Consumer medicine information

Ipratrin uni-dose; Ipratrin Adult uni-dose

Ipratropium bromide

BRAND INFORMATION

Brand name

Ipratrin uni-dose

Active ingredient

Ipratropium bromide

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ipratrin uni-dose; Ipratrin Adult uni-dose.

What is in this leaflet

This leaflet answers some common questions about Ipratrin uni-dose and Ipratrin Adult uni-dose.

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

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

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

Keep this leaflet with your medicine. You may need to read it again.

What Ipratrin is used for

Ipratrin is used to treat:

  • asthma
  • chronic obstructive bronchitis
  • people who have difficulty breathing during or after surgery using assisted ventilation

Asthma is a disease where the lining of the lungs becomes inflamed (red and swollen), making it difficult to breathe. This may be due to an allergy to house dust mites, smoke or other irritants.

Chronic obstructive bronchitis is a lung condition that can cause difficulty in breathing, wheeziness and constant coughing.

Ipratrin contains the active ingredient ipratropium bromide. It belongs to a group of medicines called anticholinergic bronchodilators.

Ipratrin opens up the air passages in people suffering from asthma, chronic bronchitis and difficulty breathing during or after surgery.

It begins to act quickly after use but may take up to 2 hours to give maximum benefit.

Ask your doctor if you have any questions about why Ipratrin has been prescribed for you. Your doctor may have prescribed it for another reason.

Ipratrin is available only with a doctor's prescription.

There is no evidence that Ipratrin is addictive.

Before you use Ipratrin

When you must not use it

Do not use Ipratrin if you have an allergy to:

  • ipratropium bromide or any other medicines used to treat breathing problems
  • similar medicines which contain atropine or medicines like atropine
  • any of the ingredients listed at the end of this leaflet.
  • any other anticholinergic medicines.

Some of the 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
  • rash, itching or hives on the skin

Do not use Ipratrin after the expiry date printed on the ampoule or pack, or if the packaging is torn or shows signs of tampering. If you take this medicine after the expiry date has passed, it may not work as well.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start using this medicine, contact your doctor or pharmacist.

Before you start to use it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you are pregnant or intend to become pregnant. Your doctor will discuss the possible risks and benefits of using Ipratrin during pregnancy.

Tell your doctor or pharmacist if you are breastfeeding or plan to breastfeed. Your doctor or pharmacist will discuss the possible risks and benefits of using Ipratrin during breastfeeding.

Tell your doctor if you have, or have had, any of the following medical conditions:

  • glaucoma (high pressure in the eye)
  • difficulty or pain when passing urine
  • constipation
  • cystic fibrosis
  • hyperreactive airway.

If you have not told your doctor about any of the above, tell him/her before you start using Ipratrin.

Taking other medicines

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

Some medicines and Ipratrin may interfere with each other. These include:

  • medicines used to treat heart problems such as adrenaline
  • medicines used to treat asthma or a lung condition called chronic obstructive pulmonary disease (COPD) such as theophylline and salbutamol or tiotropium
  • other nebuliser solutions such as disodium cromoglycate that contain the preservative benzalkonium chloride.

This is because some nebuliser solutions may not mix well with Ipratrin and may need to be nebulised separately.

These medicines may be affected by Ipratrin, or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Ipratrin may be used with other medicines that relax the air passages for additional symptom relief, when prescribed by a doctor.

Your doctor and pharmacist may have more information on medicines to be careful with or avoid while using Ipratrin.

How to use Ipratrin

Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.

If you are not sure how to use a nebuliser mask, or do not understand the instructions on the pack, ask your doctor or pharmacist for help.

You must make sure that a nebuliser mask is properly fitted to your or your child’s nose and mouth before nebulising and inhaling Ipratrin. Fit the nebuliser mask to your or your child’s nose and mouth before nebulising and inhaling to prevent the mist from contacting your eyes.

