ADVAIR DISKUS ADVAIR - GlaxoSmithKline

Discontinuance
Treatment with inhaled corticosteroids should not be stopped abruptly in patients with
asthma due to risk of exacerbation. In this case, therapy should be titrated down
gradually, under physician supervision. For patients with COPD, cessation of therapy
may be associated with symptomatic decompensation and should be supervised by a
physician.
Cardiovascular Effects
Pharmacological side-effects of beta-2 agonist treatment, such as palpitations have been
reported, but tend to be transient and to reduce with regular therapy (see ADVERSE
REACTIONS). A small increase in QTc interval has been reported with therapeutic
doses of salmeterol. Cardiovascular effects such as increased blood pressure and heart
rate may occasionally be seen with all sympathomemetic drugs, especially at higher than
therapeutic doses.
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. Fatalities have been reported following
excessive use of aerosol preparations containing sympathomimetic amines, the exact
cause of which is unknown. Cardiac arrest was reported in several instances.
In individual patients any beta 2 -adrenergic agonist may have a clinically significant
cardiac effect. As has been described with other beta-adrenergic agonist bronchodilators,
clinically significant changes in systolic and/or diastolic blood pressure, pulse rate, and
electrocardiograms have been seen infrequently in individual patients in controlled
clinical studies with salmeterol.
Salmeterol xinafoate/fluticasone propionate, like all products, containing
sympathomimetic amines, should be used with caution in patients with cardiovascular
disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in
patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually
responsive to sympathomimetic amines.
Occurrence of cardiovascular effects may require discontinuation of the drug.
Central Nervous System Effects
Central nervous system effect of beta-2 agonist treatment such as tremor and headache
have been reported, but tend to be transient and to reduce with regular therapy.
Other central nervous system effects of beta 2 -agonist treatment, such as situational
disorders, agitation, anxiety, irritability, sleep disorders, syncope, vertigo or, dizziness
can occur after the use of ADVAIR ® .
Ear/Nose/Throat
Symptoms of laryngeal spasm, irritation, or swelling, such as stridor and choking, have
been reported rarely in patients receiving salmeterol.
Also see Immune, Candidiasis.
July 29, 2014
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