OVERDOSE

Human Experience: As of November 1992, there were 79 reports of non-fatal acute overdoses involving sertraline HCl, of which 28 were overdoses of sertraline HCl alone and the remainder involved a combination of other drugs and/or alcohol in addition to sertraline HCl. In those cases of overdose involving only sertraline HCl, the reported doses ranged from 500 mg to 6000 mg. In a subset of 18 of these patients in whom sertraline HCl blood levels were determined, plasma concentrations ranged from <5 ng/ml to 554 ng/ml. Symptoms of overdose with sertraline HCl alone included somnolence, nausea, vomiting, tachycardia, ECG changes, anxiety and dilated pupils. Treatment was primarily supportive and included monitoring of and use of activated charcoal, gastric lavage or cathartics and hydration. Although there were no reports of death when sertraline HCl was taken alone, there were 4 deaths involving overdoses of sertraline HCl in combination with other drugs and/or alcohol. Therefore, any overdose should be treated aggressively.

Management of Overdoses: Treatment should consist of those general measures employed in the management of overdosage with any antidepressant.

Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion, or in symptomatic patients.

Activated charcoal should be administered. Due to the large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be of benefit. No specific antidotes for sertraline are known.

In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center on the treatment of any overdose.

CONTRAINDICATIONS

Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated (see WARNINGS). Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS).

Additional Information for Oral Concentrate: Sertraline HCl oral concentrate is contraindicated with disulfuram (Antabuse) due to the alcohol content of the concentrate.