Ipratropium (Systemic, Oral Inhalation) (Monograph)

Brand name: Atrovent
Drug class: Antimuscarinics/Antispasmodics
VA class: RE105
Molecular formula: C₂₀H₃₀BrNO₃•H₂O
CAS number: 66985-17- 9

Medically reviewed by Drugs.com on Jun 21, 2024. Written by ASHP.

Introduction

Bronchodilator; a nonselective, competitive antagonist at muscarinic receptors.² ²²⁴ ²²⁵ ²³²

Uses for Ipratropium (Systemic, Oral Inhalation)

Bronchospasm in COPD

Long-term treatment of reversible bronchospasm associated with COPD,¹ ² ⁴ ⁵⁸ ⁷⁶ ¹¹⁴ ¹¹⁵ ¹¹⁸ ¹²⁰ ¹²¹ ¹²² ¹²³ ¹²⁴ ¹²⁷ ¹²⁸ ¹³⁰ ²²⁸ ²³⁰ ²⁴⁴ ²⁴⁵ ²⁵³ ²⁵⁴ ²⁵⁵ ²⁵⁶ ²⁵⁷ ²⁵⁸ ²⁵⁹ ²⁶⁰ ²⁶¹ ²⁶² ²⁶³ ²⁶⁷ ²⁷⁸ ²⁸¹ ²⁸⁵ ²⁹² ²⁹³ ²⁹⁴ including chronic bronchitis¹ ² ⁴ ³⁶ ⁵⁵ ⁶¹ ⁷⁶ ⁹⁰ ¹¹⁶ ¹¹⁷ ¹¹⁹ ¹²⁰ ¹²¹ ¹²⁴ ¹²⁵ ¹²⁹ ¹³¹ ²⁸¹ and emphysema.¹ ² ⁴ ⁹⁰ ⁹¹ ¹¹⁹ ¹²⁰ ¹²⁵ ²⁸¹ ³⁴³ ³⁴⁴ ³⁴⁵ ³⁴⁷

Fixed combination with albuterol sulfate is used for the symptomatic management of bronchospasm associated with COPD in patients who continue to have evidence of bronchospasm despite the regular use of an orally inhaled bronchodilator and who require a second bronchodilator.³²⁰ ³⁴⁷

Bronchospasm in Asthma

Has been used for symptomatic treatment of acute or chronic bronchial asthma^{† [off-label]};³⁶ ⁵⁵ ⁵⁶ ⁷⁶ ⁹¹ ⁹² ¹¹⁵ ¹²⁴ ¹²⁵ ¹²⁹ ¹⁵³ ¹⁶¹ ¹⁶² ¹⁶⁴ ¹⁸⁰ ¹⁸¹ ²¹¹ ²²⁵ ²²⁸ ²⁶⁸ ³⁰² ³⁰³ ³³¹ ³³⁶ ³³⁷ β₂-adrenergic agonist bronchodilators generally preferred initially for relief of bronchospasm in asthmatic patients.¹⁶¹ ¹⁶⁴ ²²⁵ ²⁵⁷ ²⁶⁸ ³⁰² ³⁰³ ³³¹ ³³⁷

May be useful as alternative therapy in adults experiencing adverse effects (e.g., tachycardia, arrhythmia, tremor) with a β-adrenergic agonist^{† [off-label]}.³³¹ ³³⁶ ³³⁷

Some clinicians consider ipratropium as adjunctive therapy in patients with moderate or severe exacerbations (peak expiratory flow rate ≤80% of predicted) of asthma^{† [off-label]} who fail to respond adequately to β-adrenergic agonists and corticosteroids.³³¹ ³³⁷

May be useful for prevention or reversal of bronchospasm induced by β-adrenergic blocking agents^{† [off-label]} (e.g., propranolol) in asthmatic patients; β-adrenergic bronchodilators generally ineffective for this indication in such patients.³¹ ¹⁹¹ ¹⁹⁴ ²²⁵ ²⁶⁸

