Nexium

[Esomeprazole]

Overdosage & Contraindications
CONTRAINDICATIONS

NEXIUM is contraindicated in patients with known hyper-sensitivity to any component of the formulation or to substituted benzimidazoles. Clarithromycin is contraindicated in patients with a known hypersen-sitivity to any macrolide antibiotic. Concomitant administration of clarithromycin with pimozide is contraindicated. There have been post-marketing reports of drug interactions when clarithromycin and/ or erythromycin are co-admin-istered with pimozide resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation, and torsade de pointes) most likely due to inhibition of hepatic metabolism of pimozide by erythromycin and clarithromycin. Fatalities have been reported. (Please refer to full prescribing information for clarithromycin.) Amoxicillin is contraindicated in patients with a known hypersensitivity to any penicillin. (Please refer to full prescribing information for amoxicillin.)

OVERDOSAGE

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A single oral dose of esomeprazole at 510 mg/ kg (about 103 times the human dose on a body surface area basis), was lethal to rats.

The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions. There have been some reports of overdosage with esomeprazole. Reports have been received of overdosage with omeprazole in humans. Doses ranged up to 2,400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience (see omeprazole package insert Ð ADVERSE REACTIONS). No specific antidote for esomeprazole is known. Since esomeprazole is exten-sively protein bound, it is not expected to be removed by dialysis. In the event of overdosage, treatment should be symptomatic and supportive.

As with the management of any overdose, the possibility of multiple drug ingestion should be considered. For current information on treatment of any drug overdose, a certified Regional Poison Control Center should be contacted. Telephone numbers are listed in the Physicians' Desk Reference (PDR) or local telephone book.