DICYNONE ® Etamsilato

DICYNONE ® is a drug based on Etamsilate.

THERAPEUTIC GROUP: Antihemorrhagics.

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

Indications DICYNONE ® Etamsilato

DICYNONE ® is used in the prevention and treatment of bleeding during general and specialized surgical procedures.

Etamsilate is also effective in the therapeutic treatment of states of vascular fragility.

Mechanism of action DICYNONE ® Etamsilato

The etamsilato, taken orally through DICYNONE ® is effectively absorbed in the intestine and readily distributed throughout the body, over 90% bound to plasma proteins.

Maximum plasma concentrations are obtained approximately 4 hours after oral administration. The active principle persists therefore in the circulatory stream for about 8 hours, at the end of which it is eliminated, in unchanged form, mainly through the urine.

The anti-haemorrhagic action of etamsilate is guaranteed by the direct effect on platelet adhesiveness, which is decidedly enhanced, by platelet activation and by the increased expression of adhesion molecules induced by the active ingredient. This mechanism of action allows a significant reduction in the time and volume of bleedings, without increasing the risk of thrombosis.

Studies carried out and clinical efficacy

ETAMSILATE AND PREMATURED MORTALITY

Several researchers have hypothesized that the antihemorrhagic effects of etamsilate could reduce the incidence of intraventricular hemorrhages, very frequent in premature infants, improving their prognosis and clinical course. Despite numerous trials, etamsilate does not appear to significantly affect mortality reduction in these small patients.

2. REDUCED EFFECTIVENESS OF ETAMSILATE IN THE TREATMENT OF MENORRAGIA

The administration of etamsilate in patients suffering from menorrhagia did not produce the expected results, proving to be ineffective in reducing the amount and duration of bleeding. This modest action underlies the reduced use of this drug in obstetrics.

3. MOLECULAR MECHANISM OF ETAMSILATE

This study, carried out on cell cultures, made it possible to clarify the molecular mechanism through which etamsilate acts. More precisely, this active ingredient appears to be able to pre-activate platelets, increasing the expression of P-selectin and other adhesion molecules responsible for platelet adhesiveness and anti-haemorrhagic effect.

Method of use and dosage

DICYNONE ® 250 mg tablets of etamsylate or vials for injections of 250 mg: in the prophylaxis of intraoperative hemorrhagic events, the recommended dosage of etamsilate is 1.5 gr / day (equal to 6 tablets) for the 3 days preceding the operation and of 2 vials within one hour of surgery.

In the post-operative phase, the therapy must be extended with 1 - 1.5 g / day of etamsilate for as many days.

The intake of DICYNONE ® the relative dosage and the timing of intake, must be evaluated by your doctor taking into account the physio-pathological condition of the adult.

The preventive scheme in children is naturally subject to important variations, which are of exclusive specialist relevance.

IN ANY CASE, BEFORE TAKING DICYNONE ® Etamsilato - THE PRESCRIPTION AND CONTROL OF ITS OWN DOCTOR IS NECESSARY.

Warnings DICYNONE ® Etamsilato

Given the important renal secretion of etamsilate, the intake of DICYNONE ® should be performed with particular caution in all patients with reduced kidney function.

The correct timing of administration, both in the pre-operative and post-operative period, is very important in the prevention of bleeding events associated with surgery.

The presence of sodium sulfite tablets and monosodium sulfite vials may cause severe asthma attacks and allergic reactions in sensitive or asthmatic patients.

In these cases and in the presence of fever, erythema and skin rash, the intake of DICYNONE ® should be immediately suspended.

PREGNANCY AND BREASTFEEDING

The absence of studies concerning the pharmacokinetics of etamsilate during pregnancy does not allow us to establish the safety profile of DICYNONE ®, therefore we advise against taking this drug during the entire period of pregnancy and lactation.

Interactions

There are currently no known interactions with other active ingredients that could compromise the patient's health.

An increased anti-haemorrhagic effect could occur following the concomitant administration of other anti-haemorrhagic drugs.

Contraindications DICYNONE ® Etamsilato

DICYNONE ® is contraindicated in case of hypersensitivity to one of its components, and in case of severe renal failure.

Undesirable effects - Side effects

The presence of sulfites in DICYNONE ® could be associated with allergic reactions with anaphylactic symptoms.

However, DICYNONE ® appears to be well tolerated, with minor side reactions such as fever, headache, skin rash, nausea, vomiting and diarrhea, which tend to regress once therapy is stopped.