Usual Adult Dose for Schizophrenia

TREATMENT:
Immediate-Release (IR) Tablets:

• Day 1: 25 mg orally 2 times a day
• Days 2 and 3: Increase in 25 to 50 mg increments, given in divided doses 2 or 3 times daily
• Day 4: 300 to 400 mg orally per day, given in divided doses
• Titration regimen: Further dose adjustments should be made in 25 to 50 mg increments twice a day in intervals of not less than 2 days
• Maintenance dose: 150 to 750 mg orally per day in divided doses
• Maximum dose: 750 mg/day

Extended-Release (XR) Tablets:

• Day 1: 300 mg orally once a day
• Titration regimen: Increase in increments of up to 300 mg/day at intervals as frequently as 1 day
• Maintenance dose: 400 to 800 mg orally once a day
• Maximum dose: 800 mg/day

MAINTENANCE MONOTHERAPY:

• Maintenance dose: 400 to 800 mg orally once a day
• Maximum dose: 800 mg/day

Comments:

• After initial dose titration, adjustments can be made upwards or downwards depending on clinical response and tolerability.
• When restarting this drug in patients who have been off therapy for more than 1 week, the initial dosing schedule should be followed; for patients who have been off this drug for less than 1 week, the maintenance dose may be reinitiated.
• Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
• Efficacy for the treatment of schizophrenia was established in 6-week trials; the effectiveness of this drug on maintenance treatment has not been systematically evaluated.

Use: Treatment of schizophrenia

Usual Adult Dose for Bipolar Disorder

BIPOLAR MANIA TREATMENT:
IR Tablets:

• Day 1: 50 mg orally 2 times a day
• Day 2: 100 mg orally 2 times a day
• Day 3: 150 mg orally 2 times a day
• Day 4: 200 mg orally 2 times a day
• Titration regimen: Further dose adjustments should be in increments of no greater than 200 mg/day
• Maintenance dose: 400 to 800 mg per day in divided doses
• Maximum dose: 800 mg/day

BIPOLAR I DISORDER MANIC/MIXED TREATMENT:
XR Tablets:

• Day 1: 300 mg orally once a day
• Day 2: 600 mg orally once a day
• Day 3: 400 to 800 mg orally once a day
• Maintenance dose: 400 to 800 mg orally once a day
• Maximum dose: 800 mg/day

BIPOLAR DEPRESSION TREATMENT:
IR Tablets:

• Day 1: 50 mg orally once a day at bedtime
• Day 2: 100 mg orally once a day at bedtime
• Day 3: 200 mg orally once a day at bedtime
• Day 4: 300 mg orally once a day at bedtime
• Maintenance dose: 300 mg orally once a day at bedtime
• Maximum dose: 300 mg/day

TREATMENT OF DEPRESSIVE EPISODES IN BIPOLAR DISORDER:

• XR Tablets:
• Day 1: 50 mg orally once a day
• Day 2: 100 mg orally once a day
• Day 3: 200 mg orally once a day
• Day 4: 300 mg orally once a day
• Maintenance dose: 300 mg orally once a day
• Maximum dose: 300 mg/day

BIPOLAR I DISORDER MAINTENANCE:
IR Tablets:

• Maintenance dose: 200 to 400 mg orally 2 times a day
• Maximum dose: 800 mg/day

XR Tablets:

• Maintenance dose: 400 to 800 mg orally once a day
• Maximum dose: 800 mg/day

Comments:

• After initial dose titration, adjustments can be made upwards or downwards depending on clinical response and tolerability.
• Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
• When restarting this drug in patients who have been off therapy for more than 1 week, the initial dosing schedule should be followed; for patients who have been off this drug for less than 1 week, the maintenance dose may be reinitiated.
• Monotherapy treatment efficacy for acute depressive symptoms was established in 8-week trials in patients with bipolar I and II disorder, and efficacy in acute manic episodes was established in 12-week episodes in patients with bipolar I disorder.
• Adjunctive treatment efficacy was established in a 3-week trial in patients with bipolar I disorder.
• Efficacy as an adjunctive treatment was established in maintenance trials; the effectiveness of as monotherapy for the maintenance treatment has not been established.

