Indications for: XOPENEX
Adults and Adolescents ≥12 Years Old
Safety and efficacy evaluated in a 4-week, randomized, double-blind, placebo-controlled, parallel group study.
- 362 patients 12 years of age and older with mild to moderate asthma (mean baseline FEV1 60% of predicted); ~50% receiving inhaled corticosteroids.
- Randomly assigned to receive Xopenex 0.63mg, Xopenex 1.25mg, racemic albuterol sulfate 1.25mg, racemic albuterol sulfate 2.5mg, or placebo 3 times a day administered via a PARI LC Plus™ nebulizer and a Dura-Neb® portable compressor.
- Rescue med: racemic albuterol delivered by a CDC MDI as needed.
Efficacy, as measured by the mean percent change from baseline FEV1, was demonstrated for all active treatment regimens compared with placebo on day 1 and day 29.
Xopenex 1.25mg demonstrated the largest mean percent change from baseline in FEV1 on both days 1 and 29, compared with other active treatments.
Xopenex 0.63mg and racemic albuterol sulfate 2.5mg produced a clinically comparable mean percent change from baseline FEV1 on both day 1 and 29.
Mean time to onset of a 15% increase in FEV1 over baseline; mean time to peak effect; and mean duration of effect (>15% increase from baseline FEV1) after 4 weeks of treatment, respectively:
- Xopenex 0.63mg: 17 minutes, 1.5 hours, ~5 hours
- Xopenex 1.25mg: 10 minutes, 1.5 hours, ~6 hours
Children 6 to 11 Years Old
Safety and efficacy evaluated in a randomized, double-blind, placebo- and active-controlled study in children with mild to moderate asthma (n=316; mean baseline FEV1 73% of predicted).
Following 1-week placebo run-in, patients were randomly assigned to Xopenex (0.31mg or 0.63mg), racemic albuterol (1.25mg or 2.5mg), or placebo, delivered 3 times a day for 3 weeks using a PARI LC Plus™ nebulizer and a Dura-Neb® 3000 compressor.
Efficacy, as measured by mean peak percent change from baseline FEV1, was demonstrated for all active treatment regimens compared with placebo on day 1 and day 21.
Onset of effect (time to a 15% increase in FEV1 over test-day baseline) and duration of effect (maintenance of a >15% increase in FEV1 over test-day baseline) of levalbuterol were clinically comparable to those of racemic albuterol.
Initially 0.63mg by nebulization 3 times daily at 6–8hr intervals; may increase to 1.25mg 3 times daily.
<6yrs: not established. 6–11yrs: 0.31mg by nebulization 3 times daily; max 0.63mg 3 times daily.
Do not exceed recommended dose. Monitor for increased need; if inadequate control, reevaluate and consider adding an antiinflammatory (eg, corticosteroids). Sensitivity to sympathomimetics. Discontinue if paradoxical bronchospasm, cardiovascular effects, or hypersensitivity reactions occur. Cardiovascular disorders (esp. coronary insufficiency, arrhythmias, hypertension). Seizure disorders. Diabetes. Hyperthyroidism. Hypokalemia. Renal impairment; monitor (esp. in elderly). Elderly. Labor & delivery. Pregnancy. Nursing mothers.
Avoid within 2 weeks of MAOIs, tricyclic antidepressants. Avoid other short-acting sympathomimetic aerosol bronchodilators, epinephrine. Antagonized by β-blockers. Caution with other drugs that may lower serum potassium (eg, diuretics). Monitor digoxin.
Accidental injury, bronchitis, dizziness, pharyngitis, rhinitis, vomiting, palpitations, chest pain, tachycardia, headache, tremor, nervousness.
The primary route of elimination of albuterol enantiomers is through renal excretion. Less than 20% of the drug is detected in the feces.
Generic Drug Availability:
Soln 0.31mg/3mL, 0.63mg/3mL, 1.25mg/3mL—24 vials; 1.25mg/0.5mL—30 vials