Introduction

Synthetic quaternary ammonium antimuscarinic.

Uses for Ipratropium (EENT)

Common Cold

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

Seasonal Allergic Rhinitis

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

Perennial Rhinitis

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

Ipratropium (EENT) Dosage and Administration

Administration

Intranasal Administration

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

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

Dosage

Intranasal spray pump delivers 0.07 mL of solution per actuation.

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

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

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.

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

Seasonal Allergic Rhinitis

Intranasal

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

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.

Adults

Common Cold

Intranasal

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

Seasonal Allergic Rhinitis

Intranasal

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

Perennial Rhinitis

Intranasal

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

Prescribing Limits

Pediatric Patients

Common Cold

Intranasal

Safety and efficacy beyond 4 days not established.

Seasonal Allergic Rhinitis

Intranasal

Safety and efficacy beyond 3 weeks not established.

Adults

Common Cold

Intranasal

Safety and efficacy beyond 4 days not established.

Seasonal Allergic Rhinitis

Intranasal

Safety and efficacy beyond 3 weeks not established.

Contraindications

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

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

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

General Precautions

Ocular Effects

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

Genitourinary Effects

Caution in patients with prostatic hypertrophy or bladder neck obstruction.

Specific Populations

Pregnancy

Category B.

Lactation

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

Pediatric Use

Safety established based on studies in children.

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.

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

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

Common Adverse Effects

Nasal dryness, epistaxis.

Administration

Intranasal Administration

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

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

Dosage

Intranasal spray pump delivers 0.07 mL of solution per actuation.

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

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

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.

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

Seasonal Allergic Rhinitis

Intranasal

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

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.

Adults

Common Cold

Intranasal

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

Seasonal Allergic Rhinitis

Intranasal

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

Perennial Rhinitis

Intranasal

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

Prescribing Limits

Pediatric Patients

Common Cold

Intranasal

Safety and efficacy beyond 4 days not established.

Seasonal Allergic Rhinitis

Intranasal

Safety and efficacy beyond 3 weeks not established.

Adults

Common Cold

Intranasal

Safety and efficacy beyond 4 days not established.

Seasonal Allergic Rhinitis

Intranasal

Safety and efficacy beyond 3 weeks not established.

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

Antimuscarinic Agents

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