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PRISTIQ: OVERDOSAGE

Human Experience with Overdosage

There is limited clinical experience with desvenlafaxine succinate overdosage in humans. In pre-marketing clinical studies, no cases of fatal acute overdose of desvenlafaxine were reported.

Among the patients included in the MDD pre-marketing studies of Pristiq (Desvenlafaxine), there were four adults who ingested desvenlafaxine succinate (4000 mg of desvenlafaxine alone, 900, 1800 and 5200 mg - in combination with other drugs); all patients recovered. In addition, one patient's 11-month-old child accidentally ingested 600 mg of desvenlafaxine succinate, was treated, and recovered. The adverse reactions reported within 5 days of an overdose > 600 mg that were possibly related to Pristiq included: vomiting, headache, agitation, nausea, constipation, dizziness, diarrhea, dry mouth, paresthesia, and tachycardia.

Pristiq (Desvenlafaxine Succinate) is the major active metabolite of venlafaxine. Overdose experience reported with venlafaxine (the parent drug of this medicine) is presented below; the identical information can be found in the Overdosage section of the venlafaxine package insert.

In postmarketing experience, overdose with venlafaxine (the parent drug of Pristiq) has occurred predominantly in combination with alcohol and / or other drugs. The most commonly reported events in overdosage include tachycardia, changes in level of consciousness (ranging from somnolence to coma), mydriasis, vomiting, and seizures. Electrocardiogram changes (e.g., prolongation of QT interval, bundle branch block, QRS prolongation), sinus and ventricular tachycardia, hypotension, rhabdomyolysis, bradycardia, vertigo, serotonin syndrome, liver necrosis, and death have been reported.

Published retrospective studies report that venlafaxine overdosage may be associated with an increased risk of fatal outcomes compared to that observed with SSRI antidepressant products, but lower than that for tricyclic antidepressants. Epidemiological studies have shown that venlafaxine-treated patients have a higher pre-existing burden of suicide risk factors than SSRI-treated patients. The extent to which the finding of an increased risk of fatal outcomes can be attributed to the toxicity of venlafaxine in overdosage, as opposed to some characteristic(s) of venlafaxine-treated patients, is not clear.

Prescriptions for Pristiq (Desvenlafaxine) should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

Management of Overdosage

Treatment should consist of those general measures employed in the management of overdosage with any SSRI/SNRI.

Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also 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.

Induction of emesis is not recommended. Because of the moderate volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be of benefit. No specific antidotes for desvenlafaxine are known.

In managing an overdose, consider the possibility of multiple drug involvement. The physician should consider contacting a local poison control center for additional information on the treatment of any overdose.



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