Steward Cross
Concise Prescribing Info
Schizophrenia; acute manic & mixed episodes associated w/ bipolar I disorder & for maintaining stability or preventing recurrence as monotherapy in adults & adolescents ≥13 yr & as an adjunct to lithium or valproate in adults; irritability associated w/ autistic disorder; Tourette's disorder. Adjunctive therapy to antidepressants for major depressive disorder (MDD).
Dosage/Direction for Use
Schizophrenia Adult Recommended starting & target dose: 10 or 15 mg once daily. Usual dose range: 10-30 mg/day. Dose increase should not be made before 2 wk, the time needed to achieve steady state. Periodically reassess to determine the need for maintenance treatment. Adolescent Recommended target dose: 10 mg/day. Periodically reassess to determine the need for maintenance treatment. Bipolar disorder Adult Recommended starting dose: Monotherapy: 15 mg once daily. Adjunctive therapy w/ lithium or valproate: 10-15 mg once daily. Recommended target dose for mono- & adjunctive therapy: 15 mg/day. Dose may be increased to 30 mg/day. Maintenance dose: Same dose needed to stabilize patient during acute treatment. Adolescent Recommended starting dose: Monotherapy: 2 mg/day, titrate to 5 mg/day after 2 days & a target dose of 10 mg/day after 2 additional days. Subsequently increase dose in 5 mg/day increments if needed. Maintenance dose: Same dose needed to stabilize patient during acute treatment. Irritability associated w/ autistic disorder Paed 6-17 yr Recommended dose range: 5-15 mg/day. Initially 2 mg/day, increase to 5 mg/day & subsequently to 10-15 mg/day if needed. Gradually adjust dose up to 5 mg/day at intervals of no <1 wk. Tourette's disorder Paed 6-18 yr Recommended dose range: 5-20 mg/day. Patient ≥50 kg Initially 2 mg/day for 2 days, increase to 5 mg/day for 5 days, w/ a target dose of 10 mg/day on day 8. Can be increased up to 20 mg/day. Gradually adjust dose in 5 mg/day increments at intervals of no <1 wk. <50 kg Initially 2 mg/day, w/ a target dose of 5 mg/day after 2 days. Can be increased up to 10 mg/day. Gradually adjust dose at intervals of no <1 wk. Adjunctive treatment of MDD Recommended starting dose: 2-5 mg/day. Recommended dose range: 2-15 mg/day. Dosage adjustment of up to 5 mg/day should occur gradually at intervals of no <1 wk.
May be taken with or without food.
Special Precautions
Increased mortality in elderly patients w/ dementia-related psychosis. Increased incidence of cerebrovascular adverse events (eg, stroke, transient ischemic attack), including fatalities. May worsen depression &/or emergence of suicidal ideation & behaviour or unusual behavioural changes in patients w/ MDD. Patient w/ depressive symptoms should be adequately screened for bipolar disorder prior to initiating treatment w/ antidepressants. Neuroleptic malignant syndrome. Consider discontinuation if signs & symptoms of tardive dyskinesia appear. Consider dose reduction & close clinical monitoring if signs & symptoms of extrapyramidal symptoms other than akathisia & Parkinsonism appear. Identify all possible risk factors for venous thromboembolism before & during treatment, & undertake preventive measures. Hyperglycemia/DM (regularly monitor for worsening of glucose control). Dyslipidaemia. Wt gain. Patients w/ known CV disease (history of MI or ischemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease or predisposing conditions to hypotension (dehydration, hypovolemia & treatment w/ antihypertensives). Perform a complete blood count in patients w/ history of clinically significant low WBC/absolute neutrophil count (ANC) or drug-induced leukopenia/neutropenia during the 1st few mth of therapy. Discontinue in patients w/ severe neutropenia (ANC <1,000/mm3). History of seizures or those w/ a lowered seizure threshold. Potential impairment of judgment, thinking, or motor skills. Patients who will be experiencing conditions which may contribute to core body temp elevation; at risk for aspiration pneumonia. Closely supervise high-risk suicidal patients. Potential pathological gambling & other compulsive behaviours. Patients w/ sleep apnoea or risk factors for developing sleep apnoea. Patients w/ diseases, conditions or medications that could exacerbate effects of somnolence, postural hypotension, motor & sensory instability (which may lead to falls & fractures, or other injuries), should complete fall risk assessments when initiating treatment & recurrently for patients on long-term therapy. Evaluate for history of drug abuse. May affect ability to drive or operate machinery. Pregnancy & lactation. Neonates exposed to treatment during the 3rd trimester of pregnancy; consider monitoring for extrapyramidal &/or w/drawal symptoms. Not approved for MDD or agitation associated w/ schizophrenia or bipolar mania in paed population. Not approved for psychosis associated w/ Alzheimer's disease. CYP2D6 poor metabolizers (Caucasians & Black/African Americans).
Adverse Reactions
Headache, nausea, vomiting, insomnia. Adult: Constipation, dizziness, akathisia, anxiety, restlessness. Paed: Somnolence, extrapyramidal disorder, fatigue, increased appetite & wt, nasopharyngitis.
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). May enhance the effect of antihypertensives. Greater intensity of sedation & orthostatic hypotension in combination w/ benzodiazepines (eg, lorazepam). Avoid alcohol.
MIMS Class
ATC Classification
N05AX12 - aripiprazole ; Belongs to the class of other antipsychotics.
Abilify tab 5 mg
Abilify tab 10 mg
Abilify tab 15 mg
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