{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "clozapine",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "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",
        "cached_file": "labels/clozapine.json",
        "verbatim": true
      },
      {
        "text": "( 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",
        "cached_file": "labels/clozapine.json",
        "verbatim": true
      },
      {
        "text": "( 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",
        "cached_file": "labels/clozapine.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "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",
        "cached_file": "labels/clozapine.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "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",
        "cached_file": "labels/clozapine.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "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",
        "cached_file": "labels/clozapine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/clozapine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/clozapine.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/clozapine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/clozapine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/clozapine.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Risk Summary Clozapine is present in human milk.",
        "source": "US FDA label for clozapine (Clozapine), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/clozapine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/clozapine.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/clozapine.json",
        "verbatim": true
      }
    ]
  }
}