Advair Diskus

[Salmeterol/Fluticasone]

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ADVAIR DISKUS is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.

Hypersensitivity to any of the ingredients of these preparations contraindicates their use (see DESCRIPTION and ADVERSE REACTIONS: Observed During Clinical Practice: Non-Site Specific).

OVERDOSAGE

ADVAIR DISKUS:

No deaths occurred in rats given combinations of salmeterol and fluticasone propionate at acute inhalation doses of 3.6 and 1.9 mg/kg, respectively (approximately 320 and 15 times the maximum recommended daily inhalation dose in adults on a mg/m 2 basis).

Fluticasone Propionate:

Chronic overdosage with fluticasone propionate may result in signs/symptoms of hypercorticism (see PRECAUTIONS: General: Metabolic and Other Effects). 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 doses 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. The oral and subcutaneous median lethal doses in mice and rats were >1,000 mg/kg (>4,300 and >8,700 times, respectively, the maximum recommended daily inhalation dose in adults on a mg/m 2 basis).

Salmeterol:

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 signs and 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.

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