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IPRATROPIUM BROMIDE NEBULISER SOLUTION

Active substance(s): IPRATROPIUM BROMIDE MONOHYDRATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Ipratropium Bromide Nebuliser Solution

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains 0.025% w/v (250 micrograms/ml) ipratropium
bromide.

3.

PHARMACEUTICAL FORM
A clear, colourless, isotonic inhalation solution.

4

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
Ipratropium bromide is indicated for the treatment of reversible airways
obstruction.

4.2.

Posology and Method of Administration
Ipratropium Bromide Nebuliser Solution may be administered from an
intermittent positive pressure ventilator or from a suitable nebuliser.
Dosage:
Adults (including the elderly): 0.4 - 2.0 ml solution up to four times daily.
Children (3 - 14 years): 0.4 - 2.0 ml solution up to three times daily.
If the nebuliser solution needs to be diluted to obtain a final volume suitable
for the particular nebuliser being used then dilute only with sterile 0.9%
sodium chloride solution.

4.3.

Contra-indications
Known hypersensitivity to atropine or ipratropium bromide.

4.4.

Special Warnings and Special Precautions for Use
There have been rare reports of paradoxical bronchospasm associated with the
use of both hypotonic and isotonic nebulised solutions of ipratropium
bromide. Therefore the use of the nebuliser solution should be subject to close
medical supervision during initial dosing. The patient should be advised to
seek medical advice should a reduced response become apparent.
Careful instruction must be given to the patient on the correct administration
of Ipratropium Bromide Nebuliser Solution and they must be warned not to
allow the solution or mist into the eyes. There have been rare reports of acute
angle-closure glaucoma when nebulised ipratropium bromide has been used in
combination with nebulised beta2-agonist bronchodilators. Increases in intraocular pressure can be prevented by protecting the eyes. Patients who are
susceptible to glaucoma should be warned specifically of the need for ocular
protection. Increases in intra-ocular pressure have not been observed with
nebulised ipratropium bromide when inhaled at doses of up to 1mg.
Anticholinergic agents can precipitate acute urinary retention in patients with
prostatic hypertrophy. Caution is required in the use of nebulised ipratropium
bromide in these patients.

4.5

Interaction with other medicinal products and other forms of interaction
There have been no reports of interactions during trials with ipratropium.

4.6.

Pregnancy and Lactation
Animal teratology and reproduction studies have demonstrated no adverse
effects. The safety of ipratropium bromide in human pregnancy has not been
established. As with all medicines, Ipratropium Bromide Nebuliser Solution
should not be used during pregnancy, especially during the first trimester,
unless the expected benefit is thought to outweigh any possible risk to the
foetus.
It is not known to what extent ipratropium bromide passes into breast milk.
The product should not be given to nursing mothers unless considered
essential by the physician.

4.7.

Effects on Ability to Drive and Use Machines

None known.

4.8.

Undesirable Effects
At therapeutic doses anticholinergic side effects are unlikely, however some
patients may complain of a dry mouth. Nebulised ipratropium bromide has
rarely been reported to cause urinary retention and constipation.
No adverse effect on clearance of bronchial secretion has been shown in the
therapeutic dose range.

4.9.

Overdose
Palpitation and increases in heart rate have been produced with inhaled doses
of 5mg. Side effects have not been caused by single inhaled doses of 2mg in
adults and 1mg in children. Single oral doses of 30mg of ipratropium bromide
caused anticholinergic side effects, but these did not require treatment.

5

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties
Ipratropium bromide is a competitive antagonist of muscarinic acetylcholine
receptors. It exhibits its greatest potency on bronchial receptors, whether
given intravenously or inhaled, but causes no tachycardia. No anticholinergic
effects have been observed on cardiac function, bladder function or in the eye.
Ipratropium bromide is able to inhibit reflex-induced bronchoconstriction
following exercise, inhalation of cold air and the early response to inhaled
antigens. It also reverses the bronchoconstriction induced by inhaled
cholinergic agonists.
Inhalation of 0.04mg of ipratropium from a metered dose aerosol causes
bronchodilation, the maximal effect is seen after 30 - 60 minutes, with a
duration of 4 hours. This is a dose-related effect and use of a nebuliser
produces greater bronchodilation, a dose of 0.5mg producing maximal
bronchodilation.

5.2.

Pharmacokinetic Properties

Studies using 14C-labelled ipratropium showed that 2.8% of an inhaled dose is
excreted in urine, compared to 7.2% following oral administration and 70%
after intravenous administration, thus demonstrating that absorption from the
lungs is negligible and it is poor from the gastrointestinal tract. Intravenous
injection gives a plasma elimination half life of 3.6 hours.
Ipratropium is metabolised and is actively eliminated into bile and urine.
However, following intravenous administration, up to 50% appears unchanged
in urine. Ipratropium has a wide therapeutic range, but since little of it is
absorbed following inhalation, there is unlikely to be clinically significant
alterations in its pharmacokinetics in patients with impaired renal or hepatic
function.

5.3.

Preclinical Safety Data
There are no specific preclinical findings.

6

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Sodium chloride Ph. Eur.
Water for injections Ph. Eur.
Hydrochloric acid, Concentrated Ph Eur.

6.2.

Incompatibilities
None known.

6.3.

Shelf Life
1 ml ampoule: 18 months
2 ml ampoule: 24 months
Once the outer is opened use within 6 months.

6.4.

Special Precautions for Storage

Store in boxes below 25°C protected from light.
The ampoule should be opened immediately before use and any solution
remaining after use should be discarded.

6.5.

Nature and Contents of Container
Sterile, 2ml unit dose, polyethylene ampoules, containing either 1ml or 2ml of
a 0.025% w/v solution of ipratropium bromide in isotonic saline, packed into
cartons. Cartons are available in two sizes; 20 or 60 ampoules packed in strips
of 10.

6.6.

Instruction for Use/Handling
Ipratropium Bromide Nebuliser Solution is for inhalation from an intermittent
positive pressure ventilator or from a suitable nebuliser which should be
operated according to the manufacturers instructions.
To open the plastic ampoule, take a strip of ampoules from the box, remove
one ampoule and replace the rest back in the box. Hold the ampoule upright
and open by twisting off the top. Squeeze the liquid into the solution holder of
the machine.

7

MARKETING AUTHORISATION HOLDER
Generics [UK] Ltd t/a Mylan
Station Close
Potters Bar
Herts
EN6 1TL

8.

MARKETING AUTHORISATION NUMBER
PL 04569/0375

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION

28/08/2003

10

DATE OF REVISION OF THE TEXT
29/01/2010

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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