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Ipratropium (oral inhalation): Pediatric drug information

Ipratropium (oral inhalation): Pediatric drug information
2024© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Ipratropium (oral inhalation): Drug information" and "Ipratropium (oral inhalation): Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Atrovent HFA
Brand Names: Canada
  • AA-Ipravent;
  • Atrovent HFA;
  • PMS-Ipratropium;
  • TEVA-Ipratropium Bromide
Therapeutic Category
  • Antiasthmatic;
  • Anticholinergic Agent;
  • Bronchodilator
Dosing: Neonatal
Bronchopulmonary dysplasia/Respiratory distress syndrome, ventilated patients

Bronchopulmonary dysplasia/Respiratory distress syndrome (RDS), ventilated patients: Very limited data available; optimal dose not established.

Nebulization:

Weight-based dosing: 25 mcg/kg/dose 3 times daily. Dosing based on a placebo controlled, comparative trial in 17 preterm infants (ipratropium group, n=5; EGA 25 to 29 weeks; PNA 19 to 103 days) with BPD and reported a significant decrease in respiratory resistance (Ref).

Fixed dosing: Some centers have used 175 mcg/dose 3 times daily administered through the ventilator circuit; dosing based on a dose range study of 10 preterm infants with BPD (EGA 24 to 28 weeks, PNA 18 to 34 days) which showed significant reduction in respiratory resistance; additional benefit observed when administered after albuterol (Ref).

Inhalation, MDI: 4 puffs/dose every 6 to 8 hours delivered as either a single dose or 2 puffs every 20 minutes for 2 inhalations. In a randomized, placebo-controlled trial in preterm neonates (n=10, PNA: 1 week; EGA: 26 to 34 weeks) with RDS which evaluated a single 72 mcg dose (4 puffs [18 mcg/puff product used; not currently available in the US]) and reported beneficial effects on blood gases and ventilator efficiency. In another trial, which was a crossover, randomized, controlled, double-blind trial of preterm neonates (n=21, PNA: 20 ± 9 days; EGA: 27.3 ± 1.6 weeks) with RDS, a significant reduction in respiratory resistance was reported in 38% of patients after a total dose of 80 mcg (40 mcg every 20 minutes for 2 doses [20 mcg/puff product used; not currently available in the US]); higher doses (120 mcg [6 puffs]) were not shown to have additional benefit (Ref).

Dosing: Pediatric
Asthma, acute exacerbation

Asthma, acute exacerbation: Limited data available (Ref): Note: For moderate to severe exacerbations, ipratropium may be considered if poor response to initial short-acting beta-2 agonist (SABA) therapy during initial management in an acute care setting (eg, emergency department). Ipratropium has not been shown to provide further benefit (eg, after first 24 hours) once the patient is hospitalized (Ref):

Children:

Nebulization: 0.25 to 0.5 mg (250 to 500 mcg) every 20 minutes for 1 hour (ie, 3 doses), then as needed; in trials, the usual reported dose is 0.25 mg (250 mcg) and reported interval range is every 1 to 8 hours typically with an increasing dosing interval as patient improves; some trials continued combination SABA/ipratropium therapy for duration of hospitalization (up to 49 hours) although trials have not demonstrated additional benefit with extended use (Ref)

Metered-dose inhaler: 4 to 8 puffs every 20 minutes as needed for up to 3 hours

Adolescents:

Nebulization: 0.5 mg (500 mcg) every 20 minutes for 3 doses, then as needed

Metered-dose inhaler: 8 puffs every 20 minutes as needed for up to 3 hours

Asthma, maintenance therapy

Asthma, maintenance therapy (nonacute): Limited data available: Note: Evidence is lacking that ipratropium provides added benefit to beta-2 agonists in long-term control asthma therapy (Ref)

Children <12 years:

Nebulization: 0.25 to 0.5 mg (250 to 500 mcg) every 6 to 8 hours

Metered-dose inhaler: 1 to 2 inhalations every 6 hours; not to exceed 12 inhalations/day

Children ≥12 years and Adolescents:

Nebulization: 0.25 to 0.5 mg (250 to 500 mcg) every 6 hours

Metered-dose inhaler: 2 to 3 inhalations every 6 hours; maximum daily dose: 12 inhalations/day

Bronchospasm associated with chronic pulmonary conditions

Bronchospasm associated with chronic pulmonary conditions: Children ≥12 years and Adolescents: Nebulization: 0.5 mg (500 mcg, one unit-dose vial) 3 to 4 times daily with doses 6 to 8 hours apart

Bronchospasm, wheezing

Bronchospasm, wheezing: Limited data available; efficacy results variable: Infants: Nebulization: 0.125 to 0.25 mg (125 to 250 mcg) every 4 hours has been found helpful in some infants with chronic or recurrent wheezing, and some patients with bronchiolitis; however, most bronchiolitis data suggests ipratropium is not effective (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling (not studied); however, dosage adjustment unlikely necessary due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling (not studied); however, dosage adjustment unlikely necessary due to low systemic absorption.

Dosing: Adult

(For additional information see "Ipratropium (oral inhalation): Drug information")

Asthma, acute exacerbation, moderate to severe

Asthma, acute exacerbation, moderate to severe (off-label use): Note: May consider for treatment of moderate to severe exacerbations (eg, critically ill) in combination with a short-acting beta-adrenergic agonist. Nebulized therapy may be preferred in patients who have more severe symptoms or who cannot effectively use an inhaler (Ref).

Nebulization solution: Oral inhalation: 0.5 mg every 20 minutes for 3 doses, then hourly as needed for up to 3 hours (Ref).

Metered-dose inhaler (17 mcg/actuation): Oral inhalation: 4 to 8 inhalations with spacer every 20 minutes for 3 doses, then hourly as needed for up to 3 hours (Ref).

Chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease:

Acute exacerbation: Note: Although similar efficacy exists among formulations, some experts prefer nebulized therapy during severe chronic obstructive pulmonary disease (COPD) exacerbations (Ref). May be used in combination with an inhaled short-acting beta agonist (Ref).

For patients at home or office management:

Metered-dose inhaler (17 mcg/actuation): Oral inhalation: 2 inhalations every 4 to 6 hours as needed (Ref).

Nebulization solution: Oral inhalation: 0.5 mg every 6 to 8 hours as needed (Ref).

For patients requiring emergency department or hospital-based care:

Nebulization solution: Oral inhalation: 0.5 mg every 1 hour (up to 3 doses), then every 2 to 4 hours as needed (Ref).

Metered-dose inhaler (17 mcg/actuation): Oral inhalation: 2 to 4 inhalations every 1 hour (up to 3 doses), then every 2 to 4 hours as needed (Ref).

Intermittent symptom relief: Note: Use for intermittent symptoms on an as-needed basis rather than regularly scheduled maintenance therapy. Typically used in combination with inhaled short-acting beta agonist (SABA); combination therapy provides greater improvement in FEV1 and symptoms over monotherapy SABA (Ref).

Metered-dose inhaler (17 mcg/actuation): Oral inhalation: 2 inhalations 4 to 6 times daily as needed (Ref).

Nebulization solution: Oral inhalation: 0.5 mg every 4 to 8 hours as needed (Ref).

Maintenance (alternative agent): Note: Depending on symptoms and exacerbation risk, preferred therapy is a single long-acting bronchodilator (long-acting beta agonist or long-acting muscarinic antagonist). In patients with more symptoms (eg, Group B), preferred therapy is dual long-acting bronchodilator therapy (Ref).

Metered-dose inhaler (17 mcg/actuation): Oral inhalation: 2 inhalations every 6 hours.

Nebulization solution: Oral inhalation: 0.5 mg every 6 to 8 hours.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Respiratory: Bronchitis (10% to 23%), exacerbation of chronic obstructive pulmonary disease (8% to 23%), sinusitis (1% to 11%)

1% to 10%:

Central nervous system: Headache (6% to 7%), dizziness (3%)

Gastrointestinal: Dyspepsia (1% to 5%), nausea (4%), xerostomia (2% to 4%), dysgeusia (1%)

Genitourinary: Urinary tract infection (2% to 10%)

Neuromuscular & skeletal: Back pain (2% to 7%)

