Levitra (Vardenafil) 20 mg 1 coated tablet

The instruction on medical primeneniyulekarstvenny means of Levitra® Trade the nazvaniyelevitr ® the International unlicensed was nazvaniyevardenafit Medicinal the formatabletka film coated on 10 mg and 20 mg by Structure One tablet contains active agent – a vardenafil of a hydrochloride trihydrate of 11.852 mg or 23.705 mg (it is equivalent to a vardenafil of 10 mg and 20 mg), excipients: krospovidon, magnesium stearate, cellulose microcrystalline, silicon dioxide colloidal anhydrous, structure of a cover: a macrogoal 400, a gipromelloza, the titan dioxide (E171), ferrous oxide yellow (E172), ferrous oxide red (E172) OpisanieTabletki, film coated from light orange till gray-orange color, round shape, biconvex with a diameter about 7 mm, with an engraving 10 (for a dosage of 10 mg) or with a diameter about 8 mm, with an engraving 20 (for a dosage of 20 mg) on one party and a signature bayerovsky cross – on another. Pharmacotherapeutic gruppapreparata for treatment of urological diseases. Drugs for treatment of disturbances of an erection. VardenafilKod ATKH G04be09 Pharmacological and to the biodostupnostposla of intake vardenafit a svoystvaFarmakokinetikaVsasyvanie quickly is soaked up. At reception on an empty stomach the early peak of the maximum concentration (Cmax) can be reached in 15 minutes, however in 90% of cases – on average in 60 min. (from 30 to 120 min.). The absolute bioavailability averages 15%. The area under a ratio curve the concentration time (AUC) and Cmax increase almost in proportion to the size of a dose of a vardenafil in the recommended range (5-20 mg) after intake. At reception of a vardenafil along with the food containing a large amount of fat (57%), the speed of absorption decreases with increase in time of achievement of the maximum concentration (Tmax) to 60 min., and Cmax decreases on average by 20% without change of AUC. At reception with the food containing 30% of fats, the speed and extent of absorption of a vardenafil (Cmax, Tmax, AUC) do not change in comparison with administration of drug on an empty stomach. The RaspredelenieSredniy volume of distribution of a vardenafil in a steady condition of pharmacokinetic parameters averages 208 l, demonstrating its distribution in fabrics. Vardenafil and his main circulating metabolite (M1) well contact proteins of blood plasma (about 95% for a vardenafil or M1), and both for a vardenafil, and for M1, linking with proteins does not depend on the general concentration of drug. Proceeding from results of measurement of maintenance of a vardenafil in sperm of healthy men 90 min. later after reception, it is established that in sperm of patients no more than 0.00012% of the accepted dose can be defined. MetabolizmVardenafil is metabolized by mainly liver enzymes with participation of a system of CYP3A4 cytochrome and also CYP3A5 and the CYP2C isoforms. Vardenafit the main circulating metabolite (M1) at people formed by a dezetilirovaniye, is exposed to further metabolism with plasma elimination half-life, components are about 4 hours old. A part of a metabolite of M1 in the form of a glucuronide is in system circulation. The profile of selectivity M1 concerning phosphodiesterase is similar to that vardenafit, the ability to suppress FDE-5 of in vitro is about 28% in comparison with vardenafily that corresponds to 7% of efficiency of drug. The VyvedenieObshchiy clearance of a vardenafil is 56 l/h, final T1/2 – about 4-5 hours. After intake vardenafit in the form of metabolites it is removed mainly with a stake (91-95% of the accepted dose) and to a lesser extent – kidneys (2-6% of the accepted dose). Special groups of a patsiyentovpatsiyenta elderly to a vozrasta of healthy elderly male volunteers (& gt, 65 years) in comparison with healthy young volunteers (18-45 years) the hepatic clearance of a vardenafil is reduced. On average at the men of advanced age accepting vardenafit, AUC is 52% more also than Cmax 34% more, than at younger men. Dysfunction to a pochek of volunteers with an insignificant or moderate renal failure (clearance of creatinine, KK: 30-80 ml/min.) pharmacokinetic indicators of a vardenafil are comparable to indicators of faces of control group with normal function of kidneys. In a heavy renal failure (KK & lt, 30 ml/min.) average AUC increases by 21%, and Cmax decreases by 23% in comparison with the volunteers who do not have a renal failure. Statistically reliable correlation between clearance of creatinine and exposure of a vardenafil (AUC and Cmax) is not noted. At the patients who are on a hemodialysis, the pharmacokinetics of a vardenafil