Cardiovascular complications

During the post-marketing use of Cobra 120 Vega Extra 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 Cobra 120 Vega Extra. 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 Cobra 120 Vega Extra 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 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 Cobra 120 Vega Extra, 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 120 Vega Extra and α-blockers can lead to symptomatic hypotension in some sensitive patients, Cobra 120 Vega Extra 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 Signature Cobra Vega should be started only after achieving stabilization of hemodynamic parameters in these patients. It should also consider reducing the initial dose of Cobra 120 Vega Extra (see. "Dosage and administration"). The doctor should inform patients about what actions should be taken in case of symptoms of postural hypotension.

Clinical data

In a placebo-controlled cross-examination of patients with proven early age macular degeneration (n=9), Cobra 120 Vega Extra 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 Cobra 120 Vega Extra 25 mg), 74% (dose Sildenafil Tablets Vega Extra Cobra 50 mg) and 82% (dose Vegah Cobra 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 Cobra 120 Vega Extra 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 Cobra 120.

Pharmacokinetics

The pharmacokinetics of Cobra 120 Vega Extra in the recommended dose range is linear.

Suction. After intake of Sildenafil Tablets Vegah Extra Cobra is rapidly absorbed. Absolute bioavailability averages about 40% (25 to 63%). In vitro Cobra 120 Vega Extra at a concentration of about 1.7 ng/ml (3.5 nm) inhibits the activity of PDE-5 50%. After a single dose of Cobra 120 Vega Extra 100 mg average Cmax free Vegab Extra in plasma men is about 18 ng/ml (38 nm). Cmax when taking Cobra 120 Vega Extra inside fasting is achieved for an average of 60 minutes (from 30 to 120 minutes). When taken in combination with fatty foods, the rate of absorption decreases: Cmax decreases by an average of 29%, and Tmax increases by 60 minutes, but the degree of absorption does not change significantly (AUC decreases by 11%).

Distribution. The average Vss of Cobra 120 Vega Extra is 105 l. the Association of Cobra 120 Vega Extra 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 dose of Vegah Extra 120 Mg (an average of 188 ng) was found in sperm 90 minutes after taking the drug.

Metabolism. Vega Extra Cobra 130 Mg is metabolized mainly in the liver by the action of CYP3A4 isoenzyme (main pathway) and CYP2C9 isoenzyme (minor pathway). The main circulating active metabolite, formed as a result of N-demethylation of Vegal Extra, undergoes further metabolism. The selectivity of this metabolite against PDE is comparable to that of Vega Extra 120, and its activity against PDE-5 in vitro is about 50% of the activity of Vegah Cobra. The concentration of the metabolite in the blood plasma of healthy volunteers was about 40% of the concentration of Vega Visa. N-demethyl metabolite undergoes further metabolism; its T1/2 is about 4 no.

Breeding. The total clearance of Cobra 120 Vega Extra is 41 l/h, and the final T1/2 — 3-5 h. After oral administration, as well as after I/V, Cobra 120 Vega Extra is excreted as metabolites, mainly by the intestine (about 80% oral dose) and to a lesser extent by the kidneys (about 13% oral dose).

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 Vegah Extra 120 Indication. 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 Cobra 120 Vega Extra, consult a doctor immediately.

Bleedings

Cobra Vega 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 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 Vega Extra Strong 120 Mg — 12.9%, placebo — 0%) than in patients with primary pulmonary arterial hypertension (Cobra 120 Vega Extra — 3%, placebo — 2.4%). Patients receiving Vegah Extra 130 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 Cobra 120 Vega Extra together with other PDE-5 inhibitors or other drugs for the treatment of pulmonary hypertension containing Cobra 120 Vega Extra (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 Pills 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.

Cobra Vega