FDA-Approved Highest Dose of Latuda in Children
The FDA-approved maximum dose of lurasidone (Latuda) for pediatric patients aged 10-17 years with bipolar I depression is 80 mg per day. 1
Pediatric Dosing for Bipolar Depression
- Starting dose: 20 mg once daily as monotherapy, with no initial titration required 1
- Dose adjustment: May be increased after one week based on clinical response 1
- Effective dose range: 20-80 mg per day 1
- Maximum approved dose: 80 mg per day 1
Clinical Trial Dosing Patterns
- In the pivotal clinical study, most pediatric patients (67%) received either 20 mg or 40 mg once daily at study endpoint 1
- The mean dose administered in the pediatric bipolar depression trial was 33.6 mg/day 2
- Lurasidone demonstrated statistically significant improvement compared to placebo across the 20-80 mg/day dose range (effect size 0.45) 2
Critical Administration Requirements
Lurasidone must be taken with food containing at least 350 calories 1. This is not optional—administration with food increases absorption approximately 2-fold (AUC) and 3-fold (Cmax) 1. All clinical trials demonstrating efficacy were conducted with food administration 1.
Important Limitations and Contraindications
Not Approved Indications in Children
- Lurasidone is not approved for treatment of mania associated with bipolar disorder in pediatric patients 1
- Efficacy for schizophrenia in adolescents has been studied 3, 4, but the FDA label specifically addresses bipolar depression dosing for ages 10-17 1
Dose Modifications Required
- Moderate renal impairment (CrCl 30-50 mL/min): Maximum 80 mg/day 1
- Severe renal impairment (CrCl <30 mL/min): Maximum 80 mg/day 1
- Moderate hepatic impairment (Child-Pugh 7-9): Maximum 80 mg/day 1
- Severe hepatic impairment (Child-Pugh 10-15): Maximum 40 mg/day 1
Drug Interactions
- Contraindicated with strong CYP3A4 inhibitors (ketoconazole, clarithromycin, ritonavir) 1
- With moderate CYP3A4 inhibitors (diltiazem, erythromycin, fluconazole): Reduce lurasidone dose to half the original level 1
Safety Profile in Pediatric Patients
The most common adverse events in the pediatric bipolar depression trial were nausea and somnolence 2. Treatment demonstrated minimal effects on weight and metabolic parameters, with study completion rates of 92.0% for lurasidone versus 89.7% for placebo 2. Discontinuation rates due to adverse events were identical between groups (1.7%) 2.