Praziquantel

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications: 

• Infections due to Schistosoma haematobium and Schistosoma mansoni
• Infestations by the larvae of Taenia solium in the central nervous system (neurocysticercosis)

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy (first trimester)
• Ocular cysticercosis
• Coadministration with strong cytochrome P450 inducers, such as rifampicin

Cautions

• Breastfeeding
• Renal impairment
• Hepatic impairment
• Hepatosplenic schistosomiasis
• Patients living in areas with endemic human cysticercosis
• Cardiac irregularities  
• Epilepsy
• Other signs of potential central nervous systems involvement
• Subcutaneous nodules suggestive of cysticercosis
• Simultaneous occurrence of both schistosomiasis and CNS-cysticercosis infection
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: tab

Adult dosages below include:

• South African Standard Treatment Guideline recommendations
• South African manufacturer recommendations

Infections caused by: Cestodes (Taenia solium); Trematodes (including Schistosoma haematobium and Schistosoma mansoni )

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African Standard Treatment Guideline recommendations

Acute schistosomiasis 

• Oral (tab): 40mg/kg, as a single dose
  Refer to schistomiasis: STG, Adult 2019

Bilharzia

• Oral (tab): 40mg/kg, as a single dose
  Refer to schistosomiasis (bilharzia): STG, PHC 2020 (Amended November 2023)

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South African manufacturer recommendations

Treatment of schistosomiasis caused by S. haematobium and S. mansoni

• Oral (tab): 40mg/kg, as a single dose

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Evening administration is preferable for single dose

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OR

• Oral (tab): 20mg/kg, 4-6hrly in 2 doses in a single day

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If ingestion of tablets several times a day is prescribed, the interval between administrations should not be less than 4hrs and not more than 6hrs

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Should be swallowed whole with a little liquid, preferably during or after meals

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Neurocysticercosis (additional agent required)

• Oral (tab): 50mg/kg/day, in 3 divided doses; Treatment duration: 14 days

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The dosage and period of treatment may not be exceeded

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To be taken with food or liquid

Paed. forms avail. in SA and covered in this monograph: tab

Paed. dosages below include:

• South African Standard Treatment Guideline recommendations
• South African manufacturer recommendations

Infections caused by: Cestodes (Taenia solium); Trematodes (including Schistosoma haematobium and Schistosoma mansoni )

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African Standard Treatment Guideline recommendations

Bilharzia

• Oral (tab): 40mg/kg, immediately as a single dose or in 2 divided doses on same day
  Refer to schistosomiasis (bilharzia): STG, Paed. 2017
  Refer to schistosomiasis (bilharzia): STG, PHC 2020 (Amended November 2023)

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South African manufacturer recommendations

Treatment of schistosomiasis caused by S. haematobium and S. mansoni

Younger than 4 years

• Not established for use

Older than 4 years

• See adult dosage

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No specific dosage recommendations are provided in South African recommendations for the treatment of neurocysticercosis in children

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To be taken with food or liquid

Pregnancy

• First trimester: Contraindicated
• Second and third trimester: Caution
• Safety in pregnancy has not been established

Breastfeeding

• Caution; not recommended
• Praziquantel appears in the milk of breastfeeding women at a concentration of 20-25% of maternal serum. It is not known whether a pharmacological effect is likely to occur in children
• For short-term therapy breastfeeding should be discontinued for the day(s) of treatment and the following 24hrs

Renal Impairment

• Caution; no dose adjustment recommended
  Since 80% of praziquantel and its metabolites are excreted in the kidneys, excretion might be delayed in patients with impaired renal function

Hepatic Impairment

• Caution; no dose adjustment recommended
  Caution is warranted in uncompensated liver insufficiency and in patients with hepatosplenic schistosomiasis. Due to reduced drug metabolism in the liver, considerably higher and longer lasting concentrations of unmetabolised praziquantel can occur in vascular and/or collateral circulation, leading to prolonged plasma half-life. If necessary, the patient may be hospitalised for the duration of the treatment

Elderly

• No dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders 

• Vertigo
• Somnolence
• Drowsiness
• Seizures
• Fatigue
• Headache
• Dizziness
• Psychomotor agitation
• Mental disturbances

Cardiovascular Disorders 

• Non-specific arrhythmias

Gastrointestinal Disorders 

• Diarrhoea (very rarely bloody diarrhoea)
• Nausea and vomiting
• Abdominal pain and distress

Endocrine and Metabolic Disorders

• Anorexia
• Hyperglycemia
• Hyperthermia

Musculoskeletal Disorders 

• Myalgia

Skin and Subcutaneous Tissue Disorders 

• Urticaria
• Pruritus

Immune, Blood and Lymphatic System Disorders

• Allergic reaction
• Polyserositis
• Eosinophilia
• Fever
• Increased total white blood cell count

Sensory Disorders

• Amblyopia

Others 

• Feeling unwell

• CYP450 inducers
• Antiepileptic agents
• Dexamethasone
• Rifampicin
• CYP450 inhibitors
• Cimetidine
• Chloroquine

None routine. Specific cases may require

• Cardiac function
• Hepatic function

Additional observations

• Seizure monitoring
• Urine or faeces culture for ova

Tablet 500mg - EML (Primary)

Praziquantel is a trematodicide. In vitro studies on trematodes and cestodes (tapeworms) have shown that praziquantel induces a rapid contraction of schistosomes by a specific effect on the permeability of the cell membranes. The medicine further causes vacuolisation and disintegration of the schistosome tegument. An increased Ca²⁺ - influx may play an important role. Secondary effects are inhibition of glucose uptake, lowering of glycogen levels and stimulation of lactate release. The action of praziquantel is limited very specifically to trematodes and cestodes; nematodes (including filariae) are not affected.

Spectrum of activity: Cestodes (Taenia solium); Trematodes (including Schistosoma haematobium and Schistosoma mansoni )

Tablet 500mg

• Cysticide (Merck) originator

Tablet 600mg

• Biltricide (Bayer) originator