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Schizophrenia: Recommended Starting and Target Dose: 10 or 15 mg once a day without regard to meals. Abilify has been systematically evaluated and shown to be effective in a dose range of 10-30 mg/day, when administered as a tablet formulation; however, doses >10 or 15 mg/day, the lowest doses in these trials, were not more effective than 10 or 15 mg/day. Dosage increases should be made before 2 weeks, the time needed to achieve steady state.
Special Populations: Dosage adjustments are not routinely indicated on the basis of age, gender, race or renal or hepatic impairment status (see Pharmacokinetics under Actions).
Dosage Adjustments: Patients Taking Aripiprazole Concomitantly with Potential CYP3A4 or CYP2D6 Inhibitors: When concomitant administration of CYP3A4 inhibitor eg, ketoconazole and potential CYP2D6 inhibitors eg, quinidine, fluoxetine or paroxetine with aripiprazole occurs, aripiprazole dose should be reduced to ½ of the usual dose. When the CYP3A4 or CYP2D6 inhibitor is withdrawn from the combination therapy, aripiprazole dose should then be increased.
Patients Taking Potential CYP3A4 Inducers: When a potential CYP3A4 inducer eg, carbamazepine is added to aripiprazole therapy, the aripiprazole dose should be doubled (to 20-30 mg). Additional dose increases should be based on clinical evaluation. When carbamazepine is withdrawn from the combination therapy, the aripiprazole dose should be reduced to 10-15 mg.
Maintenance Therapy: While there is no body of evidence available to answer the question of how long a patient treated with aripiprazole should remain on it, systematic evaluation of patients with schizophrenia who had been symptomatically stable on other antipsychotic medications for periods of ≥3 months were discontinued from those medications, and were then administered Abilify 15 mg/day and observed for relapse during a period of up to 26 weeks, demonstrated a benefit of such maintenance treatment (see Pharmacology under Actions). Patients should periodically be reassessed to determine the need for maintenance treatment.
Switching From Other Antipsychotics: There are no systematically collected data to specifically address switching patients with schizophrenia from other antipsychotics to Abilify or concerning concomitant administration with other antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized.
Bipolar Disorder: Usual Starting Dose: 30 mg once a day. A dose of 30-mg/day was found to be effective when administered as the tablet formulation. Approximately 15% of patients had their dose decreased to 15 mg based on assessment of tolerability. The safety of doses >30 mg/day has not been evaluated in clinical trials.
Special Populations: See Schizophrenia.
Maintenance Therapy: While there is no body of evidence available to answer the question of how long a patient treated with aripiprazole should remain on it, patients with bipolar I disorder who had been symptomatically stable on Abilify tablets (15 or 30 mg/day with a starting dose of 30 mg/day) for at least 6 consecutive weeks and then randomized to Abilify (15 or 30 mg/day) or placebo, and monitored for relapse demonstrated a benefit of such maintenance treatment (see Pharmacology under Actions). While it is generally agreed that pharmacological treatment beyond an acute response in mania is desirable, both for maintenance of the initial response and for prevention of new manic episodes, there are no systematically obtained data to support the use of aripiprazole in such longer-term treatment (ie, beyond 6 weeks).
