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Overdosage & Contraindications
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. OVERDOSAGE Text Continues Below
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/ m 2 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/ m 2 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/ m 2 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/ m 2 basis), the inhalational median lethal dose could not be determined. Manifestations of overdosage with albuterol may include anginal pain, hypertension, hypokalemia, tachycardia 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 beta-receptor blocker, such as metoprolol tartrate may be indicated.
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