Consumer medicine information

Ipravent Inhalation Solution (Unit dose)

Ipratropium bromide

BRAND INFORMATION

Brand name

Ipravent Inhalation Solution (Unit dose)

Active ingredient

Ipratropium bromide

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ipravent Inhalation Solution (Unit dose).

What is in this leaflet

This leaflet answers some common questions about Ipravent.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What IPRAVENT INHALATION SOLUTION is used for

Ipravent belongs to a group of medicines known as anticholinergic bronchodilators. Anticholinergic bronchodilators work by relaxing the bronchial tubes (air passages) that carry air in and out of your lungs. This makes breathing less difficult.

Ipravent is used to relieve the symptoms of lung disease such as asthma or chronic obstructive bronchitis. It may be used in other conditions where breathing is difficult, such as after surgery or during assisted ventilation.

Ipravent may be used for the management of other conditions that are not mentioned above. Your doctor will be able to tell you about the specific condition for which you have been prescribed Ipravent.

Ask your doctor if you have any questions about why it has been prescribed for you.

This medicine is available only with a doctor's prescription.

Before you use it

When you must not use it

Do not use Ipravent if you have an allergy to ipratropium bromide or any of the ingredients listed at the end of this leaflet.

If you are not sure if this applies to you, check with your doctor.

Ipravent should not be given to a newborn baby.

Do not use it after the expiry date (EXP) printed on the pack.

If you use it after the expiry date has passed, it may not work as well.

Do not use it if the packaging is torn or shows signs of tampering.

Before you start to use it

Tell your doctor if

  1. You have any allergies to:
  • any other medicine, especially atropine or other anticholinergic drugs
  • any other substances, such as foods, preservatives or dyes
  1. You are pregnant or intend to become pregnant
  2. You are breast-feeding or planning to breast-feed
  3. You have, or have had, the following medical conditions:
  • an eye condition called 'glaucoma' (condition in which the pressure within the eye is raised)
  • difficulty passing urine
  • chronic constipation
  • cystic fibrosis.

If you have not told your doctor about any of the above, tell them before you use Ipravent.

Interactions with other medicines

Tell your doctor if you are using any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may have an effect on Ipravent. These include:

  • other anticholinergic medications e.g. Atrovent, Buscopan, Spiriva
  • beta adrenergics e.g. Betaloc, Visken, Nyogel
  • xanthine e.g. Nuelin
  • beta mimetics e.g. Bricanyl.

These medicines may be affected by Ipravent, or may affect how well it works. You may need to use different amounts of your medicines, or take different medicines. Your doctor will advise you.

Your doctor or pharmacist has more information on medicines to be careful with or to avoid while taking Ipravent.

How to use it

Ipravent is intended for inhalation with suitable nebulising equipment and must not be swallowed.

How much to use

Your doctor will decide what dose and how long you will receive Ipravent. However, the usual dose of Ipravent is 250 to 500mcg diluted to 2 to 3mL with normal saline and nebulised until the entire volume of solution is inhaled, every six hours.

How to use it

Ipravent is used only in a power-operated nebuliser, which can be obtained from your local pharmacy.

You will also need a mask or mouthpiece, which is used with the nebuliser so that your prescribed dose can be inhaled. The time taken to deliver a given volume of solution will depend on the equipment used, but most nebulisers will deliver 1mL of solution over 3 minutes and 2mL over 8-10 minutes. Make sure you understand how to use the nebuliser.

Do not allow Ipravent to come in contact with the eyes.

It is important to ensure that the nebuliser mask is correctly fitted over the mouth and nose to prevent the mist from contacting the eyes.

If you forget to use it

If you forget your dose, inhale it as soon as you remember. If you remember when it is almost time for your next dose, inhale only your usual dose at that time.

Do not try to make up for missed doses by taking more than one dose at a time.

This may increase the chance of getting an unwanted side effect.

If you have trouble remembering when to take you medicine, ask your pharmacist for hints.

If you inhale too much (overdose)

Accidental overdose by inhalation is unlikely. However, if you do inhale too much ipratropium bromide, you may experience some of the effects listed under "Side effects" below.

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26) or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have inhaled too much Ipravent solution.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Keep these telephone numbers handy.

While you are using it

Things you must do

Contact your doctor immediately if you experience eye pain or discomfort, or any disturbances with your sight (blurred vision, visual halos or coloured images) during or after using Ipravent.

This is because there have been rare reports of narrow-angle glaucoma with the use of Ipravent products.

