"The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary di"...
No human overdosage data has been reported for ADVAIR DISKUS (fluticasone propionate) .
No deaths occurred in rats given an inhaled single-dose combination of salmeterol 3.6 mg/kg (approximately 290 and 140 times the MRHD for adults and children, respectively, on a mg/m² basis) and 1.9 mg/kg of fluticasone propionate (approximately 15 and 35 times the MRHD for adults and children, respectively, on a mg/m² basis).
Chronic overdosage with fluticasone propionate may result in signs/symptoms of hypercorticism [see WARNINGS AND PRECAUTIONS]. Inhalation by healthy volunteers of a single dose of 4,000 mcg of fluticasone propionate inhalation powder or single doses of 1,760 or 3,520 mcg of fluticasone propionate inhalation aerosol was well tolerated. Fluticasone propionate given by inhalation aerosol at dosages of 1,320 mcg twice daily for 7 to 15 days to healthy human volunteers was also well tolerated. Repeat oral doses up to 80 mg daily for 10 days in healthy volunteers and repeat oral doses up to 20 mg daily for 42 days in patients were well tolerated. Adverse reactions were of mild or moderate severity, and incidences were similar in active and placebo treatment groups.
No deaths were seen in mice given an oral dose of 1,000 mg/kg (4,100 and 9,600 times the MRHD dose for adults and children, respectively, on a mg/m² basis). No deaths were seen in rats given an oral dose of 1,000 mg/kg (8,100 and 19,200 times the MRHD for adults and children, respectively, on a mg/m² basis).
The expected signs and symptoms with overdosage of salmeterol 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, and insomnia. Overdosage with salmeterol 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 salmeterol.
Treatment consists of discontinuation of salmeterol 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 salmeterol. 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 a 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 a 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 a 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 a mg/m² basis).
The use of ADVAIR DISKUS (fluticasone propionate) is contraindicated in the following conditions:
- Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.
- Severe hypersensitivity to milk proteins [see WARNINGS AND PRECAUTIONS, DESCRIPTION].
Last reviewed on RxList: 1/24/2011
This monograph has been modified to include the generic and brand name in many instances.
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