May be taken with or without food.
Administration
May be taken with or without food.
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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.
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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).
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CIMS Class
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ATC Classification
N05AX12 - aripiprazole ; Belongs to the class of other antipsychotics.
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