Serevent Aerosol

[salmeterol xinafoate]

Overdosage & Contraindications
CONTRAINDICATIONS

SEREVENT Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to salmeterol or any other component of the drug product (see DESCRIPTION).

OVERDOSAGE

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The expected signs and 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, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Overdosage with SEREVENT Inhalation Aerosol may be expected to result in exaggeration of the pharmacologic adverse effects associated with beta-adrenoceptor agonists, including tachycardia and/or arrhythmia, tremor, headache, and muscle cramps.

Overdosage with SEREVENT Inhalation Aerosol can lead to clinically significant prolongation of the QTc interval, which can produce ventricular arrhythmias. Other signs of overdosage may include hypokalemia and hyperglycemia.

As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse of SEREVENT Inhalation Aerosol.
Treatment consists of discontinuation of SEREVENT 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 SEREVENT Inhalation Aerosol. Cardiac monitoring is recommended in cases of overdosage.

No deaths were seen in rats at inhalation doses of 2.9 mg/kg (approximately 240 times the maximum recommended human daily inhalation dose on a mg/m 2 basis) and in dogs at 0.7 mg/kg (approximately 190 times the maximum recommended human daily inhalation dose on a mg/m 2 basis). By the oral route, no deaths occurred in mice at 150 mg/kg (approximately 6,100 times the maximum recommended human daily inhalation dose on a mg/m 2 basis) and in rats at 1,000 mg/kg (approximately 81,000 times the maximum recommended human daily inhalation dose on a mg/m 2 basis).