Tell your doctor if you need to use Ipravent more frequently than prescribed or if you need to inhale more Ipravent than prescribed to relieve your symptoms.

In these situations, your dose or treatment may need to be changed.

Tell your doctor or pharmacist if you begin taking any other medicine while you are using Ipravent.

Things to be careful of

Be careful driving or operating machinery until you know how Ipravent affects you.

When used as recommended, and when there are no side effects, Ipravent is not known to have any effect on the ability to drive or operate machinery.

Side effects

All medicines may have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for you.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while you are using Ipravent.

It helps most people with breathing problems, but it may have unwanted side effects in a few people.

Tell your doctor if you notice any of the following and they worry you:

  • headache
  • dizziness
  • throat irritation
  • cough
  • nausea and/or vomiting
  • change in bowel movements e.g. constipation, diarrhoea
  • dry mouth.

These are mild side effects of the medicine, and usually short-lived.

Tell your doctor immediately if you notice any of the following:

  • changes to your heart beat
  • difficulty passing urine
  • problems with your eyes e.g. red eyes, eye pain or discomfort, sight disturbances (blurred vision, visual halos or coloured images).

If any of the following happens, stop taking Ipravent and tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • worsening of breathing problems (induced by the inhalation process)
  • an allergic reaction to Ipravent, the signs of which may include skin rash, itching, swelling of face, lips and tongue, swelling of the throat area or difficulty breathing.

These may be serious side effects of Ipravent. You may need urgent medical attention. Serious side effects are uncommon.

Tell your doctor if you notice anything else that is making you feel unwell.

Other side effects not listed above may occur in some people.

After using it

Ipravent should be kept in the original container until it is time to use it.

Ipravent is sensitive to light and the ampoules should therefore be stored in the carton or protected from light.

Keep the medicine in a cool dry place where the temperature stays below 25°C, and protect from light. Use once only and discard any unused portion.

Do not store it or any other medicine in the bathroom, near a sink, or on a window-sill.

Do not leave it in the car.

Heat and damp can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using Ipravent or the solution has passed its expiry date, ask your pharmacist what to do with any that is left over.

Product description

What it looks like

Ipravent solution is a clear, colourless to almost colourless solution supplied in a 1mL unit dose plastic Sterineb ampoule.

Ipravent is identified by an Australian Registration Number which is found on the packaging:

  • AUST R 75644 - Ipravent Inhalation Solution 250mcg in 1mL (sterile) Sterineb ampoule (30s).
  • AUST R 75645 - Ipravent Inhalation Solution 500mcg in 1mL (sterile) Sterineb ampoule (30s).

Ingredients

Active ingredients:

  • ipratropium bromide monohydrate.

Inactive ingredients:

  • sodium chloride
  • water for injections.

Ipravent does not contain preservatives.

Manufacturer/Sponsor

Pfizer Australia Pty Ltd
ABN 50 008 422 348
38-42 Wharf Road
West Ryde NSW 2114 Australia

This leaflet was prepared in May 2012.

©Pfizer Australia 2012

® Registered Trademark

Sterinebs® are plastic ampoules produced by Pfizer

BRAND INFORMATION

Brand name

Ipravent Inhalation Solution (Unit dose)

Active ingredient

Ipratropium bromide

Schedule

S4

 

Name of the medicine

Ipratropium Bromide BP.

Excipients.

Sodium Chloride BP in Water for Injections BP. It does not contain preservatives.

Description

Chemical name: (1R,3r,5S,8r)-3-[(RS)-(3-hydroxy- 2-phenylpropanoyl)oxy]- 8-methyl-8-(1-methylethyl)- 8-azoniabicyclo [3.2.1] octane bromide. Molecular formula: C20H30BrNO3. MW: 412.4. CAS: 22254-24-6.
Ipratropium bromide is a quaternary isopropyl derivative of atropine. It appears as a white or almost white, crystalline powder, soluble in water, freely soluble in methanol and slightly soluble in alcohol. The addition of an N-isopropyl group distinguishes the molecule from atropine and is responsible for a lower lipid solubility.
Ipravent Inhalation Solution (Unit dose) contains ipratropium bromide monohydrate 261 microgram/mL ≡ ipratropium bromide (anhydrous) 250 mg or ipratropium bromide monohydrate 522 microgram/mL ≡ ipratropium bromide (anhydrous) 500 mg (see Presentation).

Pharmacology

Class of drug.

Anticholinergic bronchodilator.

Mode of action.

