APO-IPRATROPIUM ipratropium bromide anhydrous 250 microgram/mL inhalation ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ipratropium bromide monohydrate

Available from:

Aspen Pharma Pty Ltd

INN (International Name):

ipratropium bromide monohydrate

Authorization status:

Registered

Patient Information leaflet

APO-Ipratropium ipratropium bromide anhydrous 250 & 500
µ
g/mL inhalation ampoule
Page 1 of 3
APO-IPRATROPIUM
_contains the active ingredient, ipratropium bromide_
CONSUMER MEDICINE INFORMATION (CMI)
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE. ASK YOUR
DOCTOR OR PHARMACIST IF YOU DO
NOT UNDERSTAND ANYTHING OR ARE
WORRIED ABOUT TAKING THIS
MEDICINE.
This leaflet answers some
common questions about APO-
Ipratropium. It does not contain all
the available information. It does
not take the place of talking to your
doctor and pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits it is expected
to have for you.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may want to read it again.
WHAT APO-IPRATROPIUM
IS USED FOR
APO-Ipratropium contains the
active ingredient, ipratropium (as
ipratropium bromide).
It is used to prevent or to treat the
narrowing of the airways
associated with asthma.
It can also be used to relieve any
reversible airways blockage
associated with problems such as
repeated infections affecting the
airways.
Ipratropium works by opening up
the narrowed airways to assist
breathing.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor’s prescription.
There is no evidence that
ipratropium is addictive.
BEFORE YOU USE IT
_WHEN YOU MUST NOT USE IT _
DO NOT USE THIS MEDICINE IF YOU
HAVE HAD AN ALLERGIC REACTION TO
IT OR OTHER MEDICINES CONTAINING
IPRATROPIUM OR ATROPINE OR ANY OF
THE INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty breathing;
swelling of the face, lips, tongue or
other parts of the body; muscle
pain tenderness or joint pain or
rash, itching or hives on the skin.
DO NOT USE IT IF:
•
the packaging is to

Summary of Product characteristics

APO- IPRATROPIUM- Product Information
Page 1 of 6
AUSTRALIAN PRODUCT INFOMATION
APO-IPRATROPIUM (IPRATROPIUM BROMIDE)
1.
NAME OF THE MEDICINE
Ipratropium bromide.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
ampoule
contains
ipratropium
bromide
[equivalent
to
250
µg/mL
or
500
µg/mL
ipratropium bromide (anhydrous)]. The excipients include sodium
chloride. For the full list of
excipients, see Section 6.1: List of excipients.
3.
PHARMACEUTICAL FORM
Apo-Ipratropium is a clear, aqueous isotonic, preservative-free
nebuliser solution in single
use ampoules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Apo-Ipratropium is indicated for moderate asthmatic attacks; chronic
forms of asthma; asthma
in patients with diminished cardiac reserve; chronic obstructive
bronchitis with bronchospasm;
bronchospasm during or after surgery, use during assisted ventilation
with a respirator.
4.2
DOSE AND METHOD OF ADMINISTRATION
Apo-Ipratropium can be administered via a range of commercially
available nebulising devices.
Where wall oxygen is available, nebulising solutions are best
administered at a flow rate of 4 to
6 L/min.
Dosage is dependent on the mode of inhalation and the nebuliser used
and should be adjusted
to suit individual patient requirements.
Daily doses exceeding 2 mg in adults and 1 mg in children under 12
years of age should be
given under medical supervision. If the response to the treatment is
inadequate, medical advice
should be sought so that appropriate measures can be taken. It is
advisable not to greatly
exceed the recommended daily dose as this suggests additional
therapeutic modalities may be
needed.
Diluted solutions should be freshly prepared before use and any
solution remaining in the
nebuliser on completion of inhalation should be discarded.
ADULTS
The recommended dosage is 250 to 500 μg, diluted to 2 to 3 mL with
normal saline and
nebulised until the entire volume of solution is inhaled, every 6
hours.
In cases of moderate bronchospasm or with assisted ventilation, a dose
in the lower range of