Viagra 100mg tbl p / p about N2

Prescription drug

Manufacturer: Пфайзер
Рецептурный препарат
виагра  100мг тбл п/п об n2
Product is available in pharmacies:
Choose a pharmacy where you would like to pick up the goods
1 868,00 rub.
+ 38 bonuses на карту
- +
Add to cart
All products in the order are reserved for 24 hours,
after that the order is automatically canceled
Brief information

Производитель

Пфайзер

Действующее вещество

Силденафил
There are contraindications, specialist advice is required

The appearance of the product may differ from the photos on the site.

General description
Источник:  РЛС

Composition

Film-coated tablets1 table.
active substance: 
sildenafil citrate35,112/70,225/140,45 mg
(equivalent to 25/50/100 mg of sildenafil) 
excipients: MCC— 78,291/156,581/313,162 mg; calcium hydrophosphate— 26,097/52,194/104,388 mg; croscarmellose sodium— 7,5/15/30 mg; magnesium stearate-3/6/12 mg 
shell film: Opadry blue OY-LS-20921* (hypromellose, lactose, triatsetin, titanium dioxide (E171), aluminum lacquer based Indigo (Е132)— 3,75/ 7,5/15 mg; Opadry YS transparent-2-19114-A (gipromelloza, triacetin)— 1,125/2,25/4,5 mg 
*Up to 30 micrograms/g of vanillin and/or Biotin can be added to the blue film coating; the content of one or both components in the film coating will be up to 0,75/1,5/3 mcg for dosages of 25/50/100 mg, respectively 

Description of the dosage form

Blue film-coated tablets, diamond-shaped, slightly biconvex, with cut and rounded edges, with Pfizer engraving on one side and VGR 25, VGR 50 or VGR 100 on the other side, respectively.

Pharmacokinetics

The pharmacokinetics of sildenafil in the recommended dose range is linear.

Suction. After ingestion, sildenafil is rapidly absorbed. Absolute bioavailability on average is about 40% (25 to 63%). In vitro sildenafil at a concentration of about 1.7 ng / ml (3.5 nm) suppresses the activity of human PDE-5 by 50%. After a single dose of sildenafil at a dose of 100 mg, the average C max of free sildenafil in the blood plasma of men is about 18 ng / ml (38 nm). C max when taking sildenafil inside on an empty stomach is achieved on average for 60 minutes (30 to 120 minutes). When taken in combination with fatty foods, the absorption rate is reduced: C max decreases by an average of 29%, and T max increases by 60 minutes, but the degree of absorption does not significantly change (AUC decreases by 11%).

Distribution. The V ss of sildenafil is on average 105 l. the Relationship of sildenafil and its main circulating N-demethyl metabolite with plasma proteins is about 96% and does not depend on the total concentration of the drug. Less than 0.0002% of the sildenafil dose (on average 188 ng) was detected in semen 90 minutes after taking the drug.

Metabolism. Sildenafil is metabolized mainly in the liver by the action of the CYP3A4 isoenzyme (main pathway) and the CYP2C9 isoenzyme (minor pathway). The main circulating active metabolite resulting From n-demethylation of sildenafil undergoes further metabolism. The selectivity of this metabolite against PDE is comparable to that of sildenafil, and its activity against PDE-5 in vitro is about 50% of the activity of sildenafil. The concentration of the metabolite in the blood plasma of healthy volunteers was about 40% of the concentration of sildenafil. The N-demethyl metabolite undergoes further metabolism; its T 1/2 is about 4 hours.

Breeding. The total clearance of sildenafil is 41 l / h, and the final T 1/2-3-5 h. after oral administration, as well as after intravenous administration, sildenafil is excreted as metabolites, mainly by the intestines (about 80% of the oral dose) and to a lesser extent by the kidneys (about 13% of the oral dose).

Special patient groups

Old age. In healthy elderly patients (over 65 years), the clearance of sildenafil is reduced, and the concentration of free sildenafil in the blood plasma is approximately 40% higher than in young (18-45 years). Age does not have a clinically significant effect on the incidence of side effects.

