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For management of a suspected drug overdose, contact your regional Poison Control Centre.
In clinical trials, the only drug overdose death reported while taking REMERON® Tablets was in combination with amitriptyline and chlorprohixene in a non-U.S. clinical study. Based on plasma levels, the REMERON® dose taken was 30 - 45 mg, while plasma levels of amitriptyline and chlorprohixene were found to be at toxic levels. In other pre-marketing overdose cases with REMERON® Tablets, the following signs and symptoms were reported: disorientation, drowsiness, impaired memory and tachycardia. There were no reports of ECG abnormalities, coma or convulsions following overdose with REMERON® Tablets alone.
In post-marketing experience with more than 35 million patients exposed to REMERON® (based on average treatment courses of 30 mg/day during 3 months), fatal cases of overdose with REMERON® alone have been reported. In many cases details regarding the precise dose are lacking. Fatal acute overdoses with REMERON® alone are documented at doses as low as approximately 440 mg, which is estimated from the post-mortem plasma levels, assuming linear pharmacokinetics. However, survival has also been reported with a single REMERON® overdose as high as 1,350 mg.
Present experience concerning overdose with REMERON® alone indicates that symptoms are usually mild. Depression of the central nervous system with disorientation and prolonged sedation has been reported, together with tachycardia and mild hyper- or hypotension. However, there is a possibility of more serious outcomes (including fatalities) at dosages much higher than the therapeutic dose, especially with mixed overdosages. In these cases QT prolongation and Torsade de Pointes have also been reported.
Treatment should consist of those general measures employed in the management of overdose with any anti-depressant.
Ensure an adequate airway, oxygenation and ventilation. Monitor vital signs and cardiac rhythm (ECG monitoring should be undertaken). General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. Activated charcoal or gastric lavage may be appropriate.
In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control centre for additional information on the treatment of any overdose.
REMERON® is contraindicated in patients who are known to be hypersensitive to the drug or any of its components. For a complete listing, see Dosage Forms, Composition And Packaging.
Monoamine Oxidase Inhibitors
In patients receiving agents that may affect the serotonergic neurotransmitter systems in combination with a monoamine oxidase (MAO) inhibitor, there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have recently discontinued (SSRI) Selective Serotonin Reuptake Inhibitor treatment and have begun treatment on a MAO inhibitor. Some cases presented with features resembling serotonin syndrome or neuroleptic malignant syndrome (see WARNINGS AND PRECAUTIONS, Neurologic, Serotonin Syndrome/Neuroleptic Malignant Syndrome). Therefore, REMERON® should not be used in combination with MAO inhibitors (including the antibiotic linezolid, and the thiazine dye methylthioninium blue (methylene blue), which are less well-known examples of MAO inhibitors) or within a minimum of 2 weeks of terminating treatment with MAO inhibitors. Treatment with REMERON® should then be initiated cautiously and dosage increased gradually until optimal response is reached. MAO inhibitors should not be introduced within 2 weeks of cessation of therapy with REMERON®.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/22/2015
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