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Vias 100 mg coated tablets 4’s




The instruction for medical use of VIASIL medicine the Trade name Viasil Mezhdunarodnoye the unlicensed name Sildenafil Lekarstvennaya the Tablet form, coated, 50 mg and 100 mg One tablet contains Structure: active agent – sildenafit (in the form of citrate) 50.0 mg (70.0 mg) or 100.0 mg (140.0 mg), excipients: microcrystalline cellulose, potato starch, magnesium stearate, lactoses monohydrate, structure of a cover of Opadray the II blue: polyvinyl alcohol, titan dioxide (E171), polyethyleneglycol, talc, FD&C Blue No. 1 / Diamond blue FCF aluminum varnish (diamond blue (E133) of 11-13%, aluminum hydroxide of 87-89%), FD&C Blue No. 2 / Indigo carmine aluminum varnish (indigo carmine (E132) of 11-14%, aluminum hydroxide of 86-89%), FD&C Yellow No. 6 / Orange yellow FCF aluminum varnish (orange yellow (E110) of 15-18%, aluminum hydroxide of 82-85%). The description of the Tablet, coated, blue color, with a biconvex surface. Pharmacotherapeutic group Drugs for treatment of urological diseases. Other drugs for treatment of urological diseases, including spasmolysants. Drugs for treatment of disturbances of an erection. Sildenafil. The ATX G04BE03 code the Pharmacological Sildenafil Pharmacokinetics Absorption properties is quickly soaked up. Cmax at intake is on an empty stomach reached within 30 – 120 min. (on average 60 min.). The absolute bioavailability averages about 41% (25 – 63%). At reception of a sildenafil with food the speed of absorption decreases, Tmax increases for 60 min., and Cmax decreases on average by 29%. The pharmacokinetics in the range of doses of 25 – 100 mg is linear. Distribution the Volume of distribution of a sildenafil in an equilibrium state (Vd) averages 105 l that indicates its distribution in fabrics. After single dose of 100 mg of a sildenafil the average maximum concentration of a free sildenafil in blood plasma approximately makes 440 ng/ml (CV 40%). Sildenafil and his main circulating N-desmetilovy a metabolite approximately for 96% contact proteins of plasma, average maximum concentration of a free sildenafil in blood plasma makes about 18 ng/ml (38 nanometers). At measurement of concentration of a sildenafil in sperm of healthy volunteers in 90 minutes after administration of drug it is shown that less than 0.0002% (on average 188 ng) the accepted dose get into sperm. Metabolism Sildenafil is metabolized, mainly, under the influence of CYP3A4 cytochrome (main way) and CYP2C9 (additional way) of microsomal isoenzymes of a liver. The main circulating metabolite is formed by N-desmetilirovaniya of a sildenafil. This metabolite possesses selection action on FDE, like a sildenafil. Its inhibiting effect on FDE5 at the research in vitro makes about 50% of activity of the sildenafil. Concentration of a metabolite in plasma makes about 40% of concentration of a sildenafil. N-desmetilovy a metabolite is exposed to further metabolism, its final elimination half-life is approximately equal to 4 hours. Removal the General clearance of a sildenafil in an organism makes 41 l/hour, final elimination half-life – 3 – 5 hours. At intake or intravenously sildenafit it is removed in the form of metabolites, generally with a stake (about 80% of the dose accepted inside) and to a lesser extent with urine (about 13% of the dose accepted inside). Pharmacokinetics at special groups of patients Elderly patients At healthy elderly volunteers (65 years are also more senior) the clearance of a sildenafil was reduced, and concentration sildenafit and active N-desmetilovogo of a metabolite in plasma was about 90% higher than its level at healthy young volunteers (18-45 years). Owing to age difference in linking of drug with proteins of plasma, observed increase in concentration of a free sildenafil in blood plasma was 40%. The renal failure At volunteers with a slight and moderate renal failure (clearance of creatinine of 30-80 ml/min.) pharmacokinetics of a sildenafil at its single dose in (50 mg) did not change. At volunteers with a heavy renal failure (clearance of creatinine & lt, 30 ml/min.) the clearance of a sildenafil was reduced that led to increase in AUC (100%) and Cmax (88%) in comparison with the same indicators at volunteers of the same age without renal failure. Besides, AUC and Cmax N-desmetilovogo values of a metabolite were much higher at persons with a heavy renal failure, for 200% and 79%, respectively, in comparison with patients with normal function of kidneys. A liver failure At volunteers with the easy and moderated cirrhosis forms (Classes A and B on Chayld-Pyyu) the clearance of a sildenafil was reduced that led to increase in AUC (84%) and Cmax (47%) in comparison with these indicators at volunteers of the same age without abnormal liver function. The pharmacokinetics of a sildenafil at patients with a heavy liver failure was not studied. The pharmacodynamics Selectively inhibits the tsGMF-dependent phosphodiesterase of type 5 (FDE-5) which is contained mainly in unstriated muscles of a cavernous body and interferes with destruction of tsGMF. Increase in level of the last leads to decrease in intracellular concentration of calcium and relaxation of smooth muscle cells of a cavernous