What is the maximum recommended daily dose of Latuda (lurasidone) for an adult with schizophrenia?

Maximum Dose for Latuda (Lurasidone)

Adult Schizophrenia

The maximum recommended daily dose of Latuda for adults with schizophrenia is 160 mg per day. 1

• The recommended starting dose is 40 mg once daily with no initial titration required 1
• The effective dose range is 40–160 mg per day 1
• Doses above 80 mg/day do not appear to provide additional efficacy on average and may increase adverse effects such as somnolence and akathisia 2, 3, 4

Adolescent Schizophrenia (Ages 13–17)

The maximum recommended daily dose for adolescents with schizophrenia is 80 mg per day. 1

• The starting dose is 40 mg once daily 1
• The effective dose range is 40–80 mg per day 1

Bipolar Depression (Adults)

The maximum recommended daily dose for adults with bipolar I depression is 120 mg per day, whether used as monotherapy or adjunctive therapy with lithium or valproate. 1

• The starting dose is 20 mg once daily 1
• The effective dose range is 20–120 mg per day 1
• In monotherapy studies, the higher dose range (80–120 mg/day) did not provide additional efficacy compared to the lower dose range (20–60 mg/day) 1

Bipolar Depression (Pediatric Ages 10–17)

The maximum recommended daily dose for pediatric patients with bipolar I depression is 80 mg per day. 1

• The starting dose is 20 mg once daily 1
• Most patients (67%) in clinical studies received 20 mg or 40 mg once daily 1

Dose Modifications for Special Populations

Renal Impairment

For moderate to severe renal impairment, the maximum dose should not exceed 80 mg per day. 1

• Recommended starting dose is 20 mg per day for creatinine clearance <50 mL/min 1

Hepatic Impairment

For moderate hepatic impairment (Child-Pugh Score 7–9), the maximum dose is 80 mg per day; for severe hepatic impairment (Child-Pugh Score 10–15), the maximum dose is 40 mg per day. 1

• Recommended starting dose is 20 mg per day for both moderate and severe hepatic impairment 1

Drug Interactions

When co-administered with moderate CYP3A4 inhibitors (e.g., diltiazem), the maximum dose is 80 mg per day. 1

• The Latuda dose should be reduced to half of the original level 1
• Recommended starting dose is 20 mg per day 1

Critical Administration Requirements

Latuda must be taken with food (at least 350 calories) to optimize absorption. 1, 4, 5

• Administration with food increases AUC approximately 2-fold and Cmax approximately 3-fold 1
• All clinical studies administered Latuda with food 1

Common Pitfalls to Avoid

• Do not exceed 160 mg/day in adults with schizophrenia, as higher doses increase adverse effects without additional benefit 2, 3, 4
• Do not use doses above 80 mg/day in adolescents with schizophrenia or pediatric patients with bipolar depression 1
• Never administer Latuda without food, as bioavailability is substantially reduced 1, 4, 5
• Do not co-administer with strong CYP3A4 inhibitors (e.g., ketoconazole) or strong inducers (e.g., rifampin), as these are contraindicated 4