PULMICORT RESPULES budesonide 0.5mg/mL inhalation ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

budesonide, Quantity: 0.5 mg/mL

Available from:

AstraZeneca Pty Ltd

Pharmaceutical form:

Inhalation, conventional

Composition:

Excipient Ingredients: disodium edetate; sodium chloride; polysorbate 80; citric acid; sodium citrate dihydrate; water for injections

Administration route:

Inhalation

Units in package:

40 x 2mL (Export), 10 x 2mL (Export), 20 x 2mL (Export), 5 x 2mL (Export), 30 x 2mL

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Treatment of bronchial asthma and long term prophylaxis. INDICATIONS AS APPROVED 15 JULY 1997: Treatment of bronchial asthma. Pulmicort may also be used when replacement or reduction in oral steroid therapy is desirable. Treatment of acute laryngotracheobronchitis (croup) in infants and children.

Product summary:

Visual Identification: An easily resuspendable white to off-white suspension.; Container Type: Ampoule; Container Material: PE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1991-07-31

Patient Information leaflet

PULMICORT
®
P
U
L
M
I
C
O
R
T
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING PULMICORT?
Pulmicort contains the active ingredient budesonide. Pulmicort is
inhaled into the lungs for the treatment of asthma. Pulmicort may
also be used to treat croup in infants and children.
For more information, see Section 1. Why am I using Pulmicort? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PULMICORT?
Do not use if you have ever had an allergic reaction to any medicine
containing budesonide or any of the ingredients listed at the
end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Pulmicort? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Pulmicort and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE PULMICORT?
•
Pulmicort comes in two different forms: the Turbuhaler or Respules
(containing nebulising suspension) for use in a nebuliser.
•
Follow all directions given to you by your doctor or pharmacist.
More instructions can be found in Section 4. How do I use Pulmicort?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PULMICORT?
THINGS YOU
SHOULD DO
•
If you have a personal Asthma Action plan agreed with your doctor to
help manage your asthma, follow it
closely at all times.
•
Have your reliever medicine available at all times. As advised by your
doctor, this may be your Bricanyl
®
(terbutaline) Turbuhaler.
•
Be sure to rinse your mouth out with water after every time you use
Pulmicort.
•
Be sure to wash your face after each use of Pulmicort Respules.
•
Remind any doctor, dentist or pharmacist you visit that you are using
Pulmicort.
THINGS YOU
SHOU

Summary of Product characteristics

1 of 12
AUSTRALIAN PRODUCT INFORMATION
PULMICORT
®
TURBUHALER
® & PULMICORT
®
RESPULES
®
(BUDESONIDE)
1
NAME OF THE MEDICINE
Budesonide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Pulmicort Turbuhaler:_
Pulmicort Turbuhaler contains only budesonide as the active
ingredient;
either 100 μg, 200 μg or 400 μg per dose (metered dose).
_Pulmicort Respules_
: Pulmicort Respules contain budesonide 0.5 mg in 2 mL or 1 mg in 2 mL
as
the active ingredient. For the full list of Pulmicort Respules
excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
_Pulmicort Turbuhaler:_
powder for inhalation. Pulmicort Turbuhaler is a breath activated
multiple
dose dry powder inhaler.
_Pulmicort Respules_
: 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 can be used for the treatment of acute
laryngotracheobronchitis (croup) in
infants and children.
4.2
DOSE AND METHOD OF ADMINISTRATION
BRONCHIAL ASTHMA
_PULMICORT TURBUHALER _
_Initially, or during periods of severe asthma or while reducing oral
corticosteroids _
_Adults: _
400 to 2400 μg daily divided into 2 to 4 administrations. In less
severe cases 400 to 800 μg
daily may be sufficient.
Once daily dosing may be considered in adult patients with mild asthma
who require a dose of up to
400 μg budesonide per day. The dose may then be given either in the
morning or the evening.
_Children: _
200 to 400 μg daily, divided into 2 to 4 administrations. Severe
cases may require daily
doses up to 800 μg. This dose has been reported not to affect adrenal
function in children.
2 of 12
_Maintenance _
The maintenance dose should be individualised and should be the lowest
dose, which leaves the
patient symptom-free. Recommended doses are 100-400 μg daily; this
may be given as a twice
daily dose, or as a once daily dose given i