aripiprazole (Rx) - Abilify, Abilify Discmelt

Dosing Forms & Strengths

Schizophrenia

Initial: 10-15 mg PO qDay

May increase to 30 mg PO qDay after 2 weeks

Concomitant potent CYP2D6 or CYP3A4 inhibitor: half dose

Concomitant potent CYP3A4 inducer: 20-30 mg PO qDay

Bipolar Mania

Indicated for acute treatment of manic or mixed episodes associated with biploar I disorder as monotherapy and as an adjunct to lithium or valproate

Also indicated for maintenance treatment both as monotherapy and as an adjunct to lithium or valproate

Monotherapy: 15 mg PO qDay initially; may increase gradually, not to exceed 30 mg/day

Adjunct to lithium or valproate: 10-15 mg PO qDay initially; recommended daily dose is 15 mg/day; may gradually increase, not to exceed 30 mg/day

Major Depressive Disorder

Start 2-5 mg/day PO; increase by up to 5 mg qWeek PRN

Used adjunct with other antidepressants

Agitation Associated with Schizophrenia or Bipolar Mania

9.75 mg IM, may repeat no more frequently than 2 hours, no more than 30 mg/day

Lower initial dose of 5.25 mg may be warranted for some patients

Tourette's Syndrome (Orphan)

Dosing Forms & Strengths

Schizophrenia

13-17 years old: 2 mg/day PO initially, after 2 days increase to 5 mg/day; after an additional 2 days increase to recommended dose of 10 mg/day

Subsequent dose increase may be made by 5 mg/day

Maintenance dose: 10-30 mg/day

Bipolar Mania

Indicated for monotherapy or as adjunct to lithium or valproate in patients with acute manic or mixed episodes

10-17 years old: 2 mg/day PO initially, after 2 days increase to 5 mg/day; after an additional 2 days increase to recommended dose of 10 mg/day

Subsequent dose increase may be made by 5 mg/day

Maintenance dose: 10-30 mg/day

Autism

Treatment of irritability associated with autistic disorder in children aged 6-17 years

<6 years: Safety and efficacy not established

6-17 years: 2 mg/day PO initially; increase gradually at intervals no less than 1 week to target dose of 5 mg/day, may gradually increase further if needed to 10 mg/day or up to 15 mg/day if needed

Not to exceed 15 mg/day

>10%

Agitation (19%)

Akathisia (10-13%)

Anxiety (17%)

Constipation (10-11%)

Headache (27%)

Insomnia (18%)

Lightheadedness (11%)

N/V (11-15%)

Weight gain (8-30%)

1-10%

Abdominal discomfort (3%)

Blurred vision (3%)

Cough (3%)

Dizziness (10%)

Dry mouth (5%)

Dyspepsia (9%)

Extrapyramidal disorder (5%)

Fatigue (6%)

Musculoskeletal stiffness (4%)

Myalgia (2%)

Orthostatic hypotension (1-5%)

Pain (3%)

Rash

Restlessness (6%)

Rhinitis

Somnolence (5-8%)

Tremor (6%)

Xerostomia (5%)

<1%

Altered mental status

Autonomic instability

Dysphagia

Hyperpyrexia

Muscle rigidity

Neuroleptic malignant syndrome

Seizure

Tardive dyskinesia

Black Box Warnings

Patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death as shown in short-term controlled trials. The deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. This drug is not approved for the treatment of patients with dementia-related psychosis.

Contraindications

Documented hypersensitivity

Cautions

Risk of neuroleptic malignant syndrome (NMS) & EPS

Patients with known CVD, cerebrovascular disease, or predisposal to hypotension

May increase risk of suicidal tendencies in children & adolescents

FDA Warning regarding off-label use for dementia in elderly

Leukopenia/neutropenia and agranulocytosis reported; possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC) and history of drug-induced leukopenia/neutropenia ( if history of clinically significant low WBC or drug-induced leukopenia/neutropenia, monitor complete blood count (CBC) frequently during first few months of therapy; discontinue drug at first sign of a clinically significant decline <1000/mm3 in WBC in absence of other causative factors and continue monitoring WBC until recovery)

Excretion

Urine: 25%

Feces: 55%

Mechanism of Action

Atypical antipsychotic

Partial agonist at dopamine D2 & serotonin 5-HT1A receptors, antagonist at 5-HT2A receptor

Also has alpha-blocking activity