Uses:

• As monotherapy and as an adjunct to lithium or divalproex for the acute treatment of manic or mixed episodes associated with bipolar I disorder
• As monotherapy for the acute treatment of depressive episodes associated with bipolar disorder
• As an adjunct to lithium or divalproex for the maintenance treatment of bipolar 1 disorder

Usual Adult Dose for Depression

XR Tablets:

• Day 1: 50 mg orally once a day
• Day 2: 50 mg orally once a day
• Day 3: 150 mg orally once a day
• Maintenance dose: 150 mg to 300 mg orally once a day
• Maximum dose: 300 mg/day

Comments:

• After initial dose titration, adjustments can be made upwards or downwards depending on clinical response and tolerability.
• When restarting this drug in patients who have been off therapy for more than 1 week, the initial dosing schedule should be followed; for patients who have been off this drug for less than 1 week, the maintenance dose may be reinitiated.
• Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
• Efficacy was established in 6-week trials using patients with major depressive disorder (MDD) with a history of inadequate response to antidepressant treatment.

Use: As adjunctive therapy to antidepressants for the treatment of MDD

Usual Geriatric Dose for Schizophrenia

TREATMENT:
IR Tablets:

• Day 1: 25 mg orally 2 times a day
• Days 2 and 3: Increase in 25 to 50 mg increments, given in divided doses 2 or 3 times daily
• Day 4: 300 to 400 mg orally per day, given in divided doses
• Titration regimen: Further dose adjustments should be made in 25 to 50 mg increments twice a day in intervals of not less than 2 days
• Maintenance dose: 150 to 750 mg orally per day in divided doses
• Maximum dose: 750 mg/day

XR Tablets:

• Day 1: 50 mg orally once a day
• Titration regimen: Increase in increments of up to 50 mg/day at intervals as frequently as 1 day, depending on patient response.
• Maintenance dose: 400 to 800 mg orally once a day
• Maximum dose: 800 mg/day

MAINTENANCE MONOTHERAPY:

• Maintenance dose: 400 to 800 mg orally once a day
• Maximum dose: 800 mg/day

Comments:

• After initial dose titration, adjustments can be made upwards or downwards depending on clinical response and tolerability.
• When restarting this drug in patients who have been off therapy for more than 1 week, the initial dosing schedule should be followed; for patients who have been off this drug for less than 1 week, the maintenance dose may be reinitiated.
• Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
• Efficacy for the treatment of schizophrenia was established in 6-week trials; the effectiveness of this drug on maintenance treatment has not been systematically evaluated.

Use: Treatment of schizophrenia

Usual Geriatric Dose for Bipolar Disorder

BIPOLAR MANIA TREATMENT:
IR Tablets:

• Day 1: 50 mg orally once a day
• Day 2: 100 mg orally 2 times a day
• Day 3: 150 mg orally 2 times a day
• Day 4: 200 mg orally 2 times a day
• Titration regimen: Further dose adjustments should be in increments of no greater than 50 mg/day
• Maintenance dose: 400 to 800 mg per day in divided doses
• Maximum dose: 800 mg/day

BIPOLAR I DISORDER MANIC/MIXED TREATMENT:
XR Tablets:

• Day 1: 50 mg orally once a day
• Day 2: 100 mg orally once a day
• Day 3: 150 to 200 mg orally once a day
• Maintenance dose: 400 to 800 mg orally once a day
• Maximum dose: 800 mg/day

BIPOLAR DEPRESSION TREATMENT:
IR Tablets:

• Day 1: 50 mg orally once a day at bedtime
• Day 2: 100 mg orally once a day at bedtime
• Day 3: 150 mg orally once a day at bedtime
• Day 4: 200 mg orally once a day at bedtime
• Maintenance dose: 300 mg orally once a day at bedtime
• Maximum dose: 300 mg/day

TREATMENT OF DEPRESSIVE EPISODES IN BIPOLAR DISORDER:

• XR Tablets:
• Day 1: 50 mg orally once a day
• Day 2: 100 mg orally once a day
• Day 3: 200 mg orally once a day
• Day 4: 300 mg orally once a day
• Maintenance dose: 300 mg orally once a day
• Maximum dose: 300 mg/day

BIPOLAR I DISORDER MAINTENANCE:
IR Tablets:

• Maintenance dose: 200 to 400 mg orally 2 times a day
• Maximum dose: 800 mg/day

XR Tablets:

• Maintenance dose: 400 to 800 mg orally once a day
• Maximum dose: 800 mg/day

Comments:

• After initial dose titration, adjustments can be made upwards or downwards depending on clinical response and tolerability.
• Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
• When restarting this drug in patients who have been off therapy for more than 1 week, the initial dosing schedule should be followed; for patients who have been off this drug for less than 1 week, the maintenance dose may be reinitiated.
• Monotherapy treatment efficacy for acute depressive symptoms was established in 8-week trials in patients with bipolar I and II disorder, and efficacy in acute manic episodes was established in 12-week episodes in patients with bipolar I disorder.
• Adjunctive treatment efficacy was established in a 3-week trial in patients with bipolar I disorder.
• Efficacy as an adjunctive treatment was established in maintenance trials; the effectiveness of as monotherapy for the maintenance treatment has not been established.