Disorders of kidney function. In mild (CL creatinine 50-80 ml/min) and moderate (Cl creatinine 30-49 ml/min) degree of renal failure, the pharmacokinetics of sildenafil after a single oral dose of 50 mg does not change. In severe renal failure (creatinine Cl ≤30 ml/min), the clearance of sildenafil is reduced, which leads to approximately double the value of AUC (100%) and C max (88%) compared with those in normal renal function in patients of the same age group.

Liver function disorders. In patients with cirrhosis of the liver (classes A and B according to the child-Pugh classification), the clearance of sildenafil is reduced, which leads to an increase in the AUC (84%) and C max (47%) compared with those in normal liver function in patients of the same age group. The pharmacokinetics of sildenafil in patients with severe hepatic impairment (child-Pugh class C) has not been studied.

Pharmacodynamics

Sildenafil is a potent selective inhibitor of cGMP-specific PDE-5.

Mechanism of action

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

Sildenafil does not have a direct relaxing effect on the isolated human cavernous body, but it enhances the effect of nitric oxide by inhibiting PDE-5, which is responsible for the breakdown of cGMP.

Selective sildenafil against PDE5 in vitro, its activity against PDE5 superior activity against other known PDE isoenzymes: PDE-6 — 10 times; PDE-1 more than 80 times; PDE-2, PDE-4, PDE-7 PDE–11 more than 700 times. Sildenafil is 4,000 times more selective for PDE-5 compared to PDE-3, which is crucial because PDE-3 is one of the key enzymes regulating 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 the cavernous bodies of the penis.

Clinical data

Cardiac research. The use of sildenafil in doses up to 100 mg did not lead to clinically significant changes in ECG in healthy volunteers. The maximum reduction in systolic pressure in the supine position after taking sildenafil at a dose of 100 mg was 8.3 mm Hg.art., and diastolic pressure of 5.3 mm Hg.however, A more pronounced, but also transient effect on blood PRESSURE was observed in patients who took nitrates (see Contraindications and Interactions).

In a study of the hemodynamic effect of sildenafil at a single dose of 100 mg in 14 patients with severe IHD (more than 70% of patients had stenosis of at least one coronary artery), systolic and diastolic resting pressure decreased by 7 and 6%, respectively, and pulmonary systolic pressure decreased by 9%. Sildenafil did not affect cardiac output and did not disrupt blood flow in stenosed coronary arteries, and also led to an increase (approximately 13%) of 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 (other than nitrates) performed physical exercise until the severity of angina symptoms increased. The duration of the exercise 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 a placebo.

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

Studies of visual disorders. In some patients, 1 hour after taking sildenafil at a dose of 100 mg, the Farnsworth-Mansell 100 test revealed a slight and transient impairment of the ability to distinguish between shades of color (blue/green). After 2 hours after taking the drug, these changes were absent. It is believed that color vision impairment is caused by inhibition of PDE-6, which is involved in the process of color transmission in the retina. Sildenafil had no effect on visual acuity, contrast perception, electroretinogram, IOP, or pupil diameter.

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

Efficiency. The efficacy and safety of sildenafil was evaluated in 21 randomized double-blind placebo-controlled trials lasting up to 6 months in 3,000 patients aged 19 to 87 years with erectile dysfunction of various etiologies (organic, psychogenic or mixed). The effectiveness of the drug was evaluated globally using the erectile diary, the international erectile function index (a validated questionnaire on the state of sexual function) and the partner survey.

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

According to generalized data, 59% of diabetic patients, 43% of patients who underwent radical prostatectomy and 83% of patients with spinal cord injuries reported improved erections during treatment with sildenafil (compared to 16, 15 and 12% in the placebo group, respectively).

Indications of the drug

Treatment of erectile dysfunction characterized by the inability to achieve or maintain an erection of the penis sufficient for satisfactory sexual intercourse.

