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    3. Eroton 100mg 2 tablets — Made in Ukraine — Free Delivery

    Eroton 100mg 2 tablets — Made in Ukraine — Free Delivery


    Brand: Fitofarm
    Product Code: Eroton 100mg
    Availability: In Stock
    $23.03
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    Pharmacological properties

    Pharmacodynamics. Eroton is an oral preparation used to treat erectile dysfunction in men. the preparation is a citrate salt of sildenafil, a selective inhibitor of cgmf-specific PDE type 5 (PDE-5).
    Mechanism of action. The physiological mechanism of penile erection is the release of nitric oxide (NO) in the corpus cavernosum upon sexual stimulation. NO activates the enzyme guanylate cyclase, which causes an increase in cGMP levels, relaxation of the smooth muscles of the corpus cavernosum and an increase in blood flow to them.
    Sildenafil does not have a direct relaxing effect on the isolated human corpus cavernosum, but enhances the effectiveness of nitric oxide (NO), suppressing PDE-5, which is responsible for the degradation of cGMP in the corpus cavernosum.
    When a local release of NO occurs during sexual stimulation, the inhibition of PDE-5 by sildenafil causes an increase in the level of cGMP in the corpus cavernosum, resulting in relaxation of smooth muscles and increased blood flow to the corpus cavernosum.
    The use of sildenafil at the recommended doses is ineffective without sexual stimulation.
    Sildenafil is selective for PDE-5. Its effect on PDE-5 is stronger than the effect on other known PDEs.
    Visual impairment. When using sildenafil at a dose of 100 mg, in some patients, after 1 hour, a slight intermittent violation of color perception (blue / green) was revealed; 2 hours after taking the preparation, these changes disappeared. Suppression of PDE-6, which takes part in the process of light transmission in the retina, is considered a probable mechanism of color vision impairment. The effect of sildenafil on PDE-6 is 10 times inferior to its activity relative to PDE-5. Sildenafil does not affect visual acuity, perception contrast, electroretinogram, intraocular pressure, or pupilometry.
    Efficiency. The effectiveness of sildenafil, which was evaluated in relation to the ability of the preparation to provide the onset and maintenance of an erection sufficient for intercourse, was demonstrated and persisted with prolonged use of the preparation (1 year).
    When taking sildenafil in doses of 25; fifty; 100 mg improvement in erection was noted in 62; 74; 82% of patients, respectively. In addition to improving erectile function, the ICEF analysis (International Index of Erectile Function) showed that treatment with sildenafil also increased orgasm and satisfaction from intercourse.
    With sildenafil treatment, improvement was noted in 59% of patients with diabetes mellitus; in 43% of patients who underwent radical prostatectomy; in 83% of patients with spinal cord injury.
    Pharmacokinetics. Within the recommended dose range, the pharmacokinetics of sildenafil are dose proportional. The preparation is excreted from the body mainly by biotransformation in the liver (mainly with the participation of cytochrome P450 3A4) with the formation of an active metabolite with properties similar to sildenafil.
    Suction. Sildenafil is rapidly absorbed after oral administration. Cmax reached in blood plasma was recorded 30–120 min (average 60 min) after oral intake on an empty stomach. In cases where the preparation is taken with very fatty foods, the rate of absorption decreases.
    Distribution. The average volume of distribution of sildenafil in the equilibrium state is 105 liters, which indicates its penetration into the tissues. Both sildenafil and its main metabolite are approximately 96% bound to plasma proteins. Protein binding does not depend on the total concentration of the preparation.
    Metabolism. Sildenafil is metabolized primarily by liver isoenzymes. The main circulating metabolite has a selectivity for PDE-5 similar to sildenafil, but its activity for PDE-5 is about 50% of the selectivity of the parent preparation. The concentration of this metabolite in blood plasma is about 40% of the corresponding concentration of sildenafil. The final half-life of the metabolite is about 4 hours.
    Excretion. The total clearance of sildenafil is 41 l / h with a final half-life of 3-5 hours. When administered orally, sildenafil is excreted mainly in the feces (about 80% of the dose taken) and, to a lesser extent, in the urine (about 13% of the dose taken).
    Pharmacokinetics in patients of special groups
    Elderly patients. Elderly patients (65 years and older) showed decreased levels of sildenafil clearance, and sildenafil concentrations were approximately 90% higher than in young patients (18–45 years). Given the age dependence of protein binding, the corresponding increase in plasma concentration of free sildenafil was almost 40%.
    Patients with impaired renal function. In patients with mild (creatinine clearance 50–80 ml / min) and moderate (creatinine clearance 30–49 ml / min) impairment of renal function, the pharmacokinetics of sildenafil did not change after oral administration in a single dose of 50 mg. In patients with severe (creatinine clearance ≤30 ml / min) renal impairment, sildenafil clearance decreased, which led to an increase in AUC (100%) and Cmax (88%) compared with patients of the same age, but without renal impairment.
    Patients with liver failure. In patients with mild to moderate liver cirrhosis (class A and B on the Child-Pugh scale), the clearance of sildenafil decreased, which was the reason for an increase in AUC (84%) and Cmax (47%) compared with patients of the same age who were not diagnosed liver failure. The pharmacokinetics of sildenafil in patients with severely impaired liver function (class C on the Child-Pugh scale) have not been studied.

