Abilify Tablet/Abilify Discmelt

Aripiprazole

Treatment of schizophrenia, acute manic & mixed episodes associated w/ bipolar I disorder & maintenance therapy for bipolar I disorder. Special considerations in treating ped schizophrenia & bipolar I disorder. Adjunctive treatment of major depressive disorder. Irritability associated w/ autistic disorder. Tourette's disorder. Special considerations in treating ped w/ irritability associated w/ autistic disorder.

Schizophrenia Adult Starting or target dose: 10 or 15 mg/day once daily on once-a-day schedule. Dose range: 10-30 mg/day. Adolescent 13-17 yr Recommended target dose: 10 mg/day. Dose range: 10-30 mg daily. Initially 2 mg/day, titrate to 5 mg/day after 2 days & then 10 mg/day after 2 additional days. Subsequent dose: 5-mg increments up to max of 30 mg/day. Bipolar I disorder Adult 15 mg once daily as monotherapy & 10-15 mg once daily as adjunctive therapy w/ lithium or valproate. Max: 30 mg/day. Childn 10-17 yr Initially 2 mg/day, titrate to 5 mg/day after 2 days & then 10 mg/day after 2 additional days. Adjunctive treatment of major depressive disorder Adult Initially 2-5 mg/day. Dose range: 2-15 mg/day. May adjust dose gradually up to 5 mg/day at intervals of not <1 wk. Irritability associated w/ autistic disorder Childn 6-17 yr 5-15 mg/day. Initially 2 mg/day, may be increased to 5 mg/day w/ subsequent increases to 10 or 15 mg/day. May adjust dose gradually up to 5 mg/day at 1-wk interval. Tourette's disorder Childn 6-18 yr 5-20 mg/day. Childn >50 kg Initially 2 mg/day for 2 days then increased to 5 mg/day for 5 days, w/ target dose of 10 mg/day on day 8. May be increased up to 20 mg/day. May adjust dose gradually in increments of 5 mg/day at intervals of not <1 wk. <50 kg Initially 2 mg/day w/ target dose of 5 mg/day after 2 days, may be increased to 10 mg/day. May adjust dose gradually at intervals of not <1 wk.

May be taken with or without food: Abilify Discmelt: Place tab on the tongue immediately upon opening the blister & allow to disintegrate then, swallow w/o liqd. Do not split tab.

Hypersensitivity.

Elderly patients w/ dementia-related psychosis treated w/ antipsychotic drugs. Not approved for the treatment of patients w/ dementia-related psychosis. Increased incidence of cerebrovascular adverse reactions (eg, stroke, transient ischemic attack) including fatalities. Patients w/ major depressive disorder (worsening of depression &/or emergence of suicidal ideation & behavior or unusual changes in behavior). Neuroleptic malignant syndrome, tardive dyskinesia; metabolic changes including hyperglycemia/DM, dyslipidemia & body wt gain. Monitor regularly for worsening of glucose control & wt. Intense urges particularly for gambling & other compulsive behaviors. Orthostatic hypotension in patients w/ known CV & cerebrovascular disease or conditions predisposing to hypotension. Leukopenia, neutropenia & agranulocytosis may occur; perform CBC frequently in patients w/ history of significant low WBC/ANC or drug-induced leukopenia/neutropenia. Long-term therapy. Patients w/ history of seizures or conditions w/ lower seizure threshold; conditions which may contribute to elevation in core body temp. Possibility of suicide attempt in high risk patients (psychotic illnesses, bipolar disorder, & major depressive disorder). Esophageal dysmotility & aspiration (pneumonia especially to elderly). Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. May cause somnolence, postural hypotension, motor & sensory instability leading to fall & have potential for cognitive & motor impairment. Pregnancy & lactation. Childn <18 yr. Elderly.

Nausea, vomiting, headache, insomnia. Adult: Constipation, dizziness, akathisia, anxiety, restlessness. Childn: Somnolence, extrapyramidal disorder, fatigue, increased appetite & wt, nasopharyngitis. Drug reaction w/ eosinophilia & systemic symptoms (DRESS).

Increased exposure w/ strong CYP3A4 inhibitors (eg, itraconazole, clarithromycin) or strong CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine). Decreased exposure w/ strong CYP3A4 inducers (eg, carbamazepine, rifampin). Potential to enhance the effect of certain antihypertensive drugs. Greater intensity of sedation & orthostatic hypotension w/ benzodiazepines (eg, lorazepam).

Antipsychotics

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

Rx