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Viagra® (Viagra®) Instructions for use, contraindications, composition and price, 3D-packaging Last updated 14.09.2012 Description Manufacturer Recommended more relevant description: Vizarsin Dinamiko Maksigra Sildenafil-NW Show all forms of release (99) Viagra ® Active substance: Sildenafil * (Sildenafilum) Content 3D-image composition Pharmacodynamics Pharmacokinetics Indications Contraindications Pregnancy and lactation Side Effects Interactions Dosage and administration Overdose Cautions Product form Manufacturer Conditions of supply of pharmacies Storage conditions Shelf life Prices in pharmacies ATC Sildenafil G04BE03 Therapeutic Means of treatment of erectile dysfunction - PDE-5 inhibitor [Regulators potency] The nosological classification (ICD-10) F52.2 Lack of genital response 3D-image cheapest viagra super active 06/10/2015 03/24/2015 13/10/2015 07/11/2014 05/26/2015 Composition Tablets, film-coated Table 1. active substance: Sildenafil citrate 25mg  50 mg  100 mg Other ingredients: MCC; calcium hydrogenphosphate; croscarmellose sodium; magnesium stearate shell film: Opadry Blue OY-LS-20921 (contains hypromellose, lactose, triacetin, titanium dioxide (E171) aluminum lake and indigo on the basis of (E132) and Opadry clear YS-2-19114-A (contains hypromellose and triacetin) the blue coating film may be added to 30 ug / g of vanillin and / or biotin; the content of one or both of the components in the film coating is up to 0.75, 1.5 and 3.0 mg doses of 25, 50 and 100 mg, respectively, ^ Back to top The drug forms Blue pills, film-coated, diamond-shaped, slightly biconcave, with cut and rounded edges, engraved with «Pfizer» on one side and «VGR 25», «VGR 50" or «VGR 100" on the other side, respectively. ^ Back to top pharmacodynamics Sildenafil - a powerful selective inhibitor tsikloguanozinmonofosfata (cGMP) -specific phosphodiesterase type 5 (PDE-5). Mechanism of action Implementation of the physiological mechanism of erection involves the release of nitric oxide (NO) in the cavernous bodies during sexual stimulation. This in turn leads to an increase in cGMP level, the subsequent relaxation of smooth muscle of the corpora cavernosa and increase blood flow. Sildenafil has no direct relaxing effect on isolated human corpus cavernosum but enhances the effect of nitric oxide (NO) by inhibiting PDE-5, which is responsible for the breakdown of cGMP. cheapest viagra super active Sildenafil selective against PDE-5 in vitro, its activity against PDE-5 activity is superior with respect to other known PDE isoenzymes: PDE 6 - 10 times; PDE-1 - more than 80 times; 2-PDE, PDE-4, PDE-PDE-7-11 - more than 700 times. Sildenafil is 4000 times more selective against PDE-5 compared with PDE-3, which is essential, since PDE-3 is one of the key enzymes in the regulation of myocardial contractility. A mandatory condition for the effectiveness of sildenafil is sexual stimulation. Clinical data cardiac assessment Sildenafil at doses up to 100 mg did not lead to clinically meaningful changes in the ECG in healthy volunteers. Sad maximum decrease in the supine position after taking sildenafil 100 mg was 8.3 mm Hg. Art and Dad -. 5.3 mm Hg. Art. More pronounced, but also a transient effect on blood pressure was observed in patients taking nitrates (see. Sections "Contraindications" and "Interactions"). The study hemodynamic effect of sildenafil in a single dose of 100 mg in 14 patients with severe coronary artery disease (more than 70% of patients had stenosis of at least one coronary artery) and Sad Dad at rest decreased by 7 and 6%, respectively, and pulmonary systolic pressure decreased by 9%. Sildenafil had no effect on cardiac output, and did not violate the blood flow in stenotic coronary arteries, but also led to an increase (about 13%) adenozinindutsirovannogo coronary flow in stenotic and in the intact coronary arteries. In a double-blind, placebo-controlled study of 144 patients with erectile dysfunction and stable angina receiving antianginal medications (except nitrates) performed exercise to the point, when the severity of angina decreased. The duration of exercise was significantly longer (19.9 s, with 0,9-38,9) in patients taking sildenafil in a single dose of 100 mg compared with patients receiving placebo. In a randomized, double-blind, placebo-controlled study