Atrovent HFA

What Is Atrovent HFA?

Atrovent HFA (ipratropium bromide HFA) is an anticholinergic bronchodilator, packaged in an inhaler, used for maintenance and treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis, and emphysema. Atrovent HFA is available as a generic termed ipratropium bromide.

What Are Side Effects of Atrovent HFA?

Common side effects of Atrovent HFA include:

• headache
• dry mouth
• hoarseness
• cough
• stuffy nose
• sinus pain
• nausea
• upset stomach
• constipation
• back pain
• fever
• chills
• body aches
• flu symptoms
• blurred vision, and
• dizziness

Tell your doctor if you experience serious side effects of Atrovent HFA including bronchospasm (wheezing, chest tightness, trouble breathing), eye pain, seeing halos around lights, pain or burning when you urinate, urinating less than usual or not at all, or worsening of your symptoms.

Dosage for Atrovent HFA?

Atrovent HFA is available as a pressurized metered-dose aerosol unit for oral inhalation that contains a solution of ipratropium bromide. Severe side effects of Atrovent HFA may include shortness of breath, swelling of face, lips, tongue or throat, rapid heartbeats, urinary retention, and glaucoma. Patients that are hypersensitive to atropine should not be given Atrovent HFA.

Atrovent HFA During Pregnancy and Breastfeeding

There are no well controlled studies of Atrovent HFA in pregnancy or in women who are breastfeeding, or in the pediatric population; use of Atrovent HFA with these patients requires risks versus benefits be considered by the doctor and patient.

Additional Information

Our Atrovent HFA Drug Center provides a comprehensive view of available drug information as well as related drugs, user reviews, supplements, and diseases, and conditions.

 

Atrovent HFA Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

You may need to use a different bronchodilator medication if you have an allergic reaction to ipratropium inhalation.

Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medicine;
• little or no urination;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights; or
• worsened breathing problems.

Common side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;
• cough with mucus, chest tightness, trouble breathing; or
• tiredness, or headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Atrovent HFA (Ipratropium Bromide Inhalation Aerosol)

 

Atrovent HFA Professional Information

SIDE EFFECTS

The following adverse reactions are described, or described in greater detail, in other sections:

• Hypersensitivity reactions, including anaphylaxis [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
• Paradoxical bronchospasm [see WARNINGS AND PRECAUTIONS]
• 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 a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in patients.

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 HFA Inhalation Aerosol, ATROVENT CFC Inhalation Aerosol, and placebo (in one study only) in 1010 COPD patients. The following table lists the incidence of adverse reactions that occurred at a rate of greater than or equal to 3% in any ipratropium bromide group and greater than placebo in the 12-week study. The frequency of corresponding reactions in the 1-year open label study is included for comparison.

TABLE 1 : Adverse Reactions (% Patients) in ATROVENT HFA Clinical Trials

	Placebo-controlled 12 week Study 244.1405 and Active-controlled 12 week Study 244.1408			Active-controlled 1-year Study 244.2453
	Atrovent HFA (N=243) %	Atrovent CFC (N=183) %	Placebo (N=128) %	Atrovent HFA (N=305) %	Atrovent CFC (N=151) %
BODY AS A WHOLE - GENERAL DISORDERS
Back pain	2	3	2	7	3
Headache	6	9	8	7	5
Influenza-like symptoms	4	2	2	8	5
CENTRAL & PERIPHERAL NERVOUS SYSTEM DISORDERS
Dizziness	3	3	2	3	1
GASTROINTESTINAL SYSTEM DISORDERS
Dyspepsia	1	3	1	5	3
Mouth dry	4	2	2	2	3
Nausea	4	1	2	4	4
RESPIRATORY SYSTEM DISORDERS
Bronchitis	10	11	6	23	19
COPD exacerbation	8	14	13	23	23
Dyspnea	8	8	4	7	4
Sinusitis	1	4	3	11	14
URINARY SYSTEM DISORDERS
Urinary tract infection	2	3	1	10	8

Cough, rhinitis, and upper respiratory infection occurred in greater than or equal to 3% of patients in either ipratropium treatment group but not greater than placebo in the 12-week study.

In the one open label controlled study in 456 COPD patients, the overall incidence of adverse events was also similar between ATROVENT HFA and ATROVENT CFC formulations.

Overall, in the above mentioned studies, 9.3% of the patients taking 42 mcg ATROVENT HFA and 8.7% of the patients taking 42 mcg ATROVENT CFC reported at least one adverse event that was considered by the investigator to be related to the study drug. The most common drug-related adverse events were dry mouth (1.6% of ATROVENT HFA and 0.9% of ATROVENT CFC patients), and taste perversion (bitter taste) (0.9% of ATROVENT HFA and 0.3% of ATROVENT CFC patients).

As an anticholinergic drug, cases of precipitation or worsening of narrow-angle glaucoma, glaucoma, halo vision, conjunctival hyperaemia, corneal edema, mydriasis, acute eye pain, dry throat, hypotension, palpitations, urinary retention, tachycardia, constipation, bronchospasm, including paradoxical bronchospasm have been reported with the use of ATROVENT. Additional adverse reactions identified for ATROVENT seen in clinical trials include throat irritation, stomatitis, mouth edema, and vision blurred.

Allergic-type reactions such as skin rash, pruritus, angioedema including that of tongue, lips and face, urticaria (including giant urticaria), laryngospasm and anaphylactic reactions have been reported [see WARNINGS AND PRECAUTIONS].

Post-Marketing 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 to the adverse reactions reported in the controlled clinical trials, adverse reactions have been identified during post approval use of ATROVENT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Allergic-type reactions such as skin rash, angioedema including that of tongue, lips and face, urticaria (including giant urticaria), laryngospasm and anaphylactic reactions have been reported, with positive rechallenge in some cases.

Additionally, urinary retention, mydriasis, gastrointestinal distress (diarrhea, nausea, vomiting), cough and bronchospasm, including paradoxical bronchospasm, hypersensitivity reactions, intraocular pressure increased, accommodation disorder, heart rate increased, pharyngeal edema, and gastrointestinal motility disorders have been reported during the post-marketing period with use of ATROVENT.

Read the entire FDA prescribing information for Atrovent HFA (Ipratropium Bromide Inhalation Aerosol)