ADVAIR DISKUS ADVAIR - GlaxoSmithKline

Missed Dose
If a single dose is missed, instruct the patient to take the next dose when it is due.
Administration
ADVAIR ® is to be administered by oral inhalation only.
The patient should be made aware that for optimum benefit ADVAIR ® should be taken
regularly, even when asymptomatic.
As a general rule, rinsing the mouth and gargling with water after each inhalation can
help in preventing the occurrence of candidiasis. Cleansing dentures has the same effect.
OVERDOSAGE
ADVAIR ® (salmeterol xinafoate/fluticasone propionate) should not be used more
frequently than twice daily (morning and evening) at the recommended dose. Fatalities
have been reported in association with excessive use of inhaled sympathomimetic drugs
(See WARNINGS AND PRECAUTIONS). Large doses of inhaled or oral salmeterol
(12 to 20 times the recommended dose) have been associated with clinically significant
prolongation of the QTc interval, which has the potential for producing ventricular
arrhythmias.
There are no data available from clinical trials on overdose with ADVAIR ® (salmeterol
xinafoate/fluticasone propionate), however data on overdose with individual drugs is
given below.
The expected signs and symptoms of salmeterol overdosage are those typical of excessive
beta 2 -adrenergic stimulation, including tremor, headache, tachycardia, increases in
systolic blood pressure, cardiac arrhythmias, hypokalemia, hypertension and, in extreme
cases, sudden death. There is no specific treatment for an overdose of salmeterol and
fluticasone propionate. If overdose occurs, the patient should be treated supportively
with appropriate monitoring as necessary. The judicious use of a cardioselective betareceptor
blocker may be considered, bearing in mind that such medication can produce
bronchospasm.
Acute inhalation of fluticasone propionate doses in excess of those approved may lead to
temporary suppression of the hypothalamic-pituitary-adrenal axis. This does not usually
require emergency action, as normal adrenal function typically recovers within a few
days.
If higher than approved doses are continued over prolonged periods, significant
adrenocortical suppression is possible. There have been very rare reports of acute adrenal
crisis occurring in children exposed to higher than approved dosages (typically 1000 mcg
daily and above), over prolonged periods (several months or years); observed features
included hypoglycemia and sequelae of decreased consciousness and/or convulsions.
Situations which would potentially trigger acute adrenal crisis include exposure to
July 29, 2014
Page 28 of 67