Thursday, September 15, 2016

Atrovent Nasal Spray eent


Generic Name: Ipratropium Bromide eent
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

Introduction

Synthetic quaternary ammonium antimuscarinic.1 2


Uses for Atrovent Nasal Spray


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


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


Atrovent Nasal Spray 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 Atrovent Nasal Spray


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 Atrovent Nasal Spray


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


Atrovent Nasal Spray 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


ActionsActions



  • 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



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 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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