Risperdal

[Risperidone]

Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.

OVERDOSAGE

Human Experience

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Premarketing experience included eight reports of acute RISPERDAL ® ( risperidone) overdosage with estimated doses ranging from 20 to 300 mg and no fatalities. In general, reported signs and symptoms were those resulting from an exaggeration of the drug' s known pharmacological effects, i. e. , drowsiness and sedation, tachycardia and hypotension, and extrapyramidal symptoms. One case, nvolving an estimated overdose of 240 mg, was associated with hyponatremia, hypokalemia, prolonged QT, and widened QRS. Another case, involving an estimated overdose of 36 mg, was associated with a seizure.
Postmarketing experience includes reports of acute RISPERDAL ® overdosage, with estimated doses of up to 360 mg. In general, the most frequently reported signs and symptoms are those resulting from an exaggeration of the drug 's known pharmacological effects, i. e. , drowsiness, sedation, tachycardia, hypotension, and extrapyramidal symptoms.

Other adverse events reported since market introduction which were temporally ( but not necessarily causally) related to RISPERDAL ® overdose, nclude torsade de pointes, prolonged QT interval, convulsions, cardiopulmonary arrest, and rare fatality associated with multiple drug overdose.

Management of Overdosage

In case of acute overdosage, establish and maintain an airway and ensure adequate oxygenation and ventilation. Gastric lavage ( after intubation, if patient is unconscious) and administration of activated charcoal together with a laxative should be considered. Because of the rapid disintegration of RISPERDAL ® M-TAB Orally Disintegrating Tablets, pill fragments may not appear in gastric contents obtained with lavage.

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