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How To Get Viagra: Viagra instructions for use indications, contraindications, side effects description Viagra tab., Pokr. film coated, 100 mg 1, 2 or 4 pcs. (2226) - Directory of drugs and drugs

Viagra instructions for use: indications, contraindications, side effects – description Viagra tab., Pokr. film cover, 100 mg: 1, 2 or 4 pieces. (2226) – Directory of drugs and drugs

Viagra, tab., Pokr. film coated, 100 mg. (2226) Indications, contraindications, dosing regimen, side effects, overdose how long does it take for viagra to work, drug interactions. PFIZER, produced by FAREVA AMBOISE

The drug is taken orally.

For most patients, the recommended dose is 50 mg approximately 1 hour before sexual activity. Given the efficacy and tolerability, the dose may 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 / day.

In renal failure, mild and moderate severity (CK 30-80 ml / min) dose adjustment is not required, in case of severe renal failure (CK<30 мл/мин) дозу силденафила следует снизить до 25 мг.

Since the elimination of sildenafil is impaired in patients with liver damage (for example, in case of cirrhosis), the dose should be reduced to 25 mg.

Elderly patients dose adjustment is not required.

Combined use with other drugs

When combined with ritonavir, the maximum single dose of Viagra® should not exceed 25 mg, the frequency of use – 1 time in 48 hours.

When used together 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 blockers, the use of Viagra® should be started only after hemodynamic stabilization has been achieved in these patients. The feasibility of reducing the initial dose of sildenafil should be considered.

Side effect

The most frequent side effects were headache and hot flashes.

Side effects are usually mild or moderate and transient.

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In studies using a fixed dose, it has been found that the frequency of some adverse events increases with increasing dose.

The frequency of undesirable reactions is defined as follows: very often (ge; 10%), often (ge; 1% and <10%), нечасто (≥0.1% и <1%), редко (≥0.01% и <0.1%), очень редко (<0.01%), частота неизвестна (невозможно определить на основе имеющихся данных).

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

On the part of the organ of vision: often – blurred vision, blurred vision, cyanopsy; infrequently – eye pain, photophobia, photopsia, chromatopsia, eye redness / scleral injection, change in brightness of light perception, mydriasis, conjunctivitis, hemorrhage in the eye tissue, cataract, disruption of the lacrimal apparatus; rarely – swelling of the eyelids and surrounding tissues, feeling of dryness in the eyes, presence of rainbow circles in the field of view around the light source, increased eye fatigue, seeing objects in yellow (xantopsia), seeing objects in red (erythropsy), conjunctival hyperemia, irritation of the mucous membrane eye discomfort in the eyes; unknown frequency – nonarteritis anterior ischemic optic nerve neuropathy (NPINZN), retinal vein occlusion, visual field defect, diplopia *, temporary loss of vision or reduced visual acuity, increased intraocular pressure, retinal edema, vascular retinal disease, vitreous detachment / vitreous traction.

On the part of the organ of hearing: infrequently – a sudden decline or loss of hearing, noise in the ears, pain in the ears.

Since the cardiovascular system: often – “tides”; infrequently – tachycardia, palpitations, decreased blood pressure, increased heart rate, unstable angina, AV blockade, myocardial ischemia, cerebral thrombosis, cardiac arrest, heart failure, abnormalities in ECG, cardiomyopathy; rarely – atrial fibrillation, sudden cardiac death *, ventricular arrhythmia *.

From the hemopoietic system: infrequently – anemia, leukopenia.

Metabolism and nutrition: infrequently – feeling of thirst, edema, gout, uncompensated diabetes mellitus, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemia, hypernatremia.

On the part of the respiratory system: often – nasal congestion; infrequently – nasal bleeding, rhinitis, asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, increase in the volume of discharge of sputum, increased generic viagra without a doctor prescription cough; rarely – a feeling of tightness in the throat, dryness of the mucous membrane of the nasal cavity, swelling of the nasal mucosa.

On the part of the digestive system: often – nausea, dyspepsia; infrequently – gastroesophageal reflux disease, vomiting, abdominal pain, dry mouth, glossitis, gingivitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, abnormal liver function tests, rectal bleeding; rarely – hypoesthesia of the oral mucosa.

On the part of the musculoskeletal system: often – back pain; infrequently – myalgia, pain in the limbs, arthritis, arthrosis, tendon rupture, tenosynovitis, bone pain, myasthenia, synovitis.

