Overview
Ipratropium is a quaternary ammonium derivative of atropine that acts as an anticholinergic agent. It is commonly administered through inhalation which allows producing a local effect without presenting a significant systemic absorption. Ipratropium as a therapeutic agent was developed by Boehringer Ingelheim and its first monotherapy product was FDA approved in 1986, while the combination product of ipratropium and albuterol was approved in 1996.
Indication
Inhaled ipratropium is indicated in combination with inhaled beta-agonist systemic corticosteroids for the management of severe exacerbations of asthma flares requiring treatment. Asthma exacerbations are characterized by a progressive increase in one or more of asthma symptoms accompanied by a decrease in expiratory flow. As a single agent, ipratropium was indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for patients 5 years or older. It does not alleviate nasal congestion nor sneezing. Rhinorrhea refers to recurrent or chronic watery nasal discharge. This condition is debilitating and its pathogenesis and etiology is complex and not very well understood presenting very substantial cost burden. Additionally, ipratropium is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease including chronic bronchitis and emphysema. The chronic obstructive pulmonary disease includes a large number of conditions characterized by breathlessness. As this includes several conditions, the etiology, symptoms, and treatments are diverse. Ipratropium has also been studied to be used for the treatment of sialorrhea. Sialorrhea is a common symptom that accompanies different neurologic conditions and it is characterized by drooling or excessive salivation.
Associated Conditions
- Acute Exacerbation of Asthma
- Asthma
- Bronchospasm
- Chronic Obstructive Pulmonary Disease (COPD)
- Nasal Congestion Associated With the Common Cold
- Non-Allergic Rhinitis
- Perennial Allergic Rhinitis (PAR)
- Rhinitis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/04/22 | Phase 2 | Not yet recruiting | Post Graduate Institute of Medical Education and Research, Chandigarh | ||
2023/10/10 | Phase 2 | Completed | |||
2023/09/15 | Phase 3 | Active, not recruiting | Neutec Ar-Ge San ve Tic A.Ş | ||
2023/06/06 | Phase 3 | Recruiting | Neutec Ar-Ge San ve Tic A.Ş | ||
2022/09/22 | Not Applicable | Recruiting | |||
2020/11/05 | Early Phase 1 | Completed | |||
2020/03/19 | Phase 2 | Recruiting | |||
2019/11/18 | Phase 4 | Completed | |||
2019/09/24 | Phase 4 | Recruiting | Wuhan Union Hospital, China | ||
2018/11/20 | Phase 2 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-6288 | RESPIRATORY (INHALATION) | 0.5 mg in 3 mL | 12/9/2021 | |
| Physicians Total Care, Inc. | 54868-5974 | RESPIRATORY (INHALATION) | 0.5 mg in 1 1 | 11/5/2010 | |
| Proficient Rx LP | 71205-051 | RESPIRATORY (INHALATION) | 0.5 mg in 3 mL | 1/1/2024 | |
| A-S Medication Solutions | 50090-0668 | RESPIRATORY (INHALATION) | 0.5 mg in 2.5 mL | 12/19/2022 | |
| Medical Supply Distribution, Llc. | 71152-201 | RESPIRATORY (INHALATION) | 0.5 mg in 3 mL | 9/22/2017 | |
| Hikma Pharmaceuticals USA Inc. | 0054-0046 | NASAL | 42 ug in 1 1 | 7/8/2016 | |
| Rebel Distributors Corp | 42254-041 | RESPIRATORY (INHALATION) | 0.5 mg in 2.5 mL | 3/15/2011 | |
| Ritedose Pharmaceuticals, LLC | 76204-100 | RESPIRATORY (INHALATION) | 0.5 mg in 2.5 mL | 12/20/2023 | |
| Cardinal Health 107, LLC | 55154-4357 | RESPIRATORY (INHALATION) | 0.5 mg in 3 mL | 1/18/2023 | |
| Nephron Pharmaceuticals Corporation | 0487-9801 | RESPIRATORY (INHALATION) | 0.5 mg in 2.5 mL | 1/11/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| IPROVENT INHALER 20 mcg/puff | SIN14257P | AEROSOL, METERED | 20 mcg/dose | 10/23/2012 | |
| STERI-NEB IPRATROPIUM NEBULISER SOLUTION 250 mcg/ml | SIN10039P | SOLUTION | 250 mcg/ml | 9/17/1998 | |
| ATROVENT SOLUTION 0.025% | SIN02815P | SOLUTION | 0.25 mg/ml | 5/18/1989 | |
| BERODUAL N METERED DOSE INHALER | SIN11739P | AEROSOL, SPRAY | 20 mcg/dose | 11/30/2001 | |
| BERODUAL SOLUTION | SIN02664P | SOLUTION | 0.25 mg/ml | 4/28/1989 | |
| COMBIVENT UNIT DOSE VIAL FOR INHALATION | SIN09558P | SOLUTION | 0.5 mg/2.5 ml | 11/28/1997 | |
| DUOVENT UDVS NEBULISER SOLUTION | SIN07913P | SOLUTION | 0.5 mg/4 ml | 11/15/1994 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Ipratropium Bromide Aerosol | 国药准字H11021802 | 化学药品 | 气雾剂 | 11/27/2020 | |
| Ipratropium Bromide Aerosol | 国药准字H11022421 | 化学药品 | 气雾剂 | 9/16/2020 | |
| Ipratropium Bromide Solution for Inhalation | 国药准字H20184025 | 化学药品 | 吸入溶液剂 | 1/18/2022 | |
| Ipratropium Bromide Solution for Inhalation | 国药准字H20120003 | 化学药品 | 吸入溶液剂 | 1/18/2022 | |
| Ipratropium Bromide Inhalation Aerosol | 国药准字HJ20130498 | 化学药品 | 吸入气雾剂 | 1/4/2023 | |
| Ipratropium Bromide Inhalation Aerosol | 国药准字HJ20130499 | 化学药品 | 吸入气雾剂 | 1/4/2023 | |
| Ipratropium Bromide Solution for Inhalation | 国药准字H20253088 | 化学药品 | 吸入制剂 | 1/8/2025 | |
| Ipratropium Bromide Solution for Inhalation | 国药准字HJ20150159 | 化学药品 | 吸入制剂 | 9/29/2024 | |
| Ipratropium Bromide Solution for Inhalation | 国药准字HJ20150158 | 化学药品 | 吸入制剂 | 9/29/2024 | |
| Ipratropium Bromide Solution for Inhalation | 国药准字H20234171 | 化学药品 | 吸入制剂 | 9/19/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| IPRAVENT INHALER 20MCG/DOSE | N/A | N/A | N/A | 5/23/2003 |
TGA Drug Approvals
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