Medically reviewed by Drugs.com. Last updated on Feb 18, 2022.
Applies to the following strengths: 42 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Schizophrenia
42 mg orally once a day
-Dose titration is not necessary.
-This drug should be taken with food.
Use: Treatment of schizophrenia
Usual Adult Dose for Bipolar Disorder
42 mg orally once a day
-Dose titration is not required.
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): Not recommended.
CYP450 3A4 Inducers: Use should be avoided
Moderate or Strong CYP450 Inhibitors: Use should be avoided
Patients with preexisting low WBC or absolute neutrophil counts (ANC) and a history of drug-induced leukopenia or neutropenia:
-Complete blood counts (CBC) should be performed frequently for the first few months of treatment
-Treatment discontinuation should be considered at the first sign of a clinically significant decrease in WBC (in the absence of other factors)
ANC less than 1000/mm3:
-Patients should be monitored for signs/symptoms of infection (e.g., fever); prompt treatment should be given in patients with any signs/symptoms of infection.
-Treatment should be discontinued and WBC levels should be followed until levels recover
US BOXED WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS:
-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; closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of this drug have not been established in pediatric patient
-History of hypersensitivity to the active component or to any of the ingredients
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-Take orally once a day with or without food
-Limitation of use: This drug should not be used to treat dementia-related psychosis.
-CARDIOVASCULAR: Orthostatic vital signs (especially initially) in patients at risk of orthostatic hypotension and syncope
-HEMATOLOGIC: Obtain CBC at baseline and frequently during the first few months in patients with preexisting low WBC and/or a prior history of drug-induced leukopenia or neutropenia
-METABOLIC: Obtain fasting plasma glucose and lipid panel at baseline and monitor periodically, especially during long-term therapy; monitor weight
-NEUROLOGIC: Monitor for signs and symptoms of neuroleptic malignant syndrome and tardive dyskinesia
-OTHER: Perform fall risk assessments initially and regularly thereafter in patients at risk of falling
-PSYCHIATRIC: Monitor for emergence of suicidality
-Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
-Inform patients that this drug may cause somnolence, and they should avoid driving or operating machinery if these side effects occur.
-Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.
-Advise patients that this drug may cause metabolic changes such as increases in blood sugar, body weight and lipids.
-Patients should avoid overheating and dehydration.
-Patients should speak with their healthcare provider if they are taking or plan to take any new prescription or over the counter medications because there is a potential for drug interactions; patients should be advised to avoid alcohol as it may make some side effects worse.
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- During pregnancy
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- Drug class: atypical antipsychotics
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