Overdose : מינון יתר

11 OVERDOSAGE
MedDRA terminology has been used to classify the adverse reactions.
11.1 Human Experience
In clinical trials and in postmarketing experience, adverse reactions of deliberate or accidental overdosage with oral aripiprazole have been reported worldwide. These include overdoses with oral aripiprazole alone and in combination with other substances. No fatality was reported with aripiprazole alone. The largest known dose with a known outcome involved acute ingestion of 1260 mg of oral aripiprazole (42 times the maximum recommended daily dose) by a patient who fully recovered.
Deliberate or accidental overdosage was also reported in children (age 12 years and younger) involving oral aripiprazole-[o/\ ingestions up to 195 mg with no fatalities.
Common adverse reactions (reported in at least 5% of all overdose cases) reported with oral aripiprazole overdosage (alone or in combination with other substances) include vomiting, somnolence, and tremor. Other clinically important signs and symptoms observed in one or more patients with aripiprazole overdoses (alone or with other substances) include acidosis, aggression, aspartate aminotransferase increased, atrial fibrillation, bradycardia, coma, confusional state, convulsion, blood creatine phosphokinase increased, depressed level of consciousness, hypertension, hypokalemia, hypotension, lethargy, loss of consciousness, QRS complex prolonged, QT prolonged, pneumonia aspiration, respiratory arrest, status epilepticus, and tachycardia.

11.2 Management of Overdosage
No specific information is available on the treatment of overdose with aripiprazole.
An electrocardiogram should be obtained in case of overdosage and if QT interval prolongation is present, cardiac monitoring should be instituted. Otherwise, management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms. Close medical supervision and monitoring should continue until the patient recovers.
Charcoal: In the event of an overdose of ARIPLY, an early charcoal administration may be useful in partially preventing the absorption of aripiprazole. Administration of 50 g of activated charcoal, one hour after a single 15 mg oral dose of ARIPLY, decreased the mean AUC and Cmax of ARIPLY by 50%.

43
Hemodialysis: Although there is no information on the effect of hemodialysis in treating an overdose with ARIPLY, hemodialysis is unlikely to be useful in overdose management since aripiprazole is highly bound to plasma proteins.


12 DESCRIPTION
Aripiprazole is an atypical antipsychotic drug that is available as ARIPLY(aripiprazole) Tablets, dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is: 


ARIPLY Tablets are available in 5, 10, 15, and 30 mg strengths. Inactive ingredients include: Maize starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow).