Proventil HFA (Albuterol Inhalation) Drug Information: Overdosage and Contraindications

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May 27, 2012

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Chronic obstructive pulmonary disease (COPD) is comprised primarily of three related conditions - chronic bronchitis, chronic asthma, and emphysema. In each condition there is chronic obstruction of the flow of air through the airways and out of the lungs, and the obstruction generally is permanent and may be progressive over time.

While asthma features obstruction to the flow of air out of the lungs, usually, the obstruction is reversible. Between "attacks" of asthma the flow of air through the airways typically is normal. These patients do not have COPD. However, if asthma is left untreated, the chronic inflammation associated with this disease can cause the airway obstruction to become fixed. That is, between attacks, the asthmatic patient may then have abnormal air flow. This process is referred to as lung remodeling. These asthma patients with a fixed component of airway obstruction are also considered to have COPD.

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Please Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

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, eg, 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 PROVENTIL® HFA (albuterol inhalation) Inhalation Aerosol. Treatment consists of discontinuation of PROVENTIL HFA (albuterol inhalation) 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 PROVENTIL HFA (albuterol inhalation) Inhalation Aerosol.

The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 6800 times the maximum recommended daily inhalation dose for adults on a mg/m² basis and approximately 3200 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 3000 times the maximum recommended daily inhalation dose for adults on a mg/m² basis and approximately 1400 times the maximum recommended daily inhalation dose for children on a mg/m² basis). In young rats, the subcutaneous median lethal dose is approximately 2000 mg/kg (approximately 14,000 times the maximum recommended daily inhalation dose for adults on a mg/m² basis and approximately 6400 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

PROVENTIL® HFA (albuterol inhalation) Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol or any other PROVENTIL HFA (albuterol inhalation) components.

Last reviewed on RxList: 9/30/2009
This monograph has been modified to include the generic and brand name in many instances.