Ipratropium (Systemic, Oral Inhalation) Dosage and Administration

Administration

Administer by oral inhalation using an oral aerosol inhaler¹ ¹⁰ ³²⁰ or via nebulization.⁴ ²⁸¹ ³²⁹

Oral Inhalation via Metered-dose Aerosol

Ipratropium Bromide

Aerosol delivers ≥200 metered sprays per canister.¹

Patient should be instructed to clear excessive sputum from chest before inhalation.¹⁰

Shake well immediately prior to use.¹ ¹⁰ ³²⁰ Actuate aerosol inhaler 3 times prior to the initial use or if it has not been used for >24 hours.¹

Do not use mouthpiece for other aerosol drugs.¹

Exhale slowly and completely and place the mouthpiece of the inhaler well into the mouth with the lips closed around it.¹⁰ ³⁴⁸ To avoid contact of the drug with the eyes and subsequent adverse effects, close eyes during inhalation of aerosol.¹ ¹⁰ ³⁴⁸ Inhale slowly and deeply through the mouth while actuating the inhaler.¹ ¹⁰ Hold the breath for 10 seconds, withdraw the mouthpiece, and exhale slowly.¹ ¹⁰

Allow ≥15 seconds to elapse between subsequent inhalations from the aerosol inhaler.¹⁰ ³⁴⁸

Wash the mouthpiece in hot running water as needed.¹⁰ ³⁴⁸ If soap is used, rinse mouthpiece thoroughly with plain water.¹⁰ ³⁴⁸

Ipratropium Bromide and Albuterol Sulfate

Aerosol delivers ≥200 metered sprays per canister.³⁴⁶

Shake well immediately prior to use.³⁴⁶ Actuate 3 times prior to the initial use or if it has not been used for >24 hours.³⁴⁶ Do not use actuator provided for other aerosol drugs.³⁴⁶ To avoid contact of the drug with the eyes and subsequent adverse effects, close eyes during inhalation of aerosol.³⁴⁶

Exhale deeply and place mouthpiece of the inhaler into the mouth.³⁴⁶ Inhale slowly and deeply through the mouth while actuating the inhaler.³⁴⁶ Hold the breath for 10 seconds, withdraw the mouthpiece, and exhale slowly.³⁴⁶ Allow approximately 2 minutes to elapse and repeat the procedure.³⁴⁶ Rinse the mouthpiece in hot water as needed.³⁴⁶ If soap is used, rinse the mouthpiece thoroughly with plain water.³⁴⁶ When dry, replace the cap on the mouthpiece when the inhaler is not in use.³⁴⁶

Oral Inhalation via Nebulization

Ipratropium Bromide

Empty entire contents of the single-use vial of solution into the nebulizer reservoir and attach reservoir to the mouthpiece or face mask and to the compressor according to the manufacturer’s instructions.⁴ ³²⁸ ³⁵⁰

Use care when a face mask is used to avoid leakage since transient blurred vision and other adverse effects may result if the drug enters the eyes.² ²²⁵ ²⁵⁰ ²⁷⁵ ³²⁸ ³⁵⁰ (See Ocular Effects under Cautions.) Use of a mouthpiece may avoid inadvertent entry of drug into the eye.⁴

Place the mouthpiece of the nebulizer in the mouth or put on the nebulizer face mask.⁴ ¹⁵ ³²⁸ Breathe as calmly, deeply, and evenly as possible until the nebulizer stops producing mist.⁴ ³²⁸

Duration of treatment usually is about 5–15 minutes.⁴ ³²⁸

Ipratropium Bromide and Albuterol Sulfate

Place the mouthpiece of the nebulizer in the mouth or put on the nebulizer face mask.³²⁸ Breathe as calmly, deeply, and evenly as possible until the nebulizer stops producing mist.³²⁸

Duration of treatment usually is about 5–15 minutes.³²⁸

Clean the nebulizer after use according to the manufacturer’s instructions.³²⁸

Dosage

Available as ipratropium bromide.

