Concise Prescribing Info
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Schizophrenia Initial: 10 or 15 mg once daily. Maintenance: 15 mg once daily. Adjust dose at intervals of at least 2 weeks. Max: 30 mg/day. Acute manic or mixed episodes of bipolar disorder Monotherapy: Initial: 15 mg once daily. Adjunctive therapy to lithium or valproate: Initial: 10-15 mg once daily. Dose may be increased according to patient response. Max: 30 mg/day. Adjunctive therapy of major depressive disorder Initial: 2-5 mg once daily, may be adjusted gradually in increments of up to 5 mg at intervals of at least 1 week according to patient response and tolerability. Max: 15 mg/day. IM Acute manic episodes of bipolar disorder For rapid control of agitation and disturbed behaviours when oral therapy is inappropriate: As anhydrous aripiprazole solution for inj: Initial: 9.75 mg as single dose via deep inj, may be followed by a further dose after at least 2 hours if necessary. Recommended dose range: 5.25-15 mg as a single dose. Max: 3 inj/day; 30 mg/day (combined oral and IM dose). Schizophrenia For rapid control of agitation and disturbed behaviours when oral therapy is inappropriate: As anhydrous aripiprazole solution for inj: Initial: 9.75 mg as single dose via deep inj, may be followed by a further dose after at least 2 hours if necessary. Recommended dose range: 5.25-15 mg as a single dose. Max: 3 inj/day; 30 mg/day (combined oral and IM dose). Maintenance in patients stabilised with oral aripiprazole therapy: As aripiprazole monohydrate prolonged-release susp for inj: 400 mg once monthly via deep inj (minimum of 26 days between inj). After the 1st inj, therapy with 10-20 mg daily oral aripiprazole must be continued for 14 consecutive days. Dose may be reduced to 300 mg once monthly if necessary. As aripiprazole lauroxil extended-release susp for inj: Recommended initial dose: Single monthly inj equivalent to 300 mg, 450 mg or 600 mg of aripiprazole; alternatively, 600 mg once every 6 weeks. Dosage requirements and frequency may vary depending on the concomitant dose of oral aripiprazole therapy, available preparation, and inj site (refer to detailed product guideline).
May be taken with or without food.
Special Precautions
Patient with known CV disease (e.g. history of MI, ischaemic heart disease, conduction abnormalities, heart failure), cerebrovascular disease, conditions predisposing to hypotension (e.g. hypovolaemia, undergoing antihypertensive treatment), hypertension (including accelerated or malignant); family history of QT prolongation, diabetes mellitus or its risk factors (e.g. obesity, family history), prior history of impulse control issues, Lewy body dementia, Parkinson's disease, history of seizures; at risk of seizures (e.g. head trauma, alcoholism, brain damage), at risk of aspiration pneumonia (e.g. Alzheimer dementia); pre-existing low WBC count/absolute neutrophil count, history of drug-induced leucopenia/neutropenia. Patient subjected to dehydration or strenuous exercise, exposed to extreme heat, receiving drugs with anticholinergic effects. CYP2D6 poor metabolisers; patient taking CYP3A4 and/or CYP2D6 inhibitors, or potent CYP3A4 inducers. IM: Avoid use in patient receiving CYP3A4 inducers for >14 days (aripiprazole monohydrate). Not approved for the treatment of dementia-related psychosis. Avoid abrupt withdrawal. Severe hepatic impairment. Children and elderly. Pregnancy and lactation. Patient Counselling This drug may cause somnolence, sedation, and blurred vision; if affected, do not drive or operate machinery. Monitoring Parameters Screen patients for bipolar disorder before initiation of therapy for depression. Monitor mental status, vital signs (as clinically indicated), blood pressure (at baseline; repeat after 3 months then annually); weight, height, BMI, waist circumference; CBC, electrolytes and LFT (as clinically indicated), fasting plasma glucose level/HbA1c and lipid panel (at baseline; repeat after 3 months then yearly), ECG (as needed). Closely monitor for clinical worsening, suicidality, or unusual changes in behaviour, particularly during initiation of therapy or dosage adjustments. Assess for involuntary movements or parkinsonian signs, and tardive dyskinesia. Perform ocular examination yearly in patients >40 years or every 2 years in younger patients.
Adverse Reactions
Significant: Suicidal thoughts and behaviour, venous thromboembolism, QT prolongation, extrapyramidal symptoms (e.g. tardive dyskinesia, akathisia, parkinsonism); dyslipidaemia, weight gain, oesophageal dysmotility and aspiration; impulse control disorders (e.g. pathological gambling, increased sexual urges, compulsive shopping, binge or compulsive eating); falls, orthostatic hypotension, worsening depression, seizure, impaired core body temperature regulation; hypersensitivity reactions. Cardiac disorders: Tachycardia. Endocrine disorders: Hyperprolactinaemia. Eye disorders: Blurred vision, diplopia. Gastrointestinal disorders: Constipation, nausea, dyspepsia, vomiting, salivary hypersecretion, dry mouth. General disorders and administration site conditions: Fatigue, pyrexia, lethargy, inj site pain or induration (IM). Investigations: Increased blood creatine phosphokinase. Metabolism and nutrition disorders: Diabetes mellitus, increased or decreased appetite. Musculoskeletal and connective tissue disorders: Musculoskeletal stiffness. Nervous system disorders: Headache, sedation, tremor, dizziness, drooling, dystonia. Psychiatric disorders: Insomnia, anxiety, restlessness, somnolence, agitation. Reproductive system and breast disorders: Erectile dysfunction. Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, hiccups.
Potentially Fatal: Hyperglycaemia associated with ketoacidosis or hyperosmolar coma; arrhythmia, blood dyscrasias (e.g. leucopenia, neutropenia, agranulocytosis), cerebrovascular events (e.g. TIA, stroke). Rarely, neuroleptic malignant syndrome.
Drug Interactions
May enhance the effects of certain antihypertensive agents. Enhanced sedation with lorazepam. May increase plasma concentration with potent inhibitors of CYP2D6 (e.g. quinidine, fluoxetine, paroxetine) or CYP3A4 (e.g. ketoconazole, itraconazole, clarithromycin). May decrease plasma concentrations with potent CYP3A4 inducers (e.g. carbamazepine, rifampicin, rifabutin, phenytoin, phenobarbital, primidone, efavirenz, nevirapine). Increased risk of serotonin syndrome with other serotonergic drugs (e.g. serotonin-norepinephrine reuptake inhibitors, SSRIs).
CIMS Class
ATC Classification
N05AX12 - aripiprazole ; Belongs to the class of other antipsychotics.
Disclaimer: This information is independently developed by CIMS based on aripiprazole from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 CIMS. All rights reserved. Powered by
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