was not studied. Dysfunction to a pecheni of patients with an insignificant and moderate abnormal liver function (classes A and B on classification of Chayld-Pyyu) clearance of a vardenafil decreases in proportion to degree of an abnormal liver function. At easy degree of a liver failure (class A on classification of Chayld-Pyyu) increase in AUC and Cmax by 17% and 22% respectively is noted, and at moderated (class B on classification of Chayld-Pyyu) – for 160% and 133% respectively, in comparison with healthy faces of control group. At patients with a heavy abnormal liver function (class C on classification of Chayld-Pyyu) the pharmacokinetics of a vardenafil was not studied. A pharmacodynamics Vardenafil apply inside to improvement of erectile function at men with erectile dysfunction. Under natural conditions, that is at sexual stimulation, vardenafit restores the broken erectile function by increase in inflow of blood to a penis. The erection of a penis represents hemodynamic process. During sexual stimulation there is a discharge of nitrogen oxide (NO) activating enzyme guanylate cyclase that leads to increase in contents in cavernous bodies of the cyclic guanozinmonofosfat (tsGMF). In turn, it leads to relaxation of smooth muscles that promotes increase in inflow of blood to a penis. The maintenance of tsGMF depends on the speed of its synthesis with participation of guanylate cyclase and on the speed of its degradation by hydrolysis by tsGMF-phosphodiesterases (FDE). Vardenafil is powerful selection inhibitor of tsGMF-specific phosphodiesterase of the 5th type (FDE-5) – the most important for cavernous human bodies. Vardenafil considerably strengthens effect of endogenous nitrogen oxide (NO) in cavernous bodies, inhibiting FDE-5. At discharge of nitrogen oxide (NO) in response to sexual stimulation there is FDE-5 inhibition that leads to increase in contents in cavernous bodies of tsGMF. Therefore, sexual stimulation is necessary for rendering favorable therapeutic effect of a vardenafil. In the researches in vitro it is shown that vardenafit has stronger impact on FDE-5, than on other known phosphodiesterases (is stronger in & gt, 15 times, than on FDE-6, & gt, 130 times, than on FDE-1, & gt, 300 times, than on FDE-11 and & gt, 1000 times, than on FDE-2,-3,-4,-7,-8,-9 and-10). In a research of a pletizmografiya of a penis vardenafit in a dose led 20 mg to emergence of an erection sufficient for introduction of a penis to a vagina (rigidity of 60% according to RigiScan) and developing at some men in 15 min. after reception. The general answer on vardenafit in 25 min. after reception at these men was statistically reliable in comparison with placebo. Vardenafil renders a slight and temporary lowering of arterial pressure which in most cases not ssoprovozhdayetsya clinical effect. The average maximum of lowering of systolic arterial blood pressure in a dorsal decubitus after reception of 20 mg of a vardenafil makes 6.9 mm Hg, 40 mg of a vardenafil – 4.3 mm Hg in comparison with placebo. This influence is within vazodilatiruyushchy effect of FDE-5 inhibitors and, perhaps, is a consequence of increase in maintenance of tsGMF in cells of smooth muscles of vessels. Single or multiple dose of a vardenafil in a dose up to 40 mg does not cause clinically significant changes of the ECG in healthy male volunteers. In double-blind, cross, randomized study of single dose at 59 healthy men compared action of a vardenafil (10 mg and 80 mg), sildenafit (50 mg and 400 mg) and placebo on QT interval. Moxifloxacin (400 mg) was used as internal active drug of comparison. Action on QT interval was measured in an hour after administration of drug (average tmax for a vardenafil). The main objective of this research consisted in an exception of influence of single dose in 80 mg of a vardenafil on lengthening of an interval of QT more than on 10 ms in comparison with placebo, measured with correction on Friderition's (QTcF=QT/RR1/3) formula from initial level in 1 hour after reception. Results showed increase in an interval of QTs (across Friderition) on 8 ms (90% of D: 6-9) and 10 ms (90% of D: 8-11) for 10 mg and 80 mg, respectively, in comparison with placebo and also increase in an interval of QTci at 4 ms (90% of D: 3-6) and 6 ms (90% of D: 4-7) for 10 mg and 80 mg, in comparison with placebo, in 1 hour after reception. At tmax only the average change of QTcF for a vardenafil in a dose of 80 mg did not get to the extreme values established in a research (on average 10 ms, 90% of D: 8-11). When using formulas of individual correction any of indicators did not go beyond. In the separate