Abilify

Abilify

aripiprazole

Manufacturer:

Thai Otsuka

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Aripiprazole
Indications/Uses
Schizophrenia; acute manic & mixed episodes associated w/ bipolar I disorder; irritability associated w/ autistic disorder; Tourette's disorder. Adjunct in major depressive disorder.
Dosage/Direction for Use
Schizophrenia Adult Recommended starting & target dose: 10 or 15 mg once daily. Effective dose range: 10-30 mg daily administered as tab. Dose increase should not be made before 2 wk. Adolescent Recommended target dose: 10 mg daily, 13-17 yr Initially 2 mg daily, titrated to 5 mg after 2 days & to target dose of 10 mg after 2 additional days. Increase subsequent dose in 5 mg increments. Acute manic & mixed episodes associated w/ bipolar I disorder Adult Recommended starting dose: 15 mg once daily as monotherapy, 10-15 mg once daily as adjunct w/ lithium or valproate. May increase dose to max of 30 mg daily. Ped 10-17 yr Recommended starting dose as monotherapy & adjunct: 2 mg daily, titrate to 5 mg daily after 2 days & target dose of 10 mg daily after 2 additional days. Increase subsequent dose in 5 mg daily increments. Irritability associated w/ autistic disorder Ped 6-17 yr Recommended dose range: 5-10 mg daily. Initially 2 mg daily. May gradually increase to 5 mg daily at intervals of no <1 wk, w/ subsequent increase to 10 or 15 mg daily if needed. Tourette's disorder Ped 6-18 yr Recommended dose range: 5-20 mg daily. Patient weighing ≥50 kg Initially 2 mg daily for 2 days, then increase to 5 mg daily for 5 days at intervals of no <1 wk w/ target dose of 10 mg daily on day 8. May further increase up to 20 mg daily, <50 kg Initially 2 mg daily w/ target dose of 5 mg daily after 2 days. May be increased to 10 mg daily at intervals of no <1 wk. Adjunct in major depressive disorder Adult Recommended starting dose: 2-5 mg daily. Gradually adjust dose up to 5 mg daily at intervals of no <1 wk. Recommended dose range: 2-15 mg daily. CYP2D6 poor metabolizers & taking concomitant strong CYP2D6 or CYP3A4 inhibitors ½ of usual dose. CYP2D6 poor metabolizers taking concomitant strong CYP3A4 & CYP2D6 inhibitors ¼ of usual dose. Patients taking strong CYP3A4 inducers Double the usual dose over 1-2 wk.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue if NMS occurs; in severe neutropenia (ANC <1,000/mm3). Consider discontinuation in patients w/ persistently worse depression or experiencing emergent suicidality; if signs & symptoms of tardive dyskinesia appear; at 1st sign of clinically significant decline in WBC. Consider dose reduction or stopping treatment if compulsive behaviors develop. Not for treatment of depression in ped; psychosis associated w/ Alzheimer's disease. Worsening depression &/or emergence of suicidal ideation & behavior or unusual behaviour changes; cerebrovascular adverse events eg, stroke, transient ischemic attack; hyperglycemia/DM, dyslipidemia, body wt gain; pathological gambling & compulsive behaviors; orthostatic hypotension; somnolence, postural hypotension, motor & sensory instability leading to falls & fractures or other injuries; leukopenia, neutropenia, agranulocytosis; disruption of body's ability to reduce core body temp; suicide attempt; esophageal dysmotility & aspiration. Patients w/ known CV disease (history of MI or ischemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease or conditions predisposing to hypotension (dehydration, hypovolemia & antihypertensives); history of seizures or w/ conditions that lower seizure threshold; risk for aspiration pneumonia. Adequately screen patients w/ depressive symptoms for risk of bipolar disorder prior to initiating treatment. Monitor clinical worsening, suicidality & unusual behavior changes; emergence of agitation, irritability; worsening of glucose control; symptoms of hyperglycemia; wt gain; fever or other symptoms or signs of infection in patients w/ clinically significant neutropenia. Perform fasting blood glucose testing in patients w/ risk factors or develop symptoms of DM at beginning & periodically during treatment; CBC in patients w/ history of clinically significant low WBC/ANC or drug-induced leukopenia/neutropenia during 1st few mth of therapy. May impair ability to drive or operate machinery. Pregnancy & lactation. Ped patients w/ major depressive disorder or agitation associated w/ schizophrenia or bipolar mania. Elderly w/ dementia-related psychosis.
Adverse Reactions
Nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, restlessness, somnolence, extrapyramidal disorder, fatigue, increased or decreased appetite, increased wt, nasopharyngitis, blurred vision, sedation, tremor, salivary hypersecretion, pyrexia, drooling, lethargy.
Drug Interactions
Increased exposure w/ strong CYP3A4 inhibitors eg, itraconazole, clarithromycin or strong CYP2D6 inhibitors eg, quinidine, fluoxetine, paroxetine. Decreased exposure w/ strong CYP3A4 inducers eg, carbamazepine, rifampin. Enhanced effect of antihypertensives. Greater intensity of sedation & orthostatic hypotension w/ benzodiazepines eg, lorazepam.
MIMS Class
Antipsychotics / Antidepressants
ATC Classification
N05AX12 - aripiprazole ; Belongs to the class of other antipsychotics.
Presentation/Packing
Form
Abilify oral soln 1 mg/mL
Packing/Price
150 mL x 1's
Form
Abilify OD tab 10 mg
Packing/Price
30's
Form
Abilify OD tab 15 mg
Packing/Price
30's
Form
Abilify tab 2 mg
Packing/Price
30's
Form
Abilify tab 5 mg
Packing/Price
30's
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