Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Nasal, as bromide:
Atrovent: 0.03% (30 mL [DSC]); 0.06% (15 mL [DSC])
Generic: 0.03% (30 mL); 0.06% (15 mL)
Pharmacology
Mechanism of Action
Local application to nasal mucosa inhibits serous and seromucous gland secretions.
Pharmacokinetics/Pharmacodynamics
Absorption
<20%
Metabolism
To inactive metabolites via ester hydrolysis
Excretion
Allergic rhinitis: Urine (as unchanged drug): Pediatrics: Up to 11.1%; Adults: Up to 5.6%
Common cold: Urine (as unchanged drug): Pediatrics: Up to 7.8%; Adults: Up to 8.1%
Onset of Action
15 minutes
Protein Binding
Up to 9% (albumin)
Use: Labeled Indications
Allergic/nonallergic perennial rhinitis (0.03% solution): Symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children ≥6 years.
Colds (0.06% solution): Symptomatic relief of rhinorrhea associated with the common cold in adults and children ≥5 years.
Seasonal allergic rhinitis (0.06% solution): Symptomatic relief of rhinorrhea associated with seasonal allergic rhinitis in adults and children ≥5 years.
Use: Off Label
Sialorrhea (drooling)c
Limited data from a small, short-term controlled trial evaluating sublingual administration of ipratropium bromide spray in adult Parkinson patients with sialorrhea demonstrated no significant effect on objective measurements of sialorrhea (eg, weight of saliva production) but produced mild effects on subjective ratings
Contraindications
Hypersensitivity to ipratropium, atropine (and its derivatives), or any component of the formulation
Dosage and Administration
Dosing: Adult
Allergic/nonallergic perennial rhinitis: Intranasal (0.03% solution): Two sprays (21 mcg/spray) in each nostril 2 or 3 times daily (total dose: 168 to 252 mcg/day)
Colds (symptomatic relief of rhinorrhea): Intranasal (0.06% solution): Two sprays (42 mcg/spray) in each nostril 3 or 4 times daily (total dose: 504 to 672 mcg/day); use beyond 4 days has not been established
Seasonal allergic rhinitis: Intranasal (0.06% solution): Two sprays (42 mcg/spray) in each nostril 4 times daily (total dose: 672 mcg/day); use beyond 3 weeks has not been established
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Allergic/nonallergic perennial rhinitis: Children ≥6 years and Adolescents: 0.03% (21 mcg/spray) solution: Intranasal: 2 sprays (42 mcg) per nostril 2 to 3 times daily; total daily dose range: 168 to 252 mcg/day
Colds (symptomatic relief of rhinorrhea): Note: Use beyond 4 days has not been established. 0.06% (42 mcg/spray) solution: Intranasal:
Children 2 to <5 years: Limited data available: 2 sprays (84 mcg) per nostril 3 times daily; maximum daily dose: 504 mcg/day (Kim 2005)
Children 5 to 11 years: 2 sprays (84 mcg) per nostril 3 times daily; maximum daily dose: 504 mcg/day
Children ≥12 years and Adolescents: 2 sprays (84 mcg) per nostril 3 to 4 times daily; total daily dose range: 504 to 672 mcg/day
Seasonal allergic rhinitis: 0.06% (42 mcg/spray) solution: Intranasal:
Children 2 to <5 years: Limited data available: 1 spray (42 mcg) per nostril 3 times daily for 14 days (Kim 2005); maximum daily dose: 252 mcg/day
Children ≥5 years and Adolescents: 2 sprays (84 mcg) per nostril 4 times daily; maximum daily dose: 672 mcg/day; use beyond 3 weeks has not been established
Administration
Administer by the intranasal route only. Avoid spraying into or around the eyes. Blow nose gently to clear nostrils before use. Prior to initial use, prime pump by releasing 7 test sprays into the air. If the inhaler has not been used for >24 hours, reprime by releasing 2 test sprays into the air. If the inhaler has not been used for more than 7 days, reprime by releasing 7 test sprays into the air.
Storage
Store at 25°C (77°F); excursions permitted to 15°C and 25°C (59°F and 77°F). Avoid freezing.
Drug Interactions
Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Monitor therapy
Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy
Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Monitor therapy
Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy
Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Exceptions: Cannabidiol. Monitor therapy
Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Monitor therapy
Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination
Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination
Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy
Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Monitor therapy
Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination
Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy
Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination
Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy
Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Monitor therapy
Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Monitor therapy
Opioid Agonists: Anticholinergic Agents may enhance the adverse/toxic effect of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy
Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Avoid combination
Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Avoid combination
Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification
Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy
Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Avoid combination
Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Consider therapy modification
Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy
Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination
Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy
Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Adverse Reactions
1% to 10%:
Central nervous system: Headache (4% to 10%)
Gastrointestinal: Dysgeusia (≤4%), xerostomia (1% to 4%), diarrhea (2%), nausea (2%)
Respiratory: Upper respiratory tract infection (5% to 10%), epistaxis (6% to 9%), pharyngitis (≤8%), dry nose (≤5%), nasal mucosa irritation (2%), nasal congestion (1%)
<2%, postmarketing, and/or case reports: Anaphylaxis, angioedema, blurred vision, burning sensation of the nose, conjunctivitis, cough, dizziness, eye irritation, hoarseness, increased thirst, laryngospasm, palpitations, skin rash, tachycardia, tinnitus, urticaria
Warnings/Precautions
Concerns related to adverse effects:
- CNS effects: May cause dizziness, accommodation disorder, mydriasis and blurred vision; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving).
- Hypersensitivity reactions: Immediate hypersensitivity reactions (urticaria, angioedema, rash, bronchospasm, oropharyngeal edema, and anaphylaxis) have been reported. Discontinue use immediately if allergic or anaphylactoid/anaphylactic reactions occur.
Disease-related concerns:
- Glaucoma: Use with caution in patients with narrow-angle glaucoma.
- Hepatic impairment: Use with caution in patients with hepatic impairment.
- Prostatic hyperplasia/bladder neck obstruction: Use with caution in patients with prostatic hyperplasia or bladder neck obstruction.
- Renal impairment: Use with caution in patients with renal impairment.
Other warnings/precautions:
- Appropriate use: Avoid direct contact with eye. Temporary blurred vision, precipitating or worsening of narrow-angle glaucoma, mydriasis, increased intraocular pressure, acute eye pain, visual halos or colored images secondary to conjunctival and/or corneal congestion may occur. The 0.03% and 0.06% solutions do not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis or the common cold.
Pregnancy
Pregnancy Risk Factor
B
Pregnancy Considerations
Adverse events have not been observed in animal reproduction studies.
Patient Education
What is this drug used for?
- It is used to ease allergy signs.
Frequently reported side effects of this drug
- Sore throat
- Dry nose
- Headache
- Common cold symptoms
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Severe nasal irritation
- Severe nosebleeds
- Eye pain
- Severe eye irritation
- Seeing halos or bright colors around lights
- Vision changes
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
