ATROVENT HFA Inhalation aerosol, metered (2020)

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Boehringer Ingelheim Pharmaceuticals Inc.

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1. Indications and Usage

ATROVENT HFA Inhalation Aerosol is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and ...

2. Dosage and Administration

The usual starting dose of ATROVENT HFA is two inhalations four times a day. Patients may take additional inhalations as required; however, the total number of inhalations should not exceed 12 in 24 hours. ...

3. Dosage Forms and Strengths

ATROVENT HFA is an inhalation aerosol supplied in a pressurized stainless steel canister as a metered-dose inhaler with a white mouthpiece that has a clear, colorless sleeve and a green protective cap. ...

4. Contraindications

ATROVENT HFA is contraindicated in the following conditions <em>[see Warnings and Precautions (5.2)]</em>. Hypersensitivity to ipratropium bromide or other ATROVENT HFA components Hypersensitivity to atropine ...

5. Warnings and Precautions

5.1 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 ...

6. Adverse Reactions

The following adverse reactions are described, or described in greater detail, in other sections: Hypersensitivity reactions, including anaphylaxis <em>[see Contraindications (4) and Warnings and Precautions ...

6.1. Clinical Trials Experience

The adverse reaction information concerning ATROVENT HFA is derived from two 12-week, double-blind, parallel-group studies and one 1-year open-label, parallel group study. These studies compared ATROVENT ...

6.2. Postmarketing Experience

In a 5-year, placebo-controlled trial, hospitalizations for supraventricular tachycardia and/or atrial fibrillation occurred with an incidence rate of 0.5% in COPD patients receiving ATROVENT CFC. In addition ...

7. Drug Interactions

ATROVENT HFA has been used concomitantly with other drugs, including sympathomimetic bronchodilators, methylxanthines, oral and inhaled steroids commonly used in the treatment of COPD. With the exception ...

8.1. Pregnancy

Risk Summary Ipratropium is negligibly absorbed systemically following oral inhalation; therefore, maternal use is not expected to result in fetal exposure to the drug <em>[see Clinical Pharmacology (12.3)] ...

8.2. Lactation

Risk Summary There are no data on the presence of ipratropium in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. Although lipid-insoluble quaternary ...

8.4. Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

8.5. Geriatric Use

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 ...

10. Overdosage

Acute overdose by inhalation is unlikely since ipratropium bromide is not well absorbed systemically after inhalation or oral administration.

11. Description

The active ingredient in ATROVENT HFA is ipratropium bromide (as the monohydrate). It is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo[3.2.1]octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-,bromide ...

12.1. 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 ...

12.2. Pharmacodynamics

Cardiovascular effects At recommended doses, ipratropium bromide does not produce clinically significant changes in pulse rate or blood pressure. Ocular effects In studies without a positive control, ipratropium ...

12.3. Pharmacokinetics

Following administration by oral inhalation from a metered-dose inhaler, the majority of the delivered dose is deposited in the gastrointestinal tract and, to a lesser extent, in the lung, the intended ...

13.1. 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 ...

14. Clinical Studies

Conclusions regarding the efficacy of ATROVENT HFA were derived from two randomized, double-blind, controlled clinical studies. These studies enrolled males and females ages 40 years and older, with a ...

16.1. How Supplied

ATROVENT HFA is supplied in a pressurized stainless steel canister as a metered-dose inhaler with a white mouthpiece that has a clear, colorless sleeve and a green protective cap (NDC 0597-0087-17). The ...

16.2. Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. For optimal results, the canister should be at room temperature before use. ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Appropriate and safe use of ATROVENT HFA includes providing the patient with the information listed below and an understanding ...