Atrovent HFA 17 ug/1

ipratropium bromide · AEROSOL, METERED · Boehringer Ingelheim Pharmaceuticals, Inc.

2 Recalls on Record

Plain English

Atrovent HFA is a aerosol, metered containing ipratropium bromide at 17 ug/1, taken respiratory (inhalation). Manufactured by Boehringer Ingelheim Pharmaceuticals, Inc..

Key Facts

Brand Name: Atrovent HFA
Generic Name: ipratropium bromide
NDC Code (Product): 0597-0087
Manufacturer: Boehringer Ingelheim Pharmaceuticals, Inc.
Strength: 17 ug/1
Dosage Form: AEROSOL, METERED
Route: RESPIRATORY (INHALATION)
Marketing Status
Application #: NDA021527
Marketing Start: 05/01/2005

Recall History

2 Recalls on Record

Class II08/28/2012

Dispensing Solutions, Inc

Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of correctly as Atrovent HFA 12.9 grams Inhalation Aerosol

TerminatedVoluntary: Firm initiated

Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea5,938 reports

asthma3,985 reports

pneumonia3,094 reports

cough2,981 reports

wheezing2,641 reports

drug ineffective2,632 reports

fatigue2,185 reports

nausea1,936 reports

chronic obstructive pulmonary disease1,817 reports

off label use1,689 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 emphysema. ATROVENT HFA is an anticholinergic indicated for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION The usual starting dosage 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. ATROVENT HFA is a 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 2 test sprays into the air away from the face. In cases where the inhaler has not been used for more than 3 days, prime the inhaler again by releasing 2 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 [ see Patient Counseling Information (17) ]. For oral inhalatio…

Contraindications

4 CONTRAINDICATIONS ATROVENT HFA is contraindicated in the following conditions [ see Warnings and Precautions (5.2) ]. Hypersensitivity to ipratropium bromide or other ATROVENT HFA components Hypersensitivity to atropine or any of its derivatives Hypersensitivity to ipratropium bromide or other ATROVENT HFA components ( 4 ) Hypersensitivity to atropine or any of its derivatives ( 4 )

Drug Interactions

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 of albuterol, there are no formal studies fully evaluating the interaction effects of ATROVENT HFA and these drugs with respect to safety and effectiveness. Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of ATROVENT HFA with other anticholinergic-containing drugs ( 7.1 ) 7.1 Anticholinergic Agents There is potential for an additive interaction with concomitantly used anticholinergic medications. Therefore, avoid coadministration of ATROVENT HFA with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects [ see Warnings and Precautions (5.4 , 5.5) ].

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections: Hypersensitivity Reactions, Including Anaphylaxis [ see Contraindications (4) and Warnings and Precautions (5.2) ] Paradoxical Bronchospasm [ see Warnings and Precautions (5.3) ] Ocular Effects [ see Warnings and Precautions (5.4) ] Urinary Retention [ see Warnings and Precautions (5.5) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in patients. Most common adverse reactions (>5% incidence in the 12-week placebo-controlled trials) were bronchitis, COPD exacerbation, dyspnea, and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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…

Frequently Asked Questions

What is Atrovent HFA used for?

Atrovent HFA contains ipratropium bromide. It is a aerosol, metered taken respiratory (inhalation). Consult your doctor for specific uses.

Is Atrovent HFA a controlled substance?

Atrovent HFA is not classified as a controlled substance by the DEA.

What is the generic name for Atrovent HFA?

The generic name for Atrovent HFA is ipratropium bromide. There are 11 other brand versions of ipratropium bromide.

What is the NDC code for Atrovent HFA 17 ug/1?

The NDC (National Drug Code) for Atrovent HFA 17 ug/1 is 0597-0087, listed by Boehringer Ingelheim Pharmaceuticals, Inc..

Product NDC

0597-0087

Package NDC

0597-0087-17

Other Ipratropium Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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