Version May 2024
Clonorchiasis/opisthorchiasis: Oral: 25 mg/kg/dose 3 times daily for 1 to 2 days (Ref).
Neurocysticercosis, parenchymal (>2 viable cysts) (off-label use): Oral: 50 mg/kg/day in 3 divided doses (in combination with albendazole) for 10 to 14 days; may be repeated if persistent viable lesions on 6-month follow-up imaging (Ref). Note: Initiate adjunctive corticosteroid therapy prior to initiation of antiparasitic therapy. Antiparasitic therapy should not be initiated in patients with untreated hydrocephalus, calcified lesions, or cysticercal encephalitis; consult an infectious diseases specialist for specific treatment recommendations (Ref).
Schistosomiasis: Note: Repeat treatment may be needed in 2 to 4 weeks to increase effectiveness (Ref).
S. haematobium, Schistosoma intercalatum, or S. mansoni: Oral: 40 mg/kg/day as a single dose or in 2 divided doses for 1 day (Ref).
S. japonicum or S. mekongi: Oral: 60 mg/kg/day in 2 or 3 divided doses for 1 day (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
No dosage adjustment necessary.
There are no dosage adjustments provided in manufacturer's labeling. However, total drug exposure in moderate-to-severe impairment is increased.
Refer to adult dosing.
(For additional information see "Praziquantel: Pediatric drug information")
Note: Dosing interval and duration highly variable dependent on condition; for 3 times daily doses, intervals of 4 to 6 hours are suggested.
Flukes:
Clonorchiasis (Clonorchis sinensis [Chinese liver fluke]); Opisthorchiasis (Opisthorchis viverrini [Southeast Asian liver fluke]): Children and Adolescents: Oral: 25 mg/kg/dose 3 times daily at 4- to 6-hour intervals for 1 to 2 days (Ref).
Fasciolopsiasis (Fasciolopsis buski [intestinal fluke]):Limited data available: Children and Adolescents: Oral: 25 mg/kg/dose 3 times daily for 1 day (Ref).
Paragonimiasis (Paragonimus spp. [lung fluke]): Limited data available: Children and Adolescents: Oral: 25 mg/kg/dose 3 times daily for 2 to 3 days (Ref).
Schistosomiasis (Bilharziasis):
Treatment (Ref): Note: Repeat treatment may be needed in 2 to 4 weeks to increase effectiveness.
Schistosoma japonicum, Schistosoma mekongi: Children and Adolescents: Oral: 20 mg/kg/dose 3 times daily for 1 day
Schistosoma mansoni, Schistosoma haematobium, Schistosoma intercalatum: Children and Adolescents: Oral: 20 mg/kg/dose twice daily for 1 day
Control programs for endemic areas: Limited data available: Infants, Children, and Adolescents: Oral: 40 mg/kg as a single dose (Ref); a single dose of 40 mg/kg has been successfully used to treat urogenital S. haematobium in children 1 to 10 years of age (Ref) and S. mansoni in population that included infants (age range: 5 months to 7 years) (Ref); however, pharmacokinetic data suggests a lower cure rate in infants and preschool children; one possible explanation is that higher doses may be necessary in younger patients due to pharmacokinetic/dynamic differences; in preschool children, a single dose of 60 mg/kg was successfully used in children 3 to 8 years of age in a hyperendemic area to treat S. mansoni (Ref).
Tapeworms: Limited data available:
Diphyllobothrium latum (fish), Taenia saginata (beef), Taenia solium (pork); intestinal (adult) stage: Children and Adolescents: Oral: 5 to 10 mg/kg as a single dose (Ref).
Dipylidium caninum (dog); intestinal (adult) stage: Infants ≥6 months, Children, and Adolescents: Oral: 5 to 10 mg/kg as a single dose (Ref).
Hymenolepis nana (dwarf tapeworm): Children and Adolescents: Oral: 25 mg/kg as a single dose (Ref).