Sildenafil is only effective for sexual stimulation.

Contraindications

hypersensitivity to sildenafil or any other component of the drug;

use in patients receiving continuous or intermittent nitric oxide donators, organic nitrates or nitrites in any form, since sildenafil increases the hypotensive effect of nitrates (see Interaction);

the combined use of inhibitors of PDE5, including sildenafil, with the called guanylate cyclase stimulants such as riociguat, because it can lead to symptomatic hypotension;

co-use with other agents for the treatment of erectile dysfunction (the safety and effectiveness of Viagra when used together have not been studied (see Special instructions);

lactose intolerance, lactase deficiency, glucose-papacosma malabsorption;

severe liver failure (class C child-Pugh classification);

simultaneous administration of ritonavir;

severe cardiovascular diseases (severe heart failure, unstable angina, stroke or myocardial infarction suffered during the last 6 months, life-threatening arrhythmias, hypertension (blood PRESSURE >170/100 mm Hg. art.) or hypotension (blood PRESSURE <90/50 mm Hg.art.) (see Special instructions);

patients with episodes of development partizanai anterior ischemic optic neuropathies (NESN) with loss of vision in one eye;

hereditary retinitis pigmentosa (see Special instructions);

according to the registered indication it is not intended for use in women;

according to the registered indication, it is not intended for use in children under 18 years of age.

With caution: anatomic deformity of the penis (angulation, cavernous fibrosis or Peyronie's disease) (see Special instructions); diseases of, predisposing to the development of priapism (sickle-cell anemia, multiple myeloma, leukemia, thrombocythemia) (see Special instructions); diseases accompanied by haemorrhage; ulcer disease of stomach and duodenum in the acute stage; violation liver function; severe renal insufficiency (Cl creatinine <30 ml / min); patients with a history of anterior non-arteriitic ischemic optic neuropathy (see Special instructions); simultaneous administration of α-adrenoreceptor blockers.

Use during pregnancy and lactation

According to the registered indication, the drug is not intended for use in women.

Dosage and administration

Inside.

The recommended dose for most adult patients is 50 mg approximately 1 hour before sexual activity. Taking into account the effectiveness and tolerability, the dose can be increased to 100 mg or reduced to 25 mg. the Maximum recommended dose is 100 mg. the Maximum recommended frequency of use is 1 time per day.

Special patient groups

Disorders of kidney function. In mild to moderate renal failure (CL creatinine 30-80 ml/min), dose adjustment is not required, in severe renal failure (Cl creatinine <30 ml / min) - the dose of sildenafil should be reduced to 25 mg.

Liver function disorders. Since the elimination of sildenafil is impaired in patients with liver damage (in particular, cirrhosis), the dose of Viagra should be reduced to 25 mg.

Joint use with other drugs. Combined use with ritonavir is not recommended. In any case, the maximum dose of Viagra under any circumstances should not exceed 25 mg, and the frequency of use-1 time in 48 hours (see Interaction).

When used together with inhibitors of the CYP3A4 isoenzyme (erythromycin, saquinavir, ketoconazole, Itraconazole), the initial dose of Viagra should be 25 mg (see Interaction).

In order to minimize the risk of postural hypotension in patients taking alpha-blockers, Viagra should be started only after achieving stabilization of hemodynamics in these patients. Consideration should also be given to reducing the initial dose of sildenafil (see Special instructions and Interactions).

Old age. Adjustment of the dose of Viagra is not required.

Side effect

The most common side effects were headaches and hot flashes.

Usually the side effects of Viagra are mild or moderate and are transient.

In fixed-dose studies, it has been shown that the frequency of some adverse events increases with increasing doses.

The frequency of adverse reactions is represented by the following classification: very often - ≥10%; often - ≥1% and <10%; infrequently - ≥0.1% and <1%; rarely - ≥0.01% and <Of 0.1%; very rare — <0.01%; frequency unknown-cannot be determined based on available data.

