TRENTAL ® Pentoxifylline

TRENTAL ® is a drug based on pentoxifylline.

THERAPEUTIC GROUP: Peripheral vasodilator.

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications TRENTAL ® Pentoxifylline

TRENTAL ® is indicated for the treatment of cerebral and peripheral vascular diseases on an atherosclerotic and diabetic basis. Three most common applications are intermittent claudication, diabetic angiopathy, post-thrombotic syndromes, Raynaud's disease and cerebral vascular ischemia-thrombotic and embolic-based alterations.

Mechanism of action TRENTAL ® Pentoxifylline

Pentoxifylline, taken orally by TRENTAL ®, is completely absorbed at the gastrointestinal level, reaching maximum plasma concentrations approximately 30 minutes after its intake. In addition to pentoxifylline, other active metabolites are also found in the plasma, including the so-called M1, which is very important for its prolonged therapeutic action.

The therapeutic efficacy of this active ingredient is essentially due to its hemoreological properties, able to improve the deformability of red blood cells, reducing the viscosity of the blood and the aggregating capacity of the platelet and pro-thrombotic.

To these actions, essentially mediated by the modulation of some intracellular pathways (phosphodiesterases - AMPcyclic), is added the fibrinolytic and inhibitory action of leukocotary activation, which in addition to significantly reducing the potential atherosclerotic and pro-inflammatory risk, promotes the correct exchanges metabolic at the level of microcirculation, improving hemodynamic parameters.

After its therapeutic effect, pentoxifylline and its active metabolites are eliminated in the kidney in a manner proportional to the dose taken, thus avoiding any accumulation phenomenon.

Studies carried out and clinical efficacy

PENTOSSYPHYLLINE AND INFLAMMATION IN TYPE II DIABETIC PATIENTS.

Vascul Pharmacol. 2007 Aug-Sep; 47 (2-3): 118-24. Epub 2007 Jun 2.

The administration of pentoxifylline in type II diabetic patients, also affected by hypertension, resulted in a significant reduction of some inflammatory markers associated with the development of cardiovascular diseases. More precisely, a reduction in the levels of C-reactive protein by 20%, by the ESR by 18%, by the number of plasma leukocytes by 11%, by inflammatory markers such as malonidialdehyde and an increase in antioxidant pull was observed. All these effects could prevent the onset of cardiovascular diseases.

2.PENTOSSIFILLIN IN THE INTERMITTENS CLAUDICATIO

Intermittent claudication is a pathological condition characterized by pain in the lower limbs, which forces patients to have difficulty walking, a sign of peripheral vasculopathy. Despite the effectiveness of pentoxifylline in improving symptoms, in order to achieve a lasting improvement it is necessary to improve the general lifestyle, and resort to drug therapy only at a later time.

3. THE ANTI-INFLAMMATORY EFFECTS OF PENTOSSYLLILLIN

The use of pentoxifylline in patients with acute coronary syndrome (atherosclerotic-based pathology) has led to a significant decrease in plasma concentrations of inflammatory cytokines, in favor of anti-inflammatory cytokines such as IL-10 and TGF-beta. This rebalancing could be important in the prevention and regression of coronary heart disease, and more generally of atherosclerotic disease.

Method of use and dosage

TRENTAL ® modified-release tablets of 400/600 mg of pentoxifylline: the recommended dosage is one tablet of 600 mg twice a day, or one 400 mg tablet 3 times a day. The intake should be preferred after meals, at regular intervals and for long periods of treatment.

Possible adjustments of the dosage, as well as the choice of the timing of the therapeutic protocol, must be established by the doctor after a careful evaluation of the patient's physiopathological conditions.

IN ANY CASE, BEFORE TAKING TRENTAL ® Pentoxifylline - THE REQUIREMENT AND CHECK OF YOUR DOCTOR IS NECESSARY.

Warnings TRENTAL ® Pentoxifylline

TRENTAL ® should be taken with care in patients with reduced kidney function, given the urinary excretion of pentoxifylline and its active metabolites. A careful history should precede the administration of TRENTAL ® in order to avoid the onset of adverse reactions in patients with hypothesis or vascular fragility and circulatory lability.

Although the drug does not seem to directly interfere with the patient's normal perceptual abilities, the possible incidence of side effects such as dizziness and headache, could make the use of machinery or driving vehicles dangerous.

PREGNANCY AND BREASTFEEDING

The pre-clinical experimentation, conducted on laboratory animals, showed no teratogenic or mutagenic effects of pentoxifylline on the fetus. Despite these data, due to the absence of unambiguous and safe clinical trials, we do not recommend taking TRENTAL ® during the entire pregnancy and in the subsequent phase of breastfeeding. If, in the latter case, the administration of this drug is indispensable, it would be appropriate to suspend breastfeeding.

Interactions

The modest hypotensive effect of pentoxifylline could be significantly enhanced by the concomitant intake of antihypertensive drugs, resulting in poor blood pressure control.

In order to avoid this side effect, it would be advisable to monitor blood pressure levels constantly and possibly adjust the dosage.

Pentoxifylline also appears to have some metabolic effects that may require an adjustment in the dosage of oral hypoglycemic agents or insulin, in diabetic patients undergoing TRENTAL ® therapy

Contraindications TRENTAL ® Pentoxifylline

TRENTAL ® is contraindicated in case of hypersensitivity to one of its components, in cases of recent heart attack and severe bleeding.

Undesirable effects - Side effects

The side effects observed during the clinical trial, and recorded in post-marketing experience, have been clinically unimportant, revealing a good tolerability of pentoxifylline.

Gastro-enteric disorders, headache and vertigo were the most described effects, while hypersensitivity episodes and heart rate disorders were decidedly more rare. In any case, all the aforementioned adverse reactions were of a transitory nature, rapidly disappearing following discontinuation of therapy.