Ipratropium is an anticholinergic sold in the U.S. under 3 brand and generic names, for perennial allergic rhinitis, vasomotor rhinitis and bronchial spasm. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Atrovent Hfa (application NDA021527). Other ipratropium products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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 inhalation only Two inhalations four times a day, not to exceed 12 inhalations in 24 hours ( 2 )
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 compared ATROVENT HFA Inhalation Aerosol, ATROVENT CFC Inhalation Aerosol, and placebo (in one study only) in 1,010 COPD patients. The following table lists the incidence of adverse reactions that occurred at a rate of…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Spray/Inhaler | Generic | $1 | View → | |
| 2 | 70/100 | Prescription | Spray/Inhaler | Generic |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
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 )
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) ].
| $1 |
| View → |
| 3 | 70/100 | Prescription | Solution | Generic | $1 | View → |