY, OR DURING PERIODS OF SEVERE ASTHMA, OR WHILE
REDUCING ORAL CORTICOSTEROIDS _
_ADULTS _
1-2 mg twice daily.