OVERDOSE
The effects of overdosage are expected to be related
primarily to albuterol sulfate. Acute overdosage with
ipratropium bromide is unlikely since ipratropium bromide
is not well absorbed systemically after aerosol or oral
administration. The oral median lethal dose of ipratropium
bromide ranged between 1001 and 2010 mg/kg in mice (approximately
30,000 and 60, 000 times the maximum recommended human
daily inhalation dose on a mg/m2 basis, respectively);
between 1667 and 4000 mg/kg in rats (approximately 100,000
and 240,000 times the maximum recommended human daily
inhalation dose, respectively, on a mg m2 basis); and
between 400 and 1300 mg/kg (approximately 80,000 and 260,000
times the maximum recommended human daily inhalation dose,
respectively, on a mg/m2 basis) in dogs. Whereas the oral
median lethal dose of albuterol sulfate in mice and rats
was greater than 2 000 mg/kg (approximately 10,000 and
20,000 times the maximum recommended human daily inhalation
dose, respectively, on a mg/m2 basis), the inhalational
median lethal dose could not be determined. Manifestations
of overdosage with albuterol may include anginal pain,
hypertension, hypokalemia, tachycardila with rates up
to 200 beats per minute and exaggeration of the pharmacologic
effects (listed in ADVERSE REACTIONS). As with all sympathomimetic
aerosol medications, cardiac arrest and even death may
be associated with abuse. Dialysis is not appropriate
treatment for overdosage of albuterol as an inhalation
aerosol; the judicious use of a cardiovascular betareceptor
blocker, such as metoprolol tartrate may be indicated.
CONTRAINDICATIONS
Combivent® Inhalation Aerosol is contraindicated
in patients with a history of hypersensitivity to soya
lecithin or related food products such as soybean and
peanut. Combivent® Inhalation Aerosol is also contraindicated
in patients hypersensitive to any other components of
the drug product or to atropine or its derivatives.
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