If you find it difficult to breathe in and use your nebulising mask at the same time, talk to your doctor or pharmacist. They may be able to recommend another method.

Never let the Ipratrin solution or mist enter in or around your eyes. Should this occur, immediately flush your eyes with cold tap water for several minutes.

How much to use

The usual doses for adults and children are stated below.

Adults

  • 1 to 2 ampoules (250 mcg to 500 mcg) of Ipratrin uni-dose 250 mcg/1 mL, or
  • 1 ampoule (500 mcg) of Ipratrin Adult uni-dose 500 mcg/1 mL

diluted to 2 or 3 mL with normal saline, and nebulised until the entire volume of solution is inhaled, four times a day.

Depending on your condition and specific needs, your doctor may advise you to take a different dose.

Children

  • 1 ampoule (250 mcg) of Ipratrin uni-dose 250 mcg/1 mL, diluted to 2 or 3 mL with normal saline and nebulised until the entire volume of solution is inhaled, four times a day.

Depending on your child’s condition and specific needs, your doctor may advise you to give a different dose.

Use only Ipratrin uni-dose 250 mcg/1 mL, unless advised otherwise by your doctor.

Only the lower strength of Ipratrin is suitable for children, as each ampoule contains the smaller dose recommended for children.

How to use it

The liquid in Ipratrin ampoules is for inhalation only. It must not be swallowed or injected.

Diluted solutions should be freshly prepared before use.

  1. Before you use Ipratrin, prepare the nebuliser equipment for use according to the manufacturer's instructions and your doctor’s advice.
  2. Carefully tear a new ampoule from the strip. Never use one that is already open.
  3. Open the ampoule by holding it upright and twisting off the top portion. Use the solution as soon as you open the ampoule.
  4. Place the open end of the ampoule well into the nebuliser bowl and squeeze it slowly until all the liquid has been emptied into the nebuliser bowl.
  5. If your doctor has told you to dilute Ipratrin, do this just before use with 2 to 3 mL of normal saline only.
  6. Assemble the nebuliser and inhale Ipratrin as directed.
  7. Make sure your nebuliser mask is properly fitted over your mouth and nose.
This will reduce the chance of mist getting into your eyes.
  1. After use, discard any liquid remaining in the nebuliser bowl or ampoule and clean the nebuliser as recommended.

When to use it

Use your medicine at about the same time each day. Using it at the same time each day will have the best effect. It will also help you remember when to use it.

How long to use it for

Continue using Ipratrin for as long as your doctor tells you.

Ipratrin helps control your condition, but does not cure it. It is important to keep using it even if you feel well.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and have your next dose when you are meant to.

Otherwise, use it as soon as you remember, and then go back to using your medicine as you would normally.

Do not use a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to use your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or pharmacist or the Poisons Information Centre (telephone 13 11 26) or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have used too much Ipratrin. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of overdose may include:

  • fast or irregular heart beat
  • dry mouth
  • blurred vision.

While you are using Ipratrin

Things you must do

Stop using Ipratrin and tell your doctor immediately if you get sudden tightness of chest, coughing, wheezing or breathlessness immediately after using Ipratrin. These may be signs of a condition known as bronchospasm.

If you have an Asthma Action Plan that you have agreed to with your doctor, follow it closely at all times.

If you find that the usual dose of Ipratrin is not giving as much relief as before, or you need to use it more often, contact your doctor so that your condition can be checked. This is important to ensure your breathing problem is controlled properly.

Continue using Ipratrin for as long as your doctor or pharmacist tells you.

Visit your doctor regularly to check on your asthma condition.

Contact your doctor immediately if you experience irritation or a feeling of having something in the eye or any disturbances with your sight (blurred vision, visual halos or coloured images) together with red eyes, during or after using Ipratrin. This may mean that you have developed a serious eye condition called narrow angle glaucoma. This can happen if the mist gets in your eyes.