On the part of the genitourinary system: infrequently – cystitis, nocturia, an increase in the mammary glands, urinary incontinence, hematuria, impaired ejaculation, swelling of the genitals, anorgasmia, hematospermia, damage to the tissues of the penis; rarely, prolonged erections and / or priapism.

From the central and peripheral nervous system: very often – headache; often – dizziness; infrequently – drowsiness, migraine, ataxia, hypertonia, neuralgia, neuropathy, paresthesia, tremor, vertigo, symptoms of depression, insomnia, unusual dreams, increased reflexes, hypoesthesia; seldom – spasms *, repeated spasms *, syncope.

On the part of the skin and subcutaneous tissues: infrequently – skin rash, urticaria, herpes simplex, pruritus, sweating, skin ulceration, contact dermatitis, exfoliative dermatitis; frequency is unknown – Stevens-Johnson syndrome, toxic epidermal necrolysis.

Other: infrequently – fever, swelling of the face, photosensitivity reactions, shock, asthenia, fatigue, pain of different localization, chills, accidental falls, pain in the chest, accidental injuries; rarely irritability.

* Side effects identified during post-marketing studies.

Cardiovascular complications

The post-marketing use of sildenafil for the treatment of erectile dysfunction reported adverse events such as severe cardiovascular complications (including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, hemorrhagic stroke, transient ischemic stroke, I, I, I haven’t put a template, transient ischemic heart attack, I have an unpleasant heart attack, ventricular arrhythmia, hemorrhagic stroke, transient ischemic stroke, and I have an unpleasant heart attack, sudden heart death, ventricular arrhythmia, hemorrhagic stroke, transient ischemic stroke, transient ischemic attack, and I have already applied a cardiac abnormality. ), 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 connection between the observed adverse events and the specified or other factors.

Visual impairment

In rare cases, during post-registration use of all PDE5 inhibitors, including sildenafil, nonarteritis anterior ischemic optic neuropathy (NPINZN) – a rare disease and cause of loss or loss of vision was reported. Most of these patients had risk where to buy viagra factors, in particular a decrease in the ratio of excavation diameters and optic nerve head (“stagnant disc”), over 50 years of age, diabetes, hypertension, coronary artery disease, hyperlipidemia, and smoking. In an observational study, it was evaluated whether the recent use of drugs of the FDE5 inhibitor class is associated with an acute onset of NPINSN. The results indicate an approximately twofold increase in the risk of NPINZN within 5 elimination half-lives after the use of the PDE5 inhibitor. According to published literature data, the annual incidence of NPINSN 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 the event of a sudden loss of vision and consult a physician immediately. Persons who have already had a case of an NPINZN have an increased risk of a recurrence of an NPINZN. Therefore, the physician should discuss this risk with such patients and discuss with them the potential chance of adverse effects from PDE5 inhibitors. PDE5 inhibitors, incl. Sildenafil, in these patients should be used with caution and only in situations where the expected benefit exceeds the risk.

At use of the drug Viagra® in the doses exceeding recommended, the undesirable phenomena were similar with noted above, but usually met more often.

Contraindications

severe liver failure (Child-Pugh class C);

severe cardiovascular diseases (severe heart failure, unstable stenocardia, a stroke or myocardial infarction, life-threatening arrhythmias, arterial hypertension (BP> 170/100 mm Hg) or hypotension (BP) <90/50 мм рт.ст.));

episodes of the development of non-arteritis anterior ischemic optic neuropathy with vision loss in one eye;

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hereditary retinitis pigmentosa;

use in patients who constantly or intermittently donate nitric oxide, organic nitrates or nitrites in any form, since sildenafil enhances the hypotensive effect of nitrates;

the combined use of PDE5 inhibitors, including sildenafil, with guanylate cyclase teva generic viagra stimulants, such as riociguat, because this can lead to symptomatic hypotension;

simultaneous use of the drug with other drugs for the treatment of erectile dysfunction (the safety and efficacy of combination therapy has not been studied);

simultaneous use of ritonavir;

lactose intolerance, lactase deficiency, glucose-galactose malabsorption;

children and adolescents up to 18 years;

use in women;

hypersensitivity to sildenafil or to any other component of the drug.

With care: anatomic 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 involving bleeding; peptic ulcer and duodenal ulcer in the acute phase; abnormal liver function; severe renal failure (CC less than 30 ml / min); an episode of development of anterior non-arteritis ischemic neuropathy of the optic nerve in history; simultaneous reception of alpha adrenergic blockers.

