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Product Info

Product Name

Apizole Tab.

Composition

Per tablet,

Aripiprazole 5mg/10mg/15mg

Indications

Schizophrenia

Dosage

Adult
The recommended starting and target dose for Apizole Tab. is 10 or 15 mg/day administered on a once- day schedule without regard to meals. Apizole 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 3months or longer. These patients were discontinued from those medications and randomized to either Apizole 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 Apizole is 10 mg/day. Arpiprazole 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 increase 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. Apizole can be administered without regard to meas. 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 Apizole 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.

Package

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