Always use a new ampoule. Used or left over solution may become contaminated as Ipratrin does not contain a preservative.

If your doctor has told you to dilute Ipratrin, do this with normal saline only and immediately before use.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Ipratrin.

Tell any other doctors, dentists and pharmacists who are treating you that you are using this medicine.

If you plan to have surgery, tell your surgeon or anaesthetist that you are using Ipratrin. It may affect other medicines during surgery.

If you become pregnant while using this medicine, tell your doctor or pharmacist immediately.

Things you must not do

Do not take any other medicines for your breathing problems without checking with your doctor.

Do not give this medicine to anyone else, even if they have the same condition as you.

Do not use this medicine to treat any other complaints unless your doctor tells you to.

Do not stop using Ipratrin or lower the dosage, without checking with your doctor or pharmacist.

Do not allow the Ipratrin Uni-Dose mist to enter the eyes.

Do not swallow or inject the liquid. Ipratrin is intended for inhalation with a suitable nebulising machine.

Things to be careful of

Be careful driving or operating machinery until you know how Ipratrin affects you. Ipratrin may cause dizziness and blurred vision in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous. Children should be careful when performing physical activities.

Side effects

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

Ipratrin helps most people with asthma or chronic obstructive bronchitis, but may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

If you get any side effects, do not stop using Ipratrin without first talking to your doctor or pharmacist.

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

  • headache
  • dizziness
  • dry or sore mouth
  • throat irritation
  • cough
  • nausea, vomiting
  • change in bowel movements (e.g. constipation, diarrhoea, wind, indigestion, reflux (an unusual backflow of fluid))

These are the more common side effects of Ipratrin. Most of these are mild and short lived.

Tell your doctor as soon as possible if you experience difficulty passing urine. This is a serious side effect that may require medical attention.

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

  • difficulty breathing or worsening of your breathing problems
  • spasm of the muscles around the voice box, causing choking
  • swelling of the throat
  • fast or irregular heart beat, also called palpitations
  • pounding heart beat
  • allergic reaction (shortness of breath, wheezing or troubled breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin)
  • irritation or a feeling of having something in the eye, red eyes, dilated pupils, blurred vision, visual halos or coloured images

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.

After using Ipratrin

Storage

Keep Ipratrin 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.

Keep the solution in the ampoules until it is time to use them. If you remove the solution from the ampoules it may not keep well.

Discard any liquid left in opened ampoules or in the nebuliser bowl.

Keep your ampoules in a cool dry place where the temperature stays below 25°C.

Keep the ampoules away from light.

Do not store Ipratrin or any other medicine in the bathroom or near a sink. Do not leave Ipratrin in the car or on window sills. Heat, light and dampness can destroy the medicine.

Disposal

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

Product description

What it looks like

Ipratrin is available in 2 strengths:

  • Ipratrin uni-dose 250 mcg/1 mL
  • Ipratrin Adult uni-dose 500 mcg/1 mL.

Both strengths of Ipratrin come in plastic single-use ampoules containing a clear and colourless solution.

Each ampoule contains 1 mL of solution. Each pack contains 30 ampoules, arranged as 3 individually foil wrapped strips of 10 ampoules.

Ingredients

The active ingredient in Ipratrin is ipratropium bromide (anhydrous).

Each ampoule of Ipratrin uni-dose contains 261 mcg of ipratropium bromide [equivalent to 250 mcg of ipratropium bromide (anhydrous)].

Each ampoule of Ipratrin Adult uni-dose contains 522 mcg of ipratropium bromide [equivalent to 500 mcg of ipratropium bromide (anhydrous)].

Ipratrin uni-dose and Ipratrin Adult uni-dose also contains the following inactive ingredients:

  • sodium chloride
  • hydrochloric acid
  • purified water.

