Ripizol

Aripiprazole

Schizophrenia. Acute & maintenance treatment of manic & mixed episodes associated w/ bipolar I disorder as monotherapy in adults & ped patients (10-17 yr) & as an adjunct to lithium or valproate in adults. Adjunctive therapy to antidepressants for major depressive disorder (MDD). Irritability associated w/ autistic disorder. Tourette's disorder.

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 after 2 days & to the target dose of 10 mg daily after 2 additional days. Subsequently increase dose in 5 mg increments. Bipolar I disorder Acute treatment of manic & mixed episodes 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 daily. Dose may be increased to 30 mg daily. Ped patient (10-17 yr) Recommended starting dose: Mono- or adjunctive therapy: 2 mg daily, titrate to 5 mg daily after 2 days & target dose of 10 mg daily after 2 additional days. Subsequently increase dose in 5 mg daily increments if needed. Maintenance treatment Mono- or adjunctive therapy: Same dose needed to stabilize patient during acute treatment both for adult & ped patient. Adjunctive therapy to antidepressant for MDD Adult Recommended starting dose: 2-5 mg daily. Recommeded dose range: 2-15 mg daily. Dosage adjustments of up to 5 mg daily should occur gradually at intervals of no <1 wk. Irritability associated w/ autistic disorder Ped patient Recommeded 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 Ped patient (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. 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.

May be taken with or without food.

Hypersensitivity.

Increased mortality in elderly patients w/ dementia-related psychosis. Increased incidence of cerebrovascular adverse events (eg, stroke, transient ischemic attack). May worsen depression &/or emergence of suicidal ideation & behavior or unusual behavioral changes in patients w/ MDD. Monitor appropriately & observe closely during initial few mth of therapy or changes in dosage for clinical worsening, suicidality, & unusual behavioral changes. Patient w/ depressive symptoms should be adequately screened to determine risk for bipolar disorder prior to initiating treatment w/ antidepressants. NMS. Consider discontinuation in patients w/ persistently worse depression or experiencing emergent suicidality; if signs & symptoms of tardive dyskinesia appear. Metabolic changes eg, hyperglycemia/DM, dyslipidemia & wt gain. Regularly monitor worsening glucose control in patients w/ established DM who started treatment. Perform fasting glucose testing at the beginning & periodically in patients w/ risk factors for DM. Consider dose reduction or discontinuation of treatment if patient develops intense urges, particularly for gambling & inability to control these urges. Patients w/ known CV disease (history of MI & ischaemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease or predisposing conditions to hypotension (dehydration, hypovolemia & treatment w/ antihypertensives). 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. Monitor CBC in patients w/ history of clinically significant low WBC 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 w/ conditions that lower the seizure threshold eg, Alzheimer's dementia. Patients who will be experiencing conditions which may contribute to core body temp elevation (eg, strenuous exercise, extreme heat exposure, receiving concomitant medication w/ anticholinergic activity, or being subject to dehydration). Closely supervise high-risk suicidal patients. Patients at risk for aspiration pneumonia. Not approved for psychosis associated w/ Alzheimer's disease. Carefully evaluate for history of drug abuse & closely observe such patients for signs of misuse or abuse. Potential impairment of judgment, thinking or motor skills; may affect ability to operate hazardous machinery including automobiles. Pregnancy. Nursing mothers. Ped patients w/ MDD.

Nausea, vomiting, constipation, headache, insomnia. Adult: Constipation, dizziness, akathisia, anxiety, restlessness. Ped: somnolence, extrapyramidal disorder, fatigue, increased appetite & wt, nasopharyngitis.

Increased exposure w/ strong CYP3A4 inhibitors (eg, itraconazole, clarithromycin) or strong CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine). Dexreased exposure w/ strong CYP3A4 inducers (eg, carbamazepine, rifampicin). May enhance the effect of antihypertensives. Greater intensity of sedation & orthostatic hypotension in combination w/ benzodiazepines (eg, lorazepam). Avoid central acting drugs or alcohol.

Antipsychotics

N05AX12 - aripiprazole ; Belongs to the class of other antipsychotics.

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