ELITEN ® is a drug based on fosinopril sodium salt
THERAPEUTIC GROUP: Antihypertensives - ACE inhibitors not associated
Indications ELITEN ® Fosinopril
ELITEN ® is indicated in the treatment of arterial hypertension and heart failure. In both cases it is also possible to opt for a combined therapeutic treatment.
Mechanism of action ELITEN ® Fosinopril
Fosinopril in sodium salt, active ingredient of ELITEN ® is absorbed in the first tract of the small intestine for about 36% of the total dose taken orally. The active ingredient present in the drug is rapidly metabolized both in the gastro-intestinal mucosa and in hepatic level, where it is transformed into the biologically active form known as fosinoprilat This molecule reaches maximum blood concentrations 3 hours after oral administration of the prodrug.
The antihypertensive action exerted by fosinoprilat materializes in the inhibition of the angiotensin I conversion enzyme, responsible for the degradation of the aforementioned decapeptide into angiotensin II, biologically active because it is responsible for the vasoconstricting action at the arteriolar level and stimulating the secretion of aldosterone , both of which are important factors in the genesis of hypertension. In addition to the above action, fosinoprilat appears to be involved in the inhibition of a second enzyme, known as kininase II, necessary to degrade a molecule (bradykinin) with marked vasodilatory qualities.
Furthermore, several studies have demonstrated the cardioprotective effect of the active ingredient of ELITEN in terms of prevention and therapy of cardiac hypertrophy.
Fosinoprilat is distinguished from other ACE inhibitors - in addition to a prolonged half-life - for being a phosphine derivative that can be effectively eliminated by both the kidney and the liver. This double way of excretion of the drug allows, in case of reduced functionality of one of the two organs, to be able to take advantage of the vicarious function of the other, guaranteeing the maintenance of a good kinetics of elimination.
Studies carried out and clinical efficacy
1. FOSINOPRIL AND OSTEPOPOROSIS
Med Clin (Barc). 2006 Nov 11; 127: 692-4.
Evolution of the bone mass of hypertense menopausal women in treatment with fosinopril
García-Testal A, Monzó A, Rabanaque G, González A, Romeu A.
According to this study, conducted on about 50 postmenopausal women, not all suffering from high blood pressure, the administration of fosinopril could reduce the normal bone demineralization observed in menopause, responsible for the increased incidence of osteoporotic events. If the results were confirmed by other studies, the hypothesis of the involvement of the renin-angiotensin system in bone metabolism could become more and more accredited.
2. FOSINOPRIL AND INFLAMMATORY MARKERS
Am J Cardiol. 2008 Jul 15, 102: 223-5. Epub 2008 May 28.
Effect of fosinopril treatment on serum C-reactive protein levels in patients with microalbuminuria.
van der P Harst, FW Asselbergs, Hillege HL, AA Voors, van Veldhuisen DJ, WH van Gilst
Recent studies have also associated with the administration of fosinopril an anti-inflammatory effect, evidenced by the reduction in plasma levels of C reactive protein. This preventive action against atherosclerosis and cardiovascular diseases has been refuted by a recent study, conducted on 621 patients in whom a statistically significant decrease in this factor was not observed, even after 3 months of treatment.
Acta Cardiol. 2010 Jun; 65: 309-14.
Effects of combination therapy with amlodipine and fosinopril administered at different times on blood pressure and circadian blood pressure pattern in patients with essential hypertension.
Meng Y, Zhang Z, Liang X, Wu C, Qi G.
The study in question evaluated the different efficacy of combined therapy with amlodipine and fosinopril in a single dose compared to chronotherapy, ie taking the two drugs at different times of the day. The results show how chronotherapy can be more effective in reducing blood pressure. nocturnal and in restoring the correct Cicardian pressure rhythms.
Method of use and dosage
ELITEN ® 10mg tablets of fosinopril sodium salt:
for the treatment of arterial hypertension, the most effective dose seems to be that of 20 mg per day, taken in a single way; however, in the initial phase, therapy should include the administration of only one tablet per day. therapeutic effect it would be advisable to adjust the dosage or also to combine another antihypertensive drug, for example a diuretic.