Uses:

• As monotherapy and as an adjunct to lithium or divalproex for the acute treatment of manic or mixed episodes associated with bipolar I disorder
• As monotherapy for the acute treatment of depressive episodes associated with bipolar disorder
• As an adjunct to lithium or divalproex for the maintenance treatment of bipolar 1 disorder

Usual Geriatric Dose for Depression

XR Tablets:

• Day 1: 50 mg orally once a day
• Day 2: 50 mg orally once a day
• Day 3: 100 mg orally once a day
• Day 4: 150 mg orally once a day
• Maintenance dose: 150 mg to 300 mg orally once a day
• Maximum dose: 300 mg/day

Comments:

• After initial dose titration, adjustments can be made upwards or downwards depending on clinical response and tolerability.
• When restarting this drug in patients who have been off therapy for more than 1 week, the initial dosing schedule should be followed; for patients who have been off this drug for less than 1 week, the maintenance dose may be reinitiated.
• Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
• Efficacy was established in 6-week trials using patients with MDD with a history of inadequate response to antidepressant treatment.

Use: As adjunctive therapy to antidepressants for the treatment of MDD

Usual Pediatric Dose for Schizophrenia

SPECIAL CONSIDERATIONS IN TREATING PEDIATRIC PATIENTS WITH SCHIZOPHRENIA:

• Prior to initiating medication therapy, a thorough diagnostic evaluation carefully considering the risks associated with medication treatment should be performed.
• Medication treatment should be a part of a total treatment program that often includes psychological, educational, and social interventions.

13 to 17 years:
TREATMENT:
IR Tablets:

• Day 1: 25 mg orally 2 times a day
• Day 2: 50 mg orally 2 times a day
• Day 3: 100 mg orally 2 times a day
• Day 4: 150 mg orally 2 times a day
• Day 5: 200 mg orally 2 times a day
• After Day 5: Further dose adjustments should be in increments no greater than 100 mg/day
• Maintenance dose: 400 to 800 mg/per day in 2 or 3 divided doses
• Maximum dose: 800 mg/day

XR Tablets:

• Day 1: 50 mg orally once a day
• Day 2: 100 mg orally once a day
• Day 3: 200 mg orally once a day
• Day 4: 300 mg orally once a day
• Day 5: 400 mg orally once a day
• Maintenance dose: 400 to 800 mg once a day
• Maximum dose: 800 mg/day

Comments:

• After initial dose titration, adjustments can be made upwards or downwards depending on clinical response and tolerability.
• When restarting this drug in patients who have been off therapy for more than 1 week, the initial dosing schedule should be followed; for patients who have been off this drug for less than 1 week, the maintenance dose may be reinitiated.
• Efficacy was established in a 6-week trial using patients 13 to 17 years of age.

Use: Treatment of schizophrenia

Usual Pediatric Dose for Bipolar Disorder

SPECIAL CONSIDERATIONS IN TREATING PEDIATRIC PATIENTS WITH BIPOLAR 1 DISORDER:

• Prior to initiating medication therapy, a thorough diagnostic evaluation carefully considering the risks associated with medication treatment should be performed.
• Medication treatment should be a part of a total treatment program that often includes psychological, educational, and social interventions.

10 to 17 years:
BIPOLAR MANIA TREATMENT:
IR Tablets:

• Day 1: 25 mg orally 2 times a day
• Day 2: 50 mg orally 2 times a day
• Day 3: 100 mg orally 2 times a day
• Day 4: 150 mg orally 2 times a day
• Day 5: 200 mg orally 2 times a day
• After Day 5: Further dose adjustments in may be made in increments of no greater than 100 mg/day.
• Maintenance dose: 400 to 600 mg per day in 2 or 3 divided doses
• Maximum dose: 600 mg/day

BIPOLAR I DISORDER MANIC/MIXED TREATMENT:
XR Tablets:

• Day 1: 50 orally once a day
• Day 2: 100 mg orally once a day
• Day 3: 200 mg orally once a day
• Day 4: 300 mg orally once a day
• Day 5: 400 mg orally once a day
• Maintenance dose: 400 to 600 mg orally once a day
• Maximum dose: 600 mg/day

Comments:

• After initial dose titration, adjustments can be made upwards or downwards depending on clinical response and tolerability.
• Safety and efficacy have been demonstrated in the treatment of bipolar mania in children and adolescents ages 10 to 17 years; safety and efficacy have not been established in patients with bipolar depression or for maintenance treatment of bipolar disorder.

