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ARIPIPRAZOLE LAUROXIL


DIR Classification


Classification:Moderate-DIQT concern
Severity Score:2.0

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • OVERDOSAGE
  • Human Experience
  • 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.
  • ADVERSE REACTIONS
  • Clinical Studies Experience
  • Investigations: weight decreased, hepatic enzyme increased, blood glucose increased, blood lactate dehydrogenase increased, gamma glutamyl transferase increased, blood prolactin increased, blood urea increased, blood creatinine increased, blood bilirubin increased, electrocardiogram QT prolonged, glycosylated hemoglobin increased

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
307
23785
Other ADRs
154354
38227233

Odds Ratio = 3.197

Drug Property Information



ATC Code(s):
  • N05AX12 - aripiprazole lauroxil
    • N05AX - Other antipsychotics
    • N05A - ANTIPSYCHOTICS
    • N05 - PSYCHOLEPTICS
    • N - NERVOUS SYSTEM
Active Ingredient:aripiprazole lauroxil
Active Ingredient UNII:B786J7A343
Drugbank ID:DB14185
PubChem Compound:N/ADIR Classification
CTD ID:C000603935
PharmGKB:PA166161216
CAS Number:1259305-29-7
Dosage Form(s):injection, suspension, extended release
Route(s) Of Administrator:intramuscular
Daily Dose:
  • 15.0 mg/day N05AX12
Chemical Structure:
SMILE Code:
CCCCCCCCCCCC(=O)OCN1C(=O)CCC2=CC=C(OCCCCN3CCN(CC3)C3=C(Cl)C(Cl)=CC=C3)C=C12

Reference

N/A

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