Lurasidone

DRUG INFORMATION

  ADULT
    - Recommended starting dose is 20 mg per day.
      Source: US FDA label for lurasidone (lurasidone hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - Maximum recommended dose is 80 mg per day ( 2.6 , 7.1 ) Concomitant Use of a
      Moderate CYP3A4 Inducer: It may be necessary to increase the dose of lurasidone
      hydrochloride ( 2.6 , 7.1 ) 2.1 Schizophrenia Adults The recommended starting dose
      of lurasidone hydrochloride is 40 mg once daily.
      Source: US FDA label for lurasidone (lurasidone hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - Lurasidone hydrochloride has been shown to be effective in a dose range of 40 mg
      per day to 160 mg per day [see Clinical Studies ( 14.1 )] .
      Source: US FDA label for lurasidone (lurasidone hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29

  CHILD
    - Schizophrenia The safety and effectiveness of lurasidone hydrochloride 40-mg/day
      and 80-mg/day for the treatment of schizophrenia in adolescents (13 to 17 years)
      was established in a 6-week, placebo-controlled clinical study in 326 adolescent
      patients [see Dosage and Administration ( 2.1 ), Adverse Reactions ( 6.1 ) and
      Clinical Studies ( 14.1 )].
      Source: US FDA label for lurasidone (lurasidone hydrochloride), section 'pediatric
      use', retrieved 2026-08-29
    - Bipolar Depression The safety and effectiveness of lurasidone hydrochloride 20 to
      80 mg/day for the treatment of bipolar depression in pediatric patients (10 to 17
      years) was established in a 6-week, placebo-controlled clinical study in 347
      pediatric patients [see Dosage and Administration ( 2.2 ), Adverse Reactions ( 6.1
      ), and Clinical Studies ( 14.2 )].
      Source: US FDA label for lurasidone (lurasidone hydrochloride), section 'pediatric
      use', retrieved 2026-08-29
    - Efficacy was not demonstrated in a 6-week study evaluating lurasidone
      hydrochloride 20 mg/day and 60 mg/day for the treatment of pediatric patients 6 to
      17 years of age with irritability associated with autistic disorder diagnosed by
      Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision
      [DSM-IV-TR] criteria.
      Source: US FDA label for lurasidone (lurasidone hydrochloride), section 'pediatric
      use', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Therefore, the physician who elects to use lurasidone hydrochloride tablets for
      extended periods should periodically re-evaluate the long-term usefulness of the
      drug for the individual patient [see Dosage and Administration (2.1 and 2.2) ] .
      2.4 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.
      Source: US FDA label for lurasidone (lurasidone hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - Lurasidone hydrochloride is not approved for the treatment of patients with
      dementia-related psychosis [see Boxed Warning , Warnings and Precautions ( 5.1 ,
      5.3 )] . 8.6 Renal Impairment Reduce the maximum recommended dosage in patients
      with moderate or severe renal impairment (CLcr <50 mL/minute).
      Source: US FDA label for lurasidone (lurasidone hydrochloride), section 'use in
      specific populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Moderate and Severe Hepatic Impairment: Recommended starting dose is 20 mg per
      day.
      Source: US FDA label for lurasidone (lurasidone hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - The maximum recommended dose is 80 mg per day in moderate hepatic impairment and
      40 mg per day in severe hepatic impairment ( 2.5 , 8.6 ).
      Source: US FDA label for lurasidone (lurasidone hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - The dose in these patients should not exceed 80 mg per day [see Use in Specific
      Populations ( 8.6 )] . 2.5 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.
      Source: US FDA label for lurasidone (lurasidone hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29

  PREGNANCY
    - Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors
      pregnancy outcomes in women exposed to lurasidone hydrochloride during pregnancy.
      Source: US FDA label for lurasidone (lurasidone hydrochloride), section
      'pregnancy', retrieved 2026-08-29
    - For more information, contact the National Pregnancy Registry for Atypical
      Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-
      and-research-programs/pregnancyregistry/ .
      Source: US FDA label for lurasidone (lurasidone hydrochloride), section
      'pregnancy', retrieved 2026-08-29
    - Risk Summary Neonates exposed to antipsychotic drugs during the third trimester of
      pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following
      delivery [see Clinical Considerations ] .
      Source: US FDA label for lurasidone (lurasidone hydrochloride), section
      'pregnancy', retrieved 2026-08-29

  BREASTFEEDING
    - Risk Summary Lactation studies have not been conducted to assess the presence of
      lurasidone in human milk, the effects on the breastfed infant, or the effects on
      milk production.
      Source: US FDA label for lurasidone (lurasidone hydrochloride), section 'nursing
      mothers', retrieved 2026-08-29
    - The development and health benefits of breastfeeding should be considered along
      with the mother’s clinical need for lurasidone hydrochloride and any potential
      adverse effects on the breastfed infant from lurasidone hydrochloride or from the
      underlying maternal condition.
      Source: US FDA label for lurasidone (lurasidone hydrochloride), section 'nursing
      mothers', retrieved 2026-08-29
    - Pregnant rats were treated with oral lurasidone at doses of 0.4, 2, and 10
      mg/kg/day during the periods of organogenesis and lactation.
      Source: US FDA label for lurasidone (lurasidone hydrochloride), section 'use in
      specific populations', retrieved 2026-08-29