body with the subsequent increased filling of sine with blood against the background of increase in an arterial blood-groove in a penis and compression of the taking-out veins. Drug strengthens and increases duration of the erection which resulted from sexual stimulation. Inhibits retina FDE-6 (though is weaker, than FDE-5, selectivity of action 10:1) and can cause disturbances of color sight. Increases antiagregantny and dezagregatsionny effects of nitrogen oxide (II) and its donators, blocks formation of blood clots of ex Vivo. At introduction in high doses considerably increases a bleeding time (does not influence a blood clotting time). Single dose inside in doses higher than 30 mg is followed by increase in the tsGMF level in plasma. Expands both arterial, and venous vessels, causes decrease in systolic and diastolic arterial blood pressure and increase in heart rate. Has antidiuretic effect. Does not influence reproductive function. Does not influence morphology, mobility and viability of spermatozoa, volume and viscosity of an ejaculate. Has no teratogenic, mutagen, cancerogenic properties. Indications – the erectile dysfunction which is characterized by inability to achievement or preservation of an erection of a penis sufficient for satisfactory sexual intercourse. Viasila is necessary for effective action sexual stimulation. The route of administration and doses of the Tablet Viasil accept inside. Use for adult patients For most of patients the recommended dose makes 50 mg, applied in 1 hour prior to sexual intercourse. Depending on efficiency and tolerance of drug, the dose can be increased to the maximum recommended dose of 100 mg or is reduced to the minimum dose of 25 mg. Frequency of reception of the maximum recommended dose is once a day. Use for elderly patients For patients is more senior than 65 years with a liver and heavy renal failure and also at simultaneous use of strong inhibitors of P450 3A4 cytochrome (ketokonazol, itrakonazol, erythromycin, sakvinavir), use of drug of a sildenafil in an initial dose of 25 mg as higher concentrations in plasma can increase both efficiency, and frequency of side reactions is recommended. Use for patients with a renal failure with a renal failure of light and moderate severity (clearance of creatinine within 30-80 ml/min.) is not required to dose adjustment From patients. Due to the decrease in clearance of a sildenafil at patients with a heavy renal failure (clearance of creatinine & lt, 30 ml/min.), it is necessary to use drug of a sildenafil a dosage of 25 mg. Use for patients with an abnormal liver function As at patients with an abnormal liver function (for example, in cirrhosis) the clearance of a sildenafil is reduced, it is recommended to use drug of a sildenafil a dosage of 25 mg. Use for the patients taking other drugs Joint reception of a sildenafil with ritonaviry is not recommended and anyway the maximum dose of a sildenafil should not exceed 25 mg within 48 hours. Use of drug of a sildenafil in an initial dose of 25 mg is recommended for the patients receiving at the same time CYP3A4 isoenzyme inhibitors (for example, erythromycin, sakvinavir, ketokonazol, itrakonazol). For the purpose of decrease to a minimum of a likelihood of developing postural hypotension, patients have to be in a stable state when performing treatment by alpha adrenoblockers prior to use of a sildenafil. Besides, in such cases it is recommended to begin use of a sildenafil with lower doses. To apply strictly on doctor’s orders. Side effects At Viasil’s use are registered undesirable effects which were classified by the frequency of their manifestation as follows: very often (≥ 1/10), it is frequent (from ≥ 1/100 to & lt, 1/10), infrequently (from ≥ 1/1000 to & lt, 1/100) and is rare (≥ 1/10,000 and & lt, 1/1000). Very often – a headache Often – dizziness – visual distortions of color (chloropsiya, a chromatopsia, blue vision, red vision, a xanthopsia), a visual disturbance, illegibility of sight – hyperaemia, inflows – congestion of a nose – dyspepsia, nausea Infrequently – rhinitis – hypersensitivity – drowsiness, a hypesthesia – the disturbances connected with dacryagogue (xerophthalmus, dysfunction of a lacrimal gland, the raised dacryagogue), eye pain, photophobia, a photopsia, hyperaemia of vessels of eyes, brightness of visual perception, conjunctivitis – a spatial disorientation (vertigo), sonitus – tachycardia, heart consciousness – arterial hypertension, arterial hypotension – nasal bleeding, congestion of adnexal bosoms of a nose – pain in an upper part of a stomach, a gastroesophageal reflux disease, vomiting, dryness in a mouth – rash – myalgia, extremity pain – a hamaturia – thorax pain, increased fatigue, feeling of heat – the increased heart rate Seldom – an acute disorder of cerebral circulation, the tranzitorny ischemic attack, a convulsive attack *, a recurrence of a convulsive attack *, a syncope – front nearteriitny ischemic neuropathy of an optic nerve *, occlusion of vessels of a retina *, a retinal apoplexy, an arteriosclerotic retinopathy, a retina disease, glaucoma, defect of a field of vision, a diplopia, decrease in visual acuity, shortsightedness, an asthenopia, vitreous floating opacities, a disease of an iris of the