Ipratropium bromide allows bronchodilation by inhibiting cholinergic bronchomotor tone and consequently, vagal reflexes mediating bronchoconstriction are blocked. In this respect ipratropium bromide is fundamentally different from β2-agonists. The onset of bronchodilator response is seen within three to five minutes of administration. Peak response is reached 1.5 to 2 hours after inhalation. The duration of significant bronchodilator action is up to 6 hours. Ipravent can be used in combination with β2-agonists.
There is evidence that in patients who respond to ipratropium bromide greater relief of bronchospasm can be achieved by the concurrent use of ipratropium bromide, and β2-agonists, as compared to that achieved by using either drug alone. Ipratropium bromide inhibits bronchospasm induced by acetylcholine and offers partial protection against histamine and allergen induced bronchospasm. No significant alteration in sputum viscosity, sputum volume or mucociliary clearance has been observed.

Pharmacokinetics.

There are no data available relating to systemic levels of inhaled nebulised solution. Like other substances administered by inhalation, most of the dose enters the gastrointestinal tract, is unabsorbed and is excreted in the faeces. In healthy volunteers, the elimination half-life is 3.5 hours (range 1.5 to 4 hours). Eight metabolites possessing little or no anticholinergic activity have been detected.

Indications

Moderate asthmatic attacks.
Chronic forms of asthma.
Asthma in patients with diminished cardiac reserve.
Bronchospasm during or after surgery.
Chronic obstructive bronchitis with bronchospasm.
Use during assisted ventilation with a respirator.

Contraindications

Hypersensitivity to ipratropium bromide or any of the ingredients.

Precautions

Like other drugs with anticholinergic activity, ipratropium bromide should be avoided or used with caution in patients where atropine-like effects may precipitate or exacerbate a pre-existing clinical condition. Patients at particular risk are those with the following conditions.
Eyes with narrow iridocorneal angles (as acute angle closure glaucoma may be precipitated).
Tendency towards urinary retention.
Tendency towards constipation.
Patients with cystic fibrosis may be more prone to gastrointestinal motility disturbances.
Ipratropium bromide should be used with caution in patients with pre-existing urinary outflow tract obstruction (e.g. prostatic hyperplasia or bladder neck obstruction).
Patients must be instructed on the correct administration of Ipravent and warned to not allow the solution to enter the eyes. There have been isolated reports of ocular complications, e.g. mydriasis, increased intraocular pressure, acute angle closure glaucoma and eye pain as a result of direct contact of the solution.
Patients who may be predisposed to glaucoma must protect their eyes. Eye pain or discomfort, blurred vision, visual halos, or coloured images in association with red eyes from conjunctival and corneal congestion, may be signs of acute angle closure glaucoma. Should any combination of these symptoms develop, treatment with miotic drops should be initiated and specialist advice sought immediately.
Immediate hypersensitivity reactions may occur after administration of Ipravent, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, oropharyngeal oedema and anaphylaxis.

Use in pregnancy.

(Category B1)
Care is recommended during pregnancy, particularly in the first trimester. The benefits of using ipratropium bromide when pregnancy is present or suspected must be weighed against possible hazards to the foetus.

Use in lactation.

No specific studies are available to determine the excretion of ipratropium bromide in human breast milk. The benefit of using ipratropium bromide during lactation should therefore be weighed against possible effects on the child.

Use in children.

Ipravent Inhalation Solution is not recommended for use in infants less than 8 weeks old.

Mutagenicity.

Studies in rats, mice and rabbits showed no embryotoxic or teratogenic effects.

Effects on ability to drive or operate machinery.

No studies on the effects on the ability to drive and use machines have been performed. However, patients should be advised that they may experience undesirable effects such as dizziness, accommodation disorder, mydriasis and blurred vision during treatment with Ipravent. Therefore, caution should be recommended when driving a car or operating machinery. If patients experience the above mentioned side effects they should avoid potentially hazardous tasks such as driving or operating machinery.

Interactions

No significant drug interactions have been reported with ipratropium bromide, although there is some potential for an additive interaction with other concomitantly administered anticholinergic medications.
Effective bronchodilation with ipratropium bromide has been demonstrated in patients receiving β-adrenergics and xanthine preparations.
The risk of acute glaucoma in patients with a history of narrow angle glaucoma (see Precautions) may be increased when nebulised ipratropium bromide and β-mimetics are administered simultaneously.

