Praziquantel

DRUG INFORMATION

  ADULT
    - • 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
    - ( 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
    - (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

  CHILD
    - 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
    - • 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
    - • 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

  RENAL IMPAIRMENT
    - 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

  HEPATIC IMPAIRMENT
    - ( 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
    - 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
    - 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

  PREGNANCY
    - 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
    - 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
    - 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

  BREASTFEEDING
    - 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