Arpivex 10 ODT/Arpivex 15 ODT

Schizophrenia in adults & adolescents ≥15 yr. Moderate to severe manic episodes in bipolar I disorder & prevention of new manic episode in adults who experienced predominantly manic episodes & whose manic episodes responded to aripiprazole treatment. Moderate to severe manic episodes in bipolar I disorder in adolescents ≥13 yr up to 12 wk of treatment.

Adult Schizophrenia Starting dose: 10 or 15 mg daily. Maintenance dose: 15 mg once daily. Max: 30 mg daily. Manic episodes in bipolar I disorder 15 mg once daily as monotherapy or combination therapy. Max: 30 mg daily. Adolescent ≥15 yr Schizophrenia 10 mg daily, may increase subsequent dose in 5 mg increments w/o exceeding max daily dose of 30 mg. Adolescent ≥13 yr Manic episodes in bipolar I disorder 10 mg daily.

May be taken with or without food: Place tab on tongue & allow to disintegrate before swallowing w/ or w/o water. Alternatively, disperse in 1 glass of water.

Hypersensitivity.

Suicidality. CV disorders (history of MI or ischaemic heart disease, heart failure, or conduction abnormalities), cerebrovascular disease, conditions which would predispose patients to hypotension (dehydration, hypovolemia, & treatment w/ antihypertensive products) or accelerated or malignant HTN; VTE; family history of QT prolongation. Reduce dose or discontinue use if signs & symptoms of tardive dyskinesia or other extrapyramidal symptoms (eg, akathisia & parkinsonism) appear. Discontinue use if patient develops signs & symptoms of tardive dyskinesia; NMS, or presents w/ unexplained high fever w/o additional clinical manifestations of NMS. History of seizure disorder or conditions associated w/ seizures. Cerebrovascular adverse reactions (eg, stroke, transient ischaemic attack). Not indicated for patients w/ dementia-related psychosis. Observe for signs & symptoms of hyperglycaemia. Regularly monitor for worsening of glucose control in patients w/ or risk factors for DM. Monitor wt gain in adolescents w/ bipolar mania; consider dose reduction if wt gain is clinically significant. Patients at risk for aspiration pneumonia. Pathological gambling & other impulse control disorders; consider dose reduction or stopping the medication if patient develop urges. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. ADHD comorbidity. Concomitant use w/ stimulants. May cause somnolence, postural hypotension, motor & sensory instability, which may lead to falls. Severe hepatic impairment. Minor to moderate influence on the ability to drive & use machines due to potential nervous system & visual effects. Pregnancy & lactation. Not recommended for use in childn <15 yr w/ schizophrenia & childn <13 yr. Childn & adolescents <18 yr w/ irritability associated w/ autistic disorder; childn & adolescents 6-18 yr w/ tics associated w/ Tourette's disorder. Elderly w/ dementia-related psychosis.

DM; insomnia, anxiety, restlessness.; akathisia, extrapyramidal disorder, tremor, headache, sedation, somnolence, dizziness; blurred vision.

Enhanced effects of certain antihypertensive products. Overlapping adverse reactions eg, sedation w/ alcohol or other CNS products. Increased AUC w/ strong CYP2D6 inhibitor (eg, quinidine, fluoxetine, & paroxetine). Increased AUC & C_max w/ strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, & HIV-PIs). Modest increase in plasma conc w/ weak CYP3A4 (eg, diltiazem) or CYP2D6 (eg, escitalopram) inhibitors. Lower geometric means of C_max & AUC w/ strong CYP3A4 inducers (eg, carbamazepine, rifampicin, rifabutin, phenytoin, phenobarb, primidone, efavirenz, nevirapine & St. John's wort). Serotonin syndrome w/ other serotonergic products eg, SSRI/SNRI or medicinal products known to increase aripiprazole conc. Concomitant use w/ medicinal products known to cause QT prolongation or electrolyte imbalance.

Antipsychotics

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

Rx