Classes
DEA Class; Rx
Common Brand Names; Combivent Respimat
- Respiratory Inhalant Combos
Description
Combination of a short-acting antimuscarinic agent (ipratropium), with a short-acting beta-agonist (SABA, albuterol)
Primarily used in the treatment of COPD in adults, also used off-label for acute asthma exacerbation in adult and pediatric patients
Available as an oral inhalation or nebulizer solution
Indications
Treatment of chronic obstructive pulmonary disease (COPD) in patients on regular bronchodilator who continue to have bronchospasm and require second bronchodilator
Contraindications
Hypersensitivity to albuterol, ipratropium, atropine and derivatives, soy, or peanut
Adverse Effects
- Bronchitis (2-12%)
- Upper respiratory tract infection (1-10%)
- Lung disease (6%)
- Headache (3-6%)
- Dyspnea (2-5%)
- Nasopharyngitis (4%)
- Cough (3-4%)
- Pharyngitis (2-4%)
- Pain (1-3%)
- Chest pain (2.6%)
- Sinusitis (2.3%)
- Nausea (1-2%)
- Diarrhea (1.8%)
- Urinary tract infection (1.6%)
- Influenza (1.4%)
- Leg cramps (1.4%)
- Nausea (1.4%)
- Pneumonia (1.4%)
- Rhinitis (1.1%)
- Allergic-type reactions, such as skin reactions (eg, rash, pruritus, urticaria [including giant urticaria]), angioedema (eg, of tongue, lips, face), laryngospasm, and anaphylaxis
Warnings
Paradoxical bronchospasm; discontinue immediately, and administer alternative therapy
History of cardiovascular disorders; beta-adrenergic stimulation can result in clinically significant cardiovascular effects, myocardial ischemia, or electrocardiographic (ECG) changes
Avoid spraying into eyes, and contact physician if visual disturbances (eg, blurred vision or halos) occur; monitor patients with narrow-angle glaucoma
May produce clinically important hypokalemia leading to adverse cardiovascular effects in some patients
May cause immediate hypersensitivity reaction (urticaria, angioedema, rash, bronchospasm, anaphylaxis, or oropharyngeal edema); discontinue immediately, and administer alternative therapy
Use cution in patients with convulsive disorders, hyperthyroidism, diabetes mellitus, prostatic hyperplasia, or bladder-neck obstruction
Pregnancy and Lactation
There are no randomized clinical studies of the drug combination, or its individual components, ipratropium bromide and albuterol sulfate, in pregnant women; ipratropium is negligibly absorbed systemically following oral inhalation; therefore, maternal use is not expected to result in fetal exposure to drug
There are no available data on presence of drug, or components, ipratropium bromide or albuterol, in human milk, effects on breastfed infant, or on milk production; although lipid-insoluble quaternary cations pass into breast milk, ipratropium concentrations in plasma after inhaled therapeutic doses are low
Maximum Dosage
6 inhalations/day for Combivent Respimat inhalation spray; one 3-mL vial of DuoNeb administered 6 times/day via nebulization.
6 inhalations/day for Combivent Respimat inhalation spray; one 3-mL vial of DuoNeb administered 6 times/day via nebulization.
Safe and effective use of Combivent Respimat inhalation spray not established; one 3-mL vial per dose of nebulizer solution (e.g., DuoNeb) nebulization has been used off-label.
Safe and effective use of Combivent Respimat inhalation spray not established; 1.5-mL vial per dose of nebulizer solution (e.g., DuoNeb) nebulization has been used off-label.
Safe and effective use of combination product not established.
Safe and effective use of combination product not established.