Dosage of oral inhalation aerosol expressed in terms of the monohydrate.¹ ³²⁰

Dosage of inhalation solution for nebulization expressed in terms of anhydrous drug.⁴ ³²⁹ ³³⁰

Using in vitro testing at an average flow rate of 3.6 L per minute for an average of ≤15 minutes, the Pari-LC Plus nebulizer delivered at the mouthpiece approximately 46 or 42% of the original dosage of albuterol or ipratropium bromide, respectively.³²⁷

Pediatric Patients

COPD

Inhalation

Patients ≥12 years of age: 36 mcg (2 inhalations) 4 times daily via a metered-dose aerosol, given alone or in fixed combination with albuterol (90 mcg via the mouthpiece).¹ ² ³²⁰ Additional inhalations should not exceed 216 mcg (12 inhalations) of ipratropium bromide in 24 hours.¹ ³²⁰

Patients ≥12 years of age: 500 mcg (contents of 1 unit-dose vial) 3 or 4 times daily (i.e., every 6–8 hours) via a nebulizer.⁴ ³²⁹

Adults

COPD

Inhalation

Initially, 36 mcg (2 inhalations) 4 times daily via a metered-dose aerosol, given alone or in fixed combination with albuterol (90 mcg from the mouthpiece).¹ ² ³²⁰ Additional inhalations should not exceed 216 mcg (12 inhalations) in 24 hours.¹ ³²⁰

Initially, 500 mcg 3 or 4 times daily (i.e., every 6–8 hours) via a nebulizer.⁴ ³²⁹ With ipratropium bromide in fixed combination with albuterol sulfate (DuoNeb), 500 mcg 4 times daily.³²⁷ Additional inhalations should not exceed 6 inhalations daily.³²⁷

Prescribing Limits

Pediatric Patients

COPD

Inhalation

Maximum 216 mcg (12 inhalations via a metered-dose inhaler) in 24 hours.¹ ³²⁰

Maximum 12 inhalations via metered-dose inhaler in 24 hours with the fixed combination of ipratropium bromide and albuterol sulfate.³²⁰

500 mcg 3–4 times daily via a nebulizer in patients ≥12 years of age.⁴ ³²⁹

Adults

COPD

Inhalation

Maximum 216 mcg (12 inhalations via a metered-dose inhaler) in 24 hours;¹ ³²⁰ frequency of administration should not exceed 4 times daily.¹ ²⁶⁷ ³²³

Maximum 12 inhalations via metered-dose inhaler in 24 hours with the fixed combination of ipratropium bromide and albuterol sulfate.³²⁰

500 mcg 3–4 times daily via a nebulizer.⁴ ³²⁹

Special Populations

Geriatric Patients

Dosage adjustments based solely on age are not necessary.¹ ⁴

Cautions for Ipratropium (Systemic, Oral Inhalation)

Contraindications

Known hypersensitivity to the drug or any other component of the formulation, or to atropine or its derivatives.¹ ⁴ ³²⁹
Known hypersensitivity to soya lecithin or related food products, including soybeans and peanuts.¹ ²⁷⁷ ³²⁰

Warnings/Precautions

Warnings

Acute Bronchospasm

Delayed onset of action; not indicated for initial treatment.¹ ⁴ Generally should not be used alone for the management of acute bronchospasm, when a rapid response is required.¹ ⁴ ¹⁶⁴ ²²⁵

Sensitivity Reactions

Immediate hypersensitivity reactions, including rash, angioedema of the tongue, lips, and face, urticaria, bronchospasm, oropharyngeal edema, and anaphylactic reaction.¹ ⁴ ¹⁹⁶ ²¹³ ²⁷⁷ ²⁸⁵ ³²⁰ ³²⁹

