Adult Dosing
Agitation associated with Schizophrenia or Bipolar Mania
Abilify
- 9.75 mg IM x 1
- May repeat q2 hrs PRN; Min 5.25 mg IM; Max: 15 mg-30 mg IM
- Switch to oral therapy 10-30 mg/day as soon as possible
Treatment of schizophrenia
Abilify Maintena
- Initiate: 400 mg IM x monthly
- Continue treatment with aripiprazole PO (10-20 mg/day) or other oral antipsychotic for 14 consecutive days following first injection therapy
- Dosage Adjustments for Missed Doses
- If 2nd or 3rd doses are missed for >4 wk but <5 wk since last injection then administer injection immediately
- If 2nd or 3rd doses are missed for >5 wk since last injection then restart concomitant oral aripiprazole for 14 days with next administered injection
- If 4th or subsequent doses are missed for >4 wk but <6 wk since last injection then administer injection immediately
- If 4th or subsequent doses are missed for >6 wk since last injection then restart concomitant oral aripiprazole for 14 days with next administered injection
Notes:- Monthly dose should be administered no sooner than 26 days after previous injection
- Reduce dose to 300 mg/month if adverse reaction occurs with 400 mg dosage
- Dosage adjustments are recommended in patients who are poor metabolizers of CYP2D6 and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors for >14 days
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Aripiprazole is not approved for the treatment of dementia-related psychosis as it increases the risk of death in elderly dementia related psychosis patients [US Black box warning]
- Increases the risk of suicidal thinking and behavior in patients with major depressive disorder (MDD), both adult and pediatric [US Black Box Warning]
- Antipsychotic drugs cause Neuroleptic Malignant Syndrome (NMS)which is clinically manifested as hyperpyrexia, muscle rigidity, altered mental status, and autonomic instability, immediately discontinue the drug and provide intensive symptomatic treatment and medical monitoring
- Irreversible, involuntary, dyskinetic movements develops with antipsychotic drugs more likely in elderly patients, discontinue the drug on appearance of signs and symptoms
- Hyperglycemia associated with ketoacidosis or hyperosmolar coma or deaths have occurred with atypical antipsychotics. Monitor fasting blood glucose at the baseline of the treatment and periodically during the treatment
- Aripiprazole causes orthostatic hypotension, use cautiously in cardiovascular disease, cerebrovascular disease, or conditions which would predispose patients to hypotension
- Leukopenia/neutropenia and agranulocytosis occurs with antipsychotic agents. Monitor CBC count frequently during the first few months of therapy and discontinue the drug at the first sign of low WBC
- Impairs judgment, thinking or motor skills, caution patients against the use of hazardous machinery, automobiles
- Disrupt the body's ability to reduce core body temperature. Advise patients to avoid conditions which may contribute to an elevation in core body temperature
- Esophageal dysmotility and aspiration have occurred with antipsychotic drugs, causing aspiration pneumonia
Cautions: use cautiously in
- Elderly patients
- Cerbrovascular diseases
- History of MI or IHD
- Heart failure
- Dehydration
- Hypovolemia
- Antihypertensive use
- Orthostatic hypotension
- History of low WBC
- Drug induced leukopenia/neutropenia
- History of seizures
- Diabetes mellitus
- Risk of diabetes mellitus
- Risk of aspiration pneumonia
- High environmental temperature
- Depression (<25 yrs patients)
Supplemental Patient Information
- Families and caregiver of the patient should be advised to be alert to the worsening of clinical symptoms of depression and suicidal behavior and immediately report to the patient's health professional
- Aripiprazole impairs judgment, thinking, or motor skills; advise patients not to drive automobiles or operate hazardous machinery
- Advise women who have become pregnant or intend to become pregnant during therapy to report to their physician
- Advise patients to avoid alcohol during therapy
- Patients should be advised to avoid overheating and dehydration
Pregnancy Category:C
Breastfeeding: Safety unknown, Limited data indicates low level of aripiprazole in milk after daily administration of 15 mg to nursing mother. Until more data are available use alternate drug especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 14th December 2010). Aripiprazole was excreted in milk of rats, manufacturer advises to discontinue breastfeeding while administering to the nursing women.
65 yrs of age. Patients on antidepressant therapy should be closely monitored for clinical worsening, suicidality, or unusual changes in behavior
