ADVAIR DISKUS ADVAIR - GlaxoSmithKline

For COPD patients, it is important that even mild chest infections be treated immediately
since these patients may be more susceptible to damaging lung infections than healthy
individuals. Patients should be instructed to contact their physician as soon as possible if
they suspect an infection.
Physicians should recommend that COPD patients receive an annual influenza
vaccination.
Special Populations
Use In Women
Pregnant Women
There are no adequate and well-controlled studies with ADVAIR ® in pregnant women.
ADVAIR ® should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
In animal studies, some effects on the fetus, typical for a beta-agonist, occurred at
exposure levels substantially higher than those that occur with therapeutic use. Extensive
use of other beta-agonists has provided no evidence that effects in animals are relevant to
human use.
Like other glucocorticoids, fluticasone propionate is teratogenic to rodent species.
Adverse effects typical of potent corticosteroids are only seen at high systemic exposure
levels; administration by inhalation ensures minimal systemic exposure. The relevance
of these findings to humans has not yet been established since well-controlled trials
relating to fetal risk in humans are not available. Infants born of mothers who have
received substantial doses of glucocorticoids during pregnancy should be carefully
observed for hypoadrenalism.
Use in Labour and Delivery
There are no well-controlled human studies that have investigated effects of salmeterol
on preterm labour or labour at term. Because of the potential for beta-agonist
interference with uterine contractility, use of ADVAIR ® during labour should be
restricted to those patients in whom the benefits clearly outweigh the risks.
Nursing Women
Plasma levels of salmeterol after inhaled therapeutic doses are very low (85 to
200 pg/mL) in humans and therefore levels in milk should be correspondingly low.
Studies in lactating animals indicate that salmeterol is likely to be secreted in only very
small amounts in breast milk.
Glucocorticoids are excreted in human milk. The excretion of fluticasone propionate into
human breast milk has not been investigated. When measurable plasma levels were
obtained in lactating laboratory rats following subcutaneous administration, there was
evidence of fluticasone propionate in the breast milk. However, plasma levels in patients
following inhaled fluticasone propionate at recommended doses are likely to be low.
July 29, 2014
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