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.
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.
Cautions
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.
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.
Metabolized to ester hydrolysis products (tropic acid and tropane).
Elimination Route
Following IV administration, approximately 50% of dose excreted in urine as unchanged drug within 24 hours. Following intranasal administration at recommended dosages, mean percentage of dose excreted in urine as unchanged drug generally <10%.
Half-life
1.6 hours.
Stability
Storage
Intranasal
Solution
15–30°C; avoid freezing.
Actions
Nonselective competitive antagonist at muscarinic receptors.
When applied locally, inhibits secretions from serous and seromucous glands lining the nasal mucosa.
Ipratropium nasal spray has not produced appreciable changes in pupillary diameter, heart rate, or blood pressure in children or adults.
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.
Advice to Patients
Provide careful instruction on priming the pump and administration.
Importance of providing patient a copy of manufacturer’s patient information.
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. Avoid spraying ipratropium nasal spray in or around the eyes.
Importance of notifying clinician if ocular pain, blurred vision, excessive nasal dryness, or episodes of nasal bleeding develop.
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.
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.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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