    Indications

    Treatment of erectile dysfunction, which is defined as the inability to achieve and maintain an erection of the penis necessary for successful intercourse. for the effective action of the preparation, sexual arousal is necessary.

    Application

    The tablets are intended for oral administration. to realize the effect of sildenafil, sexual arousal is necessary.
    It is taken orally approximately 1 hour before intercourse.
    The initial dose of the preparation is 50 mg. Given the effectiveness and tolerability of the preparation, the dose can be increased to 100 mg or reduced to 25 mg. The maximum daily dose is 100 mg, the maximum recommended frequency of administration is 1 time per day. The activity of Eroton can manifest itself with a long duration of action when taking the preparation with food compared to taking it on an empty stomach.
    Use in elderly patients. No dose adjustment is required.
    Use in patients with impaired renal function. With mild to moderate renal failure (creatinine clearance - 30–80 mg / min), the dosage regimen does not change. In severe renal failure (creatinine clearance 30 ml / min) due to reduced clearance of sildenafil, the initial dose of the preparation is 25 mg.
    Use in patients with impaired liver function. Due to the reduced clearance of sildenafil, the initial dose of the preparation is 25 mg.
    Application during treatment with other preparations. For patients who take simultaneously preparations - inhibitors of the isoenzyme 3A4 of cytochrome P450 (erythromycin, ketoconazole, itraconazole, saquinavir, etc.), the initial dose of sildenafil is 25 mg. When taken simultaneously with ritonavir, the maximum single dose of sildenafil should not exceed 25 mg for 48 hours.
    In order to reduce the risk of postural hypotension, stabilization of the patient's condition should be achieved during therapy with α-adrenergic receptor blockers before using the preparation. In addition, the lowest dose should be started.
    If it is necessary to prescribe the preparation in a dose of 25 mg, use sildenafil in an appropriate dose.

    Contraindications

    Hypersensitivity to sildenafil and auxiliary components of the preparation; therapy with nitrates or other donors of nitric oxide (since sildenafil enhances the hypotensive effect of nitrates, which are used constantly or in emergency cases); diseases in which sexual activity is undesirable (severe forms of cardiovascular diseases, unstable angina pectoris, severe heart failure, etc.); simultaneous reception with other preparations for the treatment of erectile dysfunction.
    Reception of Eroton is contraindicated in patients who have lost vision in one eye due to non-arterial anterior ischemic optic neuropathy, regardless of whether this happened due to a previous intake of a PDE-5 inhibitor or not.
    The safety of sildenafil has not been studied in such subgroups of patients, and therefore its use is contraindicated in patients with severe hepatic impairment, arterial hypotension (BP 90/50 mm Hg), with recent stroke or myocardial infarction and known hereditary degenerative retinal diseases , such as retinitis pigmentosa (in a minority of such patients, the genetic disease PDE of the retina is noted).

    Side effects

    From the side of the nervous system - headache, dizziness, drowsiness, hypesthesia; epileptic seizure, relapse of epileptic seizure, increased fatigue;
    from the cardiovascular system - vasodilation (hot flashes), arterial hypotension or hypertension, palpitation (palpitations), transient ischemic attacks, ventricular arrhythmia, tachycardia, unstable angina pectoris, myocardial infarction, sudden cardiac arrest, syncope, stroke, epistaxis;
    on the part of the organ of vision - visual impairment (blurred vision, increased sensitivity to light), visual field defects, chromatopsia (moderate, transient, mainly color vision), eye pain, eye redness, non-arterial anterior ischemic optic neuropathy, vascular retinal occlusion ;
    on the part of the organ of hearing - ringing in the ears, sudden deafness;
    from the respiratory system - rhinitis (nasal congestion);
    from the digestive system - dyspepsia, nausea, vomiting, dry mouth;
    from the immune system - hypersensitivity reactions (including skin rash), Stevens-Johnson syndrome, toxic epidermal necrolysis;
    on the part of the reproductive system - prolonged erection and / or priapism;
    from the musculoskeletal system - myalgia, chest pain.

