Viasil tablets p/o 100mg №4×1

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Viasil tablets p / o 100 mg cont cell pack No. 4×1
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Film-coated tablets, blue in color, with a biconvex surface. The main active ingredient Sildenafil Release form Coated tablets. Dosage 100 mg Special instructions The drug is not intended for use in patients under the age of 18 years. Before you start taking the drug to diagnose erectile dysfunction, determine its possible causes and select adequate methods of treatment, you should collect a complete medical history and conduct a thorough urological and general clinical examination, especially in patients with concomitant cardiovascular diseases, in which increased sexual activity is undesirable (for example, severe forms of coronary heart disease and hypertension). Elderly patients are not recommended to prescribe high doses. Frequent (more than 1 time per day) use in high doses increases the risk of side effects. Patients with concomitant coronary heart disease are in the high-risk category. An assessment of the benefit/risk ratio is necessary in patients with heart failure, low circulating blood volume. Be wary appoint patients with arterial hypertension (BP 170/110 mm Hg. Art.) and arterial hypotension (BP 90/50 mm Hg. Art.). With extreme caution, it is prescribed to patients with concomitant arterial hypertension receiving multicomponent antihypertensive pharmacotherapy. Be wary appoint patients with diseases predisposing to the development of priapism (sickle cell anemia, multiple myeloma, leukemia). It is not recommended to combine with other drugs for the treatment of erectile dysfunction. Pharmacotherapeutic group Drugs for the treatment of erectile dysfunction. Indications for use Erectile dysfunction characterized by the inability to achieve or maintain an erection of the penis sufficient for satisfactory intercourse. Sildenafil requires sexual stimulation to be effective. Dosing and Administration Viasil tablets are taken orally. Use in Adults For most patients, the recommended dose is 50 mg taken 1 hour before sexual intercourse. Depending on the efficacy and tolerability of the drug, the dose may be increased to the maximum recommended dose of 100 mg or reduced to 25 mg. The frequency of taking the maximum recommended dose is 1 time per day. Use in elderly patients In patients over 65 years of age with hepatic and severe renal insufficiency, as well as with simultaneous use of potent inhibitors of cytochrome P450 3A4 (ketoconazole, itraconazole, erythromycin, saquinavir), it is recommended to use the drug at an initial dose of 25 mg, since higher concentrations in plasma can increase both the efficacy and the frequency of adverse reactions. Application in patients with impaired renal function In patients with impaired renal function of mild to moderate severity (creatinine clearance in the range of 30-80 ml / min), dose adjustment is not required. In connection with a decrease in the clearance of sildenafil in patients with severe renal impairment (creatinine clearance < 30 ml / min), a dose of 25 mg should be used. Use in patients with impaired liver function Since the clearance of sildenafil is reduced in patients with impaired liver function (for example, with cirrhosis), it is recommended to use a dose of 25 mg. Use in patients taking other drugs Given the data on the interaction of sildenafil while taking it with ritonavir, it is recommended not to exceed the maximum single dose of 25 mg of sildenafil within 48 hours. The use of sildenafil at an initial dose of 25 mg is recommended for patients receiving concomitant inhibitors of the CYP3A4 isoenzyme (for example, erythromycin, saquinavir, ketoconazole, itraconazole). In order to minimize the likelihood of developing postural hypotension, patients should be in a stable condition during treatment with alpha-blockers before starting the use of sildenafil. In addition, in such cases, it is recommended to start the use of sildenafil with lower doses. Use during pregnancy and lactation Sildenafil is not intended for use in women. In studies of the effect of sildenafil taken orally on reproductive function in rats and rabbits, no teratogenic effect, impaired fertility, or side effects on the peri- and postnatal development of the fetus and newborn were found. Appropriate controlled trials in women during pregnancy and lactation have not been conducted. Use in children Sildenafil is not indicated for use in children and adolescents (<18 years of age). Influence on the ability to drive vehicles and control mechanisms The effect of sildenafil on the ability to drive vehicles and control mechanisms has not been studied. In clinical trials of sildenafil, cases of dizziness and decreased vision have been reported, patients should be aware of the individual effect of the drug on the body before driving a car or operating machinery. Precautions With caution, prescribe the drug for anatomical deformity of the penis, multiple myeloma, acute leukemia, sickle cell anemia, increased