DAFLON Film-coated tablet Ref.[50939] Active ingredients: Diosmin Hesperidin

Source: Marketing Authorisation Holder  Revision Year: 2019  Publisher: Les Laboratoires Servier France.

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: VASCULOPROTECTIVE / CAPILLARY STABILIZING AGENTS / BIOFLAVONOIDS
ATC Code: C05CA53: cardiovascular system

Pharmacology

It is active upon the return vascular system in the following way:

  • it reduces venous distensibility and stasis,
  • in the microcirculation, it normalises capillary permeability and increases capillary resistance.

Clinical pharmacology

Double blind controlled studies using methods by which the effects of the product on venous haemodynamics could be demonstrated and quantified have confirmed the above pharmacological properties in man.

Dose-effect relationship

A statistically significant dose-effect relationship was established with respect to venous plethysmographic parameters: capacitance, distensibility and rate of emptying. The optimum dose-effect ratio was obtained with 2 tablets.

Venous tonic activity

DAFLON 500 mg increases venous tone: venous occlusion plethysmography with a mercury stress gauge demonstrated a decrease in the rate of emptying.

Microcirculatory activity

Double-blind controlled studies showed a statistically significant difference between placebo and the drug. In patients presenting with signs of capillary fragility, DAFLON 500 mg increases capillary resistance, as measured by angiosterrometry.

Clinical trials

Double-blind placebo-controlled trials have demonstrated the activity of the drug in phlebology, in the treatment of chronic venous insufficiency of the lower limbs (both functional and organic).

5.2. Pharmacokinetic properties

In man, following oral administration of the substance containing 14C Diosmin:

  • Excretion is mainly faecal; a mean of 14% of the dose administered is excreted in the urine
  • The elimination half-life is 11 hours.
  • The drug is extensively metabolised as evidenced by the presence of various phenol acids in the urine.

5.3. Preclinical safety data

Non-clinical data from conventional studies of repeated toxicity administration, genotoxicity and reproductive function toxicity studies do not show any specific risk for humans.

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