ATROVENT HFA- ipratropium bromide aerosol, metered
Boehringer Ingelheim Pharmaceuticals Inc.
Mechanism of Action
Ipratropium bromide is an anticholinergic (parasympatholytic) agent which, based on animal studies, appears to inhibit vagally-mediated reflexes by antagonizing the action of acetylcholine, the transmitter agent released at the neuromuscular junctions in the lung. Anticholinergics prevent the increases in intracellular concentration of Ca++ which is caused by interaction of acetylcholine with the muscarinic receptors on bronchial smooth muscle.
INDICATIONS AND USAGE
ATROVENT HFA Inhalation Aerosol is indicated as bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
2??DOSAGE AND ADMINISTRATION
The usual starting dose of ATROVENT HFA is two inhalations four times day. Patients may take additional inhalations as required; however, the total number of inhalations should not exceed 12 in 24 hours.
ATROVENT HFA is solution aerosol that does not require shaking. However, as with any other metered-dose inhaler, some coordination is required between actuating the canister and inhaling the medication.
Patients should ?prime? or actuate ATROVENT HFA before using for the first time by releasing test sprays into the air away from the face. In cases where the inhaler has not been used for more than days, prime the inhaler again by releasing test sprays into the air away from the face. Patients should avoid spraying ATROVENT HFA into their eyes.
Each inhaler provides sufficient medication for 200 actuations. The inhaler should be discarded after the labeled number of actuations has been used. The amount of medication in each actuation cannot be assured after this point, even though the canister is not completely empty.
Patients should be instructed on the proper use of their inhaler .
3??DOSAGE FORMS AND STRENGTHS
ATROVENT HFA is an inhalation aerosol supplied in pressurized stainless steel canister as metered-dose inhaler with white mouthpiece that has clear, colorless sleeve and green protective cap. Each pressurized metered-dose aerosol unit for oral inhalation contains 12.9 solution of ipratropium bromide that provides sufficient medication for 200 actuations. After priming, each actuation of the inhaler delivers 21 mcg of ipratropium bromide (as the monohydrate) from the valve and delivers 17 mcg of ipratropium bromide from the mouthpiece.
4??CONTRAINDICATIONS
ATROVENT HFA is contraindicated in the following conditions .
Hypersensitivity to ipratropium bromide or other ATROVENT HFA components
Hypersensitivity to atropine or any of its derivatives
5??WARNINGS AND PRECAUTIONS
5.1??Use for Maintenance Treatment Only
ATROVENT HFA is 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.
5.2??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 reaction occurs, therapy with ATROVENT HFA should be stopped at once and alternative treatment should be considered [see Contraindications
5.3??Paradoxical Bronchospasm
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.
5.4??Ocular Effects
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 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.
5.5??Urinary Retention
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
6??ADVERSE REACTIONS
The following adverse reactions are described, or described in greater detail, in other sections:
Hypersensitivity reactions, including anaphylaxis
Paradoxical bronchospasm
Ocular effects [see Warnings and Precautions
Urinary retention [see Warnings and Precautions
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in patients.
HOW SUPPLIED/STORAGE AND HANDLING
ATROVENT HFA is supplied in pressurized stainless steel canister as metered-dose inhaler with white mouthpiece that has clear, colorless sleeve and green protective cap (NDC 0597-0087-17). The mouthpiece has an actuation indicator visible through small window. The indicator typically moves during every to actuations. It displays the approximate number of actuations remaining in increments of 20, starting at ?200? and decreasing until it reaches ?0?.
