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Serevent Diskus

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Serevent Diskus

Serevent Diskus

OVERDOSE

The expected signs and symptoms with overdosage of SEREVENT DISKUS (salmeterol xinafoate) are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the following: 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, insomnia. Overdosage with SEREVENT DISKUS (salmeterol xinafoate) 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 medications, cardiac arrest and even death may be associated with abuse of SEREVENT DISKUS (salmeterol xinafoate) .

Treatment consists of discontinuation of SEREVENT DISKUS (salmeterol xinafoate) 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 DISKUS (salmeterol xinafoate) . Cardiac monitoring is recommended in cases of overdosage.

No deaths were seen in rats given salmeterol at an inhalation dose of 2.9 mg/kg (approximately 240 and 110 times the MRHD for adults and children, respectively, on an mg/m2 basis) and in dogs at an inhalation dose of 0.7 mg/kg (approximately 190 and 90 times the MRHD for adults and children, respectively, on an mg/m2 basis). By the oral route, no deaths occurred in mice at 150 mg/kg (approximately 6,100 and 2,900 times the MRHD for adults and children, respectively, on an mg/m2 basis) and in rats at 1,000 mg/kg (approximately 81,000 and 38,000 times the MRHD for adults and children, respectively, on an mg/m2 basis).

CONTRAINDICATIONS

Because of the risk of asthma-related death and hospitalization, use of SEREVENT DISKUS (salmeterol xinafoate) for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated [see WARNINGS AND PRECAUTIONS.].

SEREVENT DISKUS (salmeterol xinafoate) is contraindicated as primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required [see WARNINGS AND PRECAUTIONS.].

SEREVENT DISKUS (salmeterol xinafoate) is contraindicated in patients with severe hypersensitivity to milk proteins [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, DESCRIPTION].

Last reviewed on RxList: 2/28/2011
This monograph has been modified to include the generic and brand name in many instances.

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