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Praziquantel

Medically reviewed on Dec 12, 2018

Pronunciation

(pray zi KWON tel)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Biltricide: 600 mg [scored]

Generic: 600 mg

Brand Names: U.S.

  • Biltricide

Pharmacologic Category

  • Anthelmintic

Pharmacology

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

Metabolism

Extensive first-pass effect; metabolized by the liver to hydroxylated and conjugated metabolites

Excretion

Urine ~80% (>99% as metabolites)

Time to Peak

Serum: 1 to 3 hours

Half-Life Elimination

Parent drug: 0.8 to 1.5 hours; Metabolites: 4.5 hours

Protein Binding

~80%

Special Populations: Renal Function Impairment

Excretion may be delayed in patients with renal impairment, but accumulation of unchanged drug would not be expected.

Special Populations: Hepatic Function Impairment

Cmax, AUC, and half-life were significantly elevated in patients with moderate to severe liver impairment.

Use: Labeled Indications

Helminths: Treatment of infections in patients ≥1 year caused by the following: All species of Schistosoma (eg, Schistosoma mekongi, S. japonicum, S. mansoni, S. hematobium) and the liver flukes Clonorchis sinensis/Opisthorchis viverrini

Off Label Uses

Neurocysticercosis, parenchymal

Data from the phase II and phase III portions of a randomized, double blind, placebo-controlled study supports the use of praziquantel (in combination with albendazole) in the treatment of parenchymal neurocysticercosis [Garcia 2014], [Garcia 2016].

Based on the IDSA/ASTMH guidelines for the diagnosis and treatment of neurocysticercosis, praziquantel, in combination with albendazole, is an effective and recommended agent in the management of parenchymal neurocysticercosis with >2 viable cysts.

Tapeworms

Clinical experience suggests the utility of praziquantel in the treatment of a broad range of trematode and cestode infections [Liu 1996].

Contraindications

Hypersensitivity to praziquantel or any component of the formulation; ocular cysticercosis; concomitant administration with strong cytochrome P450 (CYP450) inducers, such as rifampin

Dosing: Adult

Schistosomiasis: Oral: 20 mg/kg/dose 3 times daily at 4- to 6-hour intervals for 1 day

Clonorchiasis/opisthorchiasis: Oral: 25 mg/kg/dose 3 times daily for 1 to 2 days (Drugs for Parasitic Infections 2013; manufacturer's labeling)

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 (Garcia 2014; IDSA/ASTMH [White 2018]). 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 (IDSA/ASTMH [White 2018]).

Tapeworms (off-label use): Oral: 5 to 10 mg/kg as a single dose (25 mg/kg for Hymenolepis nana) (Drugs for Parasitic Infections 2013; Liu 1996)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

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: Limited data available in children <4 years of age: Oral: 25 mg/kg/dose 3 times daily for 1 to 2 days (CDC 2012; Medical Letter [Parasitic infections 2013]; Red Book [AAP 2015])

Fasciolopsiasis (Fasciolopsis buski), Heterophyiasis (Heterophyes heterophyes), or Metagonimus yokogawai (intestinal flukes); Metorchis conjunctus (North American liver fluke): Limited data available: Children and Adolescents: Oral: 25 mg/kg/dose 3 times daily for 1 day (Medical Letter [Parasitic infections 2013]; Red Book [AAP 2015])

Nanophyetus salmincola: Limited data available: Children and Adolescents: Oral: 20 mg/kg/dose 3 times daily for 1 day (Medical Letter [Parasitic infections 2013])

Paragonimiasis (Paragonimus spp. [lung fluke]): Children and Adolescents: Oral: 25 mg/kg/dose 3 times daily for 2 days (Red Book [AAP 2015])

Schistosomiasis (Bilharziasis):

S. japonicum, S. mekongi: Limited data available in children <4 years of age: Children and Adolescents: Oral: 20 mg/kg/dose 3 times daily for 1 day (Medical Letter [Parasitic infections 2013]; Red Book [AAP 2015])

S. mansoni, S. haematobium:

Infants ≥5 months and Children <4 years: Limited data available: Oral: 40 mg/kg/day divided into 1 to 2 doses for 1 day (Medical Letter [Parasitic infections 2013]; Red Book [AAP 2015]; Sousa-Figueiredo 2012; Wami 2016); a single dose of 40 mg/kg has been successfully used to treat urogenital S. haematobium in children 1 to 10 years of age and S. mansoni in population that included infants (age range: 5 months to 7 years); however, 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 (Bustinduy 2016).

Children ≥4 years and Adolescents: 20 mg/kg/dose 2 to 3 times daily (Medical Letter [Parasitic infection 2013]); in children up to 10 years of age, large scale mass drug administration trials have shown that single doses of 40 or 60 mg/kg are also effective (Bustinduy 2016; Sousa-Figueiredo 2012; Wami 2016).

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 (Medical Letter [Parasitic infections 2013]; Red Book [AAP 2015])

Dipylidium caninum (dog); intestinal (adult) stage: Infants ≥6 months, Children, and Adolescents: Oral: 5 to 10 mg/kg as a single dose (Medical Letter [Parasitic infections 2013]; Red Book [AAP 2015])

Hymenolepis nana (dwarf tapeworm): Children and Adolescents: Oral: 25 mg/kg as a single dose (Medical Letter [Parasitic infections 2013])

Neurocysticercosis (Taenia solium [pork tapeworm]); tissue (larvae) stage: Children and Adolescents: Reported regimens variable: Oral: 50 mg/kg/day for 15 days (CDC 2017; Medical Letter [Parasitic infections 2013]); another reported regimen is: 33.3 mg/kg/dose 3 times daily for 1 day followed by 16.7 mg/kg/dose 3 times daily for 29 days (Red Book [AAP 2015]); Note: May be used in conjunction with antiseizure medication and/or corticosteroids.

Administration

Administer tablets with water during meals. 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.

Storage

Store below 30°C (86°F).

Drug Interactions

Aprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Bosentan: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Ceritinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of ceritinib with a narrow therapeutic index CYP3A substrate (eg, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus) should be avoided when possible. Exceptions are discussed separately. Monitor therapy

Chloroquine: May decrease the serum concentration of Praziquantel. Monitor therapy

Cimetidine: May increase the serum concentration of Praziquantel. Monitor therapy

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Conivaptan: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of Praziquantel. Management: Use of praziquantel with strong CYP3A4 inducers is contraindicated. Discontinue rifampin 4 weeks prior to initiation of praziquantel therapy. Rifampin may be resumed the day following praziquantel completion. Avoid combination

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Praziquantel. Monitor therapy

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Duvelisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fosnetupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Grapefruit Juice: May increase the serum concentration of Praziquantel. Monitor therapy

Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Ivosidenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Larotrectinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Lorlatinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Avoid concurrent use of lorlatinib with any CYP3A4 substrates for which a minimal decrease in serum concentrations of the CYP3A4 substrate could lead to therapeutic failure and serious clinical consequences. Consider therapy modification

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Consider therapy modification

Netupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Pitolisant: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Combined use of pitolisant with a CYP3A4 substrate that has a narrow therapeutic index should be avoided. Other CYP3A4 substrates should be monitored more closely when used with pitolisant. Consider therapy modification

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Simeprevir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

St John's Wort: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Adverse Reactions

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

Warnings/Precautions

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.

Concurrent drug therapy issues:

• Drug/drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Therapeutic levels of praziquantel may not be achieved with concurrent administration of strong inducers of cytochrome P450 (eg, rifampin); concurrent use is contraindicated.

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.

Monitoring Parameters

Liver function tests; monitor patients with cardiac irregularities during treatment; monitor for seizures; culture urine or feces for ova prior to instituting therapy

Pregnancy Considerations

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]).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience loss of strength and energy, dizziness, headache, abdominal pain, or nausea. Have patient report immediately to prescriber seizures, tachycardia, bradycardia, or abnormal heartbeat (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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