Maximum Dose for Latuda (Lurasidone)
The maximum recommended dose of Latuda (lurasidone) is 120 mg per day for adults with bipolar depression (as monotherapy or adjunctive therapy), and 80 mg per day for pediatric patients (10-17 years) with bipolar depression. 1
Adult Dosing
Bipolar Depression
- Starting dose: 20 mg once daily (no initial titration required) 1
- Effective dose range: 20-120 mg per day 1
- Maximum dose: 120 mg per day (as monotherapy or adjunctive therapy with lithium or valproate) 1
- Important note: In the monotherapy study, the higher dose range (80-120 mg per day) did not provide additional efficacy compared to the lower dose range (20-60 mg per day) 1
Schizophrenia (based on FDA-approved labeling)
- Recommended dose range: 40-160 mg per day 1, 2
- Starting dose: 40 mg per day 1, 3, 4
- While the FDA label previously recommended a maximum of 80 mg/day, this was expanded to 40-160 mg/day 2, 5
- Doses above 80 mg may be associated with dose-related increases in adverse reactions such as somnolence and akathisia, though one study found 160 mg/day tolerable 5
Pediatric Dosing (10-17 years)
- Starting dose: 20 mg once daily (no initial titration required) 1
- Effective dose range: 20-80 mg per day 1
- Maximum dose: 80 mg per day 1
- At the end of clinical studies, most pediatric patients (67%) received 20 mg or 40 mg once daily 1
- Dose may be increased after one week based on clinical response 1
Critical Dose Modifications
Renal Impairment
- Moderate impairment (CrCl 30 to <50 mL/min): Starting dose 20 mg/day; maximum 80 mg/day 1
- Severe impairment (CrCl <30 mL/min): Starting dose 20 mg/day; maximum 80 mg/day 1
Hepatic Impairment
- Moderate impairment (Child-Pugh Score 7-9): Starting dose 20 mg/day; maximum 80 mg/day 1
- Severe impairment (Child-Pugh Score 10-15): Starting dose 20 mg/day; maximum 40 mg/day 1
Drug Interactions
- Strong CYP3A4 inhibitors (ketoconazole, clarithromycin, ritonavir): Contraindicated—do not use concomitantly 1
- Moderate CYP3A4 inhibitors (diltiazem, erythromycin, fluconazole): Reduce lurasidone dose to half of original level; if starting lurasidone, use 20 mg/day starting dose with maximum of 80 mg/day 1
Administration Requirements
- Must be taken with food (at least 350 calories) to optimize absorption 1, 3, 4
- Administration with food increases AUC approximately 2-fold and Cmax approximately 3-fold 1
- Once-daily dosing 1, 4
Common Pitfalls to Avoid
- Do not exceed 120 mg/day in adults with bipolar depression, as higher doses in the 80-120 mg range did not show additional efficacy 1
- Do not use with strong CYP3A4 inhibitors—this is an absolute contraindication 1
- Do not administer without food, as bioavailability is substantially reduced 1, 3
- Do not exceed 80 mg/day in patients with any degree of renal or moderate hepatic impairment 1
- Monitor for dose-dependent adverse effects (somnolence, akathisia, nausea, parkinsonism) when increasing doses 2, 3, 4, 6