bleeding tendency, hereditary retinitis pigmentosa, peptic ulcer of the stomach and duodenum in the acute stage, severe forms of arterial hypertension, anamnestic indications of the postponed in the previous 6 months, heart attack and stroke, life-threatening arrhythmias, heart failure, unstable angina. According to post-marketing studies, transient ischemic attacks coincided in time with the use of sildenafil. In the event of an erection that persists for more than 4 hours and priapism, the patient should immediately seek medical attention to avoid damage to the tissues of the penis and irreversible impotence. In clinical trials, it has been shown that sildenafil can cause systemic vasodilation, which leads to a transient decrease in blood pressure. For most patients, this has little to no effect. However, before prescribing sildenafil, the physician should carefully consider the possible consequences of such a vasodilating effect for this particular patient, taking into account his condition, especially in combination with sexual activity. Sildenafil is contraindicated in patients with hypersensitivity to vasodilators, including patients with obstructed outflow of blood from the left ventricle (for example, with aortic stenosis, hypertrophic obstructive cardiomyopathy), and patients with a rare syndrome of multiple system atrophy, manifested by severe impairment of autonomic regulation of blood pressure. Anterior ischemic optic neuropathy not associated with arteritis (NAION, non-arteritic anterior ischemic optic neuropathy), leading to decreased vision or loss of vision, has in rare cases been observed in post-marketing studies with all PDE5 inhibitors, including sildenafil. The majority of patients with this disorder had risk factors such as a reduced optic cup-to-disk ratio (a “crowded” disc), age over 50 years, diabetes, hypertension, coronary artery atherosclerosis, hyperlipidemia, and smoking. A causal relationship between the use of PDE5 inhibitors and NAION has not been identified. Physicians should discuss with patients the increased risk of developing this disorder in those who have had prior NAION. Patients should be informed that in case of sudden loss of vision, sildenafil should be discontinued and a physician should be consulted. Sildenafil should be used with caution in patients taking alpha-blockers, as in a few of the more sensitive of them, this can lead to symptomatic hypotension. To minimize the likelihood of developing postural hypotension, patients should be hemodynamically stable on alpha-blocker treatment prior to initiating sildenafil. It is recommended to start the use of sildenafil with lower doses. In addition, physicians should instruct patients on what to do if they develop symptoms of postural hypotension. Patients who have already received PDE5 inhibitors at the optimal dose, the use of alpha-blockers should begin with the lowest dose. Unstable patients are at increased risk of symptomatic hypotension with concomitant use of PDE-5 inhibitors. The safety of the combined use of PDE-5 inhibitors and alpha-blockers may be affected by other parameters, including a decrease in intravascular volume and the use of other antihypertensive drugs. Since sildenafil has a systemic vasodilatory effect, it may enhance the hypotensive effect of other antihypertensive drugs. A small proportion of patients with congenital retinitis pigmentosa have genetic disorders of retinal phosphodiesterase. Since there are no data on the safety of the use of sildenafil in patients with retinitis pigmentosa, sildenafil should be administered to such patients with caution. In vitro human platelet studies have shown that sildenafil potentiates the antiplatelet action of sodium nitroprusside (nitric oxide donor). There are no data on the safety of sildenafil in patients with bleeding or active peptic ulcers, so sildenafil should be used with caution in such patients. Drugs for the treatment of erectile dysfunction should be used with caution in patients with anatomical deformities of the penis (eg, angulation, cavernous fibrosis, or Peyronie's disease) and in patients with diseases predisposing to the development of priapism (such as sickle cell anemia, multiple myeloma, or leukemia) . The safety and efficacy of combining sildenafil with other drugs for the treatment of erectile dysfunction have not been studied, so the use of such combinations is not recommended. In post-marketing and clinical studies, a small number of cases of sudden decrease or loss of hearing have been reported with the use of PDE5 inhibitors, including sildenafil. Most of these patients had risk factors for sudden reduction or loss of hearing. No causal relationship has been found between the use of PDE5 inhibitors and sudden decrease or loss of hearing. It is necessary to inform patients that in the event of a sudden decrease or loss of hearing, stop taking sildenafil and consult a doctor. Since Viasil contains lactose, it should not be prescribed to men with rare hereditary diseases: congenital galactosemia, lactase deficiency, glucose / galactose malabsorption syndrome. Interaction with other drugs Sildenafil is metabolized mainly by the action of cytochrome P450 (CYP) isoenzymes 3A4 (main route) and 2C9 (additional route). Therefore, inhibition of these liver isoenzymes may reduce the clearance of sildenafil, and stimulation of these isoenzymes may increase the clearance of sildenafil. You should not combine taking the drug with treatment with nitrates (nitroglycerin and other drugs of this group), molsidomine, and other nitric oxide donors. Sildenafil enhances nitroglycerin-induced orthostatic hypotension and the antiplatelet effects of sodium nitroprusside. Cimetidine, ketoconazole, itraconazole, erythromycin, saquinavir, ritonavir and a number of other drugs (CYP3A4 inhibitors) increase the concentration of sildenafil in the blood plasma, rifampicin and other CYP3A4 inducers reduce the concentration in the blood plasma. Effect of other drugs on sildenafil Pharmacokinetic data from clinical trials have shown that CYP2C9 inhibitors (such as tolbutamide, warfarin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and thiazide-like diuretics, angiotensin-converting enzyme inhibitors and blockers calcium channels do not affect the pharmacokinetics of sildenafil. The AUC of the active metabolite of sildenafil increases by 62% when taking loop and potassium-sparing diuretics and by 102% when taking non-specific beta-blockers (the clinical significance of these effects has not been determined). Grapefruit juice is a weak inhibitor of CYP3A4 and may cause a slight increase in plasma levels of sildenafil. Single doses of antacids (magnesium hydroxide / aluminum hydroxide) do not affect the bioavailability of sildenafil. In healthy male volunteers, no effect of azithromycin (500 mg daily for 3 days) on AUC, Cmax, Tmax, elimination rate constant, and half-life of sildenafil and its major circulating metabolites was found. The effect of sildenafil on other drugs Sildenafil is a weak inhibitor of cytochrome P450 isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (1C50> 150 μM). Upon reaching a peak plasma concentration of sildenafil of about 1 μM at the recommended doses, it is unlikely that sildenafil will change the clearance of substrates of these isoenzymes. In three special drug interaction studies, patients with stable benign prostatic hyperplasia (BPH) on doxazosin were treated concomitantly with the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25, 50 and 100 mg). In the population of this study, there was an average additional decrease in blood pressure in the horizontal position by 7/7 mm Hg. Art., 9/5 mm Hg. Art. and 8/4 mm Hg. Art., and in a vertical position – by 6/6 mm Hg. Art., 11/4 mm Hg. Art. and 4/5 mm Hg. Art., respectively. Rare cases of symptomatic postural hypotension have been reported when sildenafil and doxazosin were co-administered to stable patients on doxazosin therapy. In such cases, the patients’ symptoms included dizziness, but syncope was not noted. Co-administration of sildenafil to patients taking alpha-blockers may result in symptomatic hypotension in a small proportion of highly sensitive patients. There was no interaction with tolbutamide (250 mg) or warfarin (40 mg), drugs that are metabolized by CYP2C9 cytochrome P450 isoenzymes. Sildenafil (100 mg) did not affect the steady state pharmacokinetics of the HIV protease inhibitors saquinavir and ritonavir, both CYP3A4 substrate drugs. Sildenafil (50 mg) did not potentiate the increase in bleeding time caused by aspirin (150 mg). Sildenafil (50 mg) did not potentiate the hypotensive effect of alcohol in healthy volunteers who had a mean maximum blood alcohol level of 0.08% (80 mg/dL). There was no interaction observed with the simultaneous administration of sildenafil (100 mg) and amlodipine to patients with hypertension. The average additional decrease in blood pressure in the horizontal position was 8 mm Hg. Art. for systolic and 7 mm Hg. st for diastolic pressure. Analysis of safety data did not reveal differences in the side effect profile in patients taking sildenafil alone and in combination with antihypertensive drugs. Contraindications Erectile dysfunction drugs, including sildenafil, should not be used in men for whom sexual activity is not recommended (eg patients with severe cardiovascular disease such as unstable angina or severe heart failure). Contraindicated in patients with loss of vision in one eye due to anterior ischemic optic neuropathy. The safety of sildenafil has not been studied in the following patient subgroups and therefore its use is contraindicated: severe hepatic impairment, arterial hypotension (BP <90/50 mm Hg), recent stroke or myocardial infarction, and hereditary degenerative retinal diseases such as retinitis pigmentosa. Hypersensitivity to any of the components of the drug, nitrate therapy. Composition Each tablet contains: active substance - sildenafil (in the form of citrate) - 50 mg or 100 mg; excipients - microcrystalline cellulose, potato starch, magnesium stearate, lactose monohydrate, opadra II (talc, polyethylene