Clinical data
In a placebo-controlled cross-examination of patients with proven early age macular degeneration (n=9), Vega Extra Cobra 130 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 Cobra 120 Vega Extra 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 Cobra 120 Vega Extra, 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 Coin 25 mg), 74% (dose Cobra 120 Vega Extra 50 mg) and 82% (dose Cobra 120 Vega 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 Cobra 130 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 Vegab Extra.
Pharmacokinetics
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 Cobra 120 Vega Extra. 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 Extra Vega, consult a doctor immediately.
Bleedings
Cobra 120 Vega Extra enhances the antiplatelet effect of sodium nitroprusside, a nitric oxide donator, on human platelets in vitro. Data on the safety of Cobra Vega in patients with a tendency to bleeding or exacerbation of gastric ulcer and duodenal ulcer are not available, so the drug Cobra Vega 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 (Cobra 120 Vega Extra — 12.9%, placebo — 0%) than in patients with primary pulmonary arterial hypertension (Vegah Extra 120 Indication — 3%, placebo — 2.4%). Patients receiving Cobra 120 Vega Extra 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 Vega 120 Mg together with other PDE-5 inhibitors or other drugs for the treatment of pulmonary hypertension containing Vega Extra Cobra (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 Vegal Extra any negative effect on the ability to drive a car or other means was not observed. However, since when taking Cobra 120 Vega Extra 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.
Mechanism of action
The implementation 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, the subsequent relaxation of smooth muscle tissue of the cavernous body and an increase in blood flow.
Sildenafil Vega Extra 130 does not have a direct relaxing effect on the isolated cavernous human body, but enhances the effect of nitric oxide by inhibiting PDE-5, which is responsible for the disintegration of cGMP.
Selective Cobra 120 Vega Extra 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. Vega Coin is 4000 times more selective for PDE-5 than PDE-3, which is crucial because PDE-3 is one of the key enzymes in the regulation of myocardial contractility.
A prerequisite for the effectiveness of Cobra 120 Vega Extra is sexual stimulation.
Cobra 120 Vega Extra restores impaired erectile function in conditions of sexual stimulation by increasing blood flow to the cavernous bodies of the penis.
Visual impairment
In rare cases, during post-approval use of all of the inhibitors of PDE5, including Cobra 120 Vega Extra, reported NESN is a rare disease and the cause of the decrease or loss of vision. Most of these patients had risk factors, such as decreased ratios of excavation diameter to optic disc (stagnant disc), age over 50, diabetes, hypertension, CHD, hyperlipidemia, and Smoking. In an observational study evaluated whether recent use of drugs class of inhibitors PDE-5 with an acute onset NESN. The results indicate approximately a 2-fold increase in risk NESN within 5T1/2 after application of the PDE-5 inhibitor. According to published literature, the annual incidence of npins IS 2.5–11.8 cases per 100,000 men aged ≥50 years in the General population. Patients should be advised to stop Vegah Extra 120 Indication therapy in case of sudden loss of vision and consult a doctor immediately.
Persons who have already had a case NESN have an increased risk of relapse NESN. Therefore, the doctor should discuss this risk with such patients, as well as the potential chance of adverse effects of PDE-5 inhibitors. PDE-5 inhibitors, including Cobra 120 Vega Extra, 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 PINZN with loss of vision in one eye receiving Sildenafil Tablets Vega Extra Cobra is contraindicated (see "Contraindications").
A small number of patients with hereditary retinitis pigmentosa have genetically determined disorders of the PDE of the retina. Information about the safety of the drug Sildenafil Vega Extra 120 in patients with retinitis pigmentosa absent, so these patients should not be used Cobra 120 Vega Extra (see "Contraindications").
Vega Cobra