Neurocysticercosis (Taenia solium [pork tapeworm]); tissue (larvae) stage: Children and Adolescents: Oral: 50 mg/kg/day for 15 days (Ref); Note: May be used in conjunction with antiseizure medication and/or corticosteroids.
No dosage adjustments are recommended
There are no dosage adjustments provided in the manufacturer's labeling. However, total drug exposure in moderate to severe impairment is increased; use caution.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Frequency not defined. May be more frequent and/or serious in patients with a heavy worm burden.
Central nervous system: Dizziness, headache, malaise
Dermatologic: Urticaria
Gastrointestinal: Abdominal distress, nausea
Miscellaneous: Fever
<1%, postmarketing and/or case reports: Abdominal pain, anorexia, atrioventricular block, bloody diarrhea, bradycardia, cardiac arrhythmia, drowsiness, ectopic beats, eosinophilia, fatigue, hypersensitivity, hypersensitivity reaction, increased liver enzymes (minimal), myalgia, paradoxical reaction (in schistosomiasis), polyserositis, pruritus, seizure, serum sickness (in schistosomiasis; Jarisch-Herxheimer-like reaction), skin rash, ventricular fibrillation, vertigo, vomiting, weakness
Hypersensitivity to praziquantel or any component of the formulation; ocular cysticercosis; concomitant administration with strong cytochrome P450 3A enzyme (CYP3A) inducers, such as rifampin.
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Disease-related concerns:
• Cardiac arrhythmias: Monitor patients with cardiac arrhythmias during treatment; bradycardia, ectopic rhythms, ventricular fibrillation, and AV blocks have been observed with praziquantel administration.
• Central nervous system effects: Praziquantel may exacerbate central nervous system pathology due to schistosomiasis, paragonimiasis, or Taenia solium cysticercosis. Assess whether the potential benefit justifies the potential risk in patients with a history of seizures and/or other signs of potential central nervous system involvement such as subcutaneous nodules suggestive of cysticercosis.
• Hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment; reduced liver drug metabolism may result in higher and longer lasting plasma concentrations of unmetabolized praziquantel.
• Neurocysticercosis: Appropriate use: Antiparasitic therapy may worsen symptoms of neurocysticercosis by inducing an inflammatory response; adjunctive corticosteroid therapy should be started before initiation of antiparasitic therapy. Antiparasitic therapy should not be initiated in patients with untreated hydrocephalus, calcified lesions, or cysticercal encephalitis. Perform funduscopic exam prior to initiation of antiparasitic therapy to exclude intraocular cysticerci; antiparasitic therapy may lead to blindness in some cases with unsuspected intraocular parasites (IDSA/ASTMH [White 2018]).
• Schistosomiasis: Praziquantel may not be effective against migrating schistosomulae; observational data indicate that praziquantel treatment in the acute phase of the infection may not prevent progression from asymptomatic to acute schistosomiasis, or from asymptomatic/acute disease to chronic disease. In addition, use in patients with schistosomiasis may be associated with clinical deterioration such as paradoxical reactions or serum sickness Jarisch-Herxheimer-like reactions, which is a sudden inflammatory immune response likely caused by the release of schistosomal antigens. Such reactions typically occur during the acute disease phase, and may lead to life-threatening events such as respiratory failure, encephalopathy, papilledema, and/or cerebral vasculitis.
Other warnings/precautions:
• Patient information: Patients should be instructed to not drive or operate machinery on the day of treatment and the day after treatment.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Biltricide: 600 mg [scored]
Generic: 600 mg
Yes
Tablets (Biltricide Oral)
600 mg (per each): $99.65
Tablets (Praziquantel Oral)
600 mg (per each): $89.68
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Biltricide: 600 mg
Oral: According to the manufacturer, administer tablets with water during meals; however, some experts prefer administration 30 minutes before or 2 hours after a meal when treating tapeworm infections (eg, taeniasis) (PAHO 2021). Tablets should be promptly swallowed to avoid bitter taste that may cause gagging or vomiting. Tablets may be halved or quartered; do not chew. Tablets may be crushed or disintegrated and mixed with semi-solid food or liquid; use within 1 hour of mixing. Tablets are scored and may be split into four 150 mg segments.