Respiratory: Dyspnea (7% to 8%), flu-like symptoms (4% to 8%), cough (>3%), rhinitis (>3%), upper respiratory tract infection (>3%)

<1%, postmarketing, and/or case reports: Accommodation disturbance, acute eye pain, anaphylaxis, angioedema, blurred vision, bronchospasm, conjunctival hyperemia, constipation, corneal edema, decreased gastrointestinal motility, diarrhea, dry throat, glaucoma, hypersensitivity reaction, hypotension, increased intraocular pressure, laryngospasm, mouth edema, mydriasis, nausea, palpitations, pharyngeal edema, pruritus, skin rash, stomatitis, tachycardia, throat irritation, urinary retention, urticaria, visual halos around lights, vomiting

Contraindications

Hypersensitivity to ipratropium, atropine (and its derivatives), or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Bronchospasm: Paradoxical bronchospasm that may be life-threatening and may occur with use of inhaled bronchodilating agents; this should be distinguished from inadequate response. If paradoxical bronchospasm occurs, discontinue ipratropium and institute alternative therapy.

• CNS effects: May cause dizziness and blurred vision; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Hypersensitivity reactions: Hypersensitivity reactions (urticaria, angioedema, rash, bronchospasm, oropharyngeal edema), including anaphylaxis, have been reported. Discontinue therapy immediately if patient develops an allergic reaction.

Disease-related concerns:

• Glaucoma: Use with caution in patients with narrow-angle glaucoma; may increase intraocular pressure.

• Prostatic hyperplasia/bladder neck obstruction: Use with caution in patients with prostatic hyperplasia or bladder neck obstruction; may cause urinary retention.

Other warnings/precautions:

• Appropriate use: Not indicated for the initial treatment of acute episodes of bronchospasm where rescue therapy is required for rapid response. Only use in acute exacerbations of asthma in conjunction with short-acting beta-adrenergic agonists for acute episodes (NAEPP 2007).

Dosage Forms Considerations

Atrovent HFA 12.9 g canister contains 200 inhalations.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Solution, Inhalation, as bromide:

Atrovent HFA: 17 mcg/actuation (12.9 g)

Solution, Inhalation, as bromide:

Generic: 0.02% (2.5 mL)

Solution, Inhalation, as bromide [preservative free]:

Generic: 0.02% (2.5 mL)

Generic Equivalent Available: US

May be product dependent

Pricing: US

Aerosol solution (Atrovent HFA Inhalation)

17 mcg/ACT (per gram): $43.91

Solution (Ipratropium Bromide Inhalation)

0.02% (per mL): $0.14 - $1.44

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Solution, Inhalation:

Atrovent HFA: 20 mcg/actuation (1 ea) [contains alcohol, usp]

Nebulization Solution, Inhalation:

Generic: 0.125 mg/mL (2 mL); 0.25 mg/mL (0.5 mL, 1 mL, 2 mL, 20 mL)

Administration: Pediatric

Inhalation:

Nebulization: May be administered with or without dilution in NS; use of a nebulizer with a mouth piece, rather than a face mask, may be preferred to prevent contact with eyes. Compatibility with other medications (eg, albuterol, budesonide) in nebulizer has been reported (Ref); also refer to institution-specific policies.

Oral Inhalation (metered-dose inhaler): Atrovent HFA: Prior to initial use, prime inhaler by releasing 2 test sprays into the air. If the inhaler has not been used for >3 days, reprime. Avoid spraying into the eyes. Use spacer device in children <8 years; use spacer device and face mask for children ≤4 years.

Administration: Adult

For oral inhalation; avoid spraying in eyes.

Metered-dose inhaler: Prior to initial use, prime inhaler by releasing 2 test sprays into the air; inhaler does not require shaking. If the inhaler has not been used for >3 days, reprime. Wash mouthpiece once a week for 30 seconds in warm water only and let air dry. Discard inhaler once dose indicator displays “0.”

Nebulization solution: Remove unit dose vial from foil pouch and squeeze contents into nebulizer reservoir; connect nebulizer to compressor. Breathe deeply and evenly until all medication has been inhaled; inhalation time is about 5 to 15 minutes. Clean nebulizer after use. Compatibility with other medications (eg, albuterol, budesonide) in nebulizer has been reported (Ref); also refer to institution-specific policies.

