Vizarsin, 100 mg, film-coated tablets, 4 pcs.
To diagnose erectile dysfunction, determine its possible causes and select adequate treatment, it is necessary to obtain a complete medical history and conduct a thorough physical examination. Treatments for erectile dysfunction 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) (see Caution) .
).
During post-marketing studies, cases of prolonged erection and priapism have been reported. If an erection persists for more than 4 hours, you should immediately seek medical help. If treatment for priapism is not carried out immediately, it can lead to damage to the tissue of the penis and irreversible loss of potency. Medicines intended to treat erectile dysfunction should not be used by men for whom sexual activity is undesirable.
Sexual activity poses a certain risk in the presence of heart disease, therefore, before starting any therapy for erectile dysfunction, the doctor should refer the patient to an examination of the cardiovascular system. Sexual activity is undesirable in patients with heart failure, unstable angina, myocardial infarction or stroke in the last 6 months, life-threatening arrhythmias, arterial hypertension (BP >170/100 mm Hg) or arterial hypotension (BP <90/50 mm Hg . Art.) (see With caution
). Clinical studies have shown no difference in the incidence of myocardial infarction (1.1 per 100 people per year) or the incidence of cardiovascular mortality (0.3 per 100 people per year) in patients treated with sildenafil compared with patients treated with sildenafil. those receiving placebo.
Cardiovascular complications.
During 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) have been reported ), which had a temporary association 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 occurred shortly after sexual activity, and some of them occurred after taking sildenafil without subsequent sexual activity. It is not possible to establish a direct connection between the observed adverse events and these or other factors.
Arterial hypotension.
Sildenafil has a systemic vasodilating effect, leading to a transient decrease in blood pressure, which is not a clinically significant phenomenon and does not lead to any consequences in most patients. However, before prescribing Vizarsin®, the physician must carefully assess the risk of possible undesirable manifestations of the vasodilating effect in patients with relevant diseases, especially against the background of sexual activity.
Increased susceptibility to vasodilators is observed in patients with obstruction of the left ventricular outflow tract (aortic stenosis, hypertrophic obstructive cardiomyopathy), as well as the rare multiple system atrophy syndrome, manifested by severe dysregulation of blood pressure from the autonomic nervous system.
Since the simultaneous use of sildenafil and α-blockers can lead to symptomatic arterial hypotension in some sensitive patients, Vizarsin® should be used with caution in patients taking α-blockers (see “Interactions”).
To minimize the risk of developing orthostatic hypotension in patients taking α-blockers, Vizarsin® should be started only after hemodynamic parameters have stabilized in these patients. You should also consider the advisability of reducing the initial dose of Vizarsin® (see “Dosage and Administration”). The physician should inform patients about what actions to take if symptoms of orthostatic hypotension occur.
Visual impairment.
In rare cases, during post-registration use of all PDE-5 inhibitors, incl. sildenafil, reported NPINSID, a rare disease and cause of decreased or loss of vision. Most of these patients had risk factors, including a decreased papilledema/disc ratio (“congestive disc”), age over 50 years, diabetes mellitus, hypertension, coronary artery disease, hyperlipidemia, and smoking. An observational study assessed whether recent use of the PDE5 inhibitor class of drugs was associated with acute onset of NPINSID. The results indicate an approximately two-fold increase in the risk of NPINI within 5 T1/2 after use of a PDE5 inhibitor. Published literature estimates the annual incidence of NPINSID to be 2.5–11.8 cases per 100,000 men aged ≥50 years in the general population. In case of sudden loss of vision, patients should be advised to stop sildenafil therapy and consult a doctor immediately. Individuals who have already had a case of NPIND have an increased risk of recurrent NPIND. Therefore, the physician should discuss this risk with such patients, as well as the potential for adverse effects from PDE5 inhibitors. PDE-5 inhibitors, incl. sildenafil should be used with caution in such patients and only in situations where the expected benefit outweighs the risk.
A small number of patients with hereditary retinitis pigmentosa have genetically determined dysfunction of the retinal PDE. There is no information on the safety of using sildenafil in patients with retinitis pigmentosa, so Vizarsin® should be used with caution (see Precautions
).
Hearing impairment.
Some post-marketing studies have reported cases of sudden deterioration or loss of hearing associated with all PDE5 inhibitors, including sildenafil.