Use during pregnancy and lactation

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

Application for violations of the liver

Contraindicated use of the drug in severe liver failure (class C on the classification of Child-Pugh).

Precautions should be prescribed the drug for violations of the liver.

Application for violations of renal function

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Precautions should be prescribed in severe renal failure (CC less than 30 ml / min).

Use in children

The drug is not intended for use in children and adolescents under order viagra online the age of 18 years.

Use in elderly patients

Elderly patients dose adjustment is not required.

special instructions

To diagnose erectile dysfunction, determine their possible causes, and select an adequate treatment, it is necessary to gather a full medical history and conduct a thorough physical examination. Erectile dysfunction treatment should be used with caution in patients with anatomical deformation of the penis (angulation, cavernous fibrosis, Peyronie’s disease), or in patients with risk factors for priapism (sickle cell anemia, multiple myeloma, leukemia).

During postmarketing studies, cases of prolonged erection and priapism have been reported. If an erection persists for more than 4 hours, the patient should immediately seek medical attention. If priapism therapy was not carried out immediately, it can cause damage to the tissues of the penis and irreversible loss of potency.

Drugs for treating erectile dysfunction should not be given 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 an examination of the state of the cardiovascular system. Sexual activity is undesirable in patients with heart failure, unstable angina, suffered myocardial infarction or stroke in the last 6 months, life-threatening arrhythmias, arterial hypertension (BP> 170/100 mm Hg) or hypotension (BP <90/50 мм рт.ст.). Прием силденафила у таких пациентов противопоказан. В клинических исследованиях показано отсутствие различий в частоте развития инфаркта миокарда (1.1 на 100 человек в год) или частоте смертности от сердечно-сосудистых заболеваний (0.3 на 100 человек в год) у пациентов, получавших препарат Виагра®, по сравнению с пациентами, получавшими плацебо.

Cardiovascular complications

Post-marketing use of sildenafil for the treatment of erectile dysfunction reported adverse events such as serious cardiovascular complications (including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, hemorrhagic stroke, transient ischemic attack, and an arthritis, transient ischemic attack. hypotension), which had a temporary relationship 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 connection between the observed adverse events and the specified or other factors.

Hypotension

Sildenafil has a systemic vasodilating effect, leading to a transient decrease in blood pressure, which is not a clinically significant effect and does not lead to any consequences in most patients. However, before when will generic viagra be available prescribing Viagra®, the doctor should carefully evaluate the risk of possible undesirable manifestations of the vasodilating action in patients with appropriate diseases, especially against the background of sexual activity. Increased susceptibility to vasodilators is observed in patients with obstruction of the excretory tract of the left ventricle (aortic stenosis, hypertrophic obstructive cardiomyopathy), as well as with rarely encountered multiple systemic atrophy syndrome, manifested by a severe dysregulation of blood pressure in the autonomic nervous system.

Since the combined use of sildenafil and alpha-blockers may lead to symptomatic hypotension in individual sensitive patients, Viagra® should be used with caution in patients taking alpha-blockers. To minimize the risk of postural hypotension in patients taking alpha blockers, taking Viagra® should be started only after stabilization of hemodynamic parameters in these patients is achieved. It should also consider the feasibility of reducing the initial dose of Viagra®. It is necessary to inform patients about what actions should be taken in case of symptoms of postural hypotension.

Visual impairment

In rare cases, during post-registration use of all PDE5 inhibitors, including sildenafil, nonarteritis anterior ischemic optic neuropathy (NPINZN) – a rare disease and cause of loss or loss of vision was reported. Most of these patients had risk factors, in particular a decrease in the ratio of excavation diameters and optic nerve head (“stagnant disc”), over 50 years of age, diabetes, hypertension, coronary artery disease, hyperlipidemia, and smoking. In an observational study, it was evaluated whether the recent use of drugs of the FDE5 inhibitor class is associated with an acute onset of NPINSN. The results indicate an approximately twofold increase in the risk of NPINZN within 5 elimination half-lives after the use of the PDE5 inhibitor. According to published literary data, the annual incidence of NPINSN is 2.5-11.8 cases per 100,000 men ge; 50 years in the general population. Patients should be advised to discontinue sildenafil therapy in the event of a sudden loss of vision and consult a physician immediately. Persons who have already had a case of an NPINZN have an increased risk of a recurrence of an NPINZN. Therefore, the physician should discuss this risk with such patients and discuss with them the potential chance of adverse effects from PDE5 inhibitors. PDE5 inhibitors, incl. Sildenafil, in such patients should be used with caution and only in situations where the expected benefit outweighs the risk. In patients with episodes of development of NPINZN with loss of vision in one eye, sildenafil is contraindicated.

