Ipratropium Bromide Inhalation 17 ug/1
Ipratropium Bromide Inhalation · AEROSOL · Armstrong Pharmaceuticals, Inc.
Ipratropium Bromide Inhalation is a aerosol containing ipratropium bromide inhalation at 17 ug/1, taken respiratory (inhalation). Manufactured by Armstrong Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Ipratropium Bromide Inhalation
- Generic Name
- Ipratropium Bromide Inhalation
- NDC Code (Product)
17270-0401- Manufacturer
- Armstrong Pharmaceuticals, Inc.
- Strength
- 17 ug/1
- Dosage Form
- AEROSOL
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- ANDA217953
- Marketing Start
- 04/16/2026
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Ipratropium bromide 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. Ipratropium bromide HFA inhalation aerosol is an anticholinergic indicated for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The usual starting dose of ipratropium bromide HFA inhalation aerosol 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. Ipratropium bromide HFA inhalation aerosol 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 ipratropium bromide HFA inhalation aerosol 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 ipratropium bromide HFA inhalation aerosol 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 s…
Contraindications
4 CONTRAINDICATIONS Ipratropium bromide HFA inhalation aerosol is contraindicated in the following conditions [see Warnings and Precautions ( 5.2 )]. • Hypersensitivity to ipratropium bromide or other ipratropium bromide HFA inhalation aerosol components • Hypersensitivity to atropine or any of its derivatives • Hypersensitivity to ipratropium bromide or other ipratropium bromide HFA inhalation aerosol components ( 4 ) • Hypersensitivity to atropine or any of its derivatives
Drug Interactions
7 DRUG INTERACTIONS Ipratropium bromide HFA inhalation aerosol 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 ipratropium bromide HFA inhalation aerosol and these drugs with respect to safety and effectiveness. Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of ipratropium bromide HFA inhalation aerosol 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 ipratropium bromide HFA inhalation aerosol 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 Armstrong Pharmaceuticals, Inc. at 1-800-423-4136, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience The adverse reaction information concerning ipratropium bromide HFA inhalation aerosol is derived from two 12-week, double-blind, parallel-group studies and one 1-year open-label, paral…
Frequently Asked Questions
What is Ipratropium Bromide Inhalation used for?
Ipratropium Bromide Inhalation contains Ipratropium Bromide Inhalation. It is a aerosol taken respiratory (inhalation). Consult your doctor for specific uses.
Is Ipratropium Bromide Inhalation a controlled substance?
Ipratropium Bromide Inhalation is not classified as a controlled substance by the DEA.
What is the generic name for Ipratropium Bromide Inhalation?
The generic name for Ipratropium Bromide Inhalation is Ipratropium Bromide Inhalation. There are no other listed brand versions of Ipratropium Bromide Inhalation.
What is the NDC code for Ipratropium Bromide Inhalation 17 ug/1?
The NDC (National Drug Code) for Ipratropium Bromide Inhalation 17 ug/1 is 17270-0401, listed by Armstrong Pharmaceuticals, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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