Most of these patients had risk factors for sudden deterioration or loss of hearing. A cause-and-effect relationship between the use of PDE5 inhibitors and sudden hearing loss or deterioration has not been established. If there is a sudden deterioration in hearing or hearing loss while taking Vizarsin®, you should immediately consult your doctor.
Bleeding.
Sildenafil enhances the antiplatelet effect of sodium nitroprusside, an NO donor, 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 and duodenal ulcers, so Vizarsin should be used with caution in such patients (see Caution
)
. The incidence of epistaxis 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%). Patients receiving sildenafil in combination with a vitamin K antagonist had a higher incidence of epistaxis (8.8%) than patients not taking a vitamin K antagonist (1.7%).
Simultaneous use with other drugs for the treatment of erectile dysfunction. The safety and effectiveness of Vizarsin® concomitantly with other PDE5 inhibitors or other drugs for the treatment of pulmonary hypertension containing sildenafil, or other drugs for the treatment of erectile dysfunction, therefore the use of such combinations is not recommended (see “Contraindications”).
Impact on the ability to perform potentially hazardous activities that require special attention and quick reactions (for example, driving, working with moving mechanisms).
Since when taking sildenafil, it is possible to develop dizziness, decrease in blood pressure, develop chromatopsia, blurred vision, etc. side effects, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. You should also be careful about the individual effect of Vizarsin® in these situations, especially at the beginning of treatment and when changing the dosage regimen.
Composition and pharmacological action of Vizarsin
The active component of the drug is sildenafil citrate. Additionally, the medication contains form- and volume-forming substances.
Auxiliary connections are:
- microcrystalline cellulose – Avicel RN102;
- calcium dihydrogen phosphate;
- microcrystalline cellulose - Avicel PH101;
- croscarmellose sodium;
- magnesium stearate;
- hypromellose.
The film shell contains titanium dioxide, lactose monohydrate, triacetin and hypromellose as components.
The active component, being a strong selective inhibitor of cGMP-specific phosphodiesterase type 5, has a powerful vasodilating effect and restores erectile function.
The mechanism of action of sildenafil is due to the release of NO in the corpus cavernosum. During sexual stimulation, which leads to an increase in cGMP levels with subsequent relaxation of the smooth muscle tissue of the corpus cavernosum, blood flow to it increases. For the development of the therapeutic effect of sildenafil and the onset of erection, sexual stimulation is necessary.
After taking the Vizarsin tablet orally, the active substance is absorbed from the gastrointestinal tract into the blood within 20-30 minutes. The maximum concentration is reached after 60 minutes.
Metabolization of the compound is carried out by liver tissue cells with the formation of breakdown products, which are mostly excreted from the body with feces and partly by the kidneys in urine.
pros
- High efficiency of the drug
- Possibility of obtaining a rapid therapeutic effect
- Convenient dosage form of the drug
- The product has a fairly affordable price compared to analogues
Minuses
- Dispensing medication according to a doctor's prescription
- The presence of a large number of contraindications and side effects
- High likelihood of side effects and adverse reactions
- The presence of side effects that prevent you from driving a vehicle
- May interact with many medications
- Incompatible with drinking alcoholic beverages
Analogues of the drug
If side effects occur during the use of Visarsin or if the patient has contraindications to its use, the doctor may suggest the use of drug analogues that have a similar therapeutic effect on the body.
Common substitutes are:
- Sildenafil is a drug for the treatment of erectile dysfunction. The medication is available in the form of film-coated tablets with a biconvex, diamond-shaped shape. The medicine has a blue outer color and a white inner color. The active compound in the medication is sildenafil citrate. Microcrystalline cellulose, anhydrous calcium hydrogen phosphate, croscarmellose sodium, magnesium stearate, opadry II blue and opadry transparent are used as auxiliary components. The shelf life of the drug is 3 years. The medicine must be stored at a temperature not exceeding 25 degrees Celsius. Dispensing is carried out by prescription. The cost of the medicine is about 530 rubles per package, which contains 10 tablets.
- Maxigra is a drug used in the treatment of erectile dysfunction. Available in tablet form. The active ingredient is sildenafil. Excipients include sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, mannitol, corn starch, crospovidone and povidone. The medicine is available by prescription. The shelf life is 4 years. The medication should be stored at a temperature not exceeding 30 degrees. The price of the drug in pharmacies ranges from 297 to 774 rubles, depending on the dosage and number of tablets in the package.
Additionally, Viagra, Dynamico and Cialis can be used as substitutes with similar effects.
