Bushu Pharmaceutical, Ltd.

Bushu Pharmaceutical, Ltd. Drugs

• Latuda
  

  ×

  Latuda

  

  ---

  2.1. Schizophrenia

  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/day to 120 mg/day [see Clinical Studies (14.1)]. In the 6-week controlled trials, there was no suggestion of added benefit with the 120 mg/day dose, but there was a dose-related increase in certain adverse reactions. Therefore, the maximum recommended dose is 80 mg/day.

  2.2. Administration Instructions

  LATUDA should be taken with food (at least 350 calories) [see Clinical Pharmacology (12)].

  2.3. Dosage in Special Populations

  Dosage adjustments are not recommended on the basis of age, gender, and race [see Use in Specific Populations (8)].

  Dose adjustment is recommended in moderate and severe renal impairment patients. The dose in these patients should not exceed 40 mg/day [see Use in Specific Populations (8)].

  Dose adjustment is recommended in moderate and severe hepatic impairment patients. The dose in these patients should not exceed 40 mg/day [see Use in Specific Populations (8)].

  Dosing recommendation for patients taking LATUDA concomitantly with potential CYP3A4 inhibitors: When coadministration of LATUDA with a moderate CYP3A4 inhibitor such as diltiazem is considered, the dose should not exceed 40 mg/day. LATUDA should not be used in combination with a strong CYP3A4 inhibitor (e.g., ketoconazole) [see Contraindications (4); Drug Interactions (7.1)].

  Dosing recommendation for patients taking LATUDA concomitantly with potential CYP3A4 inducers: LATUDA should not be used in combination with a strong CYP3A4 inducer (e.g., rifampin) [see Contraindications (4); Drug Interactions (7.1)].

  Close
  More Info