Dosing and uses of Xopenex, Xopenex HFA (levalbuterol)
Adult dosage forms and strengths
nebulizer solution
- 0.31mg/3mL
- 0.63mg/3mL
- 1.25mg/3mL
- 1.25mg/0.5mL
aerosoL
- 45mcg/actuation
Bronchospasm
Nebulizer solution: 0.63-1.25 mg 3 times daily q6-8hr
Aerosol: 90 mcg (2 actuations of metered-dose inhaler) q4-6hr
Asthma Exacerbation
Nebulizer solution: 1.25-2.5 mg q20min for 3 doses, then 1.25-5 mg q1-4hr PRn
Aerosol: 180-360 mcg (4-8 actuations of metered-dose inhaler) q20min for ≤4 hr, then q1-4hr PRn
Pediatric dosage forms and strengths
nebulizer solution
- 0.31mg/3mL
- 0.63mg/3mL
- 1.25mg/3mL
- 1.25mg/0.5mL
aerosoL
- 45mcg/actuation
Bronchospasm
Nebulizer solution
- <5 years: 0.31-1.25 mg q4-6hr PRN
- 5-12 years: 0.31 mg q8hr; not to exceed 0.63 mg q8hr PRN
- >12 years: 0.63-1.25 mg q8hr PRN
AerosoL
- <4 years: Safety and efficacy not established
- ≥4 years: 90 mcg (2 actuations of metered-dose inhaler) q4-6hr PRN
Asthma Exacerbation
Nebulizer solution
- <12 years: 0.075 mg/kg (≥1.25 mg) q20min for 3 doses, then 0.075-0.15 mg/kg (≤5 mg) q1-4hr PRN
- ≥12 years: 1.25-2.5 mg q20min for 3 doses, then 1.25-5 mg q1-4hr PRN
AerosoL
- <4 years: Safety and efficacy not established
- ≥4 years: 180-360 mcg (4-8 actuations of metered-dose inhaler) q20min for 3 doses, then q1-4hr PRN
Geriatric dosage forms and strengths
Nebulizer solution: 0.63 mg initially in patients >65 years
Xopenex, Xopenex HFA (levalbuterol) adverse (side) effects
>10%
Headache (8-12%)
Viral infection (7-12%)
Rhinitis (3-11%)
1-10%
Pharyngitis (3-10%)
Tremor (7%)
Sinusitis (1-4%)
Flu (1-4%)
Dyspepsia (1-3%)
Leg cramps (<3%)
Generalized pain (2.8%)
Nasal edema (2.8%)
Nervousness (2.8%)
Tachycardia (2.8%)
Postmarketing Reports
Dysphonia
Gastroesophageal reflux disease, nausea
Angioedema, anaphylaxis, rash, urticaria
Chest pain, tachycardia, arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles)
Asthma, increased cough, dyspnea, dysphonia
Metabolic acidosis
Nervousness, tremor
Warnings
Contraindications
Hypersensitivity to levalbuterol or racemic albuteroL
Cautions
Cardiovascular disorder (eg, arrhythmias, hypertension, coronary insufficiency)
Risk of paradoxical bronchospasm
Has higher affinity for beta1- and beta2-adrenergic receptors than racemic albuterol has
Risk of hypersensitivity reactions
Use with caution in diabetes mellitus (beta2 agonists may increase glucose)
Risk of hypokalemia (usually transient)
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown whether drug is excreted in breast milk; discontinue, or do not nurse
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 Xopenex, Xopenex HFA (levalbuterol)
Mechanism of action
Beta2-receptor agonist with some beta1 activity; relaxes bronchial smooth muscle
Absorption
Onset: Nebulizer solution, 10-17 min; aerosol, 5.5-10.2 min
Duration: Nebulizer solution, 5-6 hr; aerosol, 3-4 hr
Peak plasma time (children): Nebulizer solution, 0.3-0.6 hr; aerosol, 0.8 hr
Peak plasma time (adults): Nebulizer solution, 0.2 hr; aerosol, 0.5 hr
Time to peak effect: Nebulizer solution, 1.5 hr; aerosol, 77 min
Elimination
Half-life: 3-3.4 hr
