Usual Adult Dose for Schizophrenia

Initial dose: 1.5 mg orally once a day
Titration regimen: The dose may be increased to 3 mg once a day on Day 2; further dose adjustments should be made in 1.5 to 3 mg increments based on efficacy and tolerability.
Maintenance dose: 1.5 to 6 mg orally once a day
Maximum dose: 6 mg/day

Comments:

• Due to the long half-life, changes in dose will not be fully reflected in plasma for several weeks; monitor for adverse reactions and treatment response several weeks after beginning therapy and after each dose adjustment.
• Doses above 6 mg once a day have not shown increased effectiveness sufficient to outweigh dose related adverse reactions.

Use: Treatment of schizophrenia

Usual Adult Dose for Bipolar Disorder

Initial dose: 1.5 mg orally once a day
Titration regimen: The dose should be increased to 3 mg once a day on Day 2; further dose adjustments should be made in 1.5 to 3 mg increments based on efficacy and tolerability.
Maintenance dose: 3 to 6 mg orally once a day
Maximum dose: 6 mg/day

Comments:

• Due to the long half-life, changes in dose will not be fully reflected in plasma for several weeks; monitor for adverse reactions and treatment response several weeks after beginning therapy and after each dose adjustment.
• Doses above 6 mg once a day have not shown increased effectiveness sufficient to outweigh dose related adverse reactions.

Use: Acute treatment of manic or mixed episodes associated with bipolar I disorder

Renal Dose Adjustments

Mild to moderate renal dysfunction (CrCl 30 mL/min or greater): No adjustment recommended.
Severe renal dysfunction (CrCl less than 30 mL/min): Not recommended.

Liver Dose Adjustments

Mild to moderate liver dysfunction (Child-Pugh score 5 to 9): No adjustment recommended.
Severe liver dysfunction (Child-Pugh score 10 to 15): Not recommended.

Dose Adjustments

Elderly: Cautious dose selection is recommended.

DOSE ADJUSTMENTS FOR CYP450 3A4 INHIBITORS:
Initiating a Strong CYP450 3A4 Inhibitor While on a Stable Dose of This Drug:

• Reduce the current dose of this drug by approximately one-half (e.g.,4.5 mg per day may be reduced to 1.5 or 3 mg per day; 1.5 mg per day may be reduced to 1.5 mg every other day).

Initiating This Drug While Receiving a Strong CYP450 3A4 Inhibitor:

• Initial dose:1.5 mg orally once a day on Days 1 and 3, with no dose given on Day 2; starting on Day 4, 1.5 mg orally once a day.
• Maximum dose: 3 mg/day

Withdrawing a Strong CYP450 3A4 Inhibitor While on This Drug:

• A dose increase of this drug may be necessary.

CYP450 3A4 INDUCERS: Concomitant use of this drug with CYP450 3A4 inducers has not been evaluated and is not recommended.

Upon discontinuation: Plasma concentrations of this drug and its active metabolites decline by 50% in approximately 1 week.

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.

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice: Take orally once a day with or without food

Storage requirements: Protect from light

General:

• It may take approximately 1 week after stopping this drug for plasma concentration to decline by 50%.
• Switching from this drug to other antipsychotics, or co-administration with other antipsychotics has not been studied.

Monitoring:

• Cardiovascular: Orthostatic vital signs in at-risk patients
• Hematologic: CBC frequently during the first few months in patients with preexisting low WBC and/or a prior history of drug-induced leukopenia or neutropenia.
• Metabolic: Monitor for increases in blood sugar, weight, and lipids

Patient advice:

• Counsel patients regarding the signs and symptoms of neuroleptic malignant syndrome (NMS), tardive dyskinesia, hyperglycemia, and diabetes mellitus; instruct patients to contact their physician immediately if signs or symptoms occur.
• This drug may impact mental alertness; have patient avoid driving or operating machinery until adverse effects are determined.
• Patients should be aware that there are a number of potential drug interactions with this drug and they should speak with a healthcare professional before starting any new medications including over the counter medications.
• Counsel patients to avoid becoming dehydrated or overheated, as well as the risk for orthostatic hypotension and syncope.
• Patients should be advised to notify their health care professional if they are pregnant or intend to become pregnant.

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