Usual Adult Dose for Schizophrenia

Initial dose: 5 mg sublingually 2 times a day
Maintenance dose: 5 mg sublingually 2 times a day, if tolerated may increase to 10 mg sublingually 2 times a day after 1 week if necessary
Maximum dose: 20 mg/day

Comments:

• Controlled trials revealed no added benefit with the higher dose, but a clear increase in certain adverse reactions.
• The safety of doses above 20 mg/day has not been evaluated in clinical studies.

Usual Adult Dose for Bipolar Disorder

Monotherapy:

• Initial dose: 10 mg sublingually 2 times a day
• Maintenance dose: 5 to 10 mg sublingually 2 times a day
• Maximum dose: 20 mg/day

• Initial dose: 5 mg sublingually 2 times a day
• Maintenance dose: 5 to 10 mg sublingually 2 times a day
• Maximum dose: 20 mg/day

• The safety of doses above 20 mg/day has not been evaluated in clinical studies.
• In controlled trials, the starting dose in monotherapy was 10 mg twice daily. On the second and subsequent days, the dose could be lowered to 5 mg twice daily, though approximately 90% of patients remained on the initial dose.
• The dose should be titrated based on clinical response and tolerability.
• There is no available evidence to answer the question of how long the patient should remain on therapy; however, it is generally recommended that responding patients be continued beyond the acute response.

• Acute monotherapy of manic or mixed episodes of bipolar I disorder
• Adjunctive treatment to lithium or valproate in bipolar I disorder
• Maintenance monotherapy treatment of bipolar I disorder

Usual Pediatric Dose for Bipolar Disorder

10 years and older

• Initial dose: 2.5 mg sublingually 2 times a day
• Titration regimen: After 3 days, may increase to 5 mg sublingually 2 times a day, and after an additional 3 days to 10 mg sublingually 2 times a day, as needed and as tolerated
• Maintenance dose: 2.5 to 10 mg sublingually 2 times a day
• Maximum dose: 20 mg/day

• Pediatric patients appear to be more sensitive to dystonia with initial dosing and therefore gradual dose escalation is recommended.
• The safety of doses above 20 mg/day has not been studied.

Renal Dose Adjustments

Mild to severe renal dysfunction (Glomerular filtration rate [GFR] 15 to 90 mL/min): No adjustment recommended.
GFR less than 15 mL/min: Data not available

Liver Dose Adjustments

Mild to moderate liver dysfunction (Child-Pugh A and B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Contraindicated

Dose Adjustments

Doses should be titrated from 5 mg to 10 mg 2 times a day based on clinical response and tolerability.

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.

• Hypersensitivity to the active component or any of the ingredients or a history of hypersensitivity reactions to this drug
• Severe liver dysfunction (Child-Pugh C)

Dialysis

Data not available

Other Comments

Administration Advice:

• Do not remove tablet from package until ready to administer.
• The tablet should not be pushed through the tablet pack.
• Patients should handle tablets with dry hands.
• Place whole tablet under tongue and allow to dissolve completely; do not split, crush, chew, or swallow the tablet
• Do not eat or drink for 10 minutes after administration.
• When taken in combination with other medications, this drug should be taken last.

• Tablets should be kept in the tablet pack until ready to be used.

• Controlled clinical trials assessing long-term use are not available; the physician who prescribes this drug should periodically re-evaluate the long-term risks and benefits for the individual patient.
• No specific recommendations are available regarding switching from other antipsychotics or for the use of concomitant antipsychotics.
• Patients should be reassessed periodically to determine continued need for treatment, and to determine the appropriate dosage for treatment.

• 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

• 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; patients should be told to avoid driving or operating machinery until adverse effects are determined.
• Advise patients to speak to physician or health care professional if they are 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 be instructed to 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.