Possible paradoxical bronchospasm.¹ ⁴ ¹⁹⁰ ¹⁹¹ ¹⁹⁶ ²⁷⁰ ²⁷¹ ²⁷² ²⁷³ ³²⁰

General Precautions

Worsening COPD

Contact a clinician immediately if a previously effective dosage regimen fails to provide the usual relief (e.g., need to increase the dose or frequency of administration of the drug).¹ Do not increase the dose or frequency of inhalation without consultation with a clinician.¹

Ocular Effects

Possible temporary blurred vision,¹ ² ⁴ ¹⁰ ³²⁸ ³⁴⁹ mydriasis,¹ ²²⁵ ²⁵⁰ ²⁷⁵ ocular pain,⁴ ³²⁸ ³²⁹ ³⁴⁹ conjunctival or corneal congestion associated with visual halos or colored images,¹ or precipitation or worsening of angle-closure glaucoma⁴ ¹⁷³ ³²⁹ ³³⁷ ³⁴⁹ following inadvertent contact of ipratropium with the eyes.⁴ ¹⁹⁰ ¹⁹¹ ³²⁸ ³⁴⁹

Minimize ocular exposure by using a mouthpiece rather than a face mask during administration via a nebulizer.⁴ ¹⁹⁰ ¹⁹¹ ³²⁹ During oral inhalation of aerosol, close eyes.¹ ² Inhalation aerosol should not be administered using the open-mouth technique in these patients with angle-closure glaucoma.¹⁷³ ¹⁹⁰ ¹⁹¹ Use with caution in patients with angle-closure glaucoma.¹ ⁴

Genitourinary Effects

Possible urinary retention/difficulty,¹ ⁴ ²⁵¹ ²⁵² ³²⁰ ³²⁹ urinary tract infection,⁴ ³²⁰ ³²⁹ or dysuria.⁴ ³²⁰

Use with caution in patients with bladder neck obstruction or prostatic hypertrophy.¹ ⁴ ¹⁹⁰ ¹⁹¹ ²²⁵ ³²⁹

Cardiovascular Effects

Possible adverse cardiovascular effects (e.g., tachycardia, palpitations, aggravated hypotension or hypertension).¹ ⁴ ³²⁹

Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.

Specific Populations

Pregnancy

Category B.¹

Lactation

Use with caution.¹ ² ⁴ ³²⁹

Pediatric Use

Safety and efficacy of oral inhalation not established in children <12 years of age.¹ ⁴ ³²⁰ ³²⁹

Hepatic Impairment

Use with caution.⁴ ³²⁹

Renal Impairment

Use with caution.⁴ ³²⁹

Common Adverse Effects

Bronchitis, upper respiratory tract infection,³²⁰ cough,¹ ² ⁴ ⁸⁷ ¹²⁰ ²⁸⁵ and dryness of the mouth,¹ ² ¹⁴ ¹⁶ ⁶⁰ ⁹⁰ ¹²⁰ ¹²⁷ throat,¹ ⁷⁵ ⁹⁰ or tongue⁸⁷ with ipratropium aerosol. Adverse effects resulting in discontinuance of nebulized ipratropium most frequently include bronchitis, dyspnea, and bronchospasm.⁴ ³²⁹

Drug Interactions

Limited systemic absorption following oral inhalation; interactions with systemically administered drugs unlikely.² ¹⁹⁰ ¹⁹¹

