BERMOXEL Tablet Ref.[49649] Active ingredients: Praziquantel

Source: Υπουργείο Υγείας (CY)  Revision Year: 2022  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: anthelmintic
ATC code: P02BA01

Praziquantel is effective against most trematodes pathogenic for humans, such as:

  • Schistosoma haematobium, Schistosoma mansoni, Schistosoma japonicum, Schistosoma intercalatum;
  • Other species of trematodes such as liver flukes like: Clonorchis sinensis, Opistorchis viverrini;
  • Lung flukes such as Paragonimus westermani.

In vitro experiments enabled to define the mode of action of praziquantel: from 0.4μg/ml, an immediate contraction is observed, followed by an immobilization of the parasite as soon as it is in contact with the product solution. An intense vacuolization of the schistosome tegument occurs.

Paediatric population

Post-marketing experience indicates that children (aged 1 to 17 years) are likely to experience side effects similar to those seen in adults when taking praziquantel.

A review of treatment programs in endemic areas was conducted by WHO which analyzed data on more than 3,000 preschool children (up to 7 years) who received praziquantel for the treatment of schistosomiasis (due to S. haematobium and S. mansoni). The reported side effects were mild and transient and it was concluded that praziquantel was well tolerated in preschool children.

5.2. Pharmacokinetic properties

Praziquantel is rapidly absorbed after oral administration. Maximum serum concentration is achieved 1-3 hours after intake. The active principle is rapidly and completely metabolized, the elimination half-life of unchanged praziquantel in serum being from 1–1,5 hours. Over 80% of the dose administered is eliminated by the kidneys within 4 days, 90% of this amount within the first 24 hours.

In breastfeeding women, the plasma concentrations of praziquantel are on average 4 times higher than those found in milk. Only 0.0008% of the dose administered is eliminated in milk.

The excretion of praziquantel (approximately 80% is excreted by the kidney) may be delayed in patients with impaired renal function.

In case of hepatocellular insufficiency, reduced metabolism of praziquantel may lead to an increase in its plasma half-life.

5.3. Preclinical safety data

Not applicable.

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