Safety and Security of Daflon 500 mg in Venous Insufficiency and in Hemorrhoidal Disease

Abstract

Daflon 500 mg* is a new flavonoid vasoprotector venotonic agent whose active principle is micronized and contains 90% diosmin and 10% flavonoids expressed as hesperidin.

In animal studies, the safety of Daflon 500 mg is shown by an LD₅₀ (lethal dose so) of more than 3 g/kg, ie, 180 times the daily therapeutic dose, as well as by the absence of any toxic effect after repeated oral dosing for thirteen and twenty-six weeks, using a dose representing 35 times the daily dosage, in the rate and primate.

Daflon 500 mg has no mutagenic action nor any significant effect on reproductive function. Gastrointestinal tolerance is good when administered orally in the rat. Transplacental passage and passage into breast milk are minimal. In the rat, 0.003% of the administered dose has been found in each fetus and 1% in breast milk.

Clinical trials fulfill international scientific requirements and have collected more than 2850 patients treated with Daflon 500 mg at the dosage of two tablets per day for six weeks to one year. The proportion of patients with side effects (10% of those treated), essentially of a gastrointestinal or autonomic nature and leading to a rate of only 1.1% trial dropouts, is less than described in 225 patients given a placebo (13.9%) in controlled trials. Satisfactory clinical acceptability already confirmed in the short term was equally found in long-term treatment.

Hemodynamic parameters (systolic and diastolic blood pressure) as well as laboratory parameters (hematology, liver and renal function, metabolic) were uninfluenced even by prolonged treatment for one year at the dosage of two tablets per day.

No contraindications have been found during the therapeutic use of Daflon 500 mg, even in the elderly and in pregnant women. No evidence has been found of any interference with combined drugs. Daflon 500 mg is free of any photosensitizing action.

Daflon 500 mg combines thoroughly proven therapeutic efficacy with excellent safety of use confirmed in specific and methodologically reliable toxicologic studies as well as in a large number of clinical trials with patients treated daily for six weeks to one year.