Aripiprazole

Hepatic and Renal Impairment No dosage adjustment for aripiprazole is required on the basis of a patient’s hepatic function (mild to severe hepatic impairment, Child-Pugh score between 5 and 15), or renal function (mild to severe renal impairment, glomerular filtration rate between 15 and 90 mL/minute) [see Clinical Pharmacology].

Hepatic and Renal Impairment No dosage adjustment for aripiprazole is required on the basis of a patient’s hepatic function (mild to severe hepatic impairment, Child-Pugh score between 5 and 15), or renal function (mild to severe renal impairment, glomerular filtration rate between 15 and 90 mL/minute) [see Clinical Pharmacology].

2 DOSAGE AND ADMINISTRATION [See table below.] Oral formulations: Administer once daily without regard to meals Known CYP2D6 poor metabolizers: Half of the usual dose 2.1 Schizophrenia Adults The recommended starting and target dose for aripiprazole oral solution is 10 or 15 mg/day administered on a once-a-day schedule without regard to meals.

Patients should be periodically reassessed to determine the continued need for maintenance treatment. Adolescents The recommended target dose of aripiprazole oral solution 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 oral solution can be administered without regard to meals [see Clinical Studies] . Patients should be periodically reassessed to determine the need for maintenance treatment.

Aripiprazole oral solution can be given without regard to meals. The recommended target dose of aripiprazole oral solution is 15 mg/day, as monotherapy or as adjunctive therapy with lithium or valproate. 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.

Aripiprazole oral solution can be given without regard to meals [see Clinical Studies ] . 2.3 Adjunctive Treatment of Major Depressive Disorder Adults The recommended starting dose for aripiprazole oral solution as adjunctive treatment for patients already taking an antidepressant is 2 to 5 mg/day. The recommended dosage range is 2 to 15 mg/day.

When the coadministered drug is withdrawn from the combination therapy, aripiprazole oral solution dosage should then be adjusted to its original level. When the coadministered CYP3A4 inducer is withdrawn, aripiprazole oral solution dosage should be reduced to the original level over 1 to 2 weeks. Patients who may be receiving a combination of strong, moderate, and weak inhibitors of CYP3A4 and CYP2D6 (e.g., a strong CYP3A4 inhibitor and a moderate CYP2D6 inhibitor or a moderate CYP3A4 inhibitor with a moderate CYP2D6 inhibitor), the dosing may be reduced to one-quarter (25%) of the usual dose initially and then adjusted to achieve a favorable clinical response. [See table below.] When adjunctive aripiprazole oral solution is administered to patients with major depressive disorder, aripiprazole oral solution should be administered without dosage adjustment as specified in Dosage and Administration. 2.8 Dosing of Oral Solution The oral solution can be substituted for tablets on a mg-per-mg basis up to the 25 mg dose level.

Patients receiving 30 mg tablets should receive 25 mg of the solution [see Clinical Pharmacology ] . 2.1 Schizophrenia Adults The recommended starting and target dose for aripiprazole oral solution is 10 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 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.

These patients were discontinued from those medications and randomized to either aripiprazole 15 mg/day or placebo, and observed for relapse [see Clinical Studies] . Patients should be periodically reassessed to determine the continued need for maintenance treatment. Adolescents The recommended target dose of aripiprazole oral solution is 10 mg/day.

The 30 mg/day dose was not shown to be more efficacious than the 10 mg/day dose. Aripiprazole oral solution can be administered without regard to meals [see Clinical Studies] . 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. Adults The recommended starting and target dose for aripiprazole oral solution is 10 or 15 mg/day administered on a once-a-day schedule without regard to meals.

Patients should be periodically reassessed to determine the continued need for maintenance treatment. Adolescents The recommended target dose of aripiprazole oral solution 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 oral solution can be administered without regard to meals [see Clinical Studies] . Patients should be periodically reassessed to determine the need for maintenance treatment.

Aripiprazole oral solution can be given without regard to meals. The recommended target dose of aripiprazole oral solution is 15 mg/day, as monotherapy or as adjunctive therapy with lithium or valproate. 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.

Aripiprazole oral solution can be given without regard to meals [see Clinical Studies ] . 2.3 Adjunctive Treatment of Major Depressive Disorder Adults The recommended starting dose for aripiprazole oral solution as adjunctive treatment for patients already taking an antidepressant is 2 to 5 mg/day. The recommended dosage range is 2 to 15 mg/day.

Dosage adjustments of up to 5 mg/day should occur gradually, at intervals of no less than 1 week [see Clinical Studies ] . Patients should be periodically reassessed to determine the continued need for maintenance treatment. Adults The recommended starting dose for aripiprazole oral solution as adjunctive treatment for patients already taking an antidepressant is 2 to 5 mg/day.

When the coadministered drug is withdrawn from the combination therapy, aripiprazole oral solution dosage should then be adjusted to its original level. When the coadministered CYP3A4 inducer is withdrawn, aripiprazole oral solution dosage should be reduced to the original level over 1 to 2 weeks. Patients who may be receiving a combination of strong, moderate, and weak inhibitors of CYP3A4 and CYP2D6 (e.g., a strong CYP3A4 inhibitor and a moderate CYP2D6 inhibitor or a moderate CYP3A4 inhibitor with a moderate CYP2D6 inhibitor), the dosing may be reduced to one-quarter (25%) of the usual dose initially and then adjusted to achieve a favorable clinical response. [See table below.] When adjunctive aripiprazole oral solution is administered to patients with major depressive disorder, aripiprazole oral solution should be administered without dosage adjustment as specified in Dosage and Administration. 2.8 Dosing of Oral Solution The oral solution can be substituted for tablets on a mg-per-mg basis up to the 25 mg dose level.

Patients receiving 30 mg tablets should receive 25 mg of the solution [see Clinical Pharmacology ] .