post-market research including 44 healthy volunteers vardenafit 10 mg or sildenafit 50 mg were applied along with gatifloksatsiny 400 mg – drug with comparable influence on QT interval. When calculating for Friderition's formula, both vardenafit, and sildenafit, increase QTs interval by 4 ms (vardenafit) and (sildenafit) 5 ms, when comparing with each drug separately. The actual clinical value of these changes of an interval of QT is unknown. Additional information on clinical issledovaniyakhv clinical trials vardenafit applied more than at 17000 men with the erectile dysfunction (ED) aged from 18 up to 89 years, many of which had multiple accompanying morbid conditions. More than 2500 patients received treatment vardenafily within 6 months and more. From them 900 patients received treatment within one year and more. Patients were distributed on the following groups: elderly (22%), with arterial hypertension (35%), diabetes (29%), coronary heart disease and other cardiovascular diseases (7%), with chronic diseases of lungs (5%), a lipidemia (22%), a depression (5%), after radical prostatectomy (9%). The following groups of patients were provided in clinical trials insufficiently: elderly (& gt, 75 years, 2.4%) and patients with some cardiovascular diseases (see the section Contraindications). Clinical trials were not conducted at patients with central nervous system diseases (except for an injury of a spinal cord), a heavy renal or liver failure, undergone operations or injuries of the bodies of a basin (except nervosberegayushchy prostatectomy) receiving radiation therapy with reduced sexual inclination or anatomic deformation of a penis. In the main researches the treatment vardenafily (tablets, film coated) led to improvement of erectile function in comparison with placebo. At a small amount of patients in attempt of commission of sexual intercourse in 4-5 hours after reception of a vardenafil the successful penetration and maintenance of an erection significantly bigger in comparison with placebo was noted. In researches using the fixed dose (a tablet, film coated) lasting 3 months at wide population of men with erectile dysfunction the successful penetration was noted – at 68% (5 mg), 76% (10 mg) and 80% (20 mg) (SEP 2) in comparison with 49% for placebo. The ability to support an erection (SEP 3) was noted at this wide population of men with erectile dysfunction at 53% (5 mg), 63% (10 mg) and 65% (20 mg) in comparison with 29% for placebo. According to summary data of the main researches of efficiency, the share of patients with a successful penetration against the background of reception of a vardenafil made 77-87% in psychogenic erectile dysfunction, 69-83% at the mixed erectile dysfunction, 64-75% in organic erectile dysfunction, elderly patients have 52-75%, 70-73% in coronary heart disease, 62-73% at a lipidemia, 74-78% in chronic diseases of lungs, 59-69% in a depression and 62-73% at a concomitant use of antihypertensive drugs. In clinical trials at patients with diabetes vardenafit in a dose 10 mg and 20 mg considerably improved erectile function, ability to achievement and maintenance of an erection, rather long for successful sexual intercourse, and rigidity of a penis in comparison with placebo. Frequency of the answer to a possibility of achievement and maintenance of an erection at patients who finished three months of treatment was 61% and 49% for 10 mg and 64% and 54% for 20 mg of a vardenafil in comparison with 36% and 23% in group of placebo. In clinical trials at the patients who transferred prostatectomy vardenafit in a dose 10 mg and 20 mg authentically improved erectile function, ability to achievement and maintenance of an erection, rather long for successful sexual intercourse, and rigidity of a penis in comparison with placebo. Frequency of influence on ability to achievement and maintenance of an erection at patients who finished three months of treatment was 47% and 37% for 10 mg and 48% and 34% for 20 mg of a vardenafil in comparison with 22% and 10% in group of placebo. In clinical trials with the flexible mode of dosing at patients after an injury of a spinal cord vardenafit considerably improved erectile function, ability to achievement and maintenance of an erection, rather long for successful sexual intercourse, and rigidity of a penis in comparison with placebo. Normal erectile function was restored (& by gt, 26 points on IIEF) at 53% of patients against the background of reception of a vardenafil in comparison with 9% of patients for placebo. Frequency of influence on ability to achievement and maintenance of an erection at patients who finished