On the part of the immune system: infrequently-hypersensitivity reactions (including skin rash), allergic reactions.

On the part of the organ of vision: often — blurred vision, blurred vision, cyanopsia; rarely, eye pain, photophobia, photopsia, chromatopsia, eye redness/injection of the sclera, changing the brightness of cvetovete, mydriasis, conjunctivitis, hemorrhage in the tissue of the eye, cataract, a disorder of the lacrimal apparatus; rarely — edema of the eyelids and adjacent tissues, a feeling of dryness in the eyes, the presence of bright circles in the field of view around the light source, fatigue eye, vision of objects in yellow color (xanthopsia), vision of objects in red color (eritrosit), redness of the conjunctiva, irritation of the mucous membranes of the eyes, discomfort in eyes; frequency is unknown — NESN, occlusion of retinal vein, defect of visual fields, diplopia* temporary loss of vision or decreased visual acuity, increased IOP, retinal edema, vascular diseases of the retina, vitreous detachment/vitreous traction.

On the part of the hearing organ: infrequently-sudden loss or loss of hearing, tinnitus, pain in the ears.

From the CCC: often — hot flashes; rare — tachycardia, palpitations, decreased blood pressure, increased heart rate, unstable angina pectoris, AV blockade, myocardial infarction, thrombosis of cerebral vessels, cardiac arrest, heart failure, deviations in the readings of the ECG, cardiomyopathy; rare — atrial fibrillation, sudden cardiac death* ventricular arrhythmia*.

From the blood and lymphatic system: rarely-anemia, leukopenia.

From the side of metabolism and nutrition: infrequently-a feeling of thirst, edema, gout, uncompensated diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemia, hypernatremia.

From the respiratory system: often-nasal congestion; infrequently-nasal bleeding, rhinitis, asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, increased volume of sputum, increased cough; rarely - a feeling of tightness in the throat, dryness of the nasal mucosa, swelling of the nasal mucosa.

From the digestive tract: often — nausea, dyspepsia; uncommon — GERD, vomiting, pain in the abdomen, dryness of the mucous membrane of the mouth, glossitis, gingivitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, rejection of liver function tests from normal, rectal bleeding; rarely, hypesthesia of the mucous membrane of the oral cavity.

From the musculoskeletal system: often-back pain; infrequently-myalgia, pain in the limbs, arthritis, arthrosis, tendon rupture, tenosynovitis, bone pain, myasthenia gravis, synovitis.

On the part of the genitourinary system: infrequently-cystitis, nocturia, breast enlargement, urinary incontinence, hematuria, ejaculation disorder, genital edema, anorgasmia, hematospermia, damage to the tissues of the penis; rarely-prolonged erection and / or priapism.

In the Central and peripheral nervous system: very often — headache; often — dizziness; infrequently — confusion, headache, ataxia, hypertonia, neuralgia, neuropathy, paresthesia, tremor, vertigo, depression, insomnia, unusual dreams, increased reflexes, hypesthesia; rare — convulsions* repeated convulsions*, fainting.

Skin and subcutaneous tissue: infrequently-skin rash, urticaria, herpes simplex, skin itching, increased sweating, skin ulceration, contact dermatitis, exfoliative dermatitis; frequency unknown-Stevens-Johnson syndrome, toxic epidermal necrolysis.

Other: infrequently-a feeling of heat, swelling of the face, photosensitivity reaction, shock, asthenia, fatigue, pain of various localization, chills, accidental falls, chest pain, accidental injuries; rarely-irritability.

Cardiovascular complications

In the course of post-marketing use of sildenafil for the treatment of erectile dysfunction, adverse events such as severe cardiovascular complications (including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, hemorrhagic stroke, transient ischemic attack, hypertension and hypotension) were reported, which had a temporary connection with the use of sildenafil. Most of these patients, but not all of them, had risk factors for cardiovascular complications. Many of these adverse events were observed shortly after sexual activity, and some of them were observed after taking sildenafil without subsequent sexual activity. It is not possible to establish the existence of a direct link between the observed undesirable phenomena and the specified or other factors.