Specific Drugs

Drug	Interaction	Comments
Antimuscarinic agents	Potential pharmacodynamic interaction (additive effects)¹ ³²⁰	Caution advised with concomitant administration¹
Methylxanthine derivatives	No adverse drug interactions reported¹¹⁵ ¹²⁰ ¹²¹ ¹³² ¹⁵⁷ ¹⁵⁸ ¹⁴⁹ ¹⁸⁷ ²²⁰ ²⁶¹ ³⁰⁵ ³²⁹
β-Adrenergic agonists	Potential pharmacodynamic interaction (additive effects)⁴ ⁶ ¹³³ ¹⁴⁷ ¹⁵² ¹⁵⁵ ²²⁵ ²²⁸ ²⁴⁶ ²⁴⁸ ²⁶⁰ ²⁶² ²⁷⁸ ²⁷⁹ ²⁸⁵ ²⁸⁷ ²⁸⁸ ²⁸⁹	If concomitant therapy is required, consider cautious use of cardioselective β-adrenergic blocking agents¹¹⁵ ¹³² ¹³⁹ ¹⁴⁶ ¹⁵³ ¹⁵⁴ ¹⁸¹ ²¹⁶
Corticosteroids	No adverse drug interactions reported⁹¹ ¹¹⁵ ¹¹⁹ ¹²⁰ ¹²¹ ¹²⁴ ¹³² ¹⁵³ ¹⁵⁴ ¹⁶⁰ ³²⁹
Cromolyn sodium	No adverse drug interactions reported¹³² ¹⁵⁹

Ipratropium (Systemic, Oral Inhalation) Pharmacokinetics

Absorption

Bioavailability

Only minimally absorbed into systemic circulation following oral inhalation.¹ ² ⁴ ⁶ ¹⁴ ¹⁰⁶ ²²⁸ ²²⁹ ²³⁰

Onset

Bronchodilation evident within 15 minutes following oral aerosol inhalation¹ ² ¹¹¹ ¹²⁰ ²³⁰ and within 15–30 minutes following oral inhalation via nebulization.⁴ ⁸⁶ ²⁸¹

Duration

Bronchodilation generally persists for 3–4 hours following oral aerosol inhalation¹ ² ¹¹¹ ¹²⁰ ²³⁰ and for 4–5 hours following nebulization.⁴ ⁸⁶ ²⁸¹

Distribution

Extent

Does not readily penetrate the CNS.² ⁴ ¹² It is not known whether the drug crosses the placenta or is distributed into milk.¹ ⁴ ⁶

Plasma Protein Binding

0–9%.¹ ⁴

Elimination

Metabolism

Metabolized partially to at least 8 metabolites.⁴ ⁸ ¹⁰⁶

Elimination Route

Excreted principally in feces as unchanged drug.² ³ ⁶ ⁷ ¹⁰⁷ ¹⁰⁹ Following oral inhalation of radiolabeled ipratropium bromide, about 69 and 3.2% of the dose was excreted in feces and urine, respectively, within 6–7 days.⁶ ¹⁰⁶ ¹⁰⁹ Undergoes some biliary elimination.⁶ ⁷

Half-life

1.6 hours (t_½β with IV administration).⁴ ¹⁹⁰ ²²⁹

Stability

Storage

Oral Inhalation

15–30 °C (metered-dose inhalers or inhalation solution of ipratropium bromide).¹ ³ ⁴ ²⁸¹ ³²⁰

2–25°C (oral inhalation solution of ipratropium bromide in fixed combination with albuterol sulfate); protect from light.³²⁷ ³²⁸

Actions

A nonselective competitive antagonist at muscarinic receptors present in airways and other organs.² ²²⁴ ²²⁵ ²³²
Relaxes smooth muscles of bronchi and bronchioles.¹ ² ⁴ ⁶
Blocks acetylcholine-induced stimulation of guanyl cyclase and reduces formation of cyclic guanosine monophosphate (cGMP), a mediator of bronchoconstriction.¹ ² ⁴ ⁶
Exhibits greater antimuscarinic activity on bronchial smooth muscle than on secretory (e.g., salivary, gastric) glands.⁶ ⁷ ¹² ¹⁶ ¹⁸ ³⁴ ²²⁵
Tolerance to bronchodilating effect does not develop with prolonged use.⁴ ¹⁴ ⁹⁰ ⁹¹ ⁹² ¹¹⁵ ¹¹⁶ ¹¹⁷ ¹¹⁸ ¹¹⁹ ¹²⁰ ¹²¹ ¹⁶⁸ ²²⁵ ²⁷⁸

