Combivent Respimat 100 ug/1

ipratropium bromide and albuterol · SPRAY, METERED · Boehringer Ingelheim Pharmaceuticals, Inc.

1 Recall on Record

Plain English

Combivent Respimat is a spray, metered containing ipratropium bromide and albuterol at 100 ug/1, taken respiratory (inhalation). Manufactured by Boehringer Ingelheim Pharmaceuticals, Inc..

Key Facts

Brand Name: Combivent Respimat
Generic Name: ipratropium bromide and albuterol
NDC Code (Product): 0597-0024
Manufacturer: Boehringer Ingelheim Pharmaceuticals, Inc.
Strength: 100 ug/1
Dosage Form: SPRAY, METERED
Route: RESPIRATORY (INHALATION)
Marketing Status
Application #: NDA021747
Marketing Start: 07/01/2012

Recall History

1 Recall on Record

Class II07/24/2015

Boehringer Ingelheim Roxane Inc

Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea421 reports

off label use205 reports

pneumonia184 reports

fatigue162 reports

drug ineffective161 reports

cough153 reports

headache136 reports

death129 reports

nausea125 reports

pain115 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE COMBIVENT RESPIMAT is a combination of ipratropium bromide (an anticholinergic agent) and albuterol sulfate (a beta 2 -adrenergic agonist) indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator. COMBIVENT RESPIMAT Inhalation Spray is a combination of ipratropium bromide (an anticholinergic agent) and albuterol sulfate (a beta 2 ‑adrenergic agonist) indicated for: Patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator (1)

Dosage & Administration

2 DOSAGE AND ADMINISTRATION The recommended dosage of COMBIVENT RESPIMAT is one inhalation four times a day. Patients may take additional inhalations as required; however, the total number of inhalations should not exceed six in 24 hours. Prior to first use, the COMBIVENT RESPIMAT cartridge is inserted into the COMBIVENT RESPIMAT inhaler and the unit is primed. When using the unit for the first time, patients are to actuate the inhaler toward the ground until an aerosol cloud is visible and then repeat the process three more times. The unit is then considered primed and ready for use. If not used for more than 3 days, patients are to actuate the inhaler once to prepare the inhaler for use. If not used for more than 21 days, patients are to actuate the inhaler until an aerosol cloud is visible and then repeat the process three more times to prepare the inhaler for use [ see Patient Counseling Information ( 17 ) ]. Safety and efficacy of additional doses of COMBIVENT RESPIMAT beyond six inhalations/24 hours have not been studied. Also, safety and efficacy of extra doses of ipratropium or albuterol in addition to the recommended doses of COMBIVENT RESPIMAT have not been studied. For o…

Contraindications

4 CONTRAINDICATIONS COMBIVENT RESPIMAT is contraindicated in the following conditions [ see Warnings and Precautions (5.6) ]: Hypersensitivity to any of the ingredients in COMBIVENT RESPIMAT Hypersensitivity to atropine or any of its derivatives Hypersensitivity to any of the ingredients in COMBIVENT RESPIMAT (4) Hypersensitivity to atropine or any of its derivatives (4)

Drug Interactions

7 DRUG INTERACTIONS COMBIVENT RESPIMAT has been used concomitantly with other drugs, including beta-adrenergic bronchodilators, methylxanthines, and oral and inhaled steroids, commonly used in the treatment of chronic obstructive pulmonary disease. There are no formal studies fully evaluating the interaction effects of COMBIVENT RESPIMAT and these drugs with respect to safety and effectiveness. Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administration of COMBIVENT RESPIMAT with other anticholinergic-containing drugs (7.1) Beta-adrenergic agonists: May increase the risk of adverse cardiovascular effects. Avoid coadministration of COMBIVENT RESPIMAT and other sympathomimetic agents (7.2) Beta-blockers: Inhibit the effect of albuterol. Consider alternative therapy in patients with hyperreactive airways (7.3) Diuretics: Electrocardiographic changes and/or hypokalemia associated with diuretics may worsen with concomitant use of beta-agonists. Consider monitoring potassium levels. (7.4) Monoamine oxidase inhibitors (MAOs) or tricyclic antidepressants: May potentiate effect of albuterol on the vascular system. Consider alternative …

Adverse Reactions

6 ADVERSE REACTIONS Use of albuterol, a beta 2 -adrenergic agonist, may be associated with the following: Paradoxical bronchospasm [ see Warnings and Precautions (5.1) ] Cardiovascular effects [ see Warnings and Precautions (5.2) ] Hypersensitivity reactions including anaphylaxis [ see Contraindications (4) and Warnings and Precautions (5.6) ] Hypokalemia [ see Warnings and Precautions (5.8) ] Albuterol is a component of COMBIVENT RESPIMAT. Use of ipratropium bromide, an anticholinergic, may result in the following: Ocular effects [ see Warnings and Precautions (5.3) ] Urinary retention [ see Warnings and Precautions (5.4) ] Ipratropium bromide is a component of COMBIVENT RESPIMAT. Most common (≥2%) adverse reactions for COMBIVENT RESPIMAT (20/100 mcg) are upper respiratory infection, nasopharyngitis, cough, bronchitis, headache, and dyspnea (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 COMBIVENT RESPIMAT 12-Week Clinical Trials The safety data described in Table 1 below are derived from one 12-week, randomized, multicenter, double-bl…

Frequently Asked Questions

What is Combivent Respimat used for?

Combivent Respimat contains ipratropium bromide and albuterol. It is a spray, metered taken respiratory (inhalation). Consult your doctor for specific uses.

Is Combivent Respimat a controlled substance?

Combivent Respimat is not classified as a controlled substance by the DEA.

What is the generic name for Combivent Respimat?

The generic name for Combivent Respimat is ipratropium bromide and albuterol. There are 12 other brand versions of ipratropium bromide and albuterol.

What is the NDC code for Combivent Respimat 100 ug/1?

The NDC (National Drug Code) for Combivent Respimat 100 ug/1 is 0597-0024, listed by Boehringer Ingelheim Pharmaceuticals, Inc..

Product NDC

0597-0024

Package NDC

0597-0024-02

Other Ipratropium Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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