Ipratrin uni-dose and Ipratrin Adult uni-dose are preservative free

Supplier

Ipratrin uni-dose and Ipratrin Adult uni-dose are supplied by:

Alphapharm Pty Limited
Level 1, 30 The Bond
30 Hickson Road
Millers Point NSW 2000
www.mylan.com.au.

Australian registration numbers:

Ipratrin uni-dose 250 mcg/1 mL – AUST R 58164

Ipratrin Adult uni-dose 500 mcg/1 mL – AUST R 62144

® Ipratrin is a registered trademark.

This leaflet was prepared on 02 August 2019

Ipratrin uni-dose&Adult_cmi\Aug19/00

Directions for use

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

Diluted solutions should be freshly prepared before use.

At the end of inhalation, leftover solution from nebuliser bowl should be discarded.

Take the following steps in using Ipratrin and if you have any problems, ask your doctor or pharmacist for assistance.

  1. Get your nebuliser ready by following the manufacturer’s instructions and advice of your doctor.
  2. Carefully tear a new vial from the strip. Never use one that had been opened already.

  1. Open the vial by twisting off the top, always taking care to hold it in an upright position.

  1. Squeeze the contents of the vial into the nebulise bowl. If dilution is necessary this should be carried out using normal saline and as instructed by your doctor.
  2. Assemble the nebuliser and take the medicine or give it to your child as directed by your doctor.

  1. After nebulisation follow the manufacturer’s instructions about cleaning your nebuliser.

Published by MIMS October 2019

BRAND INFORMATION

Brand name

Ipratrin uni-dose

Active ingredient

Ipratropium bromide

Schedule

S4

 

1 Name of Medicine

Ipratropium bromide monohydrate.

6.7 Physicochemical Properties

Ipratropium bromide monohydrate is a synthetic quaternary ammonium compound, chemically related to atropine. The addition of an N-isopropyl group distinguishes the molecule from atropine and is responsible for a lower lipid solubility.
Ipratropium bromide monohydrate is a white or off white crystalline substance. It is freely soluble in methanol, soluble in water and sparingly soluble in ethanol 96% (v/v).

Chemical name.

(1R, 3r, 5S, 8r)-3-[(RS)-(3-hydroxy-2-phenyl-propanoyl)-oxy]-8-methyl-8-(1-methylethyl)-8-azoniabicyclo[3.2.1]octane bromide monohydrate.

Molecular formula.

C20H30NO3Br.H2O.

Molecular weight.

430.4.

Chemical structure.


CAS number.

66985-17-9.

2 Qualitative and Quantitative Composition

Ipratrin uni-dose 250 microgram/1 mL: contains 261 microgram ipratropium bromide monohydrate [equivalent to 250 microgram ipratropium bromide (anhydrous)].
Ipratrin adult uni-dose 500 microgram/1 mL: contains 522 microgram ipratropium bromide monohydrate [equivalent to 500 microgram ipratropium bromide (anhydrous)].
Ipratrin uni-dose 500 microgram/2 mL: contains 522 microgram ipratropium bromide monohydrate [equivalent to 500 microgram ipratropium bromide (anhydrous)].
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Both strengths of Ipratrin Inhalation Solution come in plastic single use ampoules containing a clear colourless or almost colourless preservative free solution free from suspended particles.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Pharmacotherapeutic group: Anticholinergics.
ATC Code: R03BB01.
Ipratrin is an anticholinergic bronchodilator. It appears to inhibit vagally mediated reflexes by antagonising the action of acetylcholine, the transmitter agent released from the vagal nerve. Anticholinergics prevent the increase in intracellular calcium concentration caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle. Bronchodilation following inhalation of Ipratrin uni-doses is primarily a local, site specific effect at the bronchial smooth muscle. Ipratrin has no deleterious effect on airway mucous secretion or mucociliary clearance.
The time course of action of Ipratrin also differs from the β2-agonists in that although the onset of bronchodilator response is seen within 3 to 5 minutes of administration, peak response is not reached until 1.5 to 2 hours after inhalation. The duration of significant bronchodilator action is up to 6 hours.
Ipratrin may be used in combination with β2-agonists. There is evidence that in patients who respond to Ipratrin, the concurrent administration of Ipratrin and β2-agonists produces a greater relief of bronchospasm than either drug given alone.
Ipratrin inhibits acetylcholine induced bronchospasm and provides partial protection against histamine and allergen induced bronchospasm.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Following inhalation, 10 to 30% of the dose (depending on the formulation and inhalation technique) is generally deposited in the lungs. The major part of the dose is swallowed and passes into the gastrointestinal tract. Due to the low gastrointestinal absorption of ipratropium bromide monohydrate, the bioavailability of the portion of the dose swallowed accounts for approximately 2% of the dose. This fraction of the dose does not make a relevant contribution to the plasma concentrations of the active ingredient. The portion of the dose deposited in the lungs reaches the circulation rapidly (within minutes) and has nearly complete systemic availability.
From renal excretion data (0-24 hours), the total systemic bioavailability (pulmonary and gastrointestinal portions) of inhaled doses of ipratropium bromide monohydrate was estimated to be in the range 7 to 28%.

