Aricog Aripiprazole Dosage/Direction for Use

Recommended Dosage: Schizophrenia: The recommended starting dose for Aripiprazole is 10 or 15 mg/day administered on a once-a-day schedule without regard to meals. The maintenance dose for Aripiprazole is 15 mg/day. Doses in the range of 10 to 30 mg/day have been established as effective in clinical trials.
Bipolar mania: The recommended starting and target dose for Aripiprazole is 15 mg given once a day, without regard to meals. The dose can be increased to 30 mg/day based on clinical response. Dose adjustments, if indicated, should occur at intervals of not less than 24 hours. Antimanic efficacy (3-12 weeks) was demonstrated in doses of 15 or 30 mg/day in clinical trials. The safety of doses above 30 mg/day has not been evaluated in clinical trials.
Special populations: Renal impairment: No dosage adjustment is required in patients with renal impairment.
Hepatic impairment: No dosage adjustment is required for patients with hepatic impairment (Child-Pugh Class A, B, or C).
Paediatric: The safety and efficacy of Aripiprazole in patients under 18 years of age have not been established.
Elderly: No dosage adjustment is required for patients ≥65 years of age. However, experience with this patient population is limited.
Gender: No dosage adjustment is required for female patients relative to male patients. Patients taking medications metabolized by CYP2D6 or 3A4.
Dosage adjustment for patients taking aripiprazole concomitantly with potent CYP3A4 or CYP2D6 inhibitors: When concomitant administration of a potent CYP3A4 or CYP2D6 inhibitor with aripiprazole occurs, the aripiprazole dose should be reduced to one-half of the usual dose. When the CYP3A4 or CYP2D6 inhibitor is withdrawn from the combination therapy, the aripiprazole dose should then be increased.
Dosage adjustment for patients taking potent CYP3A4 inducers: When a potent CYP3A4 inducer is added to aripiprazole therapy, the aripiprazole dose should be doubled. Additional dose increases of aripiprazole should be based on clinical evaluation. When the CYP3A4 inducer is withdrawn from the combination therapy, the aripiprazole dose should be reduced. Consideration should be given to reducing the daily dose in individual patients who are on multiple concomitant medications that inhibit CYP3A4 and CYP2D6 enzymes.
Smoking Status: No dosage adjustment is required for smoking patients relative to non-smoking patients.
Route of Administration: Oral.
Instructions for Use: Aripiprazole tablets to take orally without regard to meals.