Ipratropium Bromide eent

Pronunciation

Class: EENT Drugs, Miscellaneous
VA Class: NT900
Chemical Name: (endo,syn-±-3-(3-Hydroxy-1-oxo-2-pheny lpropoxy)-8-methyl-8-(1-methylethyl)-8-azoniabicyclo[3.2.1]octane bromide monohydrate
Molecular Formula: C20H30BrNO3•H2O
CAS Number: 66985-17- 9
Brands: Atrovent Nasal Spray

Introduction

Synthetic quaternary ammonium antimuscarinic.1 2

Uses for Ipratropium Bromide

Common Cold

Symptomatic relief of rhinorrhea associated with the common cold in adults and children ≥5 years of age.1 Does not relieve nasal congestion or sneezing.1

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Seasonal Allergic Rhinitis

Symptomatic relief of rhinorrhea associated with seasonal allergic rhinitis in adults and children ≥5 years of age.1 Does not relieve nasal congestion, sneezing, or itching eyes.1

Perennial Rhinitis

Symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children ≥6 years of age.2 Does not relieve nasal congestion, sneezing, or postnasal drip.2

Ipratropium Bromide Dosage and Administration

Administration

Intranasal Administration

Administer in each nostril 2–4 times daily using spray pump supplied by the manufacturer.1 2

Prime pump before first dose with 7 sprays; if used regularly, no further priming required.1 2 If not used for >24 hours, reprime with 2 sprays; if not used for >7 days, reprime with 7 sprays.1 2

Dosage

Intranasal spray pump delivers 0.07 mL of solution per actuation.1 2

Ipratropium bromide 0.03% nasal spray delivers 21 mcg of ipratropium bromide per spray and about 345 sprays per bottle.2

Ipratropium bromide 0.06% nasal spray delivers 42 mcg of ipratropium bromide per spray and about 165 sprays per bottle.1

Pediatric Patients

Common Cold
Intranasal

Children 5–11 years of age: 84 mcg (2 sprays of the 0.06% solution) in each nostril 3 times daily.1

Children ≥12 years of age: 84 mcg (2 sprays of the 0.06% solution) in each nostril 3 or 4 times daily.1

Seasonal Allergic Rhinitis
Intranasal

Children ≥5 years of age: 84 mcg (2 sprays of the 0.06% solution) in each nostril 4 times daily.1

Perennial Rhinitis
Intranasal

Children ≥6 years of age: 42 mcg (2 sprays of the 0.03% solution) in each nostril 2 or 3 times daily.2

Adults

Common Cold
Intranasal

84 mcg (2 sprays of the 0.06% solution) in each nostril 3 or 4 times daily.1

Seasonal Allergic Rhinitis
Intranasal

84 mcg (2 sprays of the 0.06% solution) in each nostril 4 times daily.1

Perennial Rhinitis
Intranasal

42 mcg (2 sprays of the 0.03% solution) in each nostril 2 or 3 times daily.2

Prescribing Limits

Pediatric Patients

Common Cold
Intranasal

Safety and efficacy beyond 4 days not established.1

Seasonal Allergic Rhinitis
Intranasal

Safety and efficacy beyond 3 weeks not established.1

Adults

Common Cold
Intranasal

Safety and efficacy beyond 4 days not established.1

Seasonal Allergic Rhinitis
Intranasal

Safety and efficacy beyond 3 weeks not established.1

Cautions for Ipratropium Bromide

Contraindications

  • Known hypersensitivity to ipratropium or any ingredient in the formulation, or to atropine or its derivatives.1 2

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Immediate hypersensitivity reactions, including urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema, may occur.1 2

General Precautions

Ocular Effects

Caution in patients with angle-closure glaucoma.1 2 Ocular pain or precipitation or worsening of angle-closure glaucoma reported following inadvertent contact of the drug with the eyes.1 2

Genitourinary Effects

Caution in patients with prostatic hypertrophy or bladder neck obstruction.1 2

Specific Populations

Pregnancy

Category B.1 2

Lactation

Not known whether ipratropium is distributed into milk following intranasal administration.1 2 Caution advised.1 2

Pediatric Use

Safety established based on studies in children.1 2

Efficacy based on extrapolation from studies in adults with perennial rhinitis and adults and adolescents with common cold or seasonal allergic rhinitis and on the likelihood that the disease course, pathophysiology, and the drug’s effect in children are similar to those in adults.1 2

Safety and efficacy of 0.03% nasal spray not established in children <6 years of age.2

Safety and efficacy of 0.06% nasal spray not established in children <5 years of age.1

Common Adverse Effects

Nasal dryness, epistaxis.1 2

Interactions for Ipratropium Bromide

Limited systemic absorption of intranasal ipratropium minimizes potential for interactions with systemically administered drugs.1 2

Antimuscarinic Agents

Potential for additive pharmacologic effect with other antimuscarinic agents, including orally inhaled ipratropium.1 2

Ipratropium Bromide Pharmacokinetics

Absorption

Bioavailability

<20% following intranasal administration.1 2

Onset

Common cold: 1 hour.1

Perennial rhinitis: 1 day.2

Distribution

Plasma Protein Binding

0–9% (albumin and α1-acid glycoprotein).1 2

Elimination

Metabolism

Metabolized to ester hydrolysis products (tropic acid and tropane).1 2

Elimination Route

Following IV administration, approximately 50% of dose excreted in urine as unchanged drug within 24 hours.1 2 Following intranasal administration at recommended dosages, mean percentage of dose excreted in urine as unchanged drug generally <10%.1 2

Half-life

1.6 hours.1 2

Stability

Storage

Intranasal

Solution

15–30°C; avoid freezing.1 2

Actions

  • Nonselective competitive antagonist at muscarinic receptors.1 2

  • When applied locally, inhibits secretions from serous and seromucous glands lining the nasal mucosa.1 2

  • Ipratropium nasal spray has not produced appreciable changes in pupillary diameter, heart rate, or blood pressure in children or adults.1 2

  • Ipratropium nasal spray does not alter physiologic nasal functions such as sense of smell, ciliary beat frequency, mucociliary clearance, or air conditioning capacity of nose.1 2

Advice to Patients

  • Provide careful instruction on priming the pump and administration.1 2

  • Importance of providing patient a copy of manufacturer’s patient information.1 2

  • Risk of temporary blurring of vision, precipitation or worsening of angle-closure glaucoma, or ocular pain if ipratropium comes into direct contact with the eye.1 2 Avoid spraying ipratropium nasal spray in or around the eyes.1 2

  • Importance of notifying clinician if ocular pain, blurred vision, excessive nasal dryness, or episodes of nasal bleeding develop.1 2

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 2

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1 2

  • Importance of informing patients of other important precautionary information.1 2 (See Cautions.)

Preparations

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

Ipratropium Bromide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Nasal

Solution

21 mcg/metered spray

Atrovent Nasal Spray 0.03% (with benzalkonium chloride)

Boehringer Ingelheim

42 mcg/metered spray

Atrovent Nasal Spray 0.06% (with benzalkonium chloride)

Boehringer Ingelheim

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions August 1, 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Boehringer Ingelheim. Atrovent (ipratropium bromide) Nasal Spray 0.06% prescribing information (dated 2002 Nov 14). In: PDR electronic library (<url>http://www.thomsonhc.com</url>).

2. Boehringer Ingelheim. Atrovent (ipratropium bromide) Nasal Spray 0.03% prescribing information (dated 2002 Nov 14). In: PDR electronic library (<url>http://www.thomsonhc.com</url>).

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