Recommended Dosage of Lurasidone for Schizophrenia and Bipolar Disorder
For schizophrenia, lurasidone should be administered at 40-160 mg once daily with food (at least 350 calories), with a recommended starting dose of 40 mg/day. For bipolar depression, the recommended starting dose is 20 mg once daily with food, with an effective dose range of 20-120 mg/day for adults and 20-80 mg/day for pediatric patients (10-17 years). 1
Dosing for Schizophrenia
- The recommended starting dose for schizophrenia is 40 mg once daily 1, 2
- No initial dose titration is required 3
- Effective dose range is 40-160 mg/day 3
- Maximum recommended dose is 160 mg/day 3
- Must be taken with food (at least 350 calories) to substantially increase absorption (2-fold increase in AUC and 3-fold increase in Cmax) 1, 2
- Efficacy was established in five 6-week, fixed-dose, randomized, placebo-controlled trials 3
Dosing for Bipolar Depression
Adults:
- The recommended starting dose is 20 mg once daily (no initial titration required) 1
- Effective dose range is 20-120 mg/day as monotherapy or as adjunctive therapy with lithium or valproate 1
- Maximum recommended dose is 120 mg/day 1
- In monotherapy studies, the higher dose range (80-120 mg/day) did not provide additional efficacy compared to lower doses (20-60 mg/day) 1
Pediatric Patients (10-17 years):
- The recommended starting dose is 20 mg once daily as monotherapy 1
- Dose may be increased after one week based on clinical response 1
- Effective dose range is 20-80 mg/day 1
- Maximum recommended dose is 80 mg/day 1
- At the end of clinical studies, most pediatric patients (67%) received 20-40 mg once daily 1
Special Dosing Considerations
- Renal Impairment: For moderate (CrCl 30-50 mL/min) or severe (CrCl <30 mL/min) renal impairment, start at 20 mg/day with a maximum of 80 mg/day 1
- Hepatic Impairment:
- Drug Interactions:
- Contraindicated with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) 1, 4
- With moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin), reduce lurasidone dose to half the original dose 1
- When adding lurasidone to therapy with a moderate CYP3A4 inhibitor, start at 20 mg/day with a maximum of 80 mg/day 1
Duration of Treatment
- The effectiveness of lurasidone for longer-term use (more than 6 weeks) has not been established in controlled studies 1
- Physicians should periodically re-evaluate the long-term usefulness of the drug for individual patients 1
- For schizophrenia, general recommendations suggest that first-episode patients should receive maintenance pharmacological treatment for 1-2 years after the initial episode, given the risk for relapse 5
Clinical Considerations
- Lurasidone has a favorable metabolic profile with minimal weight gain and no clinically meaningful alterations in glucose, lipids, or ECG QT interval 3, 2
- Most common adverse events include somnolence, akathisia, nausea, and parkinsonism 3, 6
- Lurasidone has distinctive 5-HT7 antagonistic activity, which may contribute to its antidepressant effects in bipolar depression 4, 7
- Lurasidone is primarily metabolized by CYP3A4 and has a mean elimination half-life of 18 hours 4
Monitoring Recommendations
- Document target symptoms before initiating treatment 5
- Document treatment response and suspected side effects 5
- Monitor for extrapyramidal side effects, particularly akathisia which is more common with lurasidone than some other atypical antipsychotics 6
- Monitor for hyperprolactinemia 6
- For long-term use, reassess dosage needs depending on the stage of illness 5
Remember that these dosing recommendations are based on FDA guidelines and clinical evidence, but individual patient factors should always be considered when determining the optimal dose.