three months of treatment was: 76% and 59% for a vardenafil in comparison with 41% and 22% for placebo, distinction clinically and significantly (р<, 0.001). By results of long-term researches a profile of safety and Levitra's efficiency remained at the previous level. Use in pediatrics the European agency on medicines cancelled the obligation on providing results of researches of treatment of erectile dysfunction at all groups of children (see the section Special instructions). Indications - Treatment of erectile dysfunction at adult men. Erectile dysfunction is an inability to achievement and maintenance of an erection necessary for commission of sexual intercourse. Sexual stimulation is necessary for ensuring efficiency of the drug Levitra®. The route of administration and a dozyprimeneniye at adult men take the Drug inside irrespective of meal. The beginning of action can be delayed at meal with the high content of fats. The recommended dose makes one tablet of drug Левитра® 10 of mg approximately in 25-60 minutes prior to sexual contact. Depending on efficiency and shipping of treatment the dose can be increased to one tablet of drug Левитра® 20 of mg or is reduced to 5 mg a day (one tablet of drug Левитра® 5 of mg). The maximum recommended dose makes 20 mg of 1 times a day. The maximum frequency of administration of drug – 1 time a day. Special populations of a patsiyentovpatsiyenta of advanced age (65 years are also more senior) In this age group of dose adjustment of drug it is not required. However depending on individual shipping it is necessary to estimate carefully need of increase in a dose to the maximum allowed 20 mg. A liver failure At patients with an insignificant abnormal liver function (class A on classification of Chayld-Pyyu) and a moderate abnormal liver function (class B on classification of Chayld-Pyyu) it is necessary to consider an initial dose of 5 mg a day. Further, depending on efficiency and shipping of treatment, the dose can be increased. The maximum recommended dose at patients with a moderate abnormal liver function (class B on classification of Chayld-Pyyu) makes 10 mg (see the section Contraindications and Pharmacokinetics). Renal with an insignificant or moderate renal failure of change of the mode of dosing it is not required to a nedostatochnost of patients. At patients with a heavy renal failure (KK & lt, 30 ml/min.) should consider initial doses
of 5 mg. Depending on efficiency and shipping of treatment the dose can be increased up to 10 mg and 20 mg. Use in pediatrics Use of Levitry® is not shown at children and teenagers 18 years are younger. For use of Levitry® children have no reasonable indication. Use for the patients accepting others preparatysochetanny use with CYP inhibitors 3A4Doza of a vardenafil should not exceed 5 mg at its combined use with CYP3A4 inhibitors, such as erythromycin or klaritromitsin (see the section Special Instructions and Medicinal Interactions). The side deystviyapobochny reactions observed against the background of reception of Levitra® of a tablet film coated, or Levitra®, the tablets soluble in an oral cavity, in general were passing and had weak or moderate character. It was most often reported about such side reaction as a headache which was observed with a frequency of 10%. Side reactions are mentioned in an order of reduction of their frequency according to the Medical dictionary of terms of the regulating activity (MedDRA): it is very frequent (≥1/10), it is frequent (from ≥1/100 to & lt, 1/10), infrequently (from ≥1/1,000 to & lt, 1/100), it is rare (from ≥1/10,000 to & lt, 1/1,000) and it is not known (it is impossible to calculate on the basis of the available data). Within one frequency the side reactions are provided as weight reduction. It was reported about the following side reactions: Very often (≥1/10) - a headache Often (from ≥1/100 to 1/10) - dizziness - a dermahemia - congestion in a nose - dispepsiyanechasto (from ≥1/1.000 to & lt, 1/100) - allergic hypostasis and a Quincke's disease - sleep disorders - drowsiness, paresthesias and dizesteziya - disorders of vision, reddening of eyes, disturbance of color sensation, pain and discomfort in eyes, a photophobia - sonitus, dizziness - heartbeat, tachycardia - short wind, congestion in sine - a gastroesophageal reflux, gastritis, pains in a stomach and a stomach, dryness in a mouth, diarrhea, vomiting, nausea, dryness in a mouth, increase in level of transaminases - an erythema, rash - dorsodynias, increase in level of a kreatinfosfokinaza, muscle pain, the raised tone of muscles and muscular spasms - lengthening of an erection - nedomoganiyeredko (from ≥1/10.000 to & lt, 1/1000) - conjunctivitis - allergic reactions - concern, a syncope, spasms, amnesia - increase in intraocular pressure, the increased lachrymation - a myocardial infarction, ventricular tachyarrhythmias, stenocardia, arterial hypotension, arterial hypertension - nasal bleeding - increase in level gamma-glutamiltransferazy-reactions of photosensitivity - a priapism - pain in a chest kletkes the unknown frequency (frequency cannot be estimated on the basis of the available data) - nearteriitny front ischemic neuropathy of an optic nerve, disturbance of visual acuity - a sudden hearing loss - a hamaturia - hemorrhages in a penis, hemorrhages, gemospermiyadanny about development, in a penis, a hemospermia and a hamaturia were got in clinical trials and spontaneous data of post-marketing use of inhibitors of phosphodiesterase 5 of type, including vardenafit. At reception of Levitry® of a tablet, film coated, at elderly patients (at the age of 65 years is also more senior) the big frequency of a headache (16.2% in comparison with 11.8%) and dizzinesses (3.7% in comparison with 0.7%), than at younger patients was noted (65 years are younger). In general it is shown that the frequency of side reactions (in particular, dizziness) is slightly higher at patients at whom in the anamnesis the arterial hypertension is noted. Post-marketing data on other drugs given klassasosudisty it narusheniyasoobshchatsya about development of serious cardiovascular reactions, including cerebrovascular bleedings, sudden cardial death, the tranzitorny ischemic attack, unstable stenocardia and ventricular arrhythmia in temporary communication with other drugs of this class. The contraindication - hypersensitivity to any of drug components, - simultaneous use with nitrates or drugs which are donators of nitrogen oxide (such as amyle nitrite) in any form, - patients with loss of sight on one eye as a result of nearteriitny front ischemic neuropathy of an optic nerve irrespective of whether this episode is connected with preliminary influence of inhibitors of phosphodiesterase of the 5th type, - medicines, as a rule, should not be applied to treatment of erectile dysfunction at men to whom the sexual activity is not reasonable (for example, patients with a serious cardiovascular illness, such as unstable stenocardia or heavy heart failure
) - safety of the drug Levitra® was not investigated and until the relevant data are obtained, its use is contraindicated at patients with the following states: - the heavy abnormal liver function (class C on classification of Chayld-Pyyu), - the end-stage of a renal failure demanding dialysis - arterial hypotension (arterial blood pressure & lt, 90/50 mm Hg), - recently had stroke or a myocardial infarction (within the last 6 months), - unstable stenocardia and also hereditary degenerative diseases of a retina, for example, a pigmentary retinitis, - simultaneous use with powerful CYP3A4 inhibitors, such, as ketokonazol and itrakonazol (for intake) at patients is more senior than 75 years, - simultaneous use with inhibitors of HIV proteases, such, as ritonavir or indinavir which are very strong CYP3A4 inhibitors, - vardenafit simultaneous use of FDE-5 inhibitors, including, with guanylate cyclase stimulators, such, as riotsiguat (see the section Medicinal Interactions, - children's and teenage age up to 18 years. Medicinal the vzaimodeystviyavliyaniye of other drugs on vardenafilissledovaniye of in vitrovardenafil is metabolized mainly with participation of liver enzymes of a system of P450 cytochrome (CYP), namely, isoforms 3A4 and also with some participation of the CYP3A5 and CYP2C isoforms. Therefore, inhibitors of these enzymes can reduce clearance of a vardenafil. The researches in vivopri the combined use of inhibitor of HIV proteases of an indinavir (800 mg 3 times a day), powerful CYP3A4 inhibitor and Levitry® of tablets, film coated, in a dose of 10 mg the 16-fold increase in AUC is noted and vardenafit 7-fold increase in Cmax. In 24 h after reception the concentration of a vardenafil in plasma sharply decreases approximately to 4% of its Cmax. Ritonavir (600 mg two times a day) raises by 13 times of Cmaxvardenafila and by 49 times its total daily indicator of AUC at a concomitant use with Levitra ® in a dose of 5 mg. Interaction is caused by the fact that ritonavir, being very strong CYP3A4 and CYP2C9 inhibitor, blocks hepatic metabolism of a vardenafil. Ritonavir considerably extends T1/2 of a vardenafil up to 25.7 h (see the section Contraindications). Ketokonazol (200 mg), powerful CYP inhibitor 3A4, causes 10-fold increase in AUC