Usual Adult Dose for Schizophrenia

42 mg orally once a day

Use: For the treatment of schizophrenia

Usual Adult Dose for Bipolar Disorder

42 mg orally once a day

Use: As monotherapy or as adjunctive therapy with lithium or valproate, for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression)

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh Class A): No adjustment recommended
Moderate to severe liver dysfunction (Child-Pugh Class B to C): 21 mg orally once a day

Comments:

• Patients with moderate and severe liver dysfunction generally had higher exposure to this drug than those with normal liver function.

Dose Adjustments

Coadministration with CYP450 3A4 inducers: Not recommended

Coadministration with moderate CYP450 inhibitors: 21 mg orally once a day
Coadministration with strong CYP450 inhibitors: 10.5 mg orally once a day

Neutropenia:

• Patients with preexisting low WBC count or absolute neutrophil count (ANC) or history of drug-induced leukopenia or neutropenia:
• CBC should be performed frequently during the first few months of therapy.
• Discontinuation of this drug should be considered at the first sign of a clinically significant decrease in WBC count in the absence of other factors.
• Patients with clinically significant neutropenia:
• Patients should be monitored for fever or other signs/symptoms of infection and treated promptly if such signs/symptoms occur.
• This drug should be discontinued in patients with ANC less than 1000/mm3 and WBC levels should be followed until recovery.

Precautions

US BOXED WARNINGS:

• INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death; this drug is not approved for the treatment of patients with dementia-related psychosis.
• SUICIDAL THOUGHTS AND BEHAVIORS: Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies; all antidepressant-treated patients should be closely monitored for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and efficacy of this drug have not been established in pediatric patients.

• History of hypersensitivity to the active component or any of the ingredients

Dialysis

Data not available

Other Comments

Administration advice:

• Administer with or without food.
• Dose titration is not required.

• Cardiovascular: Orthostatic vital signs in patients vulnerable to hypotension, patients with known cardiovascular disease, and patients with cerebrovascular disease
• General: Weight (at baseline and frequently thereafter); for fever or other signs/symptoms of infection in patients with clinically significant neutropenia; fall risk assessments in at-risk patients (when starting therapy and periodically during long-term therapy)
• Hematologic: CBC in patients with preexisting low WBC count/ANC or history of drug-induced leukopenia/neutropenia (frequently during the first few months of therapy)
• Metabolic: Fasting plasma glucose (before or soon after starting therapy and periodically during long-term therapy); fasting lipid panel (at baseline and periodically during long-term therapy)
• Nervous System: For signs/symptoms of neuroleptic malignant syndrome and tardive dyskinesia
• Psychiatric: For clinical worsening and emergence of suicidal thoughts and behaviors in all antidepressant-treated patients (especially during initial few months of therapy and at times of dosage changes)

• Read the US FDA-approved patient labeling (Medication Guide).
• Look for emergence of suicidality, especially early during therapy; report such symptoms to health care provider.
• Contact health care provider or report to emergency room if signs/symptoms of neuroleptic malignant syndrome occur.
• Contact health care provider if signs/symptoms of tardive dyskinesia (e.g., abnormal movements) occur.
• This drug may cause somnolence; do not perform activities requiring mental alertness (e.g., driving a motor vehicle or operating hazardous machinery) until you are reasonably certain that this drug does not affect you adversely.
• Take appropriate care to avoid overheating and dehydration.
• Inform health care providers of any changes to current prescription or over-the-counter medications.
• Notify health care provider if you become pregnant or intend to become pregnant during therapy.
• Do not breastfeed during therapy.