Oral: Administer tablets with water during meals; tablets should be promptly swallowed whole (do not chew) to avoid bitter taste that may cause gagging or vomiting; tablets are scored and may be halved or quartered. Tablets may be crushed or disintegrated and mixed with semi-solid food or liquid; use within 1 hour of mixing. Studies in infants and young children have crushed the tablets and mixed in a variety of liquids (eg, orange juice, honey) to reduce the bitter taste (Ref).
Helminths: Treatment of infections in patients ≥1 year caused by the following: All species of Schistosoma (eg, Schistosoma mekongi, Schistosoma japonicum, Schistosoma mansoni, Schistosoma haematobium) and the liver flukes Clonorchis sinensis/Opisthorchis viverrini.
Neurocysticercosis, parenchymal; Tapeworms
Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Chloroquine: May decrease the serum concentration of Praziquantel. Risk C: Monitor therapy
Cimetidine: May increase the serum concentration of Praziquantel. Risk C: Monitor therapy
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
CYP3A4 Inducers (Moderate): May decrease the serum concentration of Praziquantel. Management: Consider alternatives to this combination whenever possible. If combined, monitor closely for reduced praziquantel efficacy. If possible, stop the moderate CYP3A4 inducer 2 to 4 weeks before praziquantel initiation. Risk D: Consider therapy modification
CYP3A4 Inducers (Strong): May decrease the serum concentration of Praziquantel. Risk X: Avoid combination
CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Praziquantel. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Praziquantel. Risk C: Monitor therapy
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Grapefruit Juice: May increase the serum concentration of Praziquantel. Risk C: Monitor therapy
Based on available data, an increased risk of adverse fetal or maternal outcomes has not been observed following use of praziquantel for the treatment of Schistosoma infection during pregnancy (Friedman 2018).
In areas where schistosomiasis and soil-transmitted helminthiasis is endemic, the World Health Organization recommends treatment with praziquantel during any trimester of pregnancy (WHO 2006). Non-emergent treatment of neurocysticercosis can be delayed until after pregnancy (IDSA/ASTMH [White 2018]).
Praziquantel is present in breast milk.
In one study, breast milk concentrations were <1% of the maternal dose following maternal use of praziquantel 50 mg/kg as a single oral dose or three 20 mg/kg doses (Pütter 1979).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. The World Health Organization considers praziquantel compatible for use in breastfeeding females (WHO 2002; WHO 2006).
Manufacturer recommends taking with meals; however, some experts prefer taking on an empty stomach (ie, 30 minutes before or 2 hours after a meal) when treating tapeworm infections (eg, taeniasis) (PAHO 2021).
Liver function tests; monitor patients with cardiac irregularities during treatment; monitor for seizures; culture urine or feces for ova prior to instituting therapy
Increases the cell permeability to calcium in schistosomes, causing strong contractions and paralysis of worm musculature leading to detachment of suckers from the blood vessel walls and to dislodgment
Absorption: Oral: 80%
Distribution: CSF concentration is 14% to 20% of plasma concentration
Protein binding: ~80%
Metabolism: Extensive first-pass effect; metabolized by the liver to hydroxylated and conjugated metabolites
Half-life elimination: Parent drug: 0.8 to 1.5 hours; Metabolites: 4.5 hours
Time to peak, serum: 1 to 3 hours
Excretion: Urine ~80% (>99% as metabolites)
Altered kidney function: Excretion may be delayed in patients with renal impairment, but accumulation of unchanged drug would not be expected.
Hepatic function impairment: Cmax, AUC, and half-life were significantly elevated in patients with moderate to severe liver impairment.
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