Dosing and uses of Combivent Respimat (albuterol/ipratropium)
Adult dosage forms and strengths
albuterol (base)/ipratropium bromide
aerosol metered-dose inhaler (Combivent Respimat)
- (100mcg/20mcg)/actuation
nebulizer solution (generic)
- (2.5mg/0.5mg)/3mL
Chronic Obstructive Pulmonary Disease
Treatment of chronic obstructive pulmonary disease (COPD) in patients on regular bronchodilator who continue to have bronchospasm and require second bronchodilator
Aerosol: 100 mcg/20 mcg (1 actuation of metered-dose inhaler) q6hr; not to exceed 6 actuations/day
Nebulizer solution: 3 mL inhaled q6hr; not to exceed 3 mL q4hr
Dosing Considerations
Patients aged >65 years have higher steady-state systemic exposures for albuterol and ipratropium
Pediatric dosage forms and strengths
Safety and efficacy not established
Combivent Respimat (albuterol/ipratropium) adverse (side) effects
>10%
Bronchitis (2-12%)
1-10%
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%)
<1%
Allergic-type reactions, such as skin reactions (eg, rash, pruritus, urticaria [including giant urticaria]), angioedema (eg, of tongue, lips, face), laryngospasm, and anaphylaxis
Angina
Arrhythmia
Arthralgia
Dizziness
Dry mouth
Dyspepsia
Dysphonia
Edema
Fatigue
Hypertension
Insomnia
Nervousness
Palpitation
Paresthesia
Tachycardia
Tremor
Vomiting
Postmarketing Reports
Cardiovascular: Palpitations, hypotension, myocardial infarction, decreased diastolic blood pressure (BP), increased systolic Bp
General: Anaphylactoid reactions, drowsiness, flushing, alopecia, edema, hypokalemia, mental disorder, hyperhidrosis, metabolic acidosis (with albuterol products), asthenia
Gastrointestinal (GI): Mucosal ulcers, stomatitis, heartburn, distress (diarrhea, nausea, vomiting), GI motility disorder, constipation
Muscular: Muscle spasms, muscular weakness, myalgia
Neurologic and psychiatric: Central nervous system (CNS) stimulation, coordination difficulty
Other: Throat irritation, dry throat, hoarseness
Renal: Urinary retention
Respiratory: Bronchospasm (including paradoxical bronchospasm), nasal congestion, drying of secretions, wheezing, exacerbation of COPD symptoms
Sensory: Mydriasis, precipitation or worsening of narrow-angle glaucoma, glaucoma, increased intraocular pressure (IOP), acute eye pain, halo vision, blurred vision, accommodation disorder, ocular irritation, corneal edema, conjunctival hyperemia
Warnings
Contraindications
Hypersensitivity to albuterol, ipratropium, atropine and derivatives, soy, or peanut
Cautions
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
Prostatic hyperplasia or bladder-neck obstruction
Convulsive disorders, hyperthyroidism, or diabetes mellitus
Do not exceed recommended dosage; fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma
Keep out of reach of children
Avoid freezing
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown whether drug is excreted in breast milk
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Combivent Respimat (albuterol/ipratropium)
Mechanism of action
Albuterol: Beta2-adrenergic bronchodilator
Ipratropium: Anticholinergic (parasympatholytic) agent; inhibits vagally mediated reflexes by antagonizing acetylcholine action; prevents increase in intracellular calcium concentration caused by interaction of acetylcholine with muscarinic receptors on bronchial smooth muscle
Absorption
Peak plasma time: Albuterol, 3 hr (from portion swallowed)
Peak plasma concentration: Albuterol, 419-802 pg/mL (from portion swallowed)
Distribution
Protein bound: Ipratropium, 0-9%
Metabolism
Albuterol: Conjugatively metabolized to albuterol 4'-O-sulfate
Ipratropium: Partially metabolized to inactive ester hydrolysis products
Elimination
Half-life: Albuterol, 3.6 hr (after 30-min infusion of 1.5 mg); ipratropium, 2 hr (after inhalation or IV administration)
Mean clearance: Albuterol, 439 mL/min/1.73 m²
Excretion: Albuterol, urine (27%); ipratropium, urine (4%)
Administration
Instructions
See individual package inserts for instructions on use
Avoid freezing
Aerosol metered-dose inhalers
- Insert cartridge into metered-dose inhaler, and prime unit before initial use; actuate inhaler toward ground until aerosol cloud is visible, then repeat 3 more times
- If inhaler has not been used for >3 days, actuate it once before using it again
- If inhaler has not been used for ≥21 days, repeat priming process for initial use (ie, actuate until aerosol cloud is observed, then repeat 3 more times)
Nebulizer solution
- Administer via jet nebulizer connected to air compressor with adequate air flow
- Equip with mouthpiece or suitable air mask