and 4-fold increase (300%) in Cmax vardenafit at simultaneous use with Levitroy® in a dose 5 mg (see the section Special Instructions. Though special researches of interactions were not conducted, at simultaneous use with other powerful CYP3A4 inhibitors, such as itrakonazol, it is possible to expect increase in concentration of a vardenafil in blood plasma in comparison with increase against the background of reception of a ketokonazol. It is necessary to avoid co-administration of Levitry® with powerful CYP3A4 inhibitors, such as ketokonazol and itrakonazol for intake (see. section Contraindications and Special Instructions). Simultaneous use with powerful CYP3A4 inhibitors, such as ketokonazol and itrakonazol (for intake) contraindicated at patients 75 years are more senior. Erythromycin (500 mg three times a day), CYP inhibitor 3A4, causes 4-fold increase in AUC and 3-fold increase in Cmax vardenafit at simultaneous use with Levitroy® in a dose 5 mg. Though special researches of interaction were not conducted, at combined use with klaritromitsiny it is possible to expect similar influence on AUC and Cmax of a vardenafil. When using with moderate CYP inhibitors 3A4, such as erythromycin or klaritromitsin, dose adjustment can be required (see the section Route of Administration and Doses and Special Instructions). Cimetidinum (400 mg 2 times a day), nonspecific inhibitor of P450 cytochrome, does not affect AUC and Cmax of a vardenafil at simultaneous use with Levitroy® in a dose of 20 mg at healthy volunteers. Grapefruit juice, being weak CYP inhibitor 3A4 of pristenochny intestinal metabolism, can increase several the level of a vardenafil in blood plasma (see the section Special Instructions). The pharmacokinetics of Levitry® in a dose of 20 mg did not change at its combined use with the antagonist of H2 receptors ranitidine (150 mg two times a day), digoxin, warfarin, glibenclamide, alcohol (the average maximum level of alcohol in blood of 73 mg/dl) or single doses of an antacid (hydrochloride/aluminium magnesium hydroxide). Though special researches of interaction were not conducted, the population pharmacokinetic analysis demonstrates that acetylsalicylic acid, angiotensin-converting enzyme inhibitors, beta-blockers, weak CYP3A4 inhibitors, diuretics and antidiabetic drugs (sulphonylurea and metformin) do not affect pharmacokinetics of a vardenafil. Influence of Levitry® on others preparatydanny about interaction of a vardenafil and nonspecific inhibitors of phosphodiesterase, such as theophylline and Dipiridamolum, no. The researches in vivou of 18 healthy young male volunteers vardenafit in a dose 10 mg at reception for 1-24 h before intake of nitroglycerine (in a dose of 0.4 mg sublingual) does not cause strengthening of its hypotensive effect. Vardenafil in a dose of 20 mg at reception for 1-4 h before intake of nitroglycerine (0.4 mg are sublingual) strengthens its hypotensive action at healthy faces of middle age. If vardenafit 20 mg in a dose it is appointed for 24 h before intake of nitroglycerine, strengthening of hypotensive action of the last does not happen. However information on possible strengthening of hypotensive effect of nitrates vardenafily is absent in this connection, this combination is contraindicated. Nikorandil is a hybrid of the drug opening potassium channels and nitrate. Presence of nitrate as a part of a nikorandil causes the probability of its serious interaction with vardenafily. As monotherapy by α-blockers can cause the profound lowering of arterial pressure, especially postural hypotension and a syncope, the issue of their interaction with vardenafily was studied. In two researches of interaction at healthy normotensive volunteers, it was reported about development of arterial hypotension, in certain cases symptomatic, at considerable number of examinees after reception of a vardenafil at the simultaneous forced increase to high doses of α-blockers of a tamsulozin or a terazozin. Among the persons receiving terazozin, development of hypotension (systolic arterial blood pressure in a standing position is lower than 85 mm Hg) occurred at co-administration of Levitry® and terazozin more often than in case the drugs are taken separately with time difference of reception of 6 hours. On the basis of results of researches on studying interaction of a vardenafil at the patients with a benign hyperplasia of a prostate receiving stable doses of an alfuzozin, a tamsulozin or a terazozin the following data are obtained: - At reception of Levitry® of tablets, film coated, in doses of 5, 10 or 20 mg against the background of stable therapy tamsuloziny