Generic drug of the therapeutic class: Infectiology - Parasitology
Active ingredients: Triclabendazole
laboratory: Novartis Pharma SA
Box of 4
Treatment of fascioliasis due to Fasciola hepatica or Fasciola gigantica .
Dosage EGATEN 250 mg Breakable tablet Box of 4
Treatment will be given preferably after the meal (see pharmacokinetic properties / influence of food).
- Adult and child over 6 years: 10 mg / kg body weight in a single dose.
In case of severe infestation, a second dose of 10 mg / kg within 12 to 24 hours may be considered in adults and adolescents over 15 years of age.
- Child under 6 years old:
The benefit / risk ratio of triclabendazole has not been established in children under 6 years of age.
- Renal failure :
In the absence of a study in patients with impaired renal function, the optimal dosage has not been established in this population.
- Hepatic insufficiency :
In the absence of a study in patients with hepatic impairment, the optimal dosage has not been established in this population.
- Known hypersensitivity to triclabendazole or to any of the excipients. - Concomitant treatment with cisapride, pimozide, quinidine, ergotamine or dihydroergotamine (see interactions).
- Children under 6 years: the benefit / risk ratio of triclabendazole has not been established in children under 6 years of age.
- Because of the presence of lactose, this drug is not recommended in case of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.
NOT RECOMMENDED :
- Pregnancy: no evidence of teratogenic effect in rat and rabbit studies with triclabendazole. Other benzimidazole derivatives such as mebendazole, flubendazole and albendazole have been shown to be teratogenic in some animal species. In clinical practice, there is currently no reliable data to evaluate the possible malformative or foetotoxic effect of triclabendazole when administered during pregnancy. As a precaution, triclabendazole should only be used in pregnant women when absolutely necessary and preferably after the first trimester of pregnancy.
- Breast-feeding: the passage of triclabendazole in milk is not known in human clinic. As a precaution, breastfeeding should be avoided within 72 hours after treatment.
Side effects Egaten
Some side effects associated with triclabendazole therapy may be related to the effect of the treatment on the parasite rather than the intrinsic toxicity of the drug. Thus, the urticarial cutaneous manifestations and the attacks of the general state are more frequent during the lysis of the parasite at its phase of invasion. In the days following the treatment, the abdominal and / or right hypochondrial pain as well as the disturbances of the hepatic evaluation with the type of cholestase or hepatic cytolysis can be increased because of the massive elimination of the dead moat by the tracks. bile. These effects can be increased when the parasite load is high.
The undesirable effects that have been described are:
(Frequency indicators: very common> = 10%, frequent> = 1% and = 0.1% and = 0.01% and <0.1%, very rare <0.01%).
- General condition:. Very common : sweating.
. Frequent : feeling of weakness, malaise, chest pain, fever. - Digestive system:. Very common : abdominal pain and / or right and / or epigastric hypochondrium.
. Frequent : loss of appetite, diarrhea, nausea, vomiting, jaundice, hepatobiliary colic. - Nervous system:. Frequent : feeling sick / dizziness, headache.
. Uncommon : drowsiness. - Skin:. Common : urticaria.
. Uncommon : pruritus. - Musculoskeletal system: Uncommon : back pain. - Respiratory system: Common : dyspnea, cough. Renal / metabolic disorders: Uncommon : transient rise in serum creatinine.