Clozapine

DRUG INFORMATION

  ADULT
    - Recommended starting oral dosage is 12.5 mg once daily or twice daily.
      Source: US FDA label for clozapine (Clozapine), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.2 ) If well-tolerated, increase the total daily dosage in increments of 25 mg
      to 50 mg per day at target dosage of 150 mg to 225 mg twice per day by the end of
      two weeks ( 2.2 ) Subsequently may increase the dosage in increments up to 100 mg,
      once or twice weekly.
      Source: US FDA label for clozapine (Clozapine), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.2 ) Maximum daily dosage is 450 mg twice daily.
      Source: US FDA label for clozapine (Clozapine), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness of clozapine in pediatric patients have not been
      established.
      Source: US FDA label for clozapine (Clozapine), section 'pediatric use', retrieved
      2026-08-29

  RENAL IMPAIRMENT
    - Moderate or weak CYP1A2 or CYP3A4 Inducers Consider increasing the Clozapine ODT
      dosage if necessary. 2.8 Dosage Recommendations in Patients with Renal or Hepatic
      Impairment, or CYP2D6 Poor Metabolizers It may be necessary to reduce the
      Clozapine ODT dosage in patients with significant renal impairment or hepatic
      impairment, or in CYP2D6 poor metabolizers [see Use in Specific Populations ( 8.6
      , 8.7 )] .
      Source: US FDA label for clozapine (Clozapine), section 'dosage and
      administration', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - See dosage modification based on ANC results ( 2.3 , 2.4 ) See recommendations for
      discontinuing Clozapine ODT treatment ( 2.5 ), restarting Clozapine ODT after
      interrupting dosing ( 2.6 ), dosage modifications for drug interactions ( 2.7 ),
      dosage recommendations in patients with renal or hepatic impairment and CYP2D6
      poor metabolizers ( 2.8 ) in the full prescribing information.
      Source: US FDA label for clozapine (Clozapine), section 'dosage and
      administration', retrieved 2026-08-29
    - Moderate or weak CYP1A2 or CYP3A4 Inducers Consider increasing the Clozapine ODT
      dosage if necessary. 2.8 Dosage Recommendations in Patients with Renal or Hepatic
      Impairment, or CYP2D6 Poor Metabolizers It may be necessary to reduce the
      Clozapine ODT dosage in patients with significant renal impairment or hepatic
      impairment, or in CYP2D6 poor metabolizers [see Use in Specific Populations ( 8.6
      , 8.7 )] .
      Source: US FDA label for clozapine (Clozapine), section 'dosage and
      administration', retrieved 2026-08-29
    - Clinical experience suggests that the prevalence of tardive dyskinesia appears to
      be highest among the elderly; especially elderly women [see Warnings and
      Precautions ( 5.17 )]. 8.6 Patients with Renal or Hepatic Impairment Dose
      reduction may be necessary in patients with significant impairment of renal or
      hepatic function.
      Source: US FDA label for clozapine (Clozapine), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors
      pregnancy outcomes in women exposed to atypical antipsychotics, including
      Clozapine ODT, during pregnancy.
      Source: US FDA label for clozapine (Clozapine), section 'pregnancy', retrieved
      2026-08-29
    - Healthcare providers are encouraged to advise patients to register by calling the
      National Pregnancy Registry for Atypical Antipsychotics at1-866-961-2388 or
      visiting http://womensmentalhealth.org/clinical-and-research-
      programs/pregnancyregistry/.
      Source: US FDA label for clozapine (Clozapine), section 'pregnancy', retrieved
      2026-08-29
    - Risk Summary Neonates exposed to antipsychotic drugs, including Clozapine ODT,
      during the third trimester are at risk for extrapyramidal and/or withdrawal
      symptoms following delivery ( see Clinical Considerations ).
      Source: US FDA label for clozapine (Clozapine), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Risk Summary Clozapine is present in human milk.
      Source: US FDA label for clozapine (Clozapine), section 'nursing mothers',
      retrieved 2026-08-29
    - There is one case report of sedation and a report of agranulocytosis in an infant
      exposed to clozapine through human milk (see Clinical Considerations) .
      Source: US FDA label for clozapine (Clozapine), section 'nursing mothers',
      retrieved 2026-08-29
    - There is no information on the effects of clozapine on milk production.
      Source: US FDA label for clozapine (Clozapine), section 'nursing mothers',
      retrieved 2026-08-29