Stabel-10

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

Adult Schizophrenia Initially 10 mg or 15 mg daily w/ maintenance dose of 15 mg daily administered on a once-daily schedule. Max daily dose: 30 mg. Manic episode in bipolar I disorder Initially 15 mg administered on a once-daily schedule as monotherapy or combination therapy. Max daily dose: 30 mg. Recurrence prevention of manic episode in bipolar I disorder Continue therapy at same dose in patient who has been receiving aripiprazole as monotherapy or combination therapy. Adolescent ≥15 yr Schizophrenia Initially 2 mg for 2 days, titrated to 5 mg for 2 additional days to reach recommended daily dose of 10 mg. Subsequent dose increases should be administered in 5 mg increments w/o exceeding max daily dose: 30 mg. Adolescent ≥13 yr Manic episode in bipolar I disorder Initially 2 mg for 2 days, titrated to 5 mg for 2 additional days to reach the recommended daily dose of 10 mg. Treatment duration should be the min necessary for symptom control & must not exceed 12 wk. Patient w/ severe hepatic impairment Max daily dose of 30 mg should be used w/ caution.

May be taken with or without food: Take immediately w/ or w/o liqd. Alternatively, disperse tab in water & drink the resulting susp.

Hypersensitivity.

Hypersensitivity reactions, characterised by allergic symptoms, may occur. Closely supervise high-risk patients for occurrence of suicidal behaviour reported early after initiation or switch of antipsychotic treatment w/ aripiprazole. Use w/ caution in patients w/ known CV disease (history of MI or ischemic heart disease, heart failure, or conduction abnormalities), cerebrovascular disease, conditions which would predispose patients to hypotension (dehydration, hypovolemia, & treatment w/ antihypertensives) or HTN, including accelerated or malignant; family history of QT prolongation; history of seizure disorder or conditions associated w/ seizures; at risk for aspiration pneumonia. Identify all possible risk factors for VTE before & during treatment. Consider dose reduction or discontinuation if signs & symptoms of tardive dyskinesia appear; pathological gambling & other impulse control disorders develop. Consider dose reduction & close clinical monitoring if signs & symptoms of other extrapyramidal symptoms appear. Discontinue use if patient develops signs & symptoms indicative of NMS, or presents w/ unexplained high fever w/o additional clinical manifestations of NMS. Not indicated for dementia-related psychosis. Observe for signs & symptoms of hyperglycemia & regularly monitor patients w/ DM or w/ risk factors for DM for worsening of glucose control. Monitor wt gain in adolescents w/ bipolar mania. May cause somnolence, postural hypotension, motor & sensory instability, which may lead to falls. Contains aspartame which may be harmful for people w/ phenylketonuria. Use w/ extreme caution in concomitant use w/ stimulants in patients w/ ADHD comorbidity. Minor to moderate influence on ability to drive & use machines. Not to be used in pregnancy unless expected benefit clearly justifies potential fetal risk. Discontinue breastfeeding or discontinue/abstain from therapy. Not recommended in childn <15 yr w/ schizophrenia & <13 yr w/ bipolar I disorder. Safety & efficacy have not yet been established in childn & adolescents <18 yr w/ irritability associated w/ autistic disorder, & childn 6-18 yr w/ tics associated w/ Tourette's disorder. Increased mortality in elderly w/ dementia-related psychosis. Safety & efficacy in treatment of schizophrenia or manic episodes in bipolar I disorder have not been established in elderly ≥65 yr.

DM; insomnia, anxiety, restlessness; akathisia, extrapyramidal disorder, tremor, headache, sedation, somnolence, dizziness; blurred vision; constipation, dyspepsia, nausea, salivary hypersecretion, vomiting; fatigue.

May enhance effect of certain antihypertensives. Use w/ caution in combination w/ alcohol or other CNS medicinal products w/ overlapping adverse reactions eg, sedation; medicinal products known to cause QT prolongation or electrolyte imbalance. Increased AUC w/ quinidine & other CYP2D6 potent inhibitors eg, fluoxetine & paroxetine. Increased AUC & C_max w/ ketoconazole & other CYP3A4 strong inhibitors eg, itraconazole & HIV PIs. Modest increases in plasma conc may be expected w/ weak inhibitors of CYP3A4 (eg, diltiazem) or CYP2D6 (eg, escitalopram). Lower geometric means of C_max & AUC w/ carbamazepine & other CYP3A4 inducers eg, rifampicin, rifabutin, phenytoin, phenobarb, primidone, efavirenz, nevirapine & St. John's wort. Cases of serotonin syndrome w/ other serotonergic medicinal products (eg, SSRI/SNRI) or medicinal products known to increase aripiprazole conc.

Antipsychotics

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

Rx