Proventil HFA
OVERDOSE
The expected symptoms with overdosage are those of excessive beta-adrenergic 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/min, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and sleeplessness.) Hypokalemia may also occur. Inhalation Solution Only: In isolated cases in children 2 to 12 years of age, tachycardia with rates >200 beats/min has been observed.
As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of albuterol. Treatment consists of discontinuation of albuterol together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-recptor 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 albuterol.
The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 810 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis or approximately 300 times the maximum recommended daily inhalation dose for children on a mg/m2 basis for inhalation solution, and approximately 6800 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis or approximately 3200 times the maximum recommended daily inhalation dose for children on a mg/m2 basis for inhalation aerosol or approximately 3400 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis or approximately 1600 times the maximum recommended daily inhalation dose for children on a mg/m2 basis for inhalation capsules). In mature rats, the subcutaneous median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximately 365 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis or approximately 135 times the maximum recommended daily inhalation dose for children on a mg/m2 basis for inhalation solution and approximately 3000 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis or approximately 1400 times the maximum recommended daily inhalation dose for children on a mg/m2 basis for inhalation aerosol or approximately 1500 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis or approximately 1700 times the maximum recommended daily inhalation dose for children on a mg/m2 basis for inhalation capsules). In small young rats, the subcutaneous median lethal dose is approximately 2000 mg/kg (approximately 1600 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis or approximately 600 times the maximum recommended daily inhalation dose for children on a mg/m2 basis for inhalation solution and approximately 14,000 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis or approximately 6400 times the maximum recommended daily inhalation dose for children on a mg/m2 basis for inhalation aerosol or approximately 6800 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis or approximately 3200 times the maximum recommended daily inhalation dose for children on a mg/m2 basis for inhalation capsules). The inhalational median lethal dose has not been determined in animals.
Dialysis is not appropriate treatment for overdosage of albuterol capsules for inhalation.
CONTRAINDICATIONS
Albuterol formulations are contraindicated in patients with a history of hypersensitivity to albuterol or any of the formulation components.
Generic Name: Albuterol Inhalation
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