Parasitic infestations by trematodes including

Schistosoma intercalatum, Schistosoma japonicum, Schistosoma mansoni
· Distomatoses: Clonorchis sinensis, Opisthorchis, viverrini, Paragonimus westermani.

Dosage

The dosage varies according to the parasite

Schistosoma haematobium

A single dose of 40 mg per kg of body weight.

Schistosoma mansoni

Schistosoma intercalatum

A single dose of 40 mg or 2 doses of 20 mg per kg of body weight administered in 24 hours.
Schistosoma japonicum

A single dose of 60 mg or 2 doses of 30 mg / kg body weight in 24 hours.
Clonorchis sinensis

Opisthorchis viverrini

3 doses of 25 mg per kg of body weight distributed over 24 hours.

Paragonimus westermani

3 x 25 mg / day per kg of body weight for 2 days.

Mode of administration

Oral use.

The tablets should be taken with a little liquid, without chewing, during or after a meal if possible.

In the case of a single dose, an evening dose is recommended.
In the case of repeated catches in the same day, the interval between each catch shall not be less than 4 hours and shall not exceed 6 hours.
· The number of tablets required can be calculated from the following table

Body weight In kg

Number of cpr equivalent to 1 x 20 mg / kg

Body weight In kg

Number of cpr equivalent to 1 x 25 mg / kg

Body weight In kg

Number of cpr equivalent to 1 x 30 mg / kg

20-25 / 26

¾

22-26

1

24-28

1; ¼

26 / 27-33

1

27-33

1; ¼

29-33

1; ½

34-41

1; ¼

34-38

1; ½

34-37

1; ¾

42-48

1; ½

39-44

1; ¾

38-43

2

49-56

1; ¾

45-50

2

44-48

2; ¼

57-63

2

51-56

2; ¼

49-53

2; ½

64-70

2; ¼

57-62

2; ½

54-56

2; ¾

71-78

2; ½

63-68

2; ¾

58-63

3

79-86

2; ¾

69-75

3

64-67

3; ¼

Pharmacotherapeutic group, Antihelminthics, ATC code: P02BA01

Praziquantel acts on most pathogens for humans such as

Schistosoma haematobium, Schistosoma mansoni, Schistosoma japonicum, Schistosoma intercalatum

· Other species of trematodes such as liver flukes such as Clonorchis sinensis, Opisthorchis, viverrini

· Pulmonary flukes such as Paragonimus, Westermani.

In vitro experiments determined the mode of action of praziquantel: from 0.4 μg / ml, immediate contraction was observed followed by immobilization of the parasite as soon as it came into contact; With the solution of the product. There is an intense vacuolization of the schistosome integument.

Biltricide has a moderate influence on the ability to drive, vehicles and use machines. Patients should be warned that undesirable effects such as dizziness, dizziness, or drowsiness may occur after taking praziquantel. This is why it is recommended to avoid driving and using machines during the treatment period and for 24 hours after stopping (see Effects, undesirable)

· Hypersensitivity to praziquantel or any of the excipients mentioned under section
· Ocular cysticercosis

Co-administration with rifampicin: rifampicin, being a potent inducer of cytochrome P450, effective plasma levels of praziquantel may not be achieved in co-administration (see section Interactions with other medicinal products and Other forms of interaction)

Precautions for use

Bilharziasis in the invasion phase

The praziquantel is inactive on the Schistosomules during the invasion phase. Therefore, the drug is not effective in acute phase. In addition, the use of praziquantel in the acute phase of schistosomiasis may be associated with paradoxical reactions (Jarisch-Herxheimer type responses: a sudden inflammatory immune response suspected of being caused by the release of Antigens, schistosomes). These reactions may lead to myocarditis, encephalitis and pulmonary complications, which may be life threatening.
Risk of system disorders, nervous

When schistosomiasis or distomatosis is detected in patients living in or from areas where cysticercosis is endemic, it is advisable to hospitalize the patient throughout the course of treatment. Due to its activity on larvae of Taenia solium, praziquantel may exacerbate potential ocular cysticercosis, or central nervous system damage. Praziquantel may exacerbate central nervous system disorders due to schistosomiasis, paragonimosis, or cysticercosis, Taenia solium and should not, as a rule, be administered to patients with a history of epilepsy and / Or showing signs of potential central nervous system damage such as nodules, subcutaneous evoked cysticercosis

Heart rhythm disorders

During treatment with praziquantel, patients with cardiac arrhythmias or having a history of rhythm disorders should be monitored.