glycol, titanium dioxide, polyvinyl alcohol, E 110, E 132, E 133). OverdoseSymptoms: sensation of heat, dizziness, reddening of the face, headache, blurred vision, dyspepsia, lowering blood pressure. Treatment: symptomatic therapy; dialysis is ineffective. Side effects Undesirable effects were usually transient and mild or moderate in severity. In fixed-dose studies, the frequency of adverse events increased with increasing dose. Major adverse events in the dose adjustment studies, which better reflect the recommended dose regimen, were similar to those reported in the fixed dose studies. The most commonly reported adverse events included headache and hot flashes (increased blood flow to the skin of the face). The main side effects of sildenafil taken with dose selection, observed in placebo-controlled trials and noted in ? 2% of patients taking sildenafil with a frequency greater than placebo (% occurrence in the placebo group is indicated in brackets): From the side of the nervous system and sensory organs: headache pain 16% (4%), dizziness 2% (1%), flushing 10% (1%), blurred vision (changes in color perception, increased sensitivity to light, blurred vision) 3% (0%). From the respiratory system: nasal congestion 4% (2%). From the digestive tract: dyspepsia 7% (2%), diarrhea 3% (1%). From the genitourinary system: urinary tract infections 3% (2%). On the part of the skin: rash 2% (1%). When using doses exceeding the recommended, undesirable manifestations were similar to those given above, but were noted, as a rule, more often. In the analysis of data from double-blind placebo-controlled clinical trials, including more than 700 patients / year of observation with placebo and more than 1300 with sildenafil, no difference was found in the incidence of myocardial infarction (MI) and mortality due to cardiovascular disorders in patients treated with sildenafil compared with placebo. The incidence of MI was 1.1 per 100 patients/years in both men taking sildenafil and placebo. Mortality due to cardiovascular disorders was 0.3 per 100 patients/years, both in men taking sildenafil and in those receiving placebo. Side effects of sildenafil observed in placebo-controlled trials and occurring with a frequency of less than 2% (the relationship with sildenafil is not clear). From the nervous system and sensory organs: anxiety and transient complete amnesia, cerebral circulation disorders, transient ischemic attacks, asthenia, dizziness, migraine, ataxia, tremor, neuralgia, weakening of reflexes, paresthesia, hypesthesia, fainting, depression, sleep disturbance (insomnia / drowsiness), conjunctivitis, photophobia, hemorrhages in the eyeball, mydriasis, cataracts, xerophthalmia, pain in the eyeballs and ears, ringing in the ears, deafness. From the side of the cardiovascular system and blood (hematopoiesis, hemostasis): arterial hypotension, orthostatic hypotension, tachycardia, palpitations, myocardial ischemia, angina pectoris, cardiomyopathy, heart failure, ECG changes, incl. AV blockade, cardiac arrest, cerebral thrombosis, anemia, leukopenia, ventricular arrhythmia, arterial hypertension, myocardial infarction and atrial fibrillation. From the respiratory system: pharyngitis, sinusitis, laryngitis, bronchitis, dyspnea, increased sputum, increased cough, bronchial asthma. From the digestive tract: glossitis, gingivitis, stomatitis, dry mouth, dysphagia, esophagitis, nausea, gastritis, gastroenteritis, colitis, rectal bleeding, changes in liver biochemical parameters, vomiting. From the side of metabolism: thirst, hypernatremia, gout, hyperuricemia, labile diabetes, hyper- and hypoglycemia. From the genitourinary system: nocturia, frequent urination, cystitis, urinary incontinence, ejaculation disorder, anorgasmia, genital edema, gynecomastia. From the musculoskeletal system: arthritis, arthrosis, ossalgia, myalgia, myasthenia gravis, tendon rupture, tendosynovitis, synovitis, bone pain. For the skin: urticaria, herpes simplex, itching, skin ulceration, contact dermatitis, exfoliative dermatitis. Others: peripheral edema, incl. swelling of the face, pain syndromes, incl. pain in the abdomen and chest, accidental falls, injuries and bruises, sweating, chills, photosensitivity, shock, allergic reactions. During post-marketing surveillance, the following undesirable manifestations were noted: Immune system disorders: hypersensitivity reactions (including skin rash). Nervous system disorders: seizures, series of seizures. Genitourinary disorders: prolonged erection, priapism and hematuria. Sensory disorders: eye hyperemia, diplopia, temporary loss of vision, increased IOP. Vascular disorders: hypotension, syncope, epistaxis. Hearing impairment: A small number of cases of sudden decrease or loss of hearing have been reported with the use of PDE5 inhibitors, including sildenafil. If the listed adverse reactions occur, as well as any adverse reaction not mentioned in the instructions, you should consult a doctor. Storage conditions Store in a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Viasil tablets p/o 100mg No. 4x1