eye, a mydriasis, existence in sight of iridescent circles, eye hypostasis, swelling of an eye, a visual disturbance, conjunctival hyperaemia, irritation of an eye, unusual feeling in an eye, swelled a century, discoloration of a sclera – deafness – a sudden cardiac death *, a myocardial infarction, ventricular arrhythmia *, fibrillation of auricles, unstable stenocardia – feeling of constraint in a throat, nose hypostasis, dryness mucous a nose – an oral hypesthesia – Stephens’s syndrome – Johnson *, a toxic epidermal necrolysis * – bleeding from a penis, a priapism *, a gematospermiya, strengthening of an erection – irritability * the side effects registered only during post-registration observation. * the side effects registered only during post-registration observation. The message of data on expected undesirable reactions the Message of data on the expected undesirable reactions revealed after medicine registration is of great importance. It allows to continue monitoring of a ratio of advantage and risk of medicine. Health workers and patients are asked to report about any undesirable reactions to the address specified at the end of this instruction for medical use. Contraindications – hypersensitivity to active agent or to any of excipients – a concomitant use of drugs, being donators of nitrogen oxide (amyle nitrite) or nitrates in any form – a concomitant use with guanylate cyclase stimulators (riotsiguat) – a heavy liver failure – hereditary degenerative diseases of a retina of an eye (for example, a hereditary pigmentary retinitis (the small number of these patients has inherited disorders of functions of phosphodiesterases of a retina)), – loss of sight on one eye owing to front nearteriitny ischemic neuropathy of an optic nerve, regardless of whether this episode was connected with the previous use of FDE-5 inhibitor or not – arterial hypotension (the ABP & lt, 90/50 mm Hg – a serious cardiovascular illness (for example, heavy heart failure, unstable stenocardia) – the myocardial infarction postponed to the last 6 months – the stroke which is had in the last 6 months – a concomitant use with CYP3A4 isoenzyme inhibitors (for example, ketokonazol, itrakonazol, ritonavir, erythromycin, sakvinavir, klaritromitsin) – the concomitant use of drugs for treatment of pulmonary arterial hypertension (bozentan, iloprost) and the drugs containing sildenafit or any other FDE-5 inhibitor – to men with rare hereditary intolerance of a galactose, deficiency of Lappa lactase or a sprue of glucose and a galactose – a concomitant use with other oral or local means for treatment of erectile dysfunction – children’s and teenage age up to 18 years – women With care: – anatomic deformation of a penis (including, an angulation, cavernous fibrosis or Peyroni’s disease) – the diseases contributing to development of a priapism (such as sickemia (anomaly of red blood cells), multiple myeloma (marrow cancer) or leukemia (cancer of blood cells)) – problems with blood clotting (hemophilia) – the diseases which are followed by bleeding – exacerbations of a peptic ulcer of a stomach or a duodenum – a concomitant use with drugs of group of alpha adrenoblockers. Medicinal interactions Influence of other medicines on sildenafit the Researches in Vivo At a concomitant use of a sildenafil with CYP3A4 inhibitors (such as ketokonazol, erythromycin and Cimetidinum) decrease in clearance of a sildenafil is observed. At this group of patients the increase in frequency of side effects is not observed, nevertheless, it is necessary to begin treatment in an initial dose of 25 mg. The concomitant use of inhibitor of HIV protease of the ritonavir which is strong inhibitor of P450 cytochrome in an equilibrium state (two times a day) with sildenafily (100 mg a single dose) leads 500 mg to increase in the maximum concentration (Cmax) in a sildenafil by 300% (4-hkratno) and also to increase in AUC of a sildenafil in blood plasma for 1000% (11-multiply). In 24 hours the levels of a sildenafil in blood plasma are about 200 ng/ml in comparison with about 5 ng/ml after reception only sildenafit. On these data it will be agreed with the significant effects of a ritonavir on a wide range of substrates of P450 cytochrome. Based on the above-stated data, simultaneous use of a sildenafil with ritonaviry is not recommended. Viasil does not influence pharmacokinetics of a ritonavir. The maximum dose sildenafit under such circumstances should not exceed 25 mg within 48 hours. The concomitant use of inhibitor of HIV protease of the sakvinavir which is CYP3A4 inhibitor in an equilibrium state (three times a day) with sildenafily (100 mg a single dose) leads 1200 mg to increase in Cmax of a sildenafil by 140% and also increase in AUC of a sildenafil by 210%. Sildenafil does not influence pharmacokinetics of a sakvinavir. Stronger CYP3A4 inhibitors, such as ketokonazol and itrakonazol, have more significant effect. At single dose of a sildenafil in a dose of 100 mg together with the erythromycin moderated by CYP3A4 inhibitor in an equilibrium state (500 mg two times a day within 5 days), increase in system influence of a sildenafil by 182% is observed (is determined by
the Develop value AUC). & n

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