"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.
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
|Placebo-controlled 12 week Study 244.1405 and Active-controlled 12 week Study 244.1408||Active-controlled 1-year Study 244.2453|
|BODY AS A WHOLE - GENERAL DISORDERS|
|CENTRAL & PERIPHERAL NERVOUS SYSTEM DISORDERS|
|GASTROINTESTINAL SYSTEM DISORDERS|
|RESPIRATORY SYSTEM DISORDERS|
|URINARY SYSTEM DISORDERS|
|Urinary tract infection||2||3||1||10||8|
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].
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 Atrovent HFA (ipratropium bromide inhalation aerosol) Side Effects Center for a complete guide to possible side effects
ATROVENT HFA has been used concomitantly with other drugs, including sympathomimetic bronchodilators, methylxanthines, oral and inhaled steroids commonly used in the treatment of chronic obstructive pulmonary disease. 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.
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].
Read the Atrovent HFA Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 10/8/2012
Additional Atrovent HFA Information
Atrovent HFA - User Reviews
Atrovent HFA User Reviews
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