Distribution.

Kinetic parameters describing the disposition of ipratropium bromide monohydrate were calculated from plasma concentrations after intravenous administration. A rapid biphasic decline in plasma concentrations is observed. The volume of distribution (Vz) is 338 L (approximately 4.6 L/kg). The half-life of the terminal elimination phase is about 1.6 hours. The drug is less than 20% bound to plasma proteins. The ipratropium ion does not cross the blood brain barrier, consistent with the ammonium structure of the molecule.

Metabolism.

The mean total clearance of the drug is 2.3 L/min. The major portion, approximately 60% of the systemically available dose, is eliminated by metabolic degradation, probably in the liver. The main urinary metabolites bind poorly to the muscarinic receptor and have no activity.

Excretion.

Approximately 40% of the systemically available dose is cleared via urinary excretion, corresponding to an experimental renal clearance of 0.9 L/min. After oral dosing less than 1% of the dose is renally excreted, indicating an insignificant absorption of ipratropium bromide monohydrate from the gastrointestinal tract.
In excretion balance studies, after intravenous administration of a radioactive dose, less than 10% of the drug related radioactivity (including parent compound and all metabolites), are excreted via the biliary-faecal route. The dominant excretion of drug related radioactivity occurs via the kidneys.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

Two year oral carcinogenicity studies in rats and mice have revealed no carcinogenic potential at dietary doses up to 6 mg/kg/day for Ipratrin. Results of various mutagenicity studies (Ames test, mouse dominant lethal test, mouse micronucleus test and chromosome aberration of bone marrow in Chinese hamsters) were negative.

4 Clinical Particulars

4.1 Therapeutic Indications

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.
Administration of Ipratrin via a nebuliser is intended for those patients who cannot use a metered dose aerosol.

4.3 Contraindications

Known hypersensitivity to atropine or its derivatives (such as the active substance ipratropium bromide monohydrate), or to other any of the ingredients of Ipratrin (excipients are listed under Section 6.1, see Section 6.1 List of Excipients).

4.4 Special Warnings and Precautions for Use

Hypersensitivity.

Immediate hypersensitivity reactions may occur after administration of Ipratrin, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, oropharyngeal oedema and anaphylaxis.

Paradoxical bronchospasm.

As with other inhaled medicines Ipratrin may result in paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs Ipratrin should be discontinued immediately and substituted with an alternative therapy.

Anticholinergic effects.

Like other drugs with anticholinergic activity, ipratropium bromide monohydrate 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 eyes with narrow iridocorneal angles as acute angle closure glaucoma may be precipitated, or patients with a tendency towards urinary retention or constipation.

Ocular complications.

Ipratrin should be used with caution in patients predisposed to narrow angle glaucoma.
There have been isolated reports of ocular complications (mydriasis, increased intraocular pressure, acute angle glaucoma, eye pain) as a result of direct eye contact of aerolised ipratropium bromide monohydrate, either alone or in combination with an adrenergic β2-agonist. Thus, patients must be instructed in the correct administration of Ipratrin, and warned not to allow the solution or mist to enter the eyes. A nebuliser mask must be fitted properly during inhalation.
Patients who may be predisposed to glaucoma should be specifically warned to protect their eyes. Eye pain or discomfort, blurred vision, visual halos or coloured images, in association with red eyes from conjunctival congestion and corneal oedema, 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.

Renal and urinary effects.

Ipratropium bromide monohydrate should be used with caution in patients with pre-existing urinary outflow tract obstruction (e.g. prostatic hyperplasia or bladder neck obstruction).

Gastro-intestinal motility disturbances.

Patients with cystic fibrosis may be more prone to gastrointestinal motility disturbances.

Local effects.

Ipratrin inhalation solution in the multidose bottle contains benzalkonium chloride and disodium edetate. When inhaled these agents may cause bronchospasm in sensitive patients with hyper-reactive airways. If the multidose nebulising solution is prescribed, it is suggested that patients be monitored for their FEV1, and if the FEV1 falls, therapy with the preservative free unit dose vials or metered dose aerosol should be used.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The chronic coadministration of Ipratrin inhalation with other anticholinergic drugs has not been studied. Therefore, the chronic coadministration of Ipratrin with other anticholinergic drugs is not recommended.
Beta-adrenergics and xanthine preparations may intensify the bronchodilatory effect.
The risk of acute glaucoma in patients with a history of narrow angle glaucoma (see Section 4.4 Special Warnings and Precautions for Use) may be increased when nebulised ipratropium bromide monohydrate and beta-mimetics are administered simultaneously.

Physical compatibility.

Ipratrin inhalation solutions and disodium cromoglycate inhalation solutions that contain the preservative benzalkonium chloride should not be administered simultaneously in the same nebuliser as precipitation may occur.
Ipratrin UDVs and disodium cromoglycate inhalation solutions should not be administered simultaneously in the same nebuliser.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Clinical data on fertility are not available for ipratropium bromide monohydrate.
(Category B1)
Care is recommended during pregnancy, particularly in the first trimester. The safety of Ipratrin during pregnancy has not been established. The benefits of using Ipratrin when pregnancy is confirmed or suspected must be weighed against possible hazards to the foetus. Studies in rats, mice and rabbits showed no embryo-toxic nor teratogenic effects.
No specific studies are available to determine the excretion of ipratropium bromide monohydrate in human breast milk. Although lipid insoluble quaternary cations pass into breast milk, it is unlikely that ipratropium bromide monohydrate would reach the infant to an important extent, especially when administered by inhalation. However, as many drugs are excreted into breast milk, caution should be exercised when Ipratrin is administered to breastfeeding mothers.

4.8 Adverse Effects (Undesirable Effects)

Many of the listed undesirable effects can be assigned to the anticholinergic properties of Ipratrin. As with all inhalation therapy Ipratrin may show symptoms of local irritation. Adverse drug reactions were identified from data obtained in clinical trials and pharmacovigilance during postapproval use of the drug.
The most frequent side effects reported in clinical trials were headache, dizziness, throat irritation, cough and gastrointestinal disorders (including constipation, diarrhoea, gastrointestinal motility disorder, dry mouth, nausea, stomatitis, oedema mouth and vomiting).
If the substance enters the eyes by inappropriate handling, mild and reversible disturbance of accommodation may occur. Other ocular complications have also been reported (see Section 4.4 Special Warnings and Precautions for Use). However, acute angle closure glaucoma has been reported following direct eye contact.
Allergic type reactions such as angio-edema of the tongue, lips and face may occur.
The following adverse reactions were reported in the clinical studies at the following frequency: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10,000, < 1/1000); 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, gastro-intestinal motility disorder (including reports of change in bowel motions and habits, dyspepsia, gastrointestinal reflux, and flatulence).1
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).
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.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Dosage (dose and interval).

Dosage is dependent on the mode of inhalation and the quality of nebulisation. The duration of inhalation can be controlled by the dilution volume. It is advisable not to greatly exceed the recommended daily dose as this suggests additional therapeutic modalities may be needed.

Note.

The dosage should be adapted to the individual requirements of the patient; patients should also be kept under medical supervision during treatment. Unless otherwise prescribed, the following doses are recommended.

Adults.

The recommended dose is 261 to 522 microgram [equivalent to 250 to 500 microgram ipratropium bromide (anhydrous)], 4 times daily, diluted to 2 to 3 mL with normal saline and nebulised until the entire volume of solution is consumed. Daily doses exceeding 2.088 mg [equivalent to 2 mg ipratropium bromide (anhydrous)] in adults should be given under medical supervision.
In cases of moderate bronchospasm or with assisted ventilation, a dose in the lower range of 261 microgram [equivalent to 250 microgram ipratropium bromide (anhydrous)] is recommended. In more severely distressed patients, 522 microgram ipratropium bromide [equivalent to 500 microgram ipratropium bromide (anhydrous)] has been shown to produce optimal bronchodilatation.
Ipratrin can be administered combined with an inhaled β2-agonist.

Children.

The recommended dose is 261 microgram [equivalent to 250 microgram ipratropium bromide (anhydrous)], 4 times daily, diluted to 2 to 3 mL with normal saline and nebulised until the entire volume of solution is consumed. Daily doses exceeding 1.044 mg [equivalent to 1 mg ipratropium bromide (anhydrous)] in children under 12 years of age should be given under medical supervision.

Method of administration.

Ipratrin uni-doses can be administered via a range of commercially available nebulising devices. Where wall oxygen is available, solutions are best administered at a flow rate of 6 to 8 litres per minute.
Ipratrin can be administered combined with an inhaled β2-agonist.
It is advisable not to greatly exceed the recommended daily dose.
If therapy does not produce a significant improvement or if the patient's condition gets worse, medical advice must be sought in order to determine a new plan of treatment. In the case of acute or rapidly worsening dyspnoea (difficulty in breathing) a doctor should be consulted immediately.

4.7 Effects on Ability to Drive and Use Machines

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 ipratropium bromide monohydrate. Therefore, caution should be recommended when driving a car or operating machinery. If patients experience the abovementioned side effects they should avoid potentially hazardous tasks such as driving or operating machinery.

4.9 Overdose

No symptoms specific to overdosage have been encountered. In view of the wide therapeutic range and topical administration of Ipratrin uni-dose inhalation solutions, no serious anticholinergic symptoms are to be expected. Minor systemic manifestations of anticholinergic action, including dry mouth, visual accommodation disturbances and tachycardia may occur.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Ipratrin uni-doses contain sodium chloride, hydrochloric acid and purified water.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Storage conditions.

Store the unopened Unit Dose Vials (UDV) at below 25°C. Protect from light. Diluted solutions should be freshly prepared before use and any solution remaining in the nebuliser, on completion of inhalation, should be discarded.

6.5 Nature and Contents of Container

Ipratrin uni dose 250 microgram/1 mL: Ampoules of 1 mL, packs of 30. The packs of 30 are arranged as 3 individually foil wrapped strips of 10 ampoules.
Ipratrin uni dose 500 microgram/1 mL: Ampoules of 1 mL, packs of 10* and 30. The packs of 30 are arranged as 3 individually foil wrapped strips of 10 ampoules.
Ipratrin uni dose 500 microgram/2 mL*: Ampoules of 2 mL, packs of 10 and 30.
*Product not marketed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

Summary Table of Changes