Budesonide Overdose

10 OVERDOSAGE BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL contains both budesonide and formoterol; therefore, the risks associated with overdosage for the individual components described below apply to BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL.

In pharmacokinetic studies, single doses of 960/54 mcg (12 actuations of budesonide and formoterol fumarate dihydrate 80/4.5) and 1280/36 mcg (8 actuations of 160/4.5), were administered to patients with COPD.

A total of 1920/54 mcg (12 actuations of budesonide and formoterol fumarate dihydrate 160/4.5) was administered as a single dose to both healthy subjects and patients with asthma.

In a long-term active-controlled safety study in adolescent and adult asthma patients 12 years of age and older, budesonide and formoterol fumarate dihydrate 160/4.5 was administered for up to 12 months at doses up to twice the highest recommended daily dose.

There were no clinically significant adverse reactions observed in any of these studies.

Budesonide The potential for acute toxic effects following overdose of budesonide is low.

If used at excessive doses for prolonged periods, systemic corticosteroid effects such as hypercorticism may occur [see Warnings and Precautions ] .

Budesonide at five times the highest recommended dose (3200 mcg daily) administered to humans for 6 weeks caused a significant reduction (27%) in the plasma cortisol response to a 6-hour infusion of ACTH compared with placebo (+1%).

The corresponding effect of 10 mg prednisone daily was a 35% reduction in the plasma cortisol response to ACTH.

Formoterol An overdose of formoterol would likely lead to an exaggeration of effects that are typical for beta 2 -agonists: seizures, angina, hypertension, hypotension, tachycardia, atrial and ventricular tachyarrhythmias, nervousness, headache, tremor, palpitations, muscle cramps, nausea, dizziness, sleep disturbances, metabolic acidosis, hyperglycemia, hypokalemia.

As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of formoterol.

No clinically significant adverse reactions were seen when formoterol was delivered to adult patients with acute bronchoconstriction at a dose of 90 mcg/day over 3 hours or to stable asthmatics 3 times a day at a total dose of 54 mcg/day for 3 days.

Treatment of formoterol overdosage consists of discontinuation of the medication together with institution of appropriate symptomatic and/or supportive therapy.

The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm.

There is insufficient evidence to determine if dialysis is beneficial for overdosage of formoterol.

Cardiac monitoring is recommended in cases of overdosage.