The expected symptoms with overdosage are those of excessive beta-adrenergic receptor stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and sleeplessness. Hypokalemia also may occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with the abuse of XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol. Treatment consists of discontinuation of XOPENEX HFA Inhalation Aerosol together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of XOPENEX HFA Inhalation Aerosol.

Following intravenous administration in mice, the median lethal levalbuterol HCl dose was approximately 66 mg/kg (approximately 500 times the maximum recommended daily inhalation dose of levalbuterol tartrate for adults on a mg/m² basis and approximately 230 times the maximum recommended daily inhalation dose of levalbuterol tartrate for pediatric patients on a mg/m² basis). Following intravenous administration in rats, the median lethal levalbuterol HCl dose was approximately 60 mg/kg (approximately 900 times the maximum recommended daily inhalation dose of levalbuterol tartrate for adults on a mg/m² basis and approximately 430 times the maximum recommended daily inhalation dose of levalbuterol tartrate for children on a mg/m² basis). The inhalation median lethal dose has not been determined in animals. In dogs, inhaled doses of levalbuterol HCl up to 2.73 mg/kg (approximately 140 times the maximum recommended daily inhalation dose of levalbuterol tartrate for adults on a mg/m² basis and approximately 65 times the maximum recommended daily inhalation dose of levalbuterol tartrate for children on a mg/m² basis) were tolerated without animal deaths.

XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to levalbuterol, racemic albuterol, or any other component of XOPENEX HFA Inhalation Aerosol.

Bookmark this page: