"The US Food and Drug Administration (FDA) has expanded the indication for the short-acting beta-agonist albuterol sulfate inhalation powder (ProAir RespiClick, Teva) to children aged 4 to 11 years, the company announced today.
Use for Maintenance Treatment Only
ATROVENT HFA is a bronchodilator for the maintenance treatment of bronchospasm associated with COPD and is not indicated for the initial treatment of acute episodes of bronchospasm where rescue therapy is required for rapid response.
Hypersensitivity Reactions, Including Anaphylaxis
Hypersensitivity reactions including urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema may occur after the administration of ATROVENT HFA. In clinical trials and post marketing experience with ipratropium containing products, hypersensitivity reactions such as skin rash, pruritus, angioedema of tongue, lips and face, urticaria (including giant urticaria), laryngospasm and anaphylactic reactions have been reported [see ADVERSE REACTIONS]. If such a reaction occurs, therapy with ATROVENT HFA should be stopped at once and alternative treatment should be considered [see CONTRAINDICATIONS].
ATROVENT HFA can produce paradoxical bronchospasm that can be life threatening. If this occurs, treatment with ATROVENT HFA should be stopped and other treatments considered.
ATROVENT HFA is an anticholinergic and its use may increase intraocular pressure. This may result in precipitation or worsening of narrow-angle glaucoma. Therefore, ATROVENT HFA should be used with caution in patients with narrow-angle glaucoma.
Patients should avoid spraying ATROVENT HFA into their eyes. If a patient sprays ATROVENT HFA into their eyes, they may cause eye pain or discomfort, temporary blurring of vision, mydriasis, visual halos or colored images in association with red eyes from conjunctival and corneal congestion. Advise patients to consult their physician immediately if any of these symptoms develop while using ATROVENT HFA Inhalation Aerosol.
ATROVENT HFA is an anticholinergic and may cause urinary retention. Therefore caution is advised when administering ATROVENT HFA Inhalation Aerosol to patients with prostatic hyperplasia, or bladder-neck obstruction [see DRUG INTERACTIONS].
Patient Counseling Information
See FDA-Approved Patient Labeling
Appropriate and safe use of ATROVENT HFA includes providing the patient with the information listed below and an understanding of the way it should be administered [see FDA-approved Patient Labeling].
Advise patients that ATROVENT HFA is a bronchodilator for the maintenance treatment of bronchospasm associated with COPD and is not indicated for the initial treatment of acute episodes of bronchospasm where rescue therapy is required for rapid response.
Inform patients that ATROVENT HFA can produce paradoxical bronchospasm that can be life-threatening. If paradoxical bronchospasm occurs, patients should discontinue using ATROVENT HFA.
Caution patients to avoid spraying the aerosol into their eyes and be advised that this may result in precipitation or worsening of narrow-angle glaucoma, mydriasis, increased intraocular pressure, acute eye pain or discomfort, temporary blurring of vision, visual halos or colored images in association with red eyes from conjunctival and corneal congestion. Patients should also be advised that should any combination of these symptoms develop, they should consult their physician immediately.
Since dizziness, accommodation disorder, mydriasis, and blurred vision may occur with use of ATROVENT, patients should be cautioned about engaging in activities requiring balance and visual acuity such as driving a car or operating appliances or machinery.
Inform patients that ATROVENT HFA may cause urinary retention and should be advised to consult their physicians if they experience difficulty with urination.
Frequency of Use
The action of ATROVENT HFA should last 2-4 hours. Advise patients not to increase the dose or frequency of ATROVENT HFA without patients consulting their physician. Advise patients to seek immediate medical attention if treatment with ATROVENT HFA becomes less effective for symptomatic relief, their symptoms become worse, and/or patients need to use the product more frequently than usual.
Concomitant Drug Use
Advise patients on the use of ATROVENT HFA in relation to other inhaled drugs.
Use Only as Prescribed
Remind patients that ATROVENT HFA should be used consistently as prescribed throughout the course of therapy.
Preparation for Use and Priming
Instruct patients that priming ATROVENT HFA is essential to ensure appropriate content of the medication in each actuation. Patients do not have to shake the ATROVENT HFA canister before use [see FDA-approved Patient Labeling].
FDA-Approved Patient Labeling
Remind patients to read and follow the accompanying “Instructions for Use”, which should be dispensed with the product.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Two-year oral carcinogenicity studies in rats and mice have revealed no carcinogenic activity at doses up to 6 mg/kg (approximately 240 and 120 times the maximum recommended human daily inhalation dose (MRHDID) in adults on a mg/m² basis, respectively). Results of various mutagenicity/clastogenicity studies (Ames test, mouse dominant lethal test, mouse micronucleus test and chromosome aberrations of bone marrow in Chinese hamsters) were negative.
Fertility of male or female rats at oral doses up to 50 mg/kg (approximately 2000 times the MRHDID in adults on a mg/m² basis) was unaffected by ipratropium bromide administration. At an oral dose of 500 mg/kg (approximately 20,000 times the MRHDID in adults on a mg/m² basis), ipratropium bromide produced a decrease in the conception rate.
Use In Specific Populations
Teratogenic Effects: Pregnancy Category B
There are no adequate and well-controlled studies of ATROVENT HFA (ipratropium bromide) Inhalation Aerosol in pregnant women. ATROVENT HFA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Oral reproduction studies were performed in mice, rats and rabbits at doses approximately 200, 40,000, and 10,000 times, respectively, the maximum recommended human daily inhalation dose (MRHDID) in adults (on a mg/m² basis at maternal doses in each species of 10, 1,000, and 125 mg/kg/day, respectively). Inhalation reproduction studies were conducted in rats and rabbits at doses approximately 60 and 140 times, respectively, the MRHDID in adults (on a mg/m² basis at maternal doses of 1.5 and 1.8 mg/kg/day, respectively). These studies demonstrated no evidence of teratogenic effects as a result of ipratropium bromide. Embryotoxicity was observed as increased resorption in rats at oral doses approximately 3,600 times the MRHDID in adults (on a mg/m² basis at maternal doses of 90 mg/kg/day and above). This effect is not considered relevant to human use due to the large doses at which it was observed and the difference in route of administration.
It is not known whether the active component, ipratropium bromide, is excreted in human milk. Because lipid-insoluble quaternary cations pass into breast milk, caution should be exercised when ATROVENT HFA is administered to a nursing mother.
Safety and effectiveness in the pediatric population have not been established.
In the pivotal 12-week study, both ATROVENT HFA and ATROVENT CFC formulations were equally effective in patients over 65 years of age and under 65 years of age. Of the total number of subjects in clinical studies of ATROVENT HFA, 57% were ≥ 65 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/18/2016
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