Storage/Stability

Metered-dose inhaler: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Exposure to temperatures >48°C (120°F) may cause bursting. Do not puncture inhaler, throw into a fire or incinerator, or use or store near heat or open flame.

Nebulization solution: Store at 15°C to 30°C (59°F to 86°F). Protect from light. Store unused vials in foil pouch.

Use

Nebulization: Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema alone or in combination with bronchodilators (FDA approved in ages ≥12 years and adults); has also been used to treat bronchospasm associated with asthma and as a bronchodilating agent in bronchopulmonary dysplasia and neonatal respiratory distress syndrome

Oral inhalation: Atrovent HFA: Maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema (FDA approved in adults); has also been used to treat bronchospasm associated with asthma and as a bronchodilating agent in bronchopulmonary dysplasia and neonatal respiratory distress syndrome

Medication Safety Issues
Sound-alike/look-alike issues:

Atrovent may be confused with Alupent, Serevent

Ipratropium may be confused with tiotropium

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

Agents with Clinically Relevant Anticholinergic Effects: Ipratropium (Oral Inhalation) may enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid combination

Inhaled Anticholinergic Agents: May enhance the anticholinergic effect of other Inhaled Anticholinergic Agents. Risk C: Monitor therapy

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Risk X: Avoid combination

Methacholine: Ipratropium (Oral Inhalation) may diminish the therapeutic effect of Methacholine. Management: Hold ipratropium for 12 hours before methacholine use. Risk D: Consider therapy modification

Pregnancy Considerations

Systemic exposure following inhalation is negligible; maternal use is not expected to result in fetal exposure. Data related to ipratropium for the treatment of asthma in pregnancy are limited. Based on available information, an increased risk of adverse maternal or fetal outcomes has not been observed following use during pregnancy.

Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low birth weight infants, cesarean delivery, and the development of gestational diabetes). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. Maternal treatment improves pregnancy outcomes by reducing the risk of some adverse events (eg, preterm birth, gestational diabetes). Maternal asthma symptoms should be monitored monthly during pregnancy (ERS/TSANZ [Middleton 2020]; GINA 2023).

Mechanism of Action

Blocks the action of acetylcholine at parasympathetic sites in bronchial smooth muscle causing bronchodilation; local application to nasal mucosa inhibits serous and seromucous gland secretions.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Bronchodilation: Within 15 minutes

Peak effect: 1 to 2 hours

Duration: Metered-dose inhaler: 2 to 4 hours; Nebulization solution: 4 to 5 hours, up to 7 to 8 hours in some patients

Absorption: Not readily absorbed into the systemic circulation from the surface of the lung or from the GI tract; ~7% absorbed after nebulization of a 2 mg dose