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

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

IR Tablets:

• Initial dose: 25 mg orally once a day
• Dose titration: Dose adjustments should be in increments no greater than 25 to 50 mg/day.

XR Tablets:

• Initial dose: 50 mg orally once a day
• Dose titration: Dose adjustments should be in increments no greater than 50 mg/day.

Dose Adjustments

Specific patient populations: Consider slower dose titration and lower target doses in elderly patients, debilitated patients, and/or those patients who have a predisposition to hypotensive reactions.

Switching from Other Antipsychotics:

• Although not systematically studied, it is recommended the period of overlapping antipsychotic administration should be minimized.
• When switching from depot antipsychotics, consider initiating quetiapine therapy in place of the next scheduled injection.

IR to XR Tablets:

• Patients may be switched from IR tablets to the equivalent total daily dose of XR tablets (given once a day).
• Individual dosage adjustments may be necessary.

Concomitant Use with Potent CYP450 3A4 Inducers:

• The dose of this drug should be increased up to 5-fold of the original dose when patients are concurrently receiving chronic treatment (greater than 7 to 14 days) with a potent CYP450 3A4 inducer; the dose should be titrated based on clinical response and tolerability.
• When CYP450 3A4 inducer is discontinued, the dose of this drug should be reduced to the original level within 7 to 14 days.

Concomitant Use with Potent CYP450 3A4 Inhibitors:

• The dose of this drug should be reduced to one-sixth of original dose.
• When CYP450 3A4 inhibitor is discontinued, the dose of this drug should be increased by 6-fold.

Re-initiation of Therapy:

• Therapy re-initiation has not been systematically studied.
• Patients who have been off therapy for more than 1 week: The initial dosing schedule should be followed.
• Patients who have been off this drug for less than 1 week: Gradual dose titration may not be needed, and the maintenance dose may be reinitiated.

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 BEHAVIOR:

• Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies.
• These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older.
• In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors.
• Advise families and caregivers of the need for close observation and communication with the prescriber.
• This drug is not approved for use in pediatric patients under ten years of age.

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients

Safety and efficacy for the treatment of schizophrenia have not been established in patients younger than 13 years; safety and efficacy in the maintenance treatment of schizophrenia has not been established in patients less than 18 years.

Safety and efficacy for the treatment of bipolar mania have not been established in patients younger than 10 years; safety and effectiveness in patients with bipolar depression or for the maintenance treatment of bipolar disorder has not been established in patients less than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
Immediate-release tablets:

• Take orally with or without food

Extended-release tablets:

• Swallow whole; do not split, chew, or crush.
• Take orally without food or with a light meal (approximately 300 calories).
• Take once a day, preferably in the evening.

Storage requirements:

• IR Suspension: Refrigerate; protect from light.

General:

• Patients should be periodically reassessed to determine continued need for treatment.
• Pediatric schizophrenia and bipolar I disorder present diagnostic challenges due to variable symptom profiles and variable patterns of periodicity of manic or mixed symptoms. Therefore, a thorough diagnostic evaluation should be performed, and medication treatment should only be used as part of a total treatment program.
• Patients who require chronic therapy should be maintained on the smallest dose that produces a satisfactory response.
• Patients with depression may experience worsening of their depressive symptoms and/or emergence of suicidal ideation and behavior; improvement may not occur during the first few weeks or more of treatment.
• Health care providers should periodically re-evaluate the long-term risks and benefits for the individual patient.

Monitoring:

• CARDIOVASCULAR: Blood pressure in children and adolescents at baseline and periodically during treatment
• ENDOCRINE: TSH and free T4 at baseline and periodically, if clinically indicated
• 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; patients with neutropenia should be carefully monitored for fever or other symptoms or signs of infection.
• METABOLIC: Blood glucose levels at baseline and periodically thereafter; changes in weight and lipids
• OCULAR: Slit lamp examinations or other sensitive methods to detect cataract formation at initiation and at 6-month intervals during chronic treatment.
• PSYCHIATRIC: Signs/symptoms of clinical worsening, suicidality, and unusual changes in behavior

Patient advice:

• Patients, families, and caregivers should be educated on the risks of suicidal thoughts and behaviors, as well as the risk of mania and hypomania; what to watch for and when to seek medical advice.
• This drug may impair judgment, thinking, or motor skills; have patients avoid driving or operating machinery until adverse effects are determined.
• Advise patients to speak to physician or health care professional if 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.
• Patients should be told to report signs/symptoms of drug reaction with eosinophilia and systemic symptoms (DRESS).

Frequently asked questions

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