A small number of patients with hereditary retinitis pigmentosa have genetically determined abnormalities of retinal phosphodiesterase functions. There is no information about the safety viagra substitute of Viagra® in patients with retinitis pigmentosa, therefore, sildenafil should be used with caution.

Hearing loss

In some post-marketing and clinical studies reported cases of sudden deterioration or hearing loss associated with the use of all PDE5 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 PDE5 inhibitors and the sudden deterioration of hearing or hearing loss. In the event of a sudden deterioration in hearing or hearing loss while taking sildenafil, the patient should immediately consult a doctor.

Bleeding

Sildenafil enhances the antiplatelet effect of sodium nitroprusside, a nitric oxide donator, on human platelets in vitro. There are no data on the safety of sildenafil in patients with a tendency to bleeding or exacerbation of gastric ulcer and duodenal ulcer, therefore Viagra® should be used with caution in these patients. The incidence of nasal bleeding in patients with pulmonary hypertension associated with diffuse connective tissue diseases was higher (sildenafil 12.9%, placebo 0%) than in patients with primary pulmonary hypertension (sildenafil 3%, placebo 2.4%). In patients receiving sildenafil in combination with a vitamin K antagonist, the frequency of nosebleeds was higher (8.8%) than in patients not taking a vitamin K antagonist (1.7%).

Use in conjunction with other erectile dysfunction treatments.

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The safety and efficacy of Viagra® together with other PDE5 inhibitors or other drugs for the treatment of pulmonary hypertension containing sildenafil (for example, Revacio®) or other means of treating erectile dysfunction have not been studied, so the use of such combinations is not recommended.

Influence on ability to drive motor transport and control mechanisms

Against the background of sildenafil intake, there was no negative effect on the ability to drive a car or other technical means. However, since the administration of sildenafil may cause dizziness, a decrease in blood pressure, the development of chromatopsia, blurred vision and other side effects, caution should be exercised when driving and doing other potentially dangerous activities that require increased concentration and psychomotor speed. You should also be attentive to the individual action of the drug in these situations, especially at the beginning of treatment and when changing the dosage regimen.

Overdose

With a single dose of Viagra® at a dose of up to 800 mg, adverse events were comparable to those at lower doses, but were more common.

The viagra without a doctor prescription use of the drug at a dose of 200 mg did not lead to an increase in the effectiveness of the drug, however, the frequency of adverse reactions (headache, hot flashes, dizziness, dyspepsia, nasal congestion, blurred vision) increased.

Treatment: symptomatic therapy. Hemodialysis does not accelerate the clearance of sildenafil, since the latter is actively associated with plasma proteins and is not excreted in the urine.

Drug interactions

The effect of other drugs on the metabolism of sildenafil

Sildenafil metabolism occurs mainly in the liver under the action of CYP3A4 isoenzymes (main route) and CYP2C9, therefore inhibitors of these isoenzymes can reduce the clearance of sildenafil, and inductors, respectively, increase the clearance of sildenafil.

With simultaneous use of CYP3A4 inhibitors (ketoconazole, erythromycin, cimetidine), a decrease in the clearance of sildenafil was noted.

Cimetidine (at a dose of 800 mg), which is a nonspecific CYP3A4 inhibitor, when taken concomitantly with sildenafil (at a dose of 50 mg) causes an increase in plasma concentration of sildenafil by 56%.

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

With simultaneous use of sildenafil (once at a dose of 100 mg) and saquinavir (at a dose of 1200 mg 3 times / day), which is both an HIV protease inhibitor and a CYP3A4 inhibitor, against the background of achieving a constant concentration of saquinavir in the blood, Cmax of sildenafil in the blood increased by 140%, and the AUC increased by 210%. Sildenafil had no effect on the pharmacokinetic parameters of saquinavir.

More potent inhibitors of the isoenzyme CYP3A4, such as ketoconazole or itraconazole, can cause more pronounced changes in the pharmacokinetics of sildenafil.

