Cardiovascular complications

During the post-marketing use of Vega Extra Cobra 120 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 Vega 120 Mg. 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 were observed after taking Vega Extra Cobra without subsequent sexual activity. It is not possible to establish a direct link between the reported adverse events and those or other factors.

Hypotension

Vega Extra 120 Mg 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 Vegah Extra 120 Mg, 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 the rare syndrome of multiple systemic atrophy, manifested by a severe violation of the regulation of blood PRESSURE from the autonomic nervous system.

Since the combined use of Cobra Vega 120 Mg and α-blockers can lead to symptomatic hypotension in some sensitive patients, Vega Extra 120 Mg should be used with caution in patients taking α-blockers (see "Interaction"). To minimize the risk of postural hypotension in patients taking α-blockers, the drug Vega Cobra 120 should be started only after achieving stabilization of hemodynamic parameters in these patients. It should also consider reducing the initial dose of Vega Extra Strong 120 (see. "Dosage and administration"). The doctor should inform patients about what actions should be taken in case of symptoms of postural hypotension.

Dosage and administration

Inside, can be taken with or without water. When taking the drug, you should put a tablet, dispersed in the oral cavity, on the tongue, after which it will quickly dissolve, and it can be swallowed. The tablet should be taken immediately after opening the blister. Patients who are recommended a dose of Vegah Extra 130 100 mg, the second tablet of Vega Extra 120 50 mg should be taken after complete dissolution of the first tablet.

The recommended dose for most adult patients is 50 mg approximately 1 hour before sexual activity. Taking into account the effectiveness and tolerability of the dose can be increased to 100 mg or reduced to 25 mg (only tablets coated with a film, the appropriate dosage). The maximum recommended dose is 100 mg. Patients who are recommended a dose of Cobra Vega 120 Mg 100 mg, it is necessary to take 2 table., dispersible in the oral cavity, dosage 50 mg consecutively one after another. The maximum recommended frequency of use — 1 time per day. It should be borne in mind that the absorption of Vega Cobra 120 significantly slows down when used in combination with fatty foods.

Special patient groups

Renal impairment. In mild to moderate renal failure dose adjustment is not required, in severe renal failure (Creatinine CL <30 ml/min) Vega Extra 120 Mg dose should be reduced to 25 mg.

Hepatic impairment. Since the excretion of Vega Extra 120 is disturbed in patients with liver damage (in particular, cirrhosis), the dose of Vega Extra should be reduced to 25 mg.

Joint application with other drugs. Joint use with ritonavir is not recommended. In any case, the maximum dose of Vega Extra 120 Mg under any circumstances should not exceed 25 mg, and the frequency of application — 1 time in 48 h (see "Interaction").

When combined with inhibitors of CYP3A4 isoenzyme (erythromycin, saquinavir, ketoconazole, Itraconazole), the initial dose of Vega Extra 120 Mg should be 25 mg (see "Interaction").

To minimize the risk of postural hypotension in patients taking α-blockers, Vega Extra 120 Mg should be started only after achieving hemodynamic stabilization in these patients. Consideration should also be given to reducing the initial dose of Vega Extra 120 Mg (see special instructions and Interactions).

Old age. Adjustment of the dose of Vega Extra 120 Mg is not required.

Hearing impairment

Some post-marketing and clinical studies have reported cases of sudden hearing loss or impairment associated with the use of all PDE-5 inhibitors, including Vega Extra 120 Mg. Most of these patients had risk factors for sudden impairment 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 impairment or hearing loss while taking Vega 120 Mg, consult a doctor immediately.

Bleedings

Vega Extra 120 Mg enhances the antiplatelet effect of sodium nitroprusside, a nitric oxide donator, on human platelets in vitro. Data on the safety of Cobra 120 Vega Extra in patients with a tendency to bleeding or exacerbation of gastric ulcer and duodenal ulcer are not available, so the drug Vega Extra 120 Mg in these patients should be used with caution (see With caution).

The incidence of nosebleeds in patients with pulmonary hypertension associated with diffuse connective tissue diseases was higher (Vega Extra 120 Mg — 12.9%, placebo — 0%) than in patients with primary pulmonary arterial hypertension (Vega Extra 120 Mg — 3%, placebo — 2.4%). Patients receiving Vega Extra 120 in combination with an antagonist of vitamin K, the frequency of nasal bleeding was higher (8.8 percent) than patients who were not taking an antagonist of vitamin K (1.7 percent).

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

The safety and efficacy of Sildenafil Vega Extra 130 together with other PDE-5 inhibitors or other drugs for the treatment of pulmonary hypertension containing Vegah Extra 120 Mg (eg, Revatsio®), or other means for the treatment of erection disorders have not been studied, so the use of such combinations is not recommended (see "Contraindications").

Influence on the ability to drive and mechanisms. In patients receiving Vega Extra 120 Mg any negative effect on the ability to drive a car or other means was not observed. However, since when taking Vega Extra Cobra 120 may develop dizziness, lowering blood PRESSURE, the development of chromatopsia, blurred vision, etc. side effects, care should be taken when driving and doing other potentially dangerous activities that require increased concentration and speed of psychomotor reactions. Also, you should be careful about the individual action of the drug in these situations, especially at the beginning of treatment and when changing the dosage regimen.

Clinical data

In a placebo-controlled cross-examination of patients with proven early age macular degeneration (n=9), Vega Extra 120 Mg was well tolerated at a single dose of 100 mg. There were no clinically significant changes in vision evaluated by special visual tests (visual acuity, Amsler lattice, color perception, color simulation, Humphrey perimeter and photostress).

Efficiency. The efficacy and safety of Sildenafil Vega Extra 120 were evaluated in 21 randomized double-blind placebo-controlled studies lasting up to 6 months in 3000 patients from 19 to 87 years with erectile dysfunction of different etiology (organic, psychogenic or mixed). The efficacy of the drug was evaluated globally using an erection diary, an international erectile function index (validated questionnaire on the state of sexual function) and a partner survey.

The effectiveness of Vega Extra 120 Mg, defined as the ability to achieve and maintain an erection sufficient for satisfactory sexual intercourse, has been demonstrated in all studies and confirmed in long-term studies lasting 1 year. In studies with the use of fixed-dose proportion of patients reporting that treatment improved their erections were 62% (dose of Vega Extra 120 Mg 25 mg), 74% (dose Vegah Extra 120 Mg 50 mg) and 82% (dose Vegab Extra 100 mg) compared to 25% in the placebo group. Analysis of the international index of erectile function showed that in addition to improving erection treatment Vega Extra 120 Mg also increased the quality of orgasm, allowing to achieve satisfaction from sexual intercourse and overall satisfaction.

According to the generalized data, 59% of patients with diabetes, 43% of patients who underwent radical prostatectomy and 83% of patients with spinal cord injuries (against 16, 15 and 12% in the placebo group, respectively) were reported to have improved erection in the treatment of Vega Extra 120 Mg.

Pharmacokinetics

Sildenafil Tablets Vegah Extra Cobra