Adverse Effects

Many of the listed undesirable effects can be assigned to the anticholinergic properties of ipratropium bromide. As with all inhalation therapy, ipratropium bromide may show signs of local irritation.
The most frequent side effects reported in clinical trials with ipratropium bromide were headache, dizziness, throat irritation, cough, gastrointestinal disorders (including constipation, diarrhoea, gastrointestinal motility disorder, dry mouth, nausea, stomatitis, oedema mouth and vomiting).
If the substance enters the eye by inappropriate handling, mild and reversible disturbance of accommodation may occur. Other ocular complications have also been reported (see Precautions). However, acute angle closure glaucoma has been reported following direct eye contact.
Allergic type reactions such as angioedema of the tongue, lips and face may occur.
The following adverse reactions were reported in the clinical studies of ipratropium bromide at the following frequency: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000).

Immune system disorders.

Uncommon: hypersensitivity, anaphylactic reaction.

Nervous system disorders.

Common: headache, dizziness.

Eye disorders.

Uncommon: vision blurred, mydriasis, intraocular pressure increased, glaucoma, eye pain, halo vision, conjunctival hyperaemia, corneal oedema. Rare: accommodation disorder.

Cardiac disorders.

Uncommon: palpitations, supraventricular tachycardia. Rare: atrial fibrillation, heart rate increased.

Respiratory, thoracic and mediastinal disorders.

Common: throat irritation, cough. Uncommon: bronchospasm, bronchospasm paradoxical, laryngospasm, pharyngeal oedema, dry throat.

Gastrointestinal disorders.

Common: dry mouth, nausea, gastrointestinal motility disorder (including reports of change in bowel motions and habits, dyspepsia, gastrointestinal reflux and flatulence)1. Uncommon: diarrhoea, constipation, vomiting, stomatitis, oedema mouth.

Skin and subcutaneous tissue disorders.

Uncommon: rash, pruritus, angioedema. Rare: urticaria.

Renal and urinary disorders.

Uncommon: urinary retention.
1The definition is based on a post hoc review of all ADR terms reported in the defined study dataset. Terms that report a clinically related term with greater medical specificity were excluded and added to the more specific term (e.g. ‘nausea’, ‘vomiting’).

Dosage and Administration

Ipravent Inhalation Solution in unit dose ampoules does not contain preservatives and is therefore intended for single use only. Any unused portion should be discarded.

Adults.

The recommended dosage is 250 to 500 microgram, diluted to 2 to 3 mL with normal saline and nebulised until the entire volume of solution is consumed, every six hours. Daily doses exceeding ipratropium bromide 2 mg in adults should be given under medical supervision.
In cases of moderate bronchospasm or with assisted ventilation, a dose in the lower range of 250 microgram is recommended. In severely distressed patients, 500 microgram has been shown to produce optimal bronchodilation. Inhalation may be repeated after two hours.

Dosage in children (over 8 weeks old).

A dose of 250 microgram diluted to 2 to 3 mL with normal saline is recommended for children, administered in the same manner as for adults. Daily doses exceeding ipratropium bromide 1 mg in children under 12 years of age should be given under medical supervision.
Ipravent solution can be administered via a range of commercially available nebulising devices. Solutions are best administered at a flow rate of 4 to 6 L/minute when using wall oxygen. Dosage is dependent on the mode of inhalation and the specific nebuliser used, and should be modified to suit individual patient requirements.

Compatibility.

Sodium cromoglycate may not be compatible with ipratropium bromide inhalation solution as precipitation may occur.
Dilutions of Ipravent Inhalation Solution should be carried out immediately before use. Should visible turbidity or crystallisation appear in the solution before or during inhalation, the preparation should be discarded. Any solution remaining in the nebuliser on completion of inhalation should be discarded immediately. Nebuliser bowls and associated equipment should be cleaned and maintained prior to each use according to the manufacturer's recommendations.

Overdosage

Accidental overdose by inhalation is unlikely. Adverse effects from overdosage may be expected to follow the pattern listed under Adverse Effects. Anticholinergic side effects are not severe and do not require specific reversal.

Presentation

Inhalation solution (clear, colourless to almost colourless, sterile solution), ipratropium bromide (anhydrous) 250 microgram/mL (≡ ipratropium bromide monohydrate 261 microgram/mL), 1 mL: 30's (AUST R 75644); ipratropium bromide (anhydrous) 500 microgram/mL (≡ ipratropium bromide monohydrate 522 microgram/mL), 1 mL: 30's (AUST R 75645) (sterineb ampoule).

Storage

Store below 25°C. Protect from light. Single use only. Discard unused portion.
Ipratropium bromide is sensitive to light. All ampoules must be stored in the carton or protected from light.
The expiry date (month/year) is stated on the package after the word EXP.

Poison Schedule

S4.