PRAXYLENE ® is a drug based on Naftidrofurile.
THERAPEUTIC GROUP: Peripheral vasodilator (old classification used to indicate active ingredients able to improve the hemodynamic characteristics of peripheral vascular districts)
IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects
Indications PRAXILENE ® Naftidrofurile
PRAXYLENE ® is indicated for the treatment and prevention of chronic venous ulcers and the symptoms associated with peripheral vasculopathies.
Mechanism of action PRAXYLENE ® Naftidrofurile
The active substance naphthidrofurile - contained in the PRAXYLENE ® controlled release tablets taken orally - is absorbed in the intestine reaching the maximum plasma concentrations after about 3-4 hours from the intake.
Its therapeutic properties, initially observed with the sole improvement of the peripheral vascular flow, are determined by a series of biological effects able to definitely improve the vascular and perivascular metabolic context.
More precisely, the direct spasmolytic action, the pain-relieving action exercised through the neutralization of pain mediators such as bradykinin, the improvement of the lipidemic framework, and other mechanisms in the characterization phase, guarantee the positive vasodynamic and eumetabolic effect, used as a presupposition therapeutic not only in the treatment and prevention of chronic venous ulcers, but also of all those pathologies characterized by a peripheral vascular disorder (lower limb edema, intermittent claudication and related symptoms).
After its effect, due to a marked hepatic metabolism, the naphthidrofuryl contained in PRAXYLENE ® of its metabolites are mainly excreted through the faeces.
Studies carried out and clinical efficacy
THE NAFTIDROFURILE IN THE TREATMENT OF THE INTERMITTENS CLAUDICATIO
Intermittent claudication is a pathology often due to peripheral vasculopathies based on atherosclerosis, characterized by difficulty in walking accompanied by persistent pains, triggered by the reduction in the supply of nutrients and oxygen to the muscles of the lower limbs. Naphthidoruphile, as shown by this study carried out on 1, 200 patients suffering from this disease, has guaranteed a reduction in symptoms, lengthening the timing of absence of pain and making walking easier.
2. THE NAFTIDROFURILE IN THE TREATMENT OF VASCULAR DEEMENT
The vascular problems that occur during neurodegenerative diseases, such as Alzheimer's disease, are partly responsible for the deterioration of the cognitive abilities of affected patients. This study, conducted on patients diagnosed with vascular dementia, who underwent daily therapy with 600mg of naphthidrofurile for 6 months, showed a slowing of the rate of deterioration compared to the placebo group.
3. HEMODYNAMIC EFFECTS OF NAFTIDROFURILE
The administration for only 8 days of naphthidrofuriile, in patients with atherosclerotic plaques at the level of the carotid bifurcation, ensured an improvement in the hematic elasticity and viscosity, and in the fluidity of the membranes, significantly reducing platelet aggregation. All these effects are the basis of the hemodynamic effects of PRAXYLENE.
Method of use and dosage
PRAXILENE ® naphtidrofurile 100/200 mg coated tablets: the formulation in controlled release coated tablets, of 100 and 200 mg of naphthidrofurile, allows the formulation of accurate dosages related to the therapeutic needs of the patient.
Usually the initial dosage involves the administration of 2 - 3 tablets of 200 mg a day, during meals, to continue in the maintenance phase with a halved dosage.
IN ANY CASE, BEFORE TAKING PRAXYLENE ® Naftidrofurile - THE REQUIREMENT AND CHECK OF YOUR DOCTOR IS NECESSARY.
Warnings PRAXILENE ® Naftidrofurile
The administration of PRAXYLENE ® should be carefully evaluated in case of recent cerebral haemorrhage, in order to avoid possible bleeding.
The massive intake of PRAXILENE ® at dosages decidedly higher than the therapeutic ones, could determine disorders of intracardial conduction and convulsive effects.
It should also be stressed that although the drug itself does not interfere with the patient's normal perceptive capacities, some side effects - such as dizziness and drowsiness - could make the use of machinery and driving vehicles dangerous.
PREGNANCY AND BREASTFEEDING
The absence of standardized clinical trials - related to the effects of PRAXILENE ® taken during pregnancy on the health of the fetus and the newborn - does not allow to characterize the safety and tolerability profile of the drug. Therefore, it is advisable to avoid taking naphthidrofurile during the entire period of pregnancy and lactation.
Interactions
The positive vasodimanic action, accompanied by an improvement in the haemodynamic characteristics, could be enhanced by the concomitant administration of antiarrhythmics and beta-blockers.
Contraindications PRAXILENE ® Naftidrofurile
PRAXILENE ® is contraindicated in case of pregnancy and lactation, and in case of hypersensitivity to one of its active ingredients.
Undesirable effects - Side effects
Clinical trials and post-marketing monitoring have shown only in a few cases the onset of side effects such as headache, nausea, dizziness, diarrhea, anorexia and skin rashes.
In any case, the drug appears to be well tolerated, while the aforementioned reactions appear to be of low clinical and transient significance.
Note
PRAXILENE ® can be sold only under medical prescription.
