Opipza Dosage

Generic name: ARIPIPRAZOLE 2mg
Dosage form: film, soluble
Drug class: Atypical antipsychotics

Medically reviewed by Drugs.com. Last updated on Jan 30, 2025.

Schizophrenia in Patients 13 Years and Older

Adults

The recommended starting and target dosage of OPIPZA for the treatment of schizophrenia in adults is 10 mg or 15 mg once daily. Aripiprazole has been systematically evaluated and shown to be effective in a dose range of 10 mg to 30 mg per day; however, doses higher than 10 mg or 15 mg per day were not more effective than 10 mg or 15 mg per day. Dosage increases should generally not be made before 2 weeks, the time needed to achieve steady-state.

Pediatric Patients Ages 13 Years and Older

The recommended starting dosage of OPIPZA for the treatment of schizophrenia in pediatric patients 13 years and older is 2 mg once daily. The recommended target dosage of OPIPZA is 10 mg once daily. Aripiprazole was studied in pediatric patients 13 to 17 years of age with schizophrenia at daily dosages of 10 mg and 30 mg. The starting daily dosage 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 per day dosage was not shown to be more efficacious than the 10 mg per day dosage.

Adjunctive Treatment of Major Depressive Disorder in Adults

The recommended starting dosage for OPIPZA as adjunctive treatment of MDD in adults already taking an antidepressant is 2 mg to 5 mg once daily. The recommended dosage range is 2 mg to 15 mg once daily. Dosage adjustments of up to 5 mg per day should occur gradually, at intervals of no less than one week. Patients should be periodically reassessed to determine the continued need for maintenance treatment.

Irritability Associated with Autistic Disorder in Pediatric Patients 6 years and Older

The recommended dosage range for the treatment of pediatric patients 6 to 17 years with irritability associated with autistic disorder is 5 mg to 15 mg once daily.

Dosing should be initiated at 2 mg once daily. The dose should be increased to 5 mg per day, with subsequent increases to 10 mg or 15 mg per day if needed. Dose adjustments of up to 5 mg per day should occur gradually, at intervals of no less than one week. Patients should be periodically reassessed to determine the continued need for maintenance treatment.

Tourette's Disorder in Pediatric Patients 6 years and Older

The recommended dosage range for treatment of Tourette's disorder in pediatric patients 6 years and older is 5 mg to 20 mg once daily.

For patients weighing less than 50 kg, dosage should be initiated at 2 mg once daily with a target dosage of 5 mg once daily after 2 days. The dosage can be increased to 10 mg once daily in patients who do not achieve optimal control of tics. Dosage adjustments should occur gradually at intervals of no less than one week.

For patients weighing 50 kg or more, dosing should be initiated at 2 mg once daily for 2 days, and then increased to 5 mg once daily for 5 days, with a target dosage of 10 mg once daily on Day 8. The dosage can be increased up to 20 mg once daily for patients who do not achieve optimal control of tics. Dosage adjustments should occur gradually in increments of 5 mg per day at intervals of no less than one week.

Patients should be periodically reassessed to determine the continued need for maintenance treatment.

Important Administration Information

Instruct patients and/or caregivers to read the "Instruction for Use" carefully for complete directions on how to properly dose and administer OPIPZA.

Administer OPIPZA orally with or without food.

Apply OPIPZA on top of the tongue where it dissolves in saliva and can be swallowed in a normal manner without the need for water or other liquids.

The patient should refrain from chewing the film and should not swallow an undissolved film. Do not cut or split OPIPZA.

Administer only one oral film at a time. If an additional film is needed to complete the dosage, administer after the previous film has completely dissolved.

Dosage Recommendations and Modifications for Cytochrome P450 Considerations

Dosage recommendations and modifications for patients who are known CYP2D6 poor metabolizers and/or in patients taking concomitant CYP3A4 inhibitors, CYP2D6 inhibitors, or strong CYP3A4 inducers are described in Table 1.

When the coadministered drug is withdrawn from the combination therapy, Aripiprazole Oral Film dosage should be adjusted to its previous dose. When the coadministered CYP3A4 inducer is withdrawn, Aripiprazole Oral Film dosage should be reduced to the previous dose over 1 to 2 weeks. Patients 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 recommended dose initially and then adjusted to achieve clinical response.

Table 1: Dosage Recommendations and Modifications for OPIPZA in Patients Who are Known CYP2D6 Poor Metabolizers and in Patients Taking Concomitant CYP2D6 Inhibitors and/or 3A4 Inhibitors, CYP3A4 Inducers
Patient Population	Dosage Recommendations and Modifications for OPIPZA
CYP2D6 Poor Metabolizers
Known CYP2D6 Poor Metabolizers	Administer half of the recommended dose
Known CYP2D6 Poor Metabolizers taking concomitant strong CYP3A4 inhibitors	Administer a quarter of the recommended dose
Patients Taking OPIPZA with CYP2D6 Inhibitors and/or CYP3A4 Inhibitors, CYP3A4 Inducers
Concomitant use of OPIPZA with strong CYP2D6 or CYP3A4 inhibitors	Administer half of the recommended dose
Concomitant use of OPIPZA with strong CYP2D6 and CYP3A4 inhibitors	Administer a quarter of the recommended dose
Concomitant use of OPIPZA with strong CYP3A4 inducers	Double the recommended dose over 1 to 2 weeks

When adjunctive OPIPZA is administered to patients with major depressive disorder, OPIPZA should be administered without dosage adjustment as specified in Dosage and Administration (2.2).