{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "praziquantel",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "• Schistosomiasis : 20 mg/kg bodyweight 3 times a day separated by 4 to 6 hours for 1 day only.",
        "source": "US FDA label for praziquantel (Biltricide), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/praziquantel.json",
        "verbatim": true
      },
      {
        "text": "( 2.1 ) • Clonorchiasis and Opisthorchiasis : 2 5 mg/kg 3 times a day separated by 4 to 6 hours for 1 day only.",
        "source": "US FDA label for praziquantel (Biltricide), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/praziquantel.json",
        "verbatim": true
      },
      {
        "text": "(2.2) • For additional administration instructions see the full prescribing information. 2.1 Recommended Dosage Schistosomiasis The recommended dosage for the treatment of schistosomiasis is 20 mg/kg bodyweight administered orally three times a day separated by 4 to 6 hours, for 1 day only.",
        "source": "US FDA label for praziquantel (Biltricide), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/praziquantel.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and dosing recommendations of Biltricide in pediatric patients 1 to 17 years have been established. Safety of Biltricide in pediatric patients younger than 1 year of age has not been established. Post-marketing experience and published literature indicates that pediatric patients 1 to 17 years of age treated with praziquantel experience similar adverse reactions as adults treated with praziquantel [see Adverse Reactions ( 6 )] .",
        "source": "US FDA label for praziquantel (Biltricide), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/praziquantel.json",
        "verbatim": true
      },
      {
        "text": "• Schistosomiasis : 20 mg/kg bodyweight 3 times a day separated by 4 to 6 hours for 1 day only. ( 2.1 ) • Clonorchiasis and Opisthorchiasis : 2 5 mg/kg 3 times a day separated by 4 to 6 hours for 1 day only. ( 2.1) • Take with water during meals. Do not chew or keep segments in the mouth. ( 2.2 ) • For pediatric patients under 6 years of age, the tablets may be crushed or disintegrated and mixed with semi-solid food or liquid.",
        "source": "US FDA label for praziquantel (Biltricide), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/praziquantel.json",
        "verbatim": true
      },
      {
        "text": "• Schistosomiasis : 20 mg/kg bodyweight 3 times a day separated by 4 to 6 hours for 1 day only.",
        "source": "US FDA label for praziquantel (Biltricide), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/praziquantel.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "No kidney-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for praziquantel (Biltricide), retrieved 2026-08-29",
        "cached_file": "labels/praziquantel.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "( 8.4 ) • Hepatic Impairment: Monitor patients for adverse reactions when administering the recommended dose of Biltricide to hepatosplenic schistosomiasis patients with moderate to severe liver impairment (Child-Pugh Class B or C).",
        "source": "US FDA label for praziquantel (Biltricide), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/praziquantel.json",
        "verbatim": true
      },
      {
        "text": "Monitor patients with cardiac arrhythmias during treatment. 5.5 Hepatic Impairment in Hepatosplenic Schistosomiasis Patients Reduced hepatic metabolism of praziquantel results in higher and sustained plasma concentrations of unmetabolized praziquantel in patients with liver impairment [see Clinical Pharmacology ( 12.3 )].",
        "source": "US FDA label for praziquantel (Biltricide), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/praziquantel.json",
        "verbatim": true
      },
      {
        "text": "Monitor patients for adverse reactions when administering the recommended dose of Biltricide to hepatosplenic schistosomiasis patients with moderate or severe liver impairment (Child-Pugh Class B or C).",
        "source": "US FDA label for praziquantel (Biltricide), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/praziquantel.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Published studies have not identified an association with Biltricide use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data) .",
        "source": "US FDA label for praziquantel (Biltricide), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/praziquantel.json",
        "verbatim": true
      },
      {
        "text": "In animal reproduction studies conducted in pregnant rats and rabbits no adverse developmental outcomes were observed with oral administration of praziquantel during organogenesis at approximately 0.65 times (rats) or 1.3 times (rabbits) the highest recommended human daily dose of 75 mg/kg/day, based on body surface area.",
        "source": "US FDA label for praziquantel (Biltricide), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/praziquantel.json",
        "verbatim": true
      },
      {
        "text": "The estimated background risk of major birth defects and miscarriage for the indicated population are unknown.",
        "source": "US FDA label for praziquantel (Biltricide), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/praziquantel.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Nothing on breastfeeding in this label. Treat as unknown, not as safe.",
        "source": "Read and found silent: the US FDA label for praziquantel (Biltricide), retrieved 2026-08-29",
        "cached_file": "labels/praziquantel.json",
        "verbatim": false
      }
    ]
  }
}