Renal insufficiency

Since 80% of praziquantel and its metabolites are excreted renally, excretion may be delayed in patients with renal insufficiency

Hepatic insufficiency and hepatosplenic bilharziasis

Praziquantel should be administered with caution in cases of severe hepatic insufficiency and in patients with schistosomiasis, hepatosplenic, considerably higher, and persistent concentrations of unmetabolized praziquantel can be observed due to Of the decrease in the hepatic metabolism of praziquantel leading to a prolongation of its plasma half-life

Associations, contraindicated

+; Rifampicin

Significant decrease in plasma concentrations of praziquantel with risk of treatment failure due to increased hepatic metabolism of praziquantel by rifampicin

Associations, deprecated

+ Anticonvulsant enzymatic inducers (carbamazepine, phenytoin, phenobarbital, primidone)

Significantly decreased plasma concentrations of praziquantel with risk of treatment failure due to increased hepatic metabolism by the inducer

Associations subject to precautions, use

+; Dexamethasone

Decreased plasma concentrations of praziquantel with risk of treatment failure by increased hepatic metabolism of praziquantel by dexamethasone

Treatment with dexamethasone should be discontinued at least one week before administration of praziquantel

Concomitant administration of cytochrome P450 inhibitors, such as, for example, cimetidine, may increase praziquantel plasma concentrations by decreasing hepatic metabolism

Not applicable.

No cases of overdose have been reported.
Pregnancy

Studies in the animal did not demonstrate embryotoxic or teratogenic effects. The data reported in the literature show a significant number of women treated with no effect, deleterious.

Analyzes published by WHO on the benefit / risk ratio of praziquantel in areas where schistosomiasis and soil-borne helminthoses are endemic have shown that the benefits of treating women of reproductive age or The benefits of treatment for a pregnant woman include a reduction in maternal anemia, an improvement in the birth weight and survival of the newborn, born. Therefore, praziquantel may be used during pregnancy if clinically warranted

Breastfeeding

Praziquantel is excreted in maternal milk at 0.0008% of the dose administered to the mother

The possibility of a pharmacological effect in the breast-fed infant is not determined.
Fertility

There is no clinical data on fertility

Praziquantel showed no effect on fertility during studies in the animal

The undesirable effects of praziquantel vary according to dose, and duration of treatment. They depend also on the parasite concerned and its location and the extent and age of the parasite.

The following undesirable reactions have been described in publications and / or are derived from spontaneous notifications.

The adverse reactions identified during post-marketing surveillance, for which a frequency can not be estimated, are listed in frequency, "indeterminate".
System organ classes

Frequency: unknown

Hematologic and lymphatic system disorders

Eosinophilia

Immune system disorders

Allergic reactions

Disorders of the nervous system

Headache

Dizziness

Dizziness

Somnolence

Convulsions
Cardiac disorders

Arrhythmia

Gastrointestinal disorders

Gastrointestinal and abdominal pain

Nausea

Vomiting
Anorexia

Diarrhea

Bloody diarrhea

Skin and subcutaneous tissue disorders

Urticaria

Pruritus

Skin Rash

Musculoskeletal and connective tissue disorders

Myalgies

General disorders and site abnormalities

Fatigue

Malaise

Fever

Reporting of suspected adverse reactions

The reporting of suspected adverse effects after authorization of the drug is important. It provides continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers for Pharmacovigilance. Website: www.ansm.sante.fr.

Parasitic infestations by trematodes including: Schistosoma, Schistosoma, Schistosoma intercalatum, Schistosoma japonicum, Schistosoma mansoni, disturbatoses: Clonorchis sinensis, Opisthorchis, viverrini, Paragonimus westermani.