Ripizol Dosage/Direction for Use

Schizophrenia: Adults: The recommended starting and target dose for ARIPIPRAZOLE is 10 mg/day or 15 mg/day administered on a once a-day schedule without regard to meals. ARIPIPRAZOLE has been systematically evaluated and shown to be effective in a dose range of 10 mg/day to 30 mg/day, when administered as the tablet formulation; however, doses higher than 10 mg/day or 15 mg/day were not more effective than 10 mg/day 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 a trial involving patients with schizophrenia who had been symptomatically stable on other antipsychotic medications for periods of 3 months or longer.
Adolescents: The recommended target dose of ARIPIPRAZOLE 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. ARIPIPRAZOLE can be administered without regard to meals.
Maintenance Treatment: The efficacy of ARIPIPRAZOLE for the maintenance treatment of schizophrenia in the adolescent population has not been evaluated. While there is no body of evidence available to answer the question of how long the adolescent patient treated with ARIPIPRAZOLE should be maintained on the drug, maintenance efficacy can be extrapolated from adult data along with comparisons of ARIPIPRAZOLE pharmacokinetic parameters in adult and pediatric patients. Thus, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. 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 ARIPIPRAZOLE 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 to 15 mg given once daily as adjunctive therapy with lithium or valproate. ARIPIPRAZOLE can be given without regard to meals. The recommended target dose of ARIPIPRAZOLE is 15 mg/day as monotherapy or as adjunctive therapy with lithium or valproate. The dose may be increase increased to 30 mg/day based on clinical response. The safety of doses above 30 mg/day has not been evaluated.
Pediatrics: The recommended starting dose in pediatric patients (10 to 17 years) as monotherapy is 2 mg/day, with titration to 5 mg/day after 2 days, and a target dose of 10 mg/day after 2 additional days. Recommended dosing as adjunctive therapy to lithium or valproate is the same. Subsequent dose increases, if needed, should be administered in 5 mg/day increments. ARIPIPRAZOLE can be given without regard to meals.
Maintenance Treatment: The recommended dose for maintenance treatment, whether as monotherapy or as adjunctive therapy, is the same dose needed to stabilized patients during acute treatment, both for adults and pediatric patients. Patients should be periodically reassessed to determine the continued need for maintenance treatment.
Adjunctive Treatment of Major Depressive Disorder: Adults: The recommended starting dose for ARIPIPRAZOLE as adjunctive treatment for patients already taking an antidepressant is 2 to 5 mg/day. The recommended dosage range of 2 to 15 mg/day. Dose adjustments of up to 5 mg/day should occur gradually, at intervals of no less than 1 week.
Maintenance Treatment: The efficacy of ARIPIPRAZOLE for adjunctive maintenance treatment of major depressive disorder has not been evaluated.
Irritability Associated with Autistic Disorder: The recommended dosage range for the treatment of pediatric patients with irritability associated with autistic disorder is 5 to 15 mg/day.
Dosing should be initiated at 2 mg/day. The dose should be increased to 5 mg/day, with subsequent increases to 10 or 15 mg/day if needed. Dose adjustments of up to 5 mg/day should occur gradually, at intervals of no less than 1 week.
Maintenance Treatment: The efficacy of ARIPIPRAZOLE for the maintenance treatment of irritability associated with autistic disorder has not been evaluated.
Tourette's Disorder: Pediatric Patients (6 to 18 years): The recommended dosage range for Tourette's Disorder is 5 to 20 mg/day.
For patients weighing less than 50 kg, dosing should be initiated at 2 mg/day with a target dose of 5 mg/day after 2 days. The dose can be increased to 10 mg/day in patients who do not achieve optimal control of tics. Dosage adjustments should occur gradually at intervals of no less than 1 week.
For patients weighing 50 kg or more, dosing should be initiated at 2 mg/day for 2 days, and then increased to 5 mg/day for 5 days, with a target dose of 10 mg/day on day 8. The dose can be increased up to 20 mg/day for patients who do not achieve optimal control of tics. Dosage adjustment should occur gradually in increments of 5 mg/day at intervals of no less than 1 week.
Patients should be periodically reassessed to determine the continued need for maintenance treatment.
Dosage Adjustments for Cytochrome P450 Considerations: Dosage adjustments are recommended in patients who are known CYP2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors or strong CYP3A4 inducers. When the CYP3A4 and/or CYP2D6 inhibitor is withdrawn from the combination therapy, ARIPIPRAZOLE dosage should be increased. When the CYP3A4 inducer is withdrawn from the combination therapy, ARIPIPRAZOLE dosage should be reduced to 10 mg to 15 mg. Patients who may be receiving a combination of strong, moderate and a weak inhibitors of CYP3A4 and CYP2D6 (e.g., a strong CYP3A4 inhibitor with a moderate CYP2D6 inhibitor or a moderate CYP3A4 inhibitor with a moderate CYP2D6 inhibitor), the dosing maybe reduced to one-quarter (25%) of the usual dose initially and then adjusted to achieve a favorable clinical response. (See Table 2.)


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When adjunctive ARIPIPRAZOLE is administered to patients with major depressive disorder, ARIPIPRAZOLE should be administered without dosage adjustment as specified previously.