Abilify Discmelt

Abilify Discmelt

aripiprazole

Manufacturer:

Otsuka
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Contents
Aripiprazole.
Indications/Uses
Acute agitation in schizophrenia and bipolar disorders; acute (adult and adolescents) and maintenance (adult) treatment in patients with schizophrenia; acute mania and mixed episodes treatment in patients with bipolar disorder for adult, adolescents and children; maintenance (adult) treatment in patients with bipolar disorder; adjunctive therapy for major depressive disorder.
Dosage/Direction for Use
Usual Dose: Schizophrenia: Adults: Recommended Starting and Target Dose: 10 or 15 mg once daily without regard to meals.
Abilify Discmelt has been systematically evaluated and shown to be effective in a dose range of 10-30 mg daily. However, doses higher than 10 or 15 mg daily were not more effective than 10 or 15 mg daily. Dosage increases should not be made 2 weeks before the time needed to achieve steady state.
Adolescents: Starting Daily Dose: 2 mg titrated to 5 mg after 2 days and to the target dose of 10 mg after 2 additional days. Subsequent dose increases should be administered in 5 mg increments. The 30 mg daily dose was not shown to be more efficacious than the 10 mg daily dose.
Bipolar Disorder: Adults: Starting Dose: 30 mg once daily without regard to meals. A dose of 30 mg daily was found to be effective when administered as the tablet formulation. Approximately 15% of patients had their dose decreased to 15 mg based on tolerability assessment. The safety of doses above 30 mg daily has not been evaluated in clinical trials.
Children and Adolescents: The efficacy of aripiprazole has been established in the treatment of children and adolescent patients 10-17 years with bipolar I disorder at doses of 10 or 30 mg daily. Recommended Target Dose: 10 mg daily. Starting Daily Dose: 2 mg daily titrated to 5 mg daily after 2 days and to the target dose of 10 mg after 2 additional days.
Subsequent dose increases should be administered without regard to meals.
Major Depressive Disorder: Adults: Recommended Starting Dose: Adjunctive Treatment for Patients Taking an Antidepressants: 2-5 mg daily. The efficacy as an adjunctive therapy was established within a dose range of 2-15 mg daily.
Dose adjustment of up to 5 mg daily should occur gradually at intervals of no less than 1 week.
Overdosage
Treatment should be symptomatic and supportive eg, adequate airway maintenance, cardiovascular monitoring and close medical supervision. Activated charcoal reduces serum concentration.
Contraindications
Hypesensitivity to aripiprazole.
Special Precautions
Clinical improvement may take several days to some weeks. Monitoring the patient throughout this period is recommended. Reduce dose or discontinue if signs or symptoms of tardive dyskinesia appear. Discontinue if patient develops signs and symptoms indicative of neuroleptic malignant syndrome. Caution in patients with a history of seizure.
Effects on the Ability to Drive or Operate Machinery: Until individual patient response is established, caution is advised when driving or operating machines.
Use in pregnancy & lactation: Do not use in pregnancy unless the benefit outweighs the risk.
Breastfeeding is not advised during treatment.
Use In Pregnancy & Lactation
Do not use in pregnancy unless the benefit outweighs the risk.
Breastfeeding is not advised during treatment.
Adverse Reactions
Adverse events occurred in ≥10% of patients treated with Abilify Discmelt are headache, nausea, vomiting, constipation, anxiety, insomnia, lightheadedness, somnolence, akathisia, dyspepsia, agitation.
Drug Interactions
Both CYP3A4 and CYP2D6 are responsible for Abilify Discmelt metabolism. Agents that induce CYP3A4 (eg, carbamazepine) could cause an increase in Abilify Discmelt clearance and lower blood levels. Inhibitors of CYP3A4 (eg, ketoconazole) or CYP2D6 (eg, quinidine, fluoxetine or paroxetine) can inhibit Abilify Discmelt elimination and cause increased blood levels.
MIMS Class
Antipsychotics
ATC Classification
N05AX12 - aripiprazole ; Belongs to the class of other antipsychotics.
Presentation/Packing
Form
Abilify Discmelt orally disintegrating tab 10 mg
Packing/Price
1 × 10's
Form
Abilify Discmelt orally disintegrating tab 15 mg
Packing/Price
1 × 10's
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