Visual impairment

In rare cases, all PDE-5 inhibitors, including sildenafil, were reported during post-registration use of NSAIDS, a rare disease and the cause of reduced or lost vision. Most of these patients had risk factors, such as a decrease in the ratio of the diameter of the excavation and the optic disc (congestive disc), age over 50 years, diabetes, hypertension, CHD, hyperlipidemia, and Smoking. An observational study assessed whether recent use of drugs of the PDE-5 inhibitor class was associated with acute onset of NSAIDS. The results indicate an approximately 2-fold increase in the risk of developing NSAIDS within 5T 1/2 after the use of the PDE-5 inhibitor. According to published literature data, the annual incidence of NPINZN is 2.5-11.8 cases per 100,000 men aged ≥50 years in the General population. Patients should be advised to discontinue sildenafil therapy in case of sudden vision loss and consult a doctor immediately. Individuals who have already had a case of NSAID have an increased risk of recurrence of NSAID. Therefore, the doctor should discuss this risk with such patients, as well as the potential for adverse effects of PDE-5 inhibitors. PDE-5 inhibitors, including sildenafil, should be used with caution in these patients and only in situations where the expected benefit outweighs the risk.

When using the drug Viagra in doses exceeding the recommended, adverse events were similar to those noted above, but usually occurred more often.

* Side effects identified during post-marketing research.

Interaction

Effect of other drugs on the pharmacokinetics of sildenafil

Sildenafil metabolism occurs mainly under the action of CYP3A4 isoenzymes (the main pathway), so inhibitors of this isoenzyme can reduce the clearance of sildenafil, and inducers, respectively, increase the clearance of sildenafil. There was a decrease in the clearance of sildenafil with simultaneous use of inhibitors of the CYP3A4 isoenzyme (ketoconazole, erythromycin, cimetidine).

Cimetidine (800 mg), a non-specific inhibitor of the CYP3A4 isoenzyme, when taken together with sildenafil (50 mg) causes an increase in the concentration of sildenafil in plasma by 56%.

A single dose of 100 mg of sildenafil together with erythromycin (500 mg/day 2 times a day for 5 days), a moderate inhibitor of the CYP3A4 isoenzyme, against the background of achieving a constant concentration of erythromycin in the blood, leads to an increase in the AUC of sildenafil by 182%.

When taking sildenafil (once 100 mg) and saquinavir (1200 mg/day 3 times a day), an HIV protease inhibitor and CYP3A4 isoenzyme, against the background of achieving a constant concentration of saquinavir in the blood, the C max of sildenafil increased by 140%, and the AUC increased by 210%.

Stronger inhibitors of the CYP3A4 isoenzyme, such as ketoconazole and Itraconazole, can also cause more pronounced changes in the pharmacokinetics of sildenafil.

The simultaneous use of sildenafil (100 mg once) and ritonavir (500 mg 2 times a day), an inhibitor of HIV protease and a strong inhibitor of cytochrome P450, on the background to achieve a constant concentration of ritonavir in the blood leads to an increase in Cmax sildenafil 300% (4 times), a AUC by 1000% (11-fold). After 24 hours, the concentration of sildenafil in the blood plasma is about 200 ng / ml (after a single application of one sildenafil-5 ng / ml). This is consistent with the effect of ritonavir on a wide range of cytochrome P450 substrates. Sildenafil does not affect the pharmacokinetics of ritonavir. Given these data, simultaneous administration of ritonavir and sildenafil is not recommended. In any case, the maximum dose of sildenafil under any circumstances should not exceed 25 mg for 48 hours. If sildenafil is taken in the recommended doses by patients receiving simultaneously strong inhibitors of the CYP3A4 isoenzyme, the C max of free sildenafil does not exceed 200 nm, and the drug is well tolerated.

A single dose of antacid (magnesium hydroxide/aluminum hydroxide) does not affect the bioavailability of sildenafil.

