Latuda Dosage/Direction for Use

Schizophrenia: Adults: The recommended starting dose of LATUDA is 40 mg once daily. Initial dose titration is not required. LATUDA has been shown to be effective in a dose range of 40 mg per day to 160 mg per day [see Pharmacology: Pharmacodynamics: Clinical Studies: Schizophrenia under Actions]. The maximum recommended dose is 160 mg per day.
Adolescents (15 - 17 years): The recommended starting dose of LATUDA is 40 mg once daily. Initial dose titration is not required. LATUDA has been shown to be effective in a dose range of 40 mg per day to 80 mg per day [see Pharmacology: Pharmacodynamics: Clinical Studies: Schizophrenia under Actions]. The maximum recommended dose is 80 mg per day.
Depressive Episodes Associated with Bipolar I Disorder: Adults: The recommended starting dose of LATUDA in adults is 20 mg given once daily as monotherapy or as adjunctive therapy with lithium or valproate. Initial dose titration is not required. LATUDA has been shown to be effective in a dose range of 20 mg per day to 120 mg per day as monotherapy or as adjunctive therapy with lithium or valproate [see Pharmacology: Pharmacodynamics: Clinical Studies: Depressive Episodes Associated with Bipolar I Disorder under Actions]. The maximum recommended dose, as monotherapy or as adjunctive therapy with lithium or valproate, is 120 mg per day. In the monotherapy study, the higher dose range (80 mg to 120 mg per day) did not provide additional efficacy, on average, compared to the lower dose range (20 to 60 mg per day) [see Pharmacology: Pharmacodynamics: Clinical Studies: Depressive Episodes Associated with Bipolar I Disorder under Actions].
Adolescent Patients (13 - 17 years): The recommended starting dose of LATUDA is 20 mg given once daily as monotherapy. Initial dose titration is not required. The dose may be increased after one week based on clinical response. LATUDA has been shown to be effective in a dose range of 20 mg per day to 80 mg per day as monotherapy. At the end of the clinical study, most of the patients (67%) received 20 mg or 40 mg once daily [see Pharmacology: Pharmacodynamics: Clinical Studies: Depressive Episodes Associated with Bipolar I Disorder under Actions]. The maximum recommended dose is 80 mg per day.
The efficacy of LATUDA in the treatment of mania associated with bipolar disorder has not been established.
Administration Information: LATUDA should be taken with food (at least 350 calories). Administration with food substantially increases the absorption of LATUDA. Administration with food increases the AUC approximately 2-fold and increases the C_max approximately 3-fold. In the clinical studies, LATUDA was administered with food [see Pharmacology: Pharmacokinetics under Actions].
The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Schizophrenia and Depressive Episodes Associated with Bipolar I Disorder as previously mentioned].
Dose Modifications for Renal Impairment: Dose adjustment is recommended in moderate (creatinine clearance: 30 to <50 mL/min) and severe renal impairment (creatinine clearance <30 mL/min) patients. The recommended starting dose is 20 mg per day. The dose in these patients should not exceed 80 mg per day [see Renal Impairment under Precautions].
Dose Modifications for Hepatic Impairment: Dose adjustment is recommended in moderate (Child-Pugh Score = 7 to 9) and severe hepatic impairment (Child-Pugh Score = 10 to 15) patients. The recommended starting dose is 20 mg per day. The dose in moderate hepatic impairment patients should not exceed 80 mg per day and the dose in severe hepatic impairment patients should not exceed 40 mg per day [see Hepatic Impairment under Precautions].
Dose Modifications Due to Drug Interactions of CYP3A4 Inhibitors and CYP3A4 Inducers: Concomitant Use with CYP3A4 Inhibitors: LATUDA should not be used concomitantly with a strong CYP3A4 inhibitor (e.g. ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see Contraindications].
If LATUDA is being prescribed and a moderate CYP3A4 inhibitor (e.g., diltiazem, atazanavir, erythromycin, fluconazole, verapamil, etc.) is added to the therapy, the LATUDA dose should be reduced to half of the original dose level. Similarly, if a moderate CYP3A4 inhibitor is being prescribed and LATUDA is added to the therapy, the recommended starting dose of LATUDA is 20 mg per day, and the maximum recommended dose of LATUDA is 80 mg per day [see Contraindications; Drugs Having Clinically Important Interactions with LATUDA under Interactions].
Grapefruit and grapefruit juice should be avoided in patients taking LATUDA, since these may inhibit CYP3A4 and alter LATUDA concentrations [see Drugs Having Clinically Important Interactions with LATUDA under Interactions].
Concomitant Use with CYP3A4 Inducers: LATUDA should not be used concomitantly with a strong CYP3A4 inducer (e.g., rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine, etc.) [see Contraindications; Drugs Having Clinically Important Interactions with LATUDA under Interactions]. If LATUDA is used concomitantly with a moderate CYP3A4 inducer, it may be necessary to increase the LATUDA dose after chronic treatment (7 days or more) with the CYP3A4 inducer.