Aplirex

Strengths

Aplirex 2, Aplirex5, Aplirex 10, Aplirex 15, Aplirex 20, Aplirex 30

Dosage Form

Tablets

Composition

Aplirex 2
Each tablet contains:
Aripiprazole 2 mg

Aplirex 5
Each tablet contains:
Aripiprazole 5 mg

Aplirex 10
Each tablet contains:
Aripiprazole 10 mg

Aplirex 15
Each tablet contains:
Aripiprazole 15 mg

Aplirex 20
Each tablet contains:
Aripiprazole 20 mg

Aplirex 30
Each tablet contains:
Aripiprazole 30 mg

Packaging

Aplirex 2: 20 tablets
Aplirex 5: 20 tablets
Aplirex 10: 20 tablets
Aplirex 15: 20 tablets
Aplirex 20: 20 tablets
Aplirex 30: 20 tablets

Indications

Aplirex is indicated for the treatment of:
• Schizophrenia.
• Acute treatment of manic and mixed episodes associated with bipolar I disorder.
• Adjunctive treatment of major depressive disorder.
• Irritability associated with autistic disorder.
• Treatment of Tourette's disorder.

Dosage and Administration

Schizophrenia:
- Adults:
The recommended starting and target dose for Aplirex is 10 or 15 mg/day administered on a once-a-day schedule without regard to meals. Aplirex has been systematically evaluated and shown to be effective in a dose range of 10 to 30 mg/day, when administered as the tablet formulation; however, doses higher than 10 or 15 mg/day were not more effective than 10 or 15 mg/day. Dosage increases should generally not be made before 2 weeks, the time needed to achieve steady-state.
Maintenance Treatment: Maintenance of efficacy in schizophrenia was demonstrated in a trial involving patients with schizophrenia who had been symptomatically stable on other antipsychotic medications for periods of 3 months or longer. These patients were discontinued from those medications and randomized to either Aplirex 15 mg/day or placebo, and observed for relapse. Patients should be periodically reassessed to determine the continued need for maintenance treatment.
- Adolescents:
The recommended target dose of Aplirex is 10 mg/day. Aripiprazole was studied in adolescent patients 13 to 17 years of age with schizophrenia at daily doses of 10 mg and 30 mg. The starting daily dose of the tablet formulation in these patients was 2 mg, which was 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/day dose was not shown to be more efficacious than the 10 mg/day dose. Aplirex can be administered without regard to meals. Patients should be periodically 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 Aplirex 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 I Disorder:
Acute Treatment of Manic and Mixed Episodes:
- Adults: The recommended starting dose in adults is 15 mg given once daily as monotherapy and 10 mg to 15 mg given once daily as adjunctive therapy with lithium or valproate. Aplirex can be given without regard to meals. The dose may be increased to 30 mg/day based on clinical response. The safety of doses above 30 mg/day has not been evaluated in clinical trials.