Advice to Patients

Importance of providing patients with a copy of the manufacturer’s patient information.¹ ⁴
Importance of using proper administration technique.¹ ⁴
Importance of advising patients that oral inhalation is not intended for occasional use.¹ ⁴ Use consistently throughout the course of therapy for maximum effectiveness.¹ ⁴
Importance of contacting a clinician if symptoms of COPD are not relieved by usually effective doses or if they worsen.¹ Do not increase the dosage or frequency of administration without consultation with a clinician.¹
Importance of advising patients to close their eyes during oral inhalation of aerosol¹ ² to avoid inadvertent contact of the drug with the eyes and subsequent adverse effects.¹ ¹⁰
Importance of contacting a clinician immediately if ocular symptoms develop.¹
Importance of advising patients that blurring of vision, precipitation or aggravation of narrow angle glaucoma, mydriasis, visual halos, colored images in association with conjunctival or corneal congestion, or eye pain or discomfort may result from contact of the inhalation solution with the eyes.¹
Importance of informing clinicians if ocular adverse effects develop.¹
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.³²⁰
Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Ipratropium Bromide
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral Inhalation	Aerosol	18 mcg/metered spray	Atrovent (with chlorofluorohydrocarbon propellants and soya lecithin)	Boehringer Ingelheim
	Solution, for nebulization	0.02%*	Atrovent (preservative-free)	Boehringer Ingelheim
			Ipratropium Bromide Inhalation Solution (preservative-free)	Alpharma

Ipratropium Bromide Combinations
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral Inhalation Only	Aerosol	18 mcg with Albuterol Sulfate 90 mcg (of albuterol) per metered spray	Combivent (with chlorofluorohydrocarbon propellants and soya lecithin)	Boehringer Ingelheim
	Solution, for nebulization	0.5 mg with Albuterol Sulfate 2.5 mg (of albuterol) per 3 mL	DuoNeb	Dey

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

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297. Diamond L, Dockhorn RJ, Grossman J et al. A dose-response study of the efficacy and safety of ipratropium bromide nasal spray in the treatment of the the common cold. J Allergy Clin Immunol. 1995; 95:1139-46. http://www.ncbi.nlm.nih.gov/pubmed/7751531?dopt=AbstractPlus

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306. Lehrer PM, Hochron SM, Rausch L et al. Effects of aerosol ipratropium bromide on cardiac vagal tone. Chest. 1994; 105:1701-4. http://www.ncbi.nlm.nih.gov/pubmed/8205863?dopt=AbstractPlus

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308. Liggett SB, Daughaday CC, Senior RM. Ipratropium in patients with COPD receiving cholinesterase inhibitors. Chest. 1988; 94:210-2. http://www.ncbi.nlm.nih.gov/pubmed/2968227?dopt=AbstractPlus

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310. Patel KR, Tullett WM. Bronchoconstriction in response to ipratropium bromide. BMJ. 1983; 286:1318. http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=1547644&blobtype=pdf http://www.ncbi.nlm.nih.gov/pubmed/6220756?dopt=AbstractPlus

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327. Dey Laboratories. DuoNeb (ipratropium bromide/albuterol sulfate) inhalation solution prescribing information. Napa, CA; 2005 Apr.

328. Dey. DuoNeb (albuterol sulfate/ipratropium bromide) inhalation solution patient instructions. Napa, CA: 2005 Apr.

329. Dey. Ipratropium bromide 0.02% inhalation solution prescribing instructions. Napa, CA: 1998 Apr.

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Ipratropium (Systemic, Oral Inhalation) (Monograph)

Introduction

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Bronchospasm in COPD

Bronchospasm in Asthma

Ipratropium (Systemic, Oral Inhalation) Dosage and Administration

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Ipratropium Bromide

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Ipratropium Bromide

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