In studies involving healthy volunteers, while the use of endothelina receptor antagonist of bosentan (an inducer of CYP3A4 (moderate), CYP2C9 and possibly of CYP2C19) Css (125 mg 2 times per day) and sildenafil in Css (80 mg 3 times a day), a decrease in AUC and Cmax sildenafil 62.6 52.4%, respectively. Sildenafil increased the AUC and C max of bosentan by 49.8 and 42%, respectively.

It is assumed that the simultaneous use of sildenafil with powerful inducers of the CYP3A4 isoenzyme, such as rifampicin, may lead to a greater decrease in the concentration of sildenafil in blood plasma.

CYP2D6 isoenzyme inhibitors (SSRIs, tricyclic antidepressants), thiazide and thiazide-like diuretics, ACE inhibitors and calcium antagonists do not affect the pharmacokinetics of sildenafil.

Azithromycin (500 mg / day for 3 days) has no effect on the AUC, C max, T max, excretion rate constant, and T 1/2 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 (IC 50 >150 mmol). When taking sildenafil in recommended doses, its C max is about 1 mmol, so it is unlikely that sildenafil can affect the clearance of substrates of these isoenzymes.

Sildenafil increases the hypotensive effect of nitrates both with long-term use of the latter, and when they are prescribed for urgent indications. In this regard, the use of sildenafil in combination with nitrates or nitric oxide donators is contraindicated. In patients with benign prostatic hyperplasia with stable hemodynamics, the mean additional reduction in sad/DAP in the supine position was 7/7, 9/5 and 8/4 mmHg when the α-adrenoblocker doxazosin (4 and 8 mg) and sildenafil (25, 50 and 100 mg) were taken simultaneously.St. respectively, and in the standing position-6/6, 11/4 and 4/5 mm Hg.art. There have been reports of rare cases of symptomatic postural hypotension in these patients, manifested as vertigo (without fainting). In some sensitive patients receiving alpha-blockers, simultaneous use of sildenafil may lead to symptomatic hypotension.

There were no signs of significant interaction with tolbutamide (250 mg) or warfarin (40 mg), which are metabolized by the CYP2C9 isoenzyme.

Sildenafil (100 mg) has no effect on the pharmacokinetics of the HIV protease inhibitor, saquinavir, which is a substrate of the CYP3A4 isoenzyme, at its constant level in the blood.

Simultaneous use of sildenafil in the equilibrium state (80 mg 3 times a day) leads to an increase in the AUC and C max of bosentan (125 mg 2 times a day) by 49.8 and 42%, respectively.

Sildenafil (50 mg) does not cause an additional increase in bleeding time when taking acetylsalicylic acid (150 mg).

Sildenafil (50 mg) does not increase the hypotensive effect of alcohol in healthy volunteers with a C max of blood alcohol on average 0.08‰ (80 mg/DL).

In patients with hypertension, there were no signs of interaction of sildenafil (100 mg) with amlodipine. The average additional reduction in blood PRESSURE in the supine position is 8 mm Hg.art. (systolic) and 7 mmHg.art. (diastolic).

The use of sildenafil in combination with antihypertensive agents does not lead to additional side effects.

Overdose

Symptoms: with a single dose of Viagra at a dose of up to 800 mg, adverse events were the same as when taking the drug at lower doses, but were more common. The use of a dose of 200 mg did not lead to an increase in the effectiveness of the drug, but the frequency of adverse reactions (headache, hot flashes, dizziness, dyspepsia, nasal congestion, visual impairment) increased.

Treatment: symptomatic. Hemodialysis does not accelerate the clearance of sildenafil, because the latter actively binds to plasma proteins and is not excreted by the kidneys.

Special instruction

To diagnose erectile dysfunction, determine their possible causes and choose appropriate treatment, it is necessary to collect a full medical history and conduct a thorough physical examination. Treatment of erectile dysfunction should be used with caution in patients with anatomical deformation of the penis (angulation, cavernous fibrosis, Peyronie's disease) or risk factors for priapism (SKA, multiple myeloma, leukemia) (see with caution).

