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

Suction. After intake of Signature Cobra Vega is rapidly absorbed. Absolute bioavailability averages about 40% (25 to 63%). In vitro Vega Cobra 120 at a concentration of about 1.7 ng/ml (3.5 nm) inhibits the activity of PDE-5 50%. After a single dose of Signature Cobra Vega 100 mg average Cmax free Signature Cobra Vega in plasma men is about 18 ng/ml (38 nm). Cmax when taking Vega Cobra 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 Vega 120 Mg is 105 l. the Association of Vega 120 Mg 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 Signature Cobra Vega (an average of 188 ng) was found in sperm 90 minutes after taking the drug.

Metabolism. Cobra 120 Vega Extra 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 Vega Extra 120 Mg, undergoes further metabolism. The selectivity of this metabolite against PDE is comparable to that of Sildenafil Tablets Vega Extra Cobra, and its activity against PDE-5 in vitro is about 50% of the activity of Vega Visa. The concentration of the metabolite in the blood plasma of healthy volunteers was about 40% of the concentration of Cobra Vega Extra Strong 120mg. N-demethyl metabolite undergoes further metabolism; its T1/2 is about 4 no.

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

Clinical data

Cardiac studies. The use of Vega Extra Strong 120 in doses up to 100 mg did not lead to clinically significant ECG changes in healthy volunteers. The maximum decrease in systolic pressure in the supine position after taking Vegah Extra 130 at a dose of 100 mg was 8.3 mm Hg.art., and diastolic pressure — 5.3 mm Hg.a More pronounced, but also transient effect on blood PRESSURE was observed in patients taking nitrates (see "Contraindications" and "Interaction").

In a study of the hemodynamic effect of Signature Cobra Vega in a single dose of 100 mg in 14 patients with severe coronary artery disease (more than 70% of patients had stenosis of at least one coronary artery), systolic and diastolic resting pressure decreased by 7 and 6%, respectively, and pulmonary systolic pressure decreased by 9%. Vega Extra Cobra 120 did not affect cardiac output and did not interfere with blood flow in stenotic coronary arteries, and also led to an increase (by about 13%) of adenosine-induced coronary flow in both stenotic and intact coronary arteries. In a double-blind placebo-controlled study of 144 patients with erectile dysfunction and stable angina, taking antianginal drugs (except nitrates), exercise was performed until the severity of symptoms of angina increased. The duration of the exercise was significantly longer (19.9 seconds; 0.9–38.9 seconds) in patients taking Signature Cobra Vega in a single dose of 100 mg, compared with patients receiving placebo.

In a randomized double-blind placebo-controlled study, the effect of changing the dose of Signature Cobra Vega (up to 100 mg) in men (n=568) with erectile dysfunction and hypertension, taking more than two antihypertensive drugs, was studied. Vega 120 Mg improved erection in 71% of men compared to 18% in the placebo group. The frequency of adverse effects was comparable to that in other groups of patients, as well as in those taking more than three antihypertensive drugs.

Studies of