Clinical data

In a placebo-controlled cross-examination of patients with proven early age macular degeneration (n=9), Cobra Vega 120 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 Vega 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 Cobra Vega 120, 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 Sildenafil Vega Extra 130 25 mg), 74% (dose Extra Vega 50 mg) and 82% (dose Cobra Vega 120 100 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 Cobra 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 Cobra Vega 120.

Pharmacokinetics

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 Cobra Vega 120 100 mg, the second tablet of Vegah Extra 130 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 Vega Extra Cobra 130 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 Sildenafil Vega Extra 130 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) Cobra Vega 120 dose should be reduced to 25 mg.

Hepatic impairment. Since the excretion of Vega Extra Cobra 130 Mg is disturbed in patients with liver damage (in particular, cirrhosis), the dose of Vegab 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 Vegah Cobra 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 Vegah Extra 120 Indication should be 25 mg (see "Interaction").

To minimize the risk of postural hypotension in patients taking α-blockers, Sildenafil Vega Extra 130 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 Cobra Vega 120 is not required.

Cardiovascular complications

During the post-marketing use of Cobra Vega 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 Extra 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 Cobra 120 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 Cobra 130 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 Vega 120, 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 Vega Extra Cobra and α-blockers can lead to symptomatic hypotension in some sensitive patients, Cobra Vega 120 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 Cobra Vega 120 Mg should be started only after achieving stabilization of hemodynamic parameters in these patients. It should also consider reducing the initial dose of Cobra Vega 120 (see. "Dosage and administration"). The doctor should inform patients about what actions should be taken in case of symptoms of postural hypotension.

Cardiovascular complications

During the post-marketing use of Vega 120 Mg 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 Extra Cobra 130 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 Vegah Cobra without subsequent sexual activity. It is not possible to establish a direct link between the reported adverse events and those or other factors.

Visual impairment

In rare cases, during post-approval use of all of the inhibitors of PDE5, including Cobra Vega 120, 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 of developing 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 Cobra Vega Extra Strong 120 Mg 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 Vega 120, in such patients should be used with caution and only in situations where the expected benefit outweighs the risk.

When using the drug Cobra Vega 120 in doses exceeding the recommended, adverse events were similar to those noted above, but usually more common.

*Side effects identified during post-marketing studies.

Interaction

Effect of other drugs on the pharmacokinetics of Cobra Vega 120

The metabolism of Cobra Vega 120 occurs mainly under the action of CYP3A4 isoenzyme (main pathway), so inhibitors of this isoenzyme can reduce the clearance of Cobra Vega 120, and inducers, respectively, increase the clearance of Vega Pills. A decrease in the clearance of Vega Extra 120 Mg with simultaneous use of inhibitors of CYP3A4 isoenzyme (ketoconazole, erythromycin, cimetidine).

Cimetidine (800 mg), a nonspecific inhibitor of CYP3A4 isoenzyme, when taken together with Cobra Vega 120 (50 mg) causes an increase in the concentration of Vegal Extra in plasma by 56%.

A single dose of 100 mg of Sildenafil Vega Extra 130 together with erythromycin (500 mg/day 2 times a day for 5 days), a moderate inhibitor of CYP3A4 isoenzyme, while achieving a constant concentration of erythromycin in the blood, leads to an increase in the AUC of Sildenafil Tablets Vegah Extra Cobra by 182%.

When co-administered Cobra Vega 120 (once 100 mg) and saquinavir (1200 mg/day 3 times daily), an inhibitor of HIV protease and of CYP3A4, on the background to achieve a constant concentration of saquinavir in the blood, Cmax of Cobra Vega 120 was increased by 140% and the AUC increased by 210%.

Stronger inhibitors of CYP3A4 isoenzyme, such as ketoconazole and Itraconazole, can cause more pronounced changes in the pharmacokinetics of Vega Extra.

The simultaneous use of Vega Extra 120 (100 mg once) and ritonavir (500 mg 2 times a day), an inhibitor of HIV protease and a strong inhibitor of cytochrome P450, on the background to achieve a constant concentration of ritonavir in the blood leads to an increase in Cmax of Cobra Vega 120 by 300% (4 times), a AUC by 1000% (11-fold). After 24 h, the concentration of Cobra Vega 120 in blood plasma is about 200 ng/ml (after a single application of one Cobra Vega 120 — 5 ng/ml). This is consistent with the ritonavir effect on a wide range of cytochrome P450 substrates. Vega Cobra 120 Mg does not affect the pharmacokinetics of ritonavir. Given these data, the simultaneous reception of ritonavir and Cobra Vega 120 is not recommended. In any case, the maximum dose of Vega Extra Cobra 130 Mg under any circumstances should not exceed 25 mg for 48 hours. If Sildenafil Vega Extra 130 Mg is taken in the recommended doses, patients receiving strong inhibitors of CYP3A4 isoenzyme at the same time, then Cmax free Cobra Vega 120 does not exceed 200 nm, and the drug is well tolerated.

Single administration of antacid (magnesium hydroxide/aluminum hydroxide) does not affect the bioavailability of Vegah Extra 130.

Studies involving healthy volunteers with simultaneous use of endothelin receptor antagonist, bosentan (CYP3A4 isoenzyme inducer (moderate), CYP2C9, and possibly CYP2C19) in Css (125 mg 2 times a day) and Cobra Vega 120 in Css (80 mg 3 times a day) showed a decrease in AUC and Cmax Cobra Vega 120 by 62.6 and 52.4%, respectively. Sildenafil Tablets Vega Extra Cobra increased the AUC and Cmax of bosentan by 49.8 and 42%, respectively.

It is assumed that the simultaneous use of Cobra Vega 120 with powerful inducers of CYP3A4 isoenzyme, such as rifampicin, can lead to a greater decrease in the concentration of Vega Coin in blood plasma.

CYP2D6 isoenzyme inhibitors (SSRIs, tricyclic antidepressants), thiazide and thiazide-like diuretics, ACE inhibitors and calcium antagonists have no effect on the pharmacokinetics of Cobra Vega 120.

Azithromycin (500 mg/day for 3 days) has no effect on AUC, Cmax, Tmax, excretion rate constant and T1/2 Cobra Vega 120 or its main circulating metabolite.

Vega Cobra 120 Mg