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Viagra

Viagra
Viagra is used for erectile disfunction treatment (men impotence). It works by helping to improve blood flow in penis to get and to support erection during sexual agitation.

Brand: Sildenafil

Availability: In Stock
Average Delivery Time: 9 Days
Exp. Date: May 2024
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Product description

Drug title

Viagra (Sildenafil Citrate)

Pharmacological action

Sildenafil is a potent selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5).


Realization of the physiological mechanism of erection is associated with the release of nitric oxide (NO) in the corpora cavernosa during sexual stimulation. This, in its turn, leads to increase of cGMP level, subsequent relaxation of smooth muscle tissue of the cavernous body and increase of blood flow.


Sildenafil has no direct relaxing effect on the isolated human cavernous body, but it enhances the effect of NO by inhibiting FDE5, which is responsible for the breakdown of cGMP.


Sildenafil is selective against FDE5 in vitro, its activity against FDE5 exceeds activity against other known phosphodiesterase isoenzymes: FDE6 - 10 times; FDE1 - more than 80 times; FDE2, FDE4, FDE7-FDE11 - more than 700 times. Sildenafil is 4,000 times more selective against FDE5 compared to FDEZ, which is very important because FDEZ is one of the key enzymes in regulation of myocardial contractility.


A prerequisite for the effectiveness of sildenafil is sexual stimulation. Sildenafil restores impaired erectile function under conditions of sexual stimulation by increasing blood flow to cavernous bodies of the penis.

Clinical data


Cardiologic studies.


Sildenafil administration in doses up to 100 mg did not result in clinically significant ECG changes in healthy volunteers. Maximum decrease in systolic BP in the supine position after sildenafil administration at a dose of 100 mg was 8.3 mm Hg, and in diastolic BP - 5.3 mm Hg. A more pronounced but also transient effect on BP was noted in patients taking nitrates.


In a study of the hemodynamic effects of sildenafil in a single dose of 100 mg in 14 patients with severe CHD (more than 70% of patients had stenosis of at least one coronary artery), resting systolic and diastolic BP decreased by 7% and 6%, respectively, and pulmonary systolic BP decreased by 9%. Sildenafil did not affect cardiac output or impair blood flow in stenosed coronary arteries, and it also increased (by approximately 13%) adenosine-induced coronary flow in both stenosed and intact coronary arteries.


In a double-blind, placebo-controlled study, 144 patients with erectile dysfunction and stable angina taking antianginal drugs (except nitrates) performed exercise until the severity of angina symptoms decreased. Exercise duration was significantly longer (19.9 seconds; 0.9-38.9 seconds) in patients taking sildenafil in a single dose of 100 mg compared with patients receiving placebo.


A randomized, double-blind, placebo-controlled study examined the effect of changing the sildenafil dose (up to 100 mg) in men (n=568) with erectile dysfunction and arterial hypertension who were taking more than two antihypertensive drugs. Sildenafil improved erections in 71% of men compared with 18% in the placebo group. The incidence of adverse effects was comparable to that in other patient groups, as well as in those taking more than two antihypertensive drugs.


Studies of Visual Impairment


Mild and transient impairment in the ability to distinguish shades of color (blue/green) was detected in some patients 1 h after taking sildenafil at a dose of 100 mg using the Farnsworth-Munsel 100 test. These changes were absent 2 h after drug administration. The color vision impairment is thought to be caused by inhibition of FDE6, which is involved in the transmission of light in the retina. Sildenafil had no effect on visual acuity, contrast perception, electroretinogram, intraocular pressure, or pupil diameter.


In a placebo-controlled, crossover study of patients with proven early-onset macular degeneration (n=9), sildenafil at a single dose of 100 mg was well tolerated. There were no clinically significant changes in vision as assessed by specific visual tests (visual acuity, Amsler grid, color perception, color passage simulation, Humphrey perimeter, and photostress).


Efficacy


Efficacy and safety of sildenafil have been evaluated in 21 randomized, double-blind, placebo-controlled trials, lasting up to 6 months, in 3000 patients aged 19 to 87 years with erectile dysfunction of various etiologies (organic, psychogenic or mixed). Efficacy of the drug was evaluated globally using erection diary, International Erectile Function Index (validated sexual function questionnaire) and partner survey.


The efficacy of sildenafil, defined as the ability to achieve and maintain an erection sufficient for satisfactory intercourse, was demonstrated in all studies conducted and was confirmed in long-term studies lasting 1 year. In fixed-dose studies, the proportion of patients reporting that therapy improved their erections was 62% (sildenafil 25 mg dose), 74% (sildenafil 50 mg dose), and 82% (sildenafil 100 mg dose), compared with 25% in the placebo group. Analysis of the international erectile function index showed that in addition to improving erections, sildenafil treatment also improved the quality of the orgasm, allowing for sexual satisfaction and overall satisfaction.


According to generalized data, among the patients who reported improvement of erection with sildenafil treatment were 59% of diabetic patients, 43% of patients who had undergone radical prostatectomy and 83% of patients with spinal cord injuries (compared with 16%, 15% and 12% in the placebo group, respectively).


Pharmacokinetics

Pharmacokinetics of sildenafil in the recommended dose range is linear.


Absorption


After oral administration, sildenafil is rapidly absorbed. Absolute bioavailability averages 40% (25-63%). In vitro sildenafil at a concentration of about 1.7 ng/ml (3.5 nM) inhibits human FDE5 by 50%. After a single sildenafil dose of 100 mg, the average Cmax of free sildenafil in plasma is 18 ng/mL (38 nM) and is reached on average within 60 minutes (30-120 minutes) when taken on an empty stomach.


When taken in combination with fatty food, absorption rate is reduced; Cmax is reduced by 29% on average, Tmax is increased by 60 min. However, the degree of absorption does not change significantly (AUC decreases by 11%).


Distribution


Vd of sildenafil in equilibrium is on average 105 l. Binding of sildenafil and its main circulating N-demethyl metabolite to plasma proteins is about 96% and is independent of the total sildenafil concentration. Less than 0.0002% of the dose (188 ng on average) is detected in semen 90 min after drug administration.


Metabolism


Sildenafil is metabolized primarily in the liver by the CYP3A4 isoenzymes (major pathway) and CYP2C9 (minor pathway). The main circulating active metabolite, which is formed as a result of N-demethylation of sildenafil, undergoes further metabolism. Metabolite is comparable with sildenafil in FDE selectivity, and its activity against FDE5 in vitro is about 50% of sildenafil activity. The plasma concentration of the metabolite is about 40% of that of sildenafil. The N-demethyl metabolite is further metabolized; its T1/2 is about 4 hours.


Excretion


The total clearance of sildenafil is 41 l/h, and the final T1/2 is 3-5 h. After oral administration, as well as after IV administration, sildenafil is excreted as metabolites mainly in the faeces (about 80% of the dose) and to a lesser extent in the urine (about 13% of the dose).


Pharmacokinetics in special clinical cases


Sildenafil clearance is decreased in healthy elderly people (over 65 years of age), and plasma concentrations of free active substance are about 40% higher than its concentration in young (18-45 years of age) patients. Age has no clinically significant effect on the incidence of side effects.


In mild (KC 50-80 ml/min) and moderate (KC 30-49 ml/min) renal failure pharmacokinetic parameters of sildenafil after a single oral dosage of 50 mg do not change. In severe renal failure (CKD ≤30 ml/min) sildenafil clearance is decreased, which causes approximately twofold increase of AUC (100%) and Cmax (88%) in comparison with the same parameters in normal renal function patients of the same age group.


Sildenafil clearance is decreased in patients with cirrhosis (Child-Pugh class A and B), resulting in increased AUC (84%) and Cmax (47%) compared to normal hepatic function in patients in the same age group. Pharmacokinetics of sildenafil in patients with severe hepatic impairment (Child-Pugh class C) have not been studied.

Contraindications to use

  • Severe hepatic insufficiency (class C according to the Child-Pugh classification);
  • severe cardiovascular disease (severe heart failure, unstable angina pectoris, stroke or myocardial infarction within the last 6 months, life-threatening arrhythmias, arterial hypertension (BP >170/100 mm Hg) or hypotension (BP <90/50 mm Hg));
  • episodes of non-arteritic anterior ischemic optic neuropathy with vision loss in one eye;
  • hereditary pigmentary retinitis;
  • use in patients receiving nitric oxide donators, organic nitrates or nitrites in any form continuously or intermittently, since sildenafil enhances the hypotensive effects of nitrates;
  • concomitant use of FDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, as this may lead to symptomatic hypotension;
  • concomitant use of the drug with other drugs for the treatment of erectile dysfunction (safety and effectiveness of combined therapy have not been studied);
  • concomitant use of ritonavir;
  • lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
  • childhood and adolescence under 18 years of age;
  • use in women;
  • hypersensitivity to sildenafil or any other component of the drug.

With caution: Anatomical deformation of the penis (angulation, cavernous fibrosis or Peyronie's disease); diseases predisposing to the development of priapism (sickle cell anemia, multiple myeloma, leukemia, thrombocythemia); diseases accompanied by bleeding; gastric and duodenal ulcer in acute phase; liver dysfunction; severe renal insufficiency (CK less than 30 ml/min); history of an episode of anterior nonarteritic ischemic optic neuropathy; concomitant use of alpha-adrenoblockers.


Administration during pregnancy and lactation

The drug is not intended for use in women according to the registered indication.

Administration in liver dysfunction

It is contraindicated in severe hepatic insufficiency (class C of the Child-Pugh classification).


Caution should be exercised when using the drug in patients with hepatic impairment.


Administration in renal dysfunction

Caution should be exercised when using in patients with severe renal failure (CK values less than 30 ml/min).

Administration in children

It is contraindicated for children and adolescents under 18 years old.

Administration in elderly patients

No dosage adjustment is required for elderly patients.

Indications for Viagra

Treatment of erectile dysfunction characterized by failure to achieve or maintain an erection sufficient for satisfactory intercourse.

Sildenafil is effective only with sexual stimulation.


The drug is taken orally. Tablets dispersed in the mouth can be taken with or without water. The tablet should be placed on the tongue, after which it will quickly dissolve and can be swallowed. The tablet should be taken immediately after opening the blister. Patients who are recommended a dose of sildenafil 100 mg, the second tablet of sildenafil 50 mg should be taken after the first tablet of sildenafil 50 mg has completely dissolved.


Note that absorption of sildenafil is significantly delayed when it is used in combination with fatty foods.


For most patients, the recommended dose is 50 mg about 1 h before sexual activity. Taking into account efficacy and tolerability, the dose may be increased to 100 mg or reduced to 25 mg (only film-coated tablets of the appropriate dosage should be taken).


Maximum recommended dose is 100 mg. The maximum recommended frequency of use is 1 time per day. Patients who are recommended a dose of sildenafil 100 mg should take two tablets dispersed in the oral cavity with a dose of 50 mg sequentially one after another.


In mild to moderate renal failure (CKR 30-80 ml/min), no dose adjustment is required; in severe renal failure (CKR <30 ml/min), the sildenafil dose should be reduced to 25 mg.


Since sildenafil excretion is impaired in patients with liver damage (e.g., cirrhosis), the dose should be reduced to 25 mg.


No dose adjustment is required in elderly patients.


Concomitant use with other drugs


If used concomitantly with ritonavir, the maximum single dose of Viagra should not exceed 25 mg, the frequency of use - once every 48 hours.


In coadministration with CYP3A4 isoenzyme inhibitors (erythromycin, saquinavir, ketoconazole, itraconazole), the initial dose of Viagra® should be 25 mg.


To minimize the risk of postural hypotension in patients taking alpha-adrenoblockers, Viagra should be started only after hemodynamic stabilization has been achieved in these patients. A reduction in the initial dose of sildenafil should be considered.