Proair HFA (Albuterol Sulfate Inhalation Aerosol) Drug Information: Overdosage and Contraindications

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May 27, 2012

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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 per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia.

Hypokalemia may also occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol.

Treatment consists of discontinuation of PROAIR HFA (albuterol sulfate inhalation aerosol) 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 PROAIR HFA Inhalation Aerosol.

The oral median lethal dose of albuterol sulfate in mice is greater than 2,000 mg/kg (approximately 6,800 times the maximum recommended daily inhalation dose for adults on a mg/m² basis and approximately 3,200 times the maximum recommended daily inhalation dose for children on a mg/m² basis). In mature rats, the subcutaneous median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximately 3,000 times the maximum recommended daily inhalation dose for adults on a mg/m² basis and approximately 1,400 times the maximum recommended daily inhalation dose for children on a mg/m² basis). In young rats, the subcutaneous median lethal dose is approximately 2,000 mg/kg (approximately 14,000 times the maximum recommended daily inhalation dose for adults on a mg/m² basis and approximately 6,400 times the maximum recommended daily inhalation dose for children on a mg/m² basis). The inhalation median lethal dose has not been determined in animals.

CONTRAINDICATIONS

PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other PROAIR HFA (albuterol sulfate inhalation aerosol) Inhalation Aerosol components. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate [see WARNINGS AND PRECAUTIONS].

Last reviewed on RxList: 9/14/2010
This monograph has been modified to include the generic and brand name in many instances.