Postmarketing studies have reported cases of long-term erections and priapism. If you maintain an erection for more than 4 hours, you should immediately seek medical help. If priapism therapy was not performed immediately, it can lead to damage to the tissues of the penis and irreversible loss of potency.

Drugs intended for the treatment of erectile dysfunction should not be prescribed to men for whom sexual activity is undesirable.

Sexual activity poses a certain risk in the presence of heart disease, so before starting any therapy for erectile dysfunction, the doctor should refer the patient to the examination of the state of the CCC. Sexual activity is undesirable in patients with heart failure, unstable angina, myocardial infarction or stroke suffered in the last 6 months, life-threatening arrhythmias, hypertension (blood PRESSURE >170/100 mm Hg.art.) or hypotension (AD <90/50 mm Hg.art.). Taking sildenafil in such patients is contraindicated (see Contraindications). Clinical studies have shown no differences in the incidence of myocardial infarction (1.1 per 100 people per year) or the rate of death from cardiovascular disease (0.3 per 100 people per year) in patients treated with Viagra, compared with patients treated with placebo.

Cardiovascular complications

In the course of post-marketing use of sildenafil for the treatment of erectile dysfunction, adverse events such as severe cardiovascular complications (including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, hemorrhagic stroke, transient ischemic attack, hypertension and hypotension) were reported, which had a temporary connection with the use of sildenafil. Most of these patients, but not all of them, had risk factors for cardiovascular complications. Many of these adverse events were observed shortly after sexual activity, and some of them were observed after taking sildenafil without subsequent sexual activity. It is not possible to establish the existence of a direct link between the observed undesirable phenomena and the specified or other factors.

Hypotension

Sildenafil has a systemic vasodilating effect, leading to a transient decrease in blood PRESSURE, which is not clinically significant and does not lead to any consequences in most patients. However, before prescribing Viagra, the doctor should carefully assess the risk of possible undesirable manifestations of vasodilating action in patients with relevant diseases, especially against the background of sexual activity. Increased susceptibility to vasodilators is observed in patients with obstruction of the output tract of the left ventricle (aortic stenosis, GOCMP), as well as with a rare syndrome of multiple systemic atrophy, which manifests a severe violation of blood PRESSURE regulation by the autonomic nervous system.

Since the combined use of sildenafil and α-blockers can lead to symptomatic hypotension in some sensitive patients, Viagra should be used with caution in patients taking α-blockers (see Interaction). In order to minimize the risk of postural hypotension in patients taking alpha-blockers, viagra should be started only after achieving stabilization of hemodynamic parameters in these patients. You should also consider the feasibility of reducing the initial dose of Viagra (see Method of use and dose). The doctor should inform patients about what actions should be taken in case of symptoms of postural hypotension.

Visual impairment

In rare cases, all PDE-5 inhibitors, including sildenafil, were reported during post-registration use of NSAIDS, a rare disease and the cause of reduced or lost vision. Most of these patients had risk factors, such as a decrease in the ratio of the diameter of the excavation and the optic disc (congestive disc), age over 50 years, diabetes, hypertension, CHD, hyperlipidemia, and Smoking. An observational study assessed whether recent use of drugs of the PDE-5 inhibitor class was associated with acute onset of NSAIDS. The results indicate an approximately 2-fold increase in the risk of NSAIDS within 5T 1/2 after the use of the PDE-5 inhibitor. According to published literature data, the annual incidence of NPINZN is 2.5-11.8 cases per 100,000 men aged ≥50 years in the General population. Patients should be advised to discontinue sildenafil therapy in case of sudden vision loss and consult a doctor immediately.

Individuals who have already had a case of NSAID have an increased risk of recurrence of NSAID. Therefore, the doctor should discuss this risk with such patients, as well as the potential for adverse effects of PDE-5 inhibitors. PDE-5 inhibitors, including sildenafil, should be used with caution in these patients and only in situations where the expected benefit outweighs the risk. Sildenafil is contraindicated in patients with episodes of NSAID development with vision loss in one eye (see Contraindications).

