PULMICORT TURBUHALER 200 mcgdose

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

BUDESONIDE

Available from:

ASTRAZENECA SINGAPORE PTE LTD

ATC code:

R03BA02

Dosage:

200 mcg/dose

Pharmaceutical form:

POWDER, METERED

Composition:

BUDESONIDE 200 mcg/dose

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

Prescription Only

Manufactured by:

ASTRAZENECA AB

Authorization status:

ACTIVE

Authorization date:

1990-09-06

Patient Information leaflet

1 (9) 
PULMICORT TURBUHALER 100 AND 200 MICROGRAMS/DOSE 
_BUDESONIDE _
INHALATION POWDER 

QUALITATIVE AND QUANTITATIVE

COMPOSITION 
1 metered dose contains budesonide 100 micrograms
or 200 micrograms. 

PHARMACEUTICAL FORM 
Inhalation powder 

THERAPEUTIC INDICATIONS 
Pulmicort Turbuhaler is indicated for patients
with bronchial asthma who require maintenance 
treatment with glucocorticosteroids for control of the underlying
airways inflammation. 

POSOLOGY AND METHOD OF ADMINISTRATION 
The dosage of Pulmicort Turbuhaler is individual. 
Initially, at the beginning of inhaled corticosteroid therapy, for
therapy during periods of 
severe asthma or when scaling down or withdrawing
oral corticosteroids the dosage should 
be: 

_Children 5-7 years:_ 200-400 micrograms daily divided into 2-4
administrations. 

_Children 7 years and more:_ 200-800 micrograms daily divided into
2-4 administrations. 

_Adults:_ 200-1600 micrograms daily divided into 2-4
administrations, (less severe cases 200-
800 micrograms daily, more severe cases 800-1600 micrograms
daily). 

Administration twice daily (morning and evening) is usually
sufficient. 

The maintenance dose is individual and should be the lowest
possible. When the maintenance 
dose is 400 micrograms or lower the dose can be given once daily.
The dose may then be 
given in the morning or in the evening. If deterioration
of asthma occurs, the frequency of 
dosing and the daily dose should be increased. 

Following a single dose an effect may be expected after a few
hours. The full therapeutic 
effect is only achieved after a few weeks of treatment.
Treatment with Pulmicort Turbuhaler 
is prophylactic therapy with no demonstrated effect on
acute disorders. 

Clinical trials indicate that a larger amount of budesonide is
deposited in the lungs when 
administered with Pulmicort Turbuhaler, compared with
Pulmicort pMDI. If a patient in

Summary of Product characteristics

1
PULMICORT
® TURBUHALER
®
(BUDESONIDE)
1.
NAME OF THE MEDICINAL PRODUCT
Pulmicort Turbuhaler 100 and 200 micrograms/dose
_budesonide _
Inhalation powder
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 metered dose contains budesonide 100 micrograms or 200 micrograms.
3.
PHARMACEUTICAL FORM
Inhalation powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pulmicort Turbuhaler is indicated for patients with bronchial asthma
who require maintenance
treatment with glucocorticosteroids for control of the underlying
airways inflammation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The dosage of Pulmicort Turbuhaler is individual.
Initially, at the beginning of inhaled corticosteroid therapy, for
therapy during periods of
severe asthma or when scaling down or withdrawing oral corticosteroids
the dosage should
be:
_CHILDREN 5-7 YEARS:_
200-400 micrograms daily divided into 2-4 administrations.
_CHILDREN 7 YEARS AND MORE:_
200-800 micrograms daily divided into 2-4 administrations.
_ADULTS:_
200-1600 micrograms daily divided into 2-4 administrations, (less
severe cases 200-
800 micrograms daily, more severe cases 800-1600 micrograms daily).
Administration twice daily (morning and evening) is usually
sufficient.
The maintenance dose is individual and should be the lowest possible.
When the maintenance
dose is 400 micrograms or lower the dose can be given once daily. The
dose may then be
given in the morning or in the evening. If deterioration of asthma
occurs, the frequency of
dosing and the daily dose should be increased.
Following a single dose an effect may be expected after a few hours.
The full therapeutic
effect is only achieved after a few weeks of treatment. Treatment with
Pulmicort Turbuhaler
is prophylactic therapy with no demonstrated effect on acute
disorders.
Clinical trials indicate that a larger amount of budesonide is
deposited in the lungs when
administered with Pulmicort Turbuhaler, compared with Pulmicort pMDI.
If a patient in a
2
stable phase is transferred from Pulmicort pMDI to Pulmicort
Turbuhaler