Clinical data
In a placebo-controlled cross-examination of patients with proven early age macular degeneration (n=9), Vegah Extra 120 Indication 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 Vegal 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 Signature Cobra Vega, 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 Cobra 120 Mg 25 mg), 74% (dose Sildenafil Vega Extra 130 Mg Cobra 50 mg) and 82% (dose Vega Extra 120 Mg 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 Vega Extra Strong 120mg 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 Extra Strong 120 Mg.
Pharmacokinetics
Cardiovascular complications
During the post-marketing use of Vega Extra Cobra 130 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 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 Signature Cobra Vega 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 Signature Cobra Vega, 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 Vega Pills 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 Signature Cobra Vega, in such patients should be used with caution and only in situations where the expected benefit outweighs the risk.
When using the drug Cobra 120 Vega Extra 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 120 Vega Extra
The metabolism of Signature Cobra Vega occurs mainly under the action of CYP3A4 isoenzyme (main pathway), so inhibitors of this isoenzyme can reduce the clearance of Signature Cobra Vega, and inducers, respectively, increase the clearance of Signature Cobra Vega. A decrease in the clearance of Sildenafil Vega Extra 130 with simultaneous use of inhibitors of CYP3A4 isoenzyme (ketoconazole, erythromycin, cimetidine).
Cimetidine (800 mg), a nonspecific inhibitor of CYP3A4 isoenzyme, when taken together with Vega Extra Strong 120 (50 mg) causes an increase in the concentration of Cobra Vega Extra Strong 120mg in plasma by 56%.
A single dose of 100 mg of Signature Cobra Vega 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 Vega 120 Mg by 182%.
When co-administered Vegal Extra (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 Vegah Extra 120 Indication 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 Pills.
The simultaneous use of Signature Cobra Vega (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 Signature Cobra Vega by 300% (4 times), a AUC by 1000% (11-fold). After 24 h, the concentration of Signature Cobra Vega in blood plasma is about 200 ng/ml (after a single application of one Cobra Vega Extra Strong 120 Mg — 5 ng/ml). This is consistent with the ritonavir effect on a wide range of cytochrome P450 substrates. Signature Cobra Vega does not affect the pharmacokinetics of ritonavir. Given these data, the simultaneous reception of ritonavir and Vegah Extra 130 is not recommended. In any case, the maximum dose of Vega Pills under any circumstances should not exceed 25 mg for 48 hours. If Signature Cobra Vega is taken in the recommended doses, patients receiving strong inhibitors of CYP3A4 isoenzyme at the same time, then Cmax free Signature Cobra Vega 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 Vega Cobra.
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 Extra Vega in Css (80 mg 3 times a day) showed a decrease in AUC and Cmax Signature Cobra Vega by 62.6 and 52.4%, respectively. Signature Cobra Vega increased the AUC and Cmax of bosentan by 49.8 and 42%, respectively.
It is assumed that the simultaneous use of Signature Cobra Vega with powerful inducers of CYP3A4 isoenzyme, such as rifampicin, can lead to a greater decrease in the concentration of Signature Cobra Vega 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 Vegah Extra 120 Mg.
Azithromycin (500 mg/day for 3 days) has no effect on AUC, Cmax, Tmax, excretion rate constant and T1/2 Vegab Extra or its main circulating metabolite.
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 Sildenafil Tablets Vega Extra Cobra. 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 Vegah Cobra, consult a doctor immediately.
Bleedings
Vega Cobra enhances the antiplatelet effect of sodium nitroprusside, a nitric oxide donator, on human platelets in vitro. Data on the safety of Extra Vega in patients with a tendency to bleeding or exacerbation of gastric ulcer and duodenal ulcer are not available, so the drug Sildenafil Tablets Vega Extra Cobra 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 Cobra 120 Mg — 12.9%, placebo — 0%) than in patients with primary pulmonary arterial hypertension (Signature Cobra Vega — 3%, placebo — 2.4%). Patients receiving Vegab 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 Signature Cobra Vega together with other PDE-5 inhibitors or other drugs for the treatment of pulmonary hypertension containing Vegah Extra 120 Indication (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 Signature Cobra Vega any negative effect on the ability to drive a car or other means was not observed. However, since when taking Signature Cobra Vega 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.
Signature Cobra Vega is a weak inhibitor of cytochrome P450 — 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 ISOENZYMES (IC50 >150 µmol). When taking Vega Extra Cobra 130 Mg in recommended doses, its Cmax is about 1 µmol, so it is unlikely that Vega Extra Cobra 130 Mg can affect the clearance of the substrates of these isoenzymes.
Signature Cobra Vega increases the hypotensive effect of nitrates both with long-term use of the latter, and with their appointment for urgent indications. In this regard, the use of Signature Cobra Vega in combination with nitrates or nitric oxide donators is contraindicated. While taking α-adrenoblocker doxazosin (4 and 8 mg) and Signature Cobra Vega (25, 50 and 100 mg) in patients with benign prostate hyperplasia with stable hemodynamics, the average additional decrease in sad/dad in the supine position was 7/7, 9/5 and 8/4 mm Hg.article, respectively, while in the standing position — 6/6, 11/4 mmHg, and 4/5.art. respectively. Reported rare cases of symptomatic postural hypotension in such patients, manifested in the form of dizziness (without fainting). In some sensitive patients receiving α-blockers, simultaneous use of Cobra Vega Extra Strong 120mg can lead to symptomatic hypotension.
There were no signs of significant interaction with tolbutamide (250 mg) or warfarin (40 mg), which are metabolized by CYP2C9 isoenzyme.
Vega Extra Cobra 130 Mg (100 mg) has no effect on the pharmacokinetics of the HIV protease inhibitor, saquinavir, which is a substrate of CYP3A4 isoenzyme, at its constant level in the blood.
The simultaneous use of Signature Cobra Vega at equilibrium (80 mg 3 times a day) leads to an increase in the AUC and Cmax of bosentan (125 mg 2 times a day) by 49.8 and 42%, respectively.
Vegah Cobra (50 mg) does not cause an additional increase in bleeding time when taking acetylsalicylic acid (150 mg).
Signature Cobra Vega (50 mg) does not increase the hypotensive effect of alcohol in healthy volunteers with Cmax of alcohol in the blood on average 0.08‰ (80 mg/DL).
In patients with hypertension, no signs of interaction of Signature Cobra Vega (100 mg) with amlodipine were found. The average additional reduction in blood PRESSURE in the supine position is 8 mm Hg.V. (systolic) and 7 mm Hg.V. (diastolic).
The use of Vega Visa in combination with antihypertensive agents does not lead to additional side effects.
Cobra Vega 120 Mg
