Ipratropium Bromide

Name: Ipratropium Bromide

Ipratropium Bromide 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

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.328

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 Bromide

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

Ipratropium Bromide 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 (t½β 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

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, Dey, Holopack, Nephron, Novex, Roxane, RxElite, Teva, Warrick

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

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