Drugplain

Ipratropium Bromide and Albuterol Sulfate 2.5 mg/3mL

Ipratropium Bromide and Albuterol Sulfate · SOLUTION · Cipla USA Inc.

2 Recalls on Record
Plain English

Ipratropium Bromide and Albuterol Sulfate is a solution containing ipratropium bromide and albuterol sulfate at 2.5 mg/3mL, taken respiratory (inhalation). Manufactured by Cipla USA Inc..

Key Facts

Brand Name
Ipratropium Bromide and Albuterol Sulfate
Generic Name
Ipratropium Bromide and Albuterol Sulfate
NDC Code (Product)
69097-173
Manufacturer
Cipla USA Inc.
Strength
2.5 mg/3mL
Dosage Form
SOLUTION
Route
RESPIRATORY (INHALATION)
Marketing Status
Application #
ANDA077559
Marketing Start
12/31/2007

Recall History

2 Recalls on Record
Class II03/26/2024

Cipla USA, Inc.

Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.

TerminatedVoluntary: Firm initiated
Class II01/26/2022

CARDINAL HEALTHCARE

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

dyspnoea258 reports
drug ineffective165 reports
pneumonia112 reports
cough103 reports
fatigue103 reports
nausea86 reports
headache81 reports
death78 reports
diarrhoea68 reports
dizziness68 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Ipratropium bromide and albuterol sulfate inhalation solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.

Dosage & Administration

DOSAGE AND ADMINISTRATION The recommended dose of ipratropium bromide and albuterol sulfate inhalation solution is one 3 mL vial administered 4 times per day via nebulization with up to 2 additional 3 mL doses allowed per day, if needed. Safety and efficacy of additional doses or increased frequency of administration of ipratropium bromide and albuterol sulfate inhalation solution beyond these guidelines has not been studied and the safety and efficacy of extra doses of albuterol sulfate or ipratropium bromide in addition to the recommended doses of ipratropium bromide and albuterol sulfate inhalation solution have not been studied. The use of ipratropium bromide and albuterol sulfate inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. If a previously effective regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of worsening COPD, which would require reassessment of therapy. A Pari-LC-Plus™ nebulizer (with face mask or mouthpiece) connected to a PRONEB™ compressor was used to deliver ipratropium bromide and albuterol sulfate inhalation solution to each patient in one U.S.…

Warnings

WARNINGS Paradoxical Bronchospasm : In the clinical study of ipratropium bromide and albuterol sulfate, paradoxical bronchospasm was not observed. However, paradoxical bronchospasm has been observed with both inhaled ipratropium bromide and albuterol products and can be life-threatening. If this occurs, ipratropium bromide and albuterol sulfate should be discontinued immediately and alternative therapy instituted. Do Not Exceed Recommended Dose : Fatalities have been reported in association with excessive use of inhaled products containing sympathomimetic amines and with the home use of nebulizers. Cardiovascular Effect : Ipratropium bromide and albuterol sulfate, like other beta adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon for ipratropium bromide and albuterol sulfate at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta agonists have been reported to produce ECG changes, such as flattening of the T-wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of thes…

Contraindications

CONTRAINDICATIONS Ipratropium bromide and albuterol sulfate inhalation solution is contraindicated in patients with a history of hypersensitivity to any of its components, or to atropine and its derivatives.

Drug Interactions

Drug Interactions Anticholinergic agents : Although ipratropium bromide is minimally absorbed into the systemic circulation, there is some potential for an additive interaction with concomitantly used anticholinergic medications. Caution is, therefore, advised in the coadministration of ipratropium bromide and albuterol sulfate with other drugs having anticholinergic properties. ß-adrenergic agents : Caution is advised in the coadministration of ipratropium bromide and albuterol sulfate and other sympathomimetic agents due to the increased risk of adverse cardiovascular effects. ß-receptor blocking agents : These agents and albuterol sulfate inhibit the effect of each other. β-receptor blocking agents should be used with caution in patients with hyperreactive airways, and if used, relatively selective β1 selective agents are recommended. Diuretics : The electrocardiogram (ECG) changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by β-agonists, especially when the recommended dose of the β-agonist is exceeded. Although the clinical significance of these effects is not known,…

Adverse Reactions

ADVERSE REACTIONS Adverse reaction information concerning ipratropium bromide and albuterol sulfate was derived from the 12-week controlled clinical trial. ADVERSE EVENTS OCCURRING IN ≥ 1% OF ≥ 1 TREATMENT GROUP(S) AND WHERE THE COMBINATION TREATMENT SHOWED THE HIGHEST PERCENTAGE Body System COSTART Term Albuterol n (%) Ipratropium n (%) Ipratropium Bromide and Albuterol Sulfate n (%) NUMBER OF PATIENTS 761 754 765 N (%) Patients with AE 327 (43) 329 (43.6) 367 (48) BODY AS A WHOLE Pain 8 (1.1) 4 (0.5) 10 (1.3) Pain chest 11 (1.4) 14 (1.9) 20 (2.6) DIGESTIVE Diarrhea 5 (0.7) 9 (1.2) 14 (1.8) Dyspepsia 7 (0.9) 8 (1.1) 10 (1.3) Nausea 7 (0.9) 6 (0.8) 11 (1.4) MUSCULO-SKELETAL Cramps leg 8 (1.1) 6 (0.8) 11 (1.4) RESPIRATORY Bronchitis 11 (1.4) 13 (1.7) 13 (1.7) Lung Disease 36 (4.7) 34 (4.5) 49 (6.4) Pharyngitis 27 (3.5) 27 (3.6) 34 (4.4) Pneumonia 7 (0.9) 8 (1.1) 10 (1.3) UROGENITAL Infection urinary tract 3 (0.4) 9 (1.2) 12 (1.6) Additional adverse reactions reported in more than 1% of patients treated with ipratropium bromide and albuterol sulfate included constipation and voice alterations. In the clinical trial, there was a 0.3% incidence of possible allergic-type reactions, incl…

Frequently Asked Questions

What is Ipratropium Bromide and Albuterol Sulfate used for?

Ipratropium Bromide and Albuterol Sulfate contains Ipratropium Bromide and Albuterol Sulfate. It is a solution taken respiratory (inhalation). Consult your doctor for specific uses.

Is Ipratropium Bromide and Albuterol Sulfate a controlled substance?

Ipratropium Bromide and Albuterol Sulfate is not classified as a controlled substance by the DEA.

What is the generic name for Ipratropium Bromide and Albuterol Sulfate?

The generic name for Ipratropium Bromide and Albuterol Sulfate is Ipratropium Bromide and Albuterol Sulfate. There are 4 other brand versions of Ipratropium Bromide and Albuterol Sulfate.

What is the NDC code for Ipratropium Bromide and Albuterol Sulfate 2.5 mg/3mL?

The NDC (National Drug Code) for Ipratropium Bromide and Albuterol Sulfate 2.5 mg/3mL is 69097-173, listed by Cipla USA Inc..

Product NDC

69097-173

Package NDC

69097-173-53

Other Ipratropium Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)