The correct formulation of the dosage should be established by the doctor after a "careful evaluation of the pathological picture, of the possible administration of other antihypertensive drugs and of the physiological state of the patient, in order to avoid the appearance of side effects and maximize the therapeutic efficacy."
IN ANY CASE, BEFORE TAKING ELITEN ® Fosinopril - YOU MUST BE PRESCRIBED AND CHECKED BY YOUR DOCTOR.
Warnings ELITEN ® Fosinopril
The administration of ACE inhibitors, therefore also of ELITEN ® could be accompanied by facial, labial, lingual and laryngeal angioedema, preventing normal breathing. In these cases it would be necessary to provide for the immediate suspension of the therapy and for the implementation of the necessary practices to avoid suffocation. Furthermore, this reaction, like the dermatological ones, could occur with greater incidence in case of hypersensitivity to the active principle, which seems to be accentuated by the bite of some insects and by the use of particular dialysis membranes.
Before starting therapy with ELITEN ® it would be necessary to monitor the electrolytes and blood pressure, in order to establish the correct dosage and, if necessary, to correct the blood chemistry parameters.
Especially in the initial phase of treatment, it is possible to experience marked drops in blood pressure, which could determine the onset of hypotensive crises, however transitory; in these cases it would be advisable to review the dosage, in order to optimize the therapeutic efficacy and avoid the incidence of effects. Therefore, in patients with heart failure, for whom the risk of hypotensive crisis is increased, the administration of the drug should be carried out under close medical supervision and possibly in a hospital setting.
The same thing should be done for particular categories of patients at risk, such as immunosuppressed, patients suffering from renal and hepatic insufficiency of various kinds, and collagenopathies, in which other plasma values should also be monitored, such as azotemia, creatininemia and granulocyte counts.
Some side effects of antihypertensive drugs and ACE inhibitors, such as dizziness, headache and sleepiness, could reduce the patient's normal reactive and perceptive abilities, making it dangerous to use machinery and drive vehicles.
PREGNANCY AND BREASTFEEDING
The side effects on the health of the fetus, described in the literature on experimental models and due to the administration of ACE inhibitors during pregnancy, strongly advise against taking ELITEN ® during this period. Furthermore, considering the neonatal toxicity observed, it is advisable to discontinue breastfeeding in case of concomitant initiation of drug therapy with ACE inhibitors.
Interactions
The therapeutic efficacy of fosinoprilat could be increased by the concomitant administration of antihypertensive drugs, tricyclic antidepressants, antipsychotics, anesthetics and diuretics. This action could be used for therapeutic purposes, in case of correct dosage formulation, but could be responsible for hypotensive crisis as a result of incorrect dosages. For this reason it would be advisable to adjust the administered dose and monitor blood pressure levels. In case of administration of potassium-sparing diuretics, monitoring of the blood potassium levels should also be envisaged, to avoid situations of hyperkalaemia potentially dangerous for the patient's health.
The antihypertensive effect of ELITEN ® could be inhibited by the administration of non-steroidal anti-inflammatory drugs and drugs capable of increasing hydro-saline retention.
Fosinoprilat, as well as other ACE inhibitors, can assist the function of hypoglycemic drugs, allowing better glycemic control, probably through an enhancement of insulin sensitivity.
ELITEN ® can also increase lithium cytotoxicity.
Contraindications ELITEN ® Fosinopril
ELITEN ® is contraindicated in case of hypersensitivity to one of its components, in case of hereditary angioedema or associated with previous pharmacological treatments with ACE inhibitors, in case of severe renal and hepatic impairment and during pregnancy and lactation.
Undesirable Effects - Side Effects
The undesirable effects described for ELITEN ® are generally mild and transient. More frequently it is possible to find asthenia, chest pain, peripheral edema, headache and dry cough.
Clinically more relevant disorders are decidedly rarer and mainly affect particular categories of patients at risk (immunosuppressed, patients with heart, renal and hepatic insufficiency), manifesting themselves with neutropenia followed by recurrent infections of the respiratory and gastrointestinal tract, alterations in frequency cardiac, orthostatic hypotension and alterations of some hematoclinical parameters.
Hypersensitivity towards the active ingredient mainly occurs with angioedema and dermatological reactions.
Note
ELITEN ® can only be sold under medical prescription.
The information on ELITEN ® Fosinopril published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