The simultaneous use of sildenafil (once in a dose of 100 mg) and ritonavir (500 mg 2 times / day), which is an HIV protease inhibitor and does viagra make you last longer a strong inhibitor of cytochrome P450 isoenzymes, against the background of achieving a constant concentration of ritonavir in the blood leads to an increase in Cmax of sildenafil by 300 % (4 times), and AUC by 1000% (11 times). After 24 h, the concentration of sildenafil in the blood plasma was approximately 200 ng / ml (with a single application of sildenafil alone – 5 ng / ml). This is consistent with the effect of ritonavir on a wide range of cytochrome P450 substrates. Sildenafil does not affect ritonavir pharmacokinetics. Given these data, the simultaneous reception of ritonavir and sildenafil is not recommended. In any case, the maximum dose of sildenafil should under no circumstances exceed 25 mg within 48 hours.

If sildenafil is taken in recommended doses by patients receiving simultaneously strong inhibitors of CYP3A4, then Cmax of free sildenafil does not exceed 200 nM, and the drug is well tolerated.

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

In studies involving healthy volunteers with simultaneous use of an antagonist of endothelin receptors, bosentan (inducer of isoenzyme CYP3A4 (moderate), CYP2C9, and possibly CYP2C19) in equilibrium concentration (125 mg 2 times / day) and sildenafil in equilibrium concentration (80 mg 3 times / day) there was a decrease in AUC and Cmax of sildenafil by 62.6% and 52.4%, respectively. Sildenafil increased AUC and Cmax of bosentan by 49.8% and 42%, respectively. It is assumed that the simultaneous use of sildenafil with potent inducers of CYP3A4 isoenzyme, such as rifampicin, can lead to a greater decrease in plasma concentration of sildenafil.

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CYP2C9 isoenzyme inhibitors (such as tolbutamide, warfarin), CYP2D6 isoenzyme (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazides and thiazide-like diuretics, ACE inhibitors and calcium antagonists have no effect on pharmacokinetics.

Simultaneous administration of azithromycin (500 mg / day for 3 days) does not affect the AUC, Cmax, Tmax, elimination rate constant, and T1 / 2 of sildenafil or its main circulating metabolite.

The effect of sildenafil on other drugs

Sildenafil is a weak inhibitor of isoenzymes of the cytochrome P450 system – 1A2, 2C9, 2C19, 2D6, 2E1, and 3A4 (IK50> 150 μmol how much does viagra cost). When using sildenafil in recommended doses, its Cmax is about 1 μmol, so it is unlikely that sildenafil can affect the substrate clearance of these isoenzymes.

Sildenafil enhances the hypotensive effect of nitrates in case of long-term use, and when used for acute indications. In this regard, the use of sildenafil in combination with nitrates or nitric oxide donors is contraindicated.

While taking alpha-adrenergic blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg and 100 mg) in patients with benign prostatic hyperplasia with stable hemodynamics, the average additional decrease in systolic / diastolic blood pressure in the supine position was 7 / 7 mm Hg, 9/5 mm Hg and 8/4 mm Hg. respectively, and in the standing position – 6/6 mm pt.st., 11/4 mm pt.st. and 4/5 mm Hg respectively. Rare cases of the development of symptomatic postural hypotension, manifested in the form of dizziness (without fainting), are reported in these patients. In individual sensitive patients receiving alpha-blockers, the simultaneous use of sildenafil can lead to symptomatic hypotension.

There were no signs of significant interaction of sildenafil with tolbutamide (250 mg) or warfarin (40 mg), which are metabolized by CYP2С9.

Sildenafil at a dose of 100 mg does not affect the pharmacokinetic parameters of the HIV protease inhibitor saquinavir, a substrate of CYP3A4, at its constant concentration in the blood.

The simultaneous use of sildenafil in the equilibrium state (80 mg 3 times / day) leads to an increase in AUC and Cmax of bosentan (125 mg 2 times / day) by 49.8% and 42%, respectively.

Sildenafil at a dose of 50 mg does not cause an additional increase in bleeding time when taking acetylsalicylic acid at a dose of 150 mg.

Sildenafil at a dose of 50 mg does not enhance the hypotensive effect of ethanol in healthy volunteers with an average level of ethanol in the blood of an average of 0.08% (80 mg / dL).

In patients with arterial hypertension, there was no evidence of interaction of sildenafil (in a dose of 100 mg) with amlodipine. The average additional decrease in blood pressure in the supine position is 8 mm Hg. (systolic) and 7 mm Hg. (diastolic).

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

Viagra® storage conditions

The drug should be stored out of the reach of children at a temperature not higher than 30 ° C.

Expiration date Viagra®

Shelf life – 5 years. Do not use after the expiration date printed on the package.

Terms of implementation

The drug is available on prescription.

Contact information

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(USA)