A small number of patients with hereditary retinitis pigmentosa have genetically determined disorders of the retinal PDE function. There is no information about the safety of Viagra in patients with retinitis pigmentosa, so sildenafil should not be used in such patients (see Contraindications).

Hearing impairment

Some post-marketing and clinical studies have reported cases of sudden hearing impairment or loss associated with the use of all PDE-5 inhibitors, including sildenafil. Most of these patients had risk factors for sudden deterioration or hearing loss. There is no causal relationship between the use of PDE-5 inhibitors and sudden hearing impairment or hearing loss. In case of sudden hearing loss or hearing loss while taking sildenafil, consult your doctor immediately.

Bleedings

Sildenafil enhances the antiplatelet effect of sodium nitroprusside, a nitric oxide donator, on human platelets in vitro . Data on the safety of sildenafil in patients with a tendency to bleeding or exacerbation of gastric ulcer and duodenal ulcer are not available, so the drug Viagra in these patients should be used with caution (see with caution).

The frequency of nosebleeds in patients with pulmonary hypertension associated with diffuse connective tissue diseases was higher (sildenafil-12.9%, placebo-0%) than in patients with primary pulmonary arterial hypertension (sildenafil-3%, placebo-2.4%). In patients receiving sildenafil in combination with a vitamin K antagonist, the frequency of nasal bleeding was higher (8.8%) than in patients not taking a vitamin K antagonist (1.7%).

Use in conjunction with other means for the treatment of erectile dysfunction

The safety and efficacy of Viagra together with other PDE-5 inhibitors or other drugs for the treatment of pulmonary arterial hypertension containing sildenafil (for example, Revazio ), or other means for the treatment of erectile dysfunction have not been studied, so the use of such combinations is not recommended (see Contraindications).

Influence on the ability to drive a car and machinery. Against the background of taking sildenafil any negative impact on the ability to drive a car or other technical means was not observed. However, since taking sildenafil may develop dizziness, decreased blood PRESSURE, the development of chromatopsia, blurred vision, etc. side effects, you should be careful when driving vehicles and other potentially dangerous activities that require increased concentration and speed of psychomotor reactions. You should also pay attention to the individual action of the drug in these situations, especially at the beginning of treatment and when changing the dosage regimen.

Form release

Film-coated tablets 25 mg, 50 mg, 100 mg. 1, 2, 4, 8 or 12 table. in a blister of PVC/PE/ACLAR / aluminum foil. 1, 2 or 3 BL. in a cardboard.

On the front side of the cardboard package, a perforated line for the first opening is applied.

The protective sticker is located in the lower left corner of the back surface of the pack.

Conditions of supply of pharmacies

By prescription.

Manufacturer

Farea Amboise, France. Areas of Industrial, Ruth 29 DEZ Endyustri, 37530, Pose-Sur-SIS, France.

The legal entity in whose name the registration certificate is issued: Pfizer Inc., USA. 235 East 42nd Street, new York, new York, 10017, USA.

Consumer complaints should be sent to Pfizer LLC. 123317, Moscow, Presnenskaya nab., 10, BC Tower on the Embankment (Block C).

Tel.: (495) 287-50-00; Fax: (495) 287-53-00.

The appearance of the product may differ from the photos on the site.

Information about prescription drugs is for professionals only. The information provided should not be used by patients to make an independent decision on the use of the presented drugs and cannot serve as a substitute for a full-time consultation with a doctor.

A description of the active substances of the drug is provided. The scientific information provided is generalized and cannot be used to decide on the possibility of using a specific drug.

Analogs
Prescription drug
160,00 rub.
Product is available in pharmacies:
Prescription drug
1 430,00 rub.
Product is available in pharmacies:
Prescription drug
670,00 rub.
Product is available in pharmacies:
To the top