    Special instructions

    To diagnose erectile dysfunction, determine the possible causes of the disease and prescribe adequate treatment, it is necessary to carefully study the patient's medical history and conduct a thorough medical examination.
    For the effectiveness of Eroton, sexual stimulation is necessary.
    A certain degree of risk is associated with sexual activity due to the possibility of a heart attack. So, before starting a course of any treatment for erectile dysfunction, the doctor must check the condition of the patient's cardiovascular system. Erectile dysfunction medications should not be taken in patients for whom sexual activity is undesirable.
    Serious cardiovascular complications such as myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, and transient ischemic attack have been reported. Most, but not all, patients with such complications had a pre-existing cardiovascular risk factor. The overwhelming majority of such cases were noted during or immediately after sexual activity, a small part - after a short period after taking sildenafil without sexual activity. Other cases occurred within hours or days after the use of sildenafil and sexual activity. Thus, it is impossible to establish a direct relationship of such cases with the use of sildenafil, sexual stress, concomitant cardiovascular diseases, a combination of these factors or other factors.
    With a single dose of sildenafil in doses up to 100 mg, no clinically significant ECG changes were detected. The average maximum decrease in systolic blood pressure in patients who were in a horizontal position after oral administration of the preparation at a dose of 100 mg was 8.34 mm Hg. Art. The corresponding change in diastolic blood pressure in patients who were in a horizontal position was 5.5 / 3 mm Hg. Art. Lower than usual, but short-term, blood pressure decreased in patients who simultaneously took nitrates.
    Sildenafil exerted a systemic vasodilating effect, which led to a transient decrease in blood pressure. This effect is insignificant or does not lead to any consequences in most patients. However, before prescribing sildenafil, the physician should carefully weigh the risk of undesirable manifestations of vasodilating effects in patients with certain concomitant diseases, especially against the background of sexual activity. Hypersensitivity to vasodilators was found in patients with left ventricular obstruction (aortic stenosis, obstructive hypertrophic cardiomyopathy), as well as with multiple manifestations of systemic atrophy, which is observed in isolated cases and manifests itself in severe impairment of autonomic blood pressure control.
    Eroton at a dose of 100 mg 1 time per day when administered orally in patients with severe heart disease reduces the mean systolic blood pressure at rest and diastolic blood pressure compared to the initial level. The mean pulmonary systolic blood pressure decreased by 9%. Sildenafil had no effect on cardiac output and blood flow in stenotic coronary arteries due to improved adenosine-stimulated blood flow reserve (in coronary arteries with and without stenosis).
    In patients with erectile dysfunction and stable angina pectoris, who regularly took antianginal preparations (with the exception of nitrates) and used sildenafil at a dose of 100 mg once a day orally, there was an increase in the duration of the treadmill test and the average time of exercise before exacerbation of the symptoms of angina pectoris compared with placebo.
    In patients with concomitant hypertension, who are simultaneously taking 2 or more antihypertensive preparations, sildenafil at a dose of 100 mg once a day by mouth improved erection and increased the number of successful sexual attempts. The number of side effects was the same compared to the corresponding indicator in patients in other groups who took 3 or more antihypertensive preparations.
    Non-arterial anterior ischemic neuropathy of the optic nerve (NAION) has been reported as a cause of visual impairment or loss. In case of a sudden deterioration in vision, you should stop taking the preparation and immediately consult a doctor. Most of these patients had the following risk factors: decreased depth / area ratio (stagnant disc), age over 50, diabetes mellitus, hypertension, coronary artery disease, hyperlipidemia, and smoking. No causal relationship has been established between the use of PDE-5 inhibitors and the occurrence of NAION. The physician should warn patients who have already had NAION manifestations of the possible relapse of NAION. Patients should be warned about the need for immediate medical attention in case of sudden visual impairment.
    In patients with age-related retinal degeneration, sildenafil at a dose of 100 mg once a day by mouth was well tolerated and did not show a clinical effect during the study of visual functions in tests (visual acuity, Amsler mesh, color recognition, artificial light flux, Gumphrey perimeter and photostress).
    It is recommended to use sildenafil with caution in patients who are simultaneously taking α-adrenergic receptor blockers, since in some cases this can lead to symptomatic arterial hypotension. In order to minimize the risk of postural hypotension, stabilization of blood pressure should be achieved with the help of α-adrenergic receptor blockers before using sildenafil. It is necessary to start using sildenafil at low doses. In addition, the physician should advise the patient on what to do if symptoms of postural hypotension occur.
    Some patients with congenital retinitis pigmentosa have genetic defects in the PDE of the retina. There is no information regarding the safety of prescribing sildenafil to patients with retinitis pigmentosa, therefore, this group of patients should be prescribed sildenafil with caution.
    Sildenafil enhances the antiaggregatory effect of sodium nitroprusside (NO donor). There is no information regarding the safety of prescribing sildenafil to patients with a bleeding tendency or acute gastric ulcer, therefore, this group of patients should be prescribed sildenafil with caution.
    preparations used to treat erectile dysfunction should be used with caution in patients with anatomical deformities of the penis (such as angulation, cavernous fibrosis, or Peyronie's disease) and in patients with conditions that can lead to priapism (such as sickle cell anemia, multiple myeloma, or leukemia ).
    The safety and efficacy of combinations of sildenafil with other treatments for erectile dysfunction have not been studied, so such combinations are not recommended.
    After oral administration of a single dose of 100 mg of sildenafil, there was no effect on sperm motility and morphological properties of sperm in healthy patients.Sudden hearing loss and hearing loss have been reported in a small number of patients with PDE5 inhibitors, including sildenafil. Most of these patients had risk factors for sudden hearing loss or loss. No causal relationship has been established between the use of PDE5 inhibitors and sudden hearing loss and loss. In case of sudden hearing loss and loss, patients should be advised to stop using sildenafil and consult a doctor immediately.
    Use during pregnancy and lactation. The preparation is not used in women.
    Children. The preparation is not used in children.
    The ability to influence the reaction rate when driving or working with other mechanisms. Due to side effects (dizziness, changes in vision), sildenafil may affect the ability to drive or operate machinery. 

