Abilify

Abilify

aripiprazole

Manufacturer:

Otsuka

Distributor:

Steward Cross
Concise Prescribing Info
Contents
Aripiprazole
Indications/Uses
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. Dose range: 10-30 mg daily. Dose increases should not be made before 2 wk (time needed to achieve steady state). Adolescent Recommended target dose: 10 mg daily. Initially 2 mg daily, titrate to 5 mg daily after 2 days & to the target dose of 10 mg daily after 2 additional days. Subsequently increase dose in 5 mg increments. 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 daily. Dose may be increased to 30 mg daily. Maintenance dose: Same dose needed to stabilize patient during acute treatment. Adolescent Recommended starting dose: Monotherapy: 2 mg daily, titrate to 5 mg daily after 2 days & a target dose of 10 mg daily after 2 additional days. Subsequently increase dose in 5 mg daily 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 daily. Initially 2 mg daily, increase to 5 mg daily & subsequently to 10-15 mg daily if needed. Gradually adjust dose up to 5 mg daily at intervals of no <1 wk. Tourette's disorder Paed 6-18 yr Recommended dose range: 5-20 mg daily. Patient ≥50 kg Initially 2 mg daily for 2 days, increase to 5 mg daily for 5 days, w/ a target dose of 10 mg daily on day 8. Can be increased up to 20 mg daily. Gradually adjust dose in 5 mg daily increments at intervals of no <1 wk. <50 kg Initially 2 mg daily, w/ a target dose of 5 mg daily after 2 days. Can be increased up to 10 mg daily. Gradually adjust dose at intervals of no <1 wk. Adjunctive therapy to antidepressants for MDD Recommended starting dose: 2-5 mg daily. Recommended dosage range: 2-15 mg daily. Dosage adjustments of up to 5 mg daily should occur gradually at intervals of no <1 wk.
Administration
May be taken with or without food.
Contraindications
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 to determine risk for bipolar disorder prior to initiating treatment w/ antidepressants. NMS. Consider discontinuation if signs & symptoms of tardive dyskinesia appear. Consider dose reduction & close clinical monitoring if extrapyramidal symptoms appear. Identify all possible risk factors for VTE before & during treatment; undertake preventive measures. Hyperglycaemia/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 CBC in patients w/ history of clinically significant low WBC/ANC or drug-induced leukopenia/neutropenia during the 1st few mth of therapy. Discontinue use in patients w/ severe neutropenia (ANC <1,000/mm3). History of seizures or those w/ 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. Closely supervise high-risk suicidal patients. Patients at risk for aspiration pneumonia. 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 somnolence, postural hypotension, motor & sensory instability (which may lead to falls, fractures or other injuries); complete fall risk assessments when initiating treatment & recurrently for patients on long-term therapy. Carefully evaluate for history of drug abuse & closely observe such patients for signs of misuse or abuse. Not approved for psychosis associated w/ Alzheimer's disease. CYP2D6 poor metabolizers (Caucasians & Black/African Americans). May affect ability to operate hazardous machinery including automobiles. Pregnancy & lactation. Monitor neonates exposed to treatment during 3rd trimester of pregnancy for extrapyramidal &/or w/drawal symptoms. Paed patients w/ MDD or agitation associated w/ schizophrenia or bipolar mania.
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
Antipsychotics
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 tab 10 mg
Packing/Price
28's
Form
Abilify tab 15 mg
Packing/Price
28's
Form
Abilify tab 2 mg
Packing/Price
30's
Form
Abilify tab 5 mg
Packing/Price
28's
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