examined the effect of the change of the dose of sildenafil (100 mg) in men (n = 568) with erectile dysfunction and hypertension, taking more than two antihypertensive drugs. Sildenafil improved erections in 71% of men compared with 18% in the placebo group. The frequency of adverse events was comparable to that in other groups of patients, as well as in patients taking more than three antihypertensive drugs. Studies of visual impairment In some patients, after 1 h after administration of sildenafil 100 mg using the Farnsworth-Munselya 100 test revealed mild and transient impaired ability to distinguish between shades of color (blue / green). After 2 h after administration, these changes were absent. It is believed that a violation of color vision caused by the inhibition of PDE-6, which is involved in the transmission of light in the retina. Sildenafil had no effect on visual acuity, contrast perception, electroretinogram, intraocular pressure and pupil diameter. In a placebo-controlled crossover study of patients with proven rannevozrastnoy-related macular degeneration (n = 9), sildenafil was transferred to a single dose of 100 mg is well. There were no clinically significant changes in vision, measured at a special visual tests (visual acuity, Amsler grille, color perception, simulation of the passage of colors, Humphrey perimeter and fotostress). Efficiency The efficacy and safety of sildenafil were evaluated in 21 randomized, double-blind, placebo-controlled study lasting up to 6 months in 3000 patients aged 19 to 87 years, with ED of various etiologies (organic, psychogenic or mixed). Efficacy was evaluated using the global diary erections, International Index of Erectile Function (validated questionnaire on the status of sexual function), and survey partner. The effectiveness of sildenafil, defined as the ability to achieve and maintain an erection sufficient for satisfactory sexual intercourse, has been demonstrated in all the studies, and has been confirmed in long-term studies lasting 1 year. In studies using a fixed dose ratio of the patients reported that the treatment improved their erection was 62% (the dose of sildenafil - 25 mg), 74% (dose of sildenafil - 50 mg) and 82% (at a dose of sildenafil - 100 mg) as compared with 25% in the placebo group. Analysis of the international index of erectile function showed that in addition to improving erectile sildenafil treatment also improves the quality of orgasm, can achieve satisfaction from sexual intercourse and overall satisfaction. According to the summarized data, among patients reported improved erections in the treatment of sildenafil were 59% of patients with diabetes, 43% of patients who underwent radical prostatectomy and 83% of patients with spinal cord injuries (vs. 16, 15 and 12% in the placebo group, respectively). ^ Back to top Pharmacokinetics The pharmacokinetics of sildenafil in the recommended dose range is linear. Suction. After oral administration, sildenafil is rapidly absorbed. Absolute bioavailability averages about 40% (from 25 to 63%). In vitro sildenafil at a concentration of about 1.7 ng / ml (3.5 nM) inhibits phosphodiesterase type 5 (PDE-5) 50% human. After a single dose of sildenafil 100 mg of sildenafil free mean Cmax in the blood plasma of men is approximately 18 ng / ml (38 nM). Cmax while taking sildenafil inside fasting achieved on average over 60 minutes (30 to 120 min). When taken in conjunction with fatty food decreases the rate of absorption: Cmax decreased by an average of 29%, and Tmax increased to 60 minutes, but the degree of absorption is not significantly changed (AUC decreased 11%). Distribution. VSS sildenafil averages 105 liters. Communication sildenafil and its main circulating metabolite N-demetilnogo plasma proteins is approximately 96% and is independent of the total concentration of the drug. Less than 0.0002% of the dose of sildenafil (mean 188 ng) was found in semen after 90 min after ingestion. cheapest viagra super active Metabolism. Sildenafil is metabolized primarily in the liver under the influence of isoenzyme cytochrome CYP3A4 (major route) and isoenzyme cytochrome CYP2C9 (minor route). The main circulating active metabolite resulting from the N-demethylation of sildenafil undergoes further metabolism. Selectivity of action against PDE metabolite comparable with that of sildenafil and its activity against PDE-5 in vitro is approximately 50% activity sildenafil. The concentration of metabolite in the blood plasma of healthy volunteers was about 40% of the concentration of sildenafil. N-demetilny metabolite undergoes further metabolism; T1 / 2 is about 4 hours. Withdrawal. Total clearance of sildenafil is 41 l / h, and the final T1 / 2 -. 5.3 hours after oral administration, as well as after the on / in the sildenafil as metabolites derived mainly intestine (about 80% of the oral dose) and to a lesser extent - kidneys (approximately 13% of the oral dose). Pharmacokinetics in special patient groups Elderly patients. In healthy elderly patients (65 years) decreased clearance of sildenafil and sildenafil free concentration in plasma is about 40% higher than in young (18-45 years). Age has no clinically significant effect on the incidence of side effects. Impaired renal function. In mild (creatinine Cl - 50-80 ml / min) or moderate (creatinine Cl - 30-49 ml / min) renal impairment the pharmacokinetics of sildenafil following a single oral dose of 50 mg is not changed. In severe renal insufficiency (Cl creatinine ≤30 ml / min) Sildenafil clearance is reduced, leading to a doubling of the value AUC (100%) and Cmax (88%) compared with those at normal rates of renal function in patients of the same age . Abnormal liver function. In patients with cirrhosis (stage A and B according to the classification of Child-Pugh) sildenafil clearance is reduced, leading to an increase in the value AUC (84%) and Cmax (47%) compared with those indices in normal liver function in patients of the same age group. The pharmacokinetics of sildenafil in patients with severely impaired hepatic function (stage C by Child-Pugh classification) has not been studied. ^ Back to top Indications of the drug Viagra® Treatment of erectile dysfunction characterized by the inability to achieve or retain an erection of the penis sufficient for satisfactory sexual intercourse. Sildenafil is effective only during sexual stimulation. ^ Back to top Contraindications hypersensitivity to sildenafil or any other component of the drug; use in patients treated continuously or intermittently donator of nitric oxide, organic nitrates or nitrites in any form as sildenafil enhances the hypotensive effect of nitrates (see "Interactions" section.) concomitant use with other drugs for the treatment of erectile dysfunction (Viagra® safety and efficacy of the drug in the combined use have not been studied, see "Special Instructions" section.), so the use of such combinations is not recommended; It is not intended for use in the registered indications in children under 18 years of age; It is not intended for use in the indication registered in women. Carefully: anatomical deformity of the penis (angulation, cavernous fibrosis or Peyronie's disease) (see "Special Instructions" section.) diseases that predispose to the development of priapism (sickle-cell anemia, multiple myeloma, leukemia, thrombocythemia) (see "Special Instructions" section.) diseases accompanied by bleeding; exacerbation of peptic ulcer disease; hereditary retinitis pigmentosa (see "Special Instructions" section.) heart failure, unstable angina, transferred in the last 6 months of myocardial infarction, stroke, or life-threatening arrhythmia, hypertension (blood pressure> 170/100 mm Hg. Art.) or hypotension (blood pressure <90/50 mm Hg. Art.) (see para. See "Special instructions"). ^ Back to top Pregnancy and breast-feeding As a registered indication the drug is not intended for use in women. ^ Back to top Side effects Usually, the side effects of the drug Viagra® weakly or moderately expressed and are transient in nature. In using a fixed dose studies have shown that the frequency of certain adverse events increased with dose. Table The organs and organ systems Side effects of sildenafil,% Placebo% The most common side effects (> 1/10) Nervous system Headache 10.8 2.8 CCC vasodilatation (hot flushes to the skin of the face) 10.9 1.4 Common adverse events (> 1/100 and <1/10) Nervous system Dizziness 2.9 1.0 Body of Change in vision (blurred vision, sensitivity to light change) 2.5 0.4 Hromatopsiya (mild and transient, mostly change the perception of shades) 1.1 0.03 CCC Palpitation 1.0 0.2 Respiratory system Rhinitis (stuffy nose) 2.1 0.3 Digestive System Indigestion 3.0 0.4 When using Viagra® drug in doses greater than recommended, adverse events were similar to those noted above, but it is usually more common. Violations of the general condition: hypersensitivity reactions (including rash). Changes in the central nervous system and peripheral nervous system: convulsions. Changes in the CCC: tachycardia, decreased blood pressure, fainting, nosebleeds. Gastrointestinal disorders: vomiting. Changes in the organ of vision: eye pain, eye redness / scleral injection. Violations of the reproductive system: prolonged erection and / or priapism. ^ Back to top Interaction The influence of other drugs on the pharmacokinetics of sildenafil Metabolism Sildenafil is mainly under the influence of isoenzyme cytochrome CYP3A4 (major route) and CYP2C9, therefore inhibitors of these isoenzymes may reduce sildenafil clearance and inducers, respectively, to increase the clearance of sildenafil. Decreased clearance of sildenafil, while the use of isoenzyme cytochrome CYP3A4 inhibitors (ketoconazole, erythromycin, cimetidine). Cimetidine (800 mg), nonspecific inhibitor isoenzyme cytochrome CYP3A4, when co-administered with sildenafil (50 mg) sildenafil causes an increase in the plasma concentration of 56%. A single dose of 100 mg sildenafil together with erythromycin (500 mg / day, 2 times a day for 5 days), a specific inhibitor of the isoenzyme cytochrome CYP3A4, against the backdrop of the constant blood concentration of erythromycin, AUC increases by 182% sildenafil. When co-administered sildenafil (single dose 100 mg) and saquinavir (1200 mg / day in 3 doses), an inhibitor of HIV protease and isoenzyme cytochrome CYP3A4, against the backdrop of a constant concentration in the blood saquinavir Cmax sildenafil increased by 140%, and the AUC was increased by 210 %. Sildenafil has no effect on the pharmacokinetics of saquinavir. More potent inhibitors isoenzyme cytochrome CYP3A4, such as itraconazole and ketoconazole, and may cause larger changes of sildenafil pharmacokinetics. The simultaneous use of sildenafil (single dose 100 mg) and RTV (500 mg, 2 times a day), HIV protease inhibitor and a potent inhibitor of cytochrome P450, against the backdrop of a constant concentration in the blood of ritonavir increases the Cmax of sildenafil 300% (4 times ) and AUC - 1000% (11 times). After 24 h of sildenafil plasma concentration of about 200 ng / ml (after a single application of sildenafil - 5 ng / ml). If sildenafil is taken at the recommended doses, patients receiving both potent inhibitors isoenzyme cytochrome CYP3A4, the sildenafil free Cmax is less than 200 nM, and the drug was well tolerated. A single dose of antacid (hydroxide / magnesium aluminum hydroxide) did not affect the bioavailability of sildenafil. isoenzyme inhibitors of cytochrome CYP2C9 (tolbutamide, warfarin), cytochrome isoenzyme CYP2D6 (SSRIs, tricyclic antidepressants), thiazide and thiazide diuretics, ACE inhibitors and calcium channel blockers have no effect on the pharmacokinetics of sildenafil. Azithromycin (500 mg / day for 3 days) did not affect the AUC, Cmax, Tmax, and elimination rate constant T1 / 2 of sildenafil or its main circulating metabolite. Effect of sildenafil on other drugs Sildenafil is a weak inhibitor of cytochrome P450 isoenzymes - 1A2, 2C9, 2C19, 2D6, 2E1, and 3A4 (IC50> 150 umol). When taken in recommended doses of sildenafil, its Cmax of about 1 micromolar, it is unlikely that sildenafil may affect the clearance of substrates of these isoenzymes. Sildenafil increases hypotensive effects of nitrates as a long-term use of the latter, and at their assignment for acute indications. In this regard, the use of sildenafil in combination with nitrates or nitric oxide donators contraindicated. Art. Art. respectively. Art. Art. ^ Back to top Dosing and Administration Given the efficacy and tolerability of the dose can be increased to 100 mg or decreased to 25 mg. The maximum recommended dose is 100 mg. ^ Back to top Overdose ^ Back to top special instructions Effects on ability to drive or to perform work requiring higher rate of physical and mental reactions. ^ Back to top ^ Back to top Manufacturer Xi. ^ Back to top Conditions of supply of pharmacies On prescription. ^ Back to top Keep out of the reach of children. ^ Back to top Do not use beyond the expiration date printed on the package.

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