    Interactions

    The effect of other preparations on sildenafil. the metabolism of sildenafil is mediated mainly by cytochrome p450 (cyp). inhibitors of these isoenzymes can reduce the excretion of sildenafil, and inducers of these isoenzymes can increase its excretion.
    There was a decrease in the clearance of sildenafil while using it with CYP 3A4 inhibitors (such as ketoconazole, erythromycin, cimetidine). Cimetidine (800 mg), an inhibitor of cytochrome P450 and a nonspecific inhibitor of CYP 3A4, when taken together with sildenafil at a dose of 50 mg, decreases by 56%.
    A single dose of an antacid (magnesium hydroxide and aluminum hydroxide) does not affect the bioavailability of sildenafil.
    CYP 2C9 inhibitors (such as tolbutamide, warfarin), CYP 2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazides and related diuretics, ACE inhibitors and calcium channel blockers did not affect the pharmacokinetics of sildenafil.
    The effect of azithromycin (500 mg / day for 3 days) on the elimination rate and half-life of sildenafil or its main metabolites has not been proven.
    The effect of sildenafil on other preparations. Sildenafil is a weak inhibitor of cytochrome P450 isoforms. It is unlikely that Eroton is able to change the excretion of substrates of these isoenzymes.
    Sildenafil enhances the hypotensive effect with short-term and long-term use of nitrates, therefore, one-time or course use of nitric oxide donors, organic nitrates or organic nitrites in any form with sildenafil is contraindicated.
    When sildenafil (25; 50 and 100 mg) was used in patients with benign prostatic hyperplasia simultaneously with doxazosin therapy (4 and 8 mg), which was maintained at a stable level, an additional decrease in blood pressure and an average additional decrease in blood pressure were noted. When sildenafil and doxazosin were administered concurrently to patients refractory to doxazosin therapy, cases of symptomatic postural hypotension were infrequently reported. Her symptoms included dizziness and lack of coordination when exposed to light, but not loss of consciousness. Concomitant treatment with sildenafil in patients receiving therapy with α-adrenergic receptor blockers may lead to symptomatic arterial hypotension in some of them.
    Signs of significant interaction of sildenafil (50 mg) with tolbutamide (250 mg) or warfarin (40 mg), each of which is metabolized by CYP 2C9, have not been identified.
    Sildenafil (50 mg) does not increase the duration of bleeding caused by acetylsalicylic acid (150 mg).
    Sildenafil (50 mg) did not enhance the hypotensive effect of alcohol in healthy patients.
    There was no interaction between sildenafil (100 mg) and amlodipine in hypertensive patients.
    It is not recommended to prescribe sildenafil concurrently with ritonavir, which is a P450 inhibitor and leads to a change in the pharmacokinetic parameters of sildenafil.
    The safety analysis showed that there is no difference in the profile of adverse reactions in patients taking sildenafil alone, and in patients who use this preparation together with antihypertensive preparations.

    Overdose

    Symptoms: in case of an overdose of sildenafil (a dose of 800 mg in healthy volunteers), undesirable effects are noted, similar to those when using lower doses of the preparation, but their frequency and severity increased.
    Treatment: symptomatic therapy. Dialysis is ineffective due to the high degree of binding of sildenafil and its metabolite to blood proteins.

    Storage conditions

    In its original packaging at a temperature not exceeding 25 ° C.

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