Distribution: 15% of dose reaches lower airways

Protein Binding: ≤9%

Metabolism: Partially metabolized to inactive ester hydrolysis products

Half-life elimination: 2 hours

Excretion: Urine (50%)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Atrovent;
  • (AR) Argentina: Aerotrop | Atrovent | Atrovent hfa | Iprabron;
  • (AT) Austria: Atrovent;
  • (AU) Australia: Atrovent;
  • (BD) Bangladesh: Ipramid | Iprex;
  • (BE) Belgium: Atronase | Atrovent;
  • (BG) Bulgaria: Atrovent | Atrovent n;
  • (BR) Brazil: Atrovent | Atrovent n;
  • (CH) Switzerland: Atrovent n;
  • (CL) Chile: Aerotrop | Atrovent | Influmix | Iprasynt hfa;
  • (CN) China: Atrovent;
  • (CO) Colombia: Aspromio | Atrovent | Atrovent hfa | Biovent | Bromuro de ipratropio | Ciplatropiun | Ipramar | Iprasynt | Ipratropio bromuro | Plamune;
  • (CZ) Czech Republic: Atrovent | Atrovent n;
  • (DE) Germany: Atrovent | Atrovent n | Iprabronch | Ipratropiumbromid hexal | Ipravent;
  • (DO) Dominican Republic: Aerotrop | Atrovent | I Patrimul | Ipratum | Tropium;
  • (EC) Ecuador: Aspromio | Atrovent | Atrovent hfa | Bromuro de ipratropio | I Patrimul | Iprasynt | Ipratropio | Ipratropio bromuro | Ipravent | Protaisol;
  • (EE) Estonia: Atrovent | Atrovent n;
  • (EG) Egypt: Atrovent;
  • (ES) Spain: Atroaldo | Atrovent | Ipratropio bromuro cipla | Ipratropio bromuro Kern Pharma;
  • (FI) Finland: Atrovent | Atrovent eco;
  • (FR) France: Atrovent;
  • (GB) United Kingdom: Atrovent | Inhalvent | Ipratropium | Ipravent | Ipravent cfc;
  • (GR) Greece: Atrovent | Broncovent;
  • (HK) Hong Kong: Atrovent;
  • (HR) Croatia: Atrovent n;
  • (HU) Hungary: Atrovent | Atrovent n | Ipravent;
  • (ID) Indonesia: Atrovent;
  • (IE) Ireland: Atrovent;
  • (IL) Israel: Aerovent | Atrovent;
  • (IN) India: Ipramist | Ipratop | Ipravent;
  • (IQ) Iraq: Ipravent;
  • (IT) Italy: Atem | Rinovagos;
  • (JO) Jordan: Atrovent;
  • (JP) Japan: Atrovent;
  • (KE) Kenya: Atrovent hfa;
  • (KR) Korea, Republic of: Atrovent;
  • (KW) Kuwait: Atrovent | Atrovent n;
  • (LB) Lebanon: Atem | Atrovent | Atrovent n;
  • (LT) Lithuania: Atrovent | Atrovent n;
  • (LU) Luxembourg: Atronase | Atrovent;
  • (LV) Latvia: Atrovent;
  • (MX) Mexico: Atrovent | Bromuro de ipratropio | Ipralong | Iprasynt | Ipratropio | Protaisol;
  • (MY) Malaysia: Atrovent | Ipracip | Ipravent;
  • (NL) Netherlands: Atrovent | Atrovent(es) | Ipratropiumbromide Sandoz;
  • (NO) Norway: Atrovent;
  • (NZ) New Zealand: Atrovent;
  • (PE) Peru: Aerotrop | Atrovent | Atrovent hfa | Bromuro de ipratropio | Flavuril | Ipramar | Iprapharm | Ipratrolab | Ipratum;
  • (PH) Philippines: Atrovent;
  • (PK) Pakistan: Atem | Estravent | Ipravent | Optra | Optra HFA | Trupium;
  • (PL) Poland: Atrodil | Atrovent | Atrovent n;
  • (PR) Puerto Rico: Atrovent | Atrovent hfa | Ipratropium br;
  • (PT) Portugal: Atrovent | Atrovent pa | Brometo de ipratropio bluepharma;
  • (PY) Paraguay: Aerotrop | Anasmal | Atrovent hfa | Bromovent;
  • (QA) Qatar: Atrovent MDI | Atrovent UDV | Ipravent;
  • (RO) Romania: Atrovent | Ipravent;
  • (RU) Russian Federation: Atrovent | Atrovent n | Ipratropium aeronativ | Ipratroppem | Ipravent;
  • (SA) Saudi Arabia: Atrovent;
  • (SE) Sweden: Atrovent | Ipratropiumbromid Ebb | Ipravent;
  • (SG) Singapore: Atrovent | Iprovent;
  • (SI) Slovenia: Atrovent;
  • (SK) Slovakia: Atrovent;
  • (TH) Thailand: Atrovent;
  • (TN) Tunisia: Atroaldo | Atrovent;
  • (TR) Turkey: Atrovent | Ipracort;
  • (TW) Taiwan: Atrovent;
  • (UA) Ukraine: Atrovent | Ipratropium inteli | Ipravent;
  • (UY) Uruguay: Aerotrop | Atrovent | Estravent;
  • (VE) Venezuela, Bolivarian Republic of: Alovent | Atroaldo | Bromuro de ipratropio | Ipatrixair | Iprasynt | Ipratropio bromuro;
  • (ZA) South Africa: Atronase | Atrovent | Ipvent
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