the symptomatic lowering of arterial pressure was not observed though at 3 of 21 patients the systolic pressure & lt, 85 mm.rt is noted. St of passing character in a standing position. - At co-administration of Levitry® of tablets, film coated, in a dose of 5 mg and the terazozina in doses of 5 or 10 mg at one of 21 patients was observed symptomatic postural hypotension. At reception of Levitry® of tablets, film coated, in a dose of 5 mg and a terazozina at an interval of 6 hours the arterial hypotension was not observed. - At reception of Levitry® of tablets, film coated, in doses of 5 or 10 mg against the background of stable therapy alfuzoziny the symptomatic lowering of arterial pressure in comparison with placebo was not observed. Therefore, the combined use of the drug Levitra® and α-adrenoblockers should be carried out only at stable arterial blood pressure against the background of intake of α-adrenoblockers, at the same time the drug Levitra® it is necessary to appoint 5 mg in the minimum recommended dose. Левитру® it is possible to accept together with tamsuloziny or alfuzoziny at any time. Between reception of a vardenafil and other α-adrenoblockers it is necessary to observe a time interval. Simultaneous use of warfarin (25 mg) which is metabolized by means of CYP2C9 enzyme or digoxin (0.375 mg) and Levitry® of tablets, film coated, in a dose of 20 mg is not followed by their considerable interaction. Левитра® the tablet, film coated, in a dose of 20 mg does not influence relative bioavailability of glibenclamide (3.5 mg) at their combined use. In a special research in which vardenafit 20 mg in a dose it was appointed together with nifedipine in a dose of 30 or 60 mg at patients with hypertensia, additional decrease in the systolic and diastolic arterial blood pressure (ABP) in a prone position on 6 mm Hg and 5 mm Hg, respectively, with the accompanying increase in the heart rate (HR) by 4 beats per minute was observed. At joint reception of Levitry® of tablets, film coated, 20 mg and alcohol (the average maximum level of alcohol in blood of 73 mg/dl), vardenafit did not exponentiate effect of alcohol on arterial blood pressure and ChSS, at the same time the pharmacokinetics of a vardenafil did not change. ÏÑó¿ÔÓá® 10 mg are not exponentiated by increase in duration of bleeding at a combination with acetylsalicylic acid (2 tablets on 81 mg). Riotsiguat Preclinical trials showed additive effect on a lowering of arterial pressure at simultaneous use of FDE-5 inhibitors with riotsiguaty. In clinical trials riotsiguat showed increase in hypotensive effect of FDE-5 inhibitors. In the studied population the favorable clinical effect at use of this combination was not noted. Simultaneous use of the riotsiguat with FDE-5 inhibitors, including vardenafit, it is contraindicated (see the section Contraindications). Special ukazaniyapered that how to resolve an issue of medicinal therapy, it is necessary to collect the medical anamnesis and to perform physical inspection for diagnostics of erectile difunction and also to establish the possible reasons of its emergence. Before prescribing of any drug used for treatment of erectile dysfunction, the doctor has to estimate a condition of a cardiovascular system of the patient as there is a risk of development of complications from heart during sexual activity. Левитра® has vasodilating properties that can be followed by easy and short decrease in the ABP. Patients with obstruction of an output path of a left ventricle, for example, with an aortal stenosis, an idiopathic hypertrophic subaortal stenosis, can be sensitive to action of vazodilatator, including type phosphodiesterase 5 inhibitors. Drugs for treatment of erectile dysfunction have to be used with care at patients with anatomic deformation of a penis (curvature, cavernous fibrosis or Peyroni's disease) and also at patients with the diseases contributing to development of a priapism (sickemia, a multiple myeloma or a leukosis). Combined use of the drug Levitra®, a tablet film coated, with the drug Levitra® ODT, tablets soluble in an oral cavity, and other drugs for treatment of erectile dysfunction is not recommended as safety and efficiency of Levitry® at their combined use was not studied. Elderly patients (at the age of 65 years is also more senior) can have a reduced shipping of the maximum dose of 20 mg. The combined use with α-blokatoramiuchityvy can lead vazodilatiruyushchy effect of α-blockers and a vardenafil, their simultaneous use for some patients to development of hypotension with clinical manifestations. The combined purpose of Levitry® and α-blockers is admiss