Cipla Ipratropium Metered Dose Inhaler

MIMS Revision Date: 01 November 2025

1 Name of Medicine

Ipratropium bromide monohydrate.

2 Qualitative and Quantitative Composition

Cipla Ipratropium contains ipratropium bromide monohydrate 20.87 micrograms [equivalent to 20 micrograms of ipratropium bromide] per actuation.
Excipients with known effect. Contains 8.4 mg ethanol absolute per actuation.
For full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Cipla Ipratropium is a pressurised inhalation solution.
Each Cipla Ipratropium metered dose aerosol is a colourless solution, filled in an aluminum container fitted with a suitable metering valve and a plastic actuator.

4 Clinical Particulars

4.1 Therapeutic Indications

Cipla Ipratropium metered aerosol is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with asthma and chronic obstructive pulmonary disease (COPD).

4.2 Dose and Method of Administration

Note. One puff (metered dose) of Cipla Ipratropium contains 20.87 micrograms of ipratropium bromide monohydrate [equivalent to 20 micrograms of ipratropium bromide].
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.
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, a doctor should be consulted immediately.
Adults. Two puffs 3 to 4 times daily, although some patients may need up to 4 puffs at a time to obtain maximum benefit during early treatment.
Before first use of the inhaler, or if the inhaler has not been used for three days or more, prime the inhaler by releasing two puffs into the air.
Patients should be instructed to clean mouthpiece at least once a week. It is important to keep the mouthpiece of inhaler clean to ensure that medicine does not build up and block the spray.
Patients with poor inhaler technique will benefit from the consistent use of a spacer device with their metered aerosol. Use of a spacer will also decrease the amount of drug deposited in the mouth and back of the throat, and therefore, reduce the incidence of local irritation in susceptible patients.
In those people using a spacer, a change in formulation of the drug used, or a change in the make of the spacer may be associated with alterations in the amount of drug delivered to the lungs. The clinical significance of these alterations is uncertain. However, in these situations, the person should be monitored for any change in their condition.
If using a spacer, the patient should be instructed to breathe in and out after each actuation of the drug into the spacer. Any delay should be kept to a minimum.
Static on the walls of the spacer may cause variability in drug delivery. Patients should be instructed to wash the spacer in warm water and detergent and allow it to dry without rinsing or drying with a cloth. This should be performed before initial use of the spacer and at least monthly thereafter.
The Cipla Ipratropium metered aerosol can must only be used with the mouthpiece supplied with the product.

4.3 Contraindications

Known hypersensitivity to atropine or its derivatives (such as the active substance ipratropium bromide), or to any of the other ingredients of Cipla Ipratropium.

4.4 Special Warnings and Precautions for Use

Hypersensitivity. Immediate hypersensitivity reactions may occur after administration of ipratropium bromide pressurised inhalation aerosol, as demonstrated by rare cases of urticaria, angio-oedema, rash, bronchospasm, oropharyngeal oedema and anaphylaxis.
Paradoxical bronchospasm. As with other inhaled medicines ipratropium bromide may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs ipratropium bromide pressurised inhalation aerosol should be discontinued immediately and substituted with an alternative therapy.
Anticholinergic effects. 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 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. Ipratropium bromide pressurised inhalation aerosol 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 ipratropium bromide formulations. Thus, patients must be instructed in the correct administration of ipratropium bromide pressurised inhalation aerosol and warned not to allow the aerosol to enter the eyes.
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 pressurised inhalation aerosol 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.
Propellants. Cipla Ipratropium CFC-free metered aerosol contains the hydrofluoroalkane propellant norflurane. In animal studies, norflurane has been shown to have no significant pharmacological effects, except at very high exposure concentrations when narcosis and a relatively weak sensitisation to the arrhythmogenic effects of catecholamines were found. The potency of the cardiac sensation was less than that of trichloromethane.
Excessive inhalation of the aerosol should, however, be avoided as this carries a potential hazard, both from the propellant as well as from overdosage of the active therapeutic agent contained in the formulation. The recommended dose should not be exceeded and the patients should be so informed.
Alcohol content. Cipla Ipratropium contains about 8.4 mg of alcohol (ethanol) in each actuation. The amount in each actuation of this medicine is equivalent to less than 1 mL beer or 1 mL wine. The small amount of alcohol in this medicine will not have any noticeable effects.
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 co-administration of ipratropium bromide pressurised inhalation aerosol with other anticholinergic drugs has not been studied. Therefore, the chronic co-administration of ipratropium bromide pressurised inhalation aerosol with other anticholinergic drugs is not recommended.
Beta-adrenergics and xanthine preparations may intensify the bronchodilatory effect of ipratropium bromide.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility. Clinical data on fertility are not available for ipratropium bromide.
Use in pregnancy. (Category B1)
Care is recommended during pregnancy, particularly in the first trimester. The safety of ipratropium bromide pressurised inhalation aerosol during pregnancy has not been established. The benefits of using ipratropium bromide pressurised inhalation aerosol 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.
Use in lactation. No specific studies are available to determine the excretion of ipratropium bromide in human breast milk. Although lipid-insoluble quaternary cations pass into breast milk, it is unlikely that ipratropium bromide 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 ipratropium bromide pressurised inhalation aerosol is administered to breastfeeding mothers.

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 pressurised inhalation aerosol. 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.

4.8 Adverse Effects (Undesirable Effects)

Many of the listed undesirable effects can be assigned to the anticholinergic properties of ipratropium bromide pressurised inhalation aerosol. As with all inhalation therapy ipratropium bromide pressurised inhalation aerosol may show symptoms of local irritation. The most frequent side effects reported in clinical trials 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 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-oedema of the tongue, lips and face may also occur.
The following adverse reactions have been reported during use of ipratropium bromide pressurised inhalation aerosol in clinical trials and during the post-marketing experience 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). See Table 1.

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.

4.9 Overdose

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

5 Pharmacological Properties

Pharmacotherapeutic group: Anticholinergics. ATC code: R03BB01.

5.1 Pharmacodynamic Properties

Mechanism of action. Ipratropium bromide pressurised inhalation aerosol 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 ipratropium bromide pressurised inhalation aerosol is a local, site specific effect at the bronchial smooth muscle. Ipratropium bromide pressurised inhalation aerosol has no deleterious effect on airway mucous secretion or mucociliary clearance.
The time course of action of ipratropium bromide pressurised inhalation aerosol also differs from the β₂ agonists in that although the onset of bronchodilator response is seen within 3-5 minutes of administration, peak response is not reached until 1.5-2 hours after inhalation. The duration of significant bronchodilator action is up to 6 hours.
Ipratropium bromide pressurised inhalation aerosol may be used in combination with β₂ agonists. There is evidence that in patients who respond to ipratropium bromide pressurised inhalation aerosol, the concurrent administration of ipratropium bromide pressurised inhalation aerosol and β₂ agonists produces a greater relief of bronchospasm than either drug given alone.
Clinical trials. The use of ipratropium bromide metered aerosol, delivered using CFC-containing propellants, is well established in clinical practice. A clinical programme has been conducted to demonstrate the therapeutic equivalence of ipratropium bromide pressurised inhalation aerosol CFC-free and CFC-containing metered aerosols. The safety and efficacy of ipratropium bromide pressurised inhalation aerosol CFC-free metered aerosol, in chronic obstructive pulmonary disease (COPD) and asthma, was established from the results of one 12-month and two 12-week safety and efficacy trials conducted in COPD, a 12-week study in asthmatic adults.
A randomised, open-label, parallel design 12-month study in COPD patients, compared the safety and efficacy of ipratropium bromide metered aerosols containing either CFCs (n = 151) or norflurane (n = 305). Time profiles of forced expiratory volume in one second (FEV₁) mean changes from baseline on all test days demonstrated the efficacy and overall comparability of the ipratropium bromide pressurised inhalation aerosol CFC-free and CFC-containing aerosols. The two formulations were generally comparable throughout the trial with respect FEV₁ area under the curve for 0 to 6 hours (AUC_0-6). The overall safety profile indicated that both treatments were well tolerated.
A 12-week, double-blind, randomised trial in COPD patients, comparing safety and efficacy of ipratropium bromide pressurised inhalation aerosol CFC-free and CFC-containing metered aerosols (n = 118 and 56 respectively), concluded there were no differences in respect of changes in morning and evening peak expiratory flow rates. In addition, a randomised, double-blind, placebo and active controlled study of 12-weeks duration in COPD patients, concluded that ipratropium bromide pressurised inhalation aerosol CFC-free 42 microgram (n = 125) and 84 microgram (n = 127) were significantly more effective than placebo in terms of adjusted mean FEV₁ AUC_0-6 and peak response. For each trial, the safety profiles of both formulations were found to be comparable.
A multi-dose comparison of ipratropium bromide pressurised inhalation aerosol CFC-free with CFC-containing metered aerosol in a 12-week, double-blind, parallel group study of adult patients with bronchial asthma, demonstrated that patients who switched to the CFC-free aerosol (n = 159) from the CFC-containing aerosol (n = 75), had no change in daily peak expiratory flow rate values and usage of rescue medication. In adult study, the adverse event profile of both formulations was very similar for all events reported.
In summary, the data shows that ipratropium bromide pressurised inhalation aerosol CFC-free metered aerosol is comparable in terms of efficacy and safety to the CFC-containing formulation.

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, 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 was estimated to be in the range 7 to 28%. This is also a valid range for inhalation from ipratropium bromide pressurised inhalation aerosol CFC-free because the kinetic results (renal excretion, AUC and C_max) from the CFC-free and the CFC-containing formulations are approximately comparable.
Distribution. Kinetic parameters describing the disposition of ipratropium bromide were calculated from plasma concentrations after intravenous administration. A rapid biphasic decline in plasma concentrations is observed. The volume of distribution (V_z) 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. The main urinary metabolites bind poorly to the muscarinic receptor and have no activity.
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.
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 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. 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.
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 ipratropium bromide.

6 Pharmaceutical Particulars

6.1 List of Excipients

In addition to ipratropium bromide monohydrate, Cipla Ipratropium contains citric acid, purified water, ethanol absolute and the norflurane.

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

Store below 25°C.
Avoid storage in direct sunlight or heat. Do not puncture or incinerate, as canister may explode.
Protect from frost. As with most inhaled medications in pressurised canisters, the therapeutic effect of this medication may decrease when the canister is cold. If the Inhaler has been exposed to low temperatures, the patient should take the metal canister out of the plastic case and warm it in their hands for a minimum of two minutes.

6.5 Nature and Contents of Container

Cipla Ipratropium is contained in a aluminium container fitted with a suitable metering valve and a plastic actuator, containing 200 metered doses.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure. Ipratropium bromide 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 is a white or off-white crystalline substance. It is freely soluble in methanol, soluble in water and slightly soluble in ethanol 96% (v/v).
The chemical name for ipratropium bromide (as monohydrate) is (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.
The molecular formula is C₂₀H₃₀NO₃Br.H₂O and the molecular weight is 430.4.
Ipratropium bromide has the following structural formula:

CAS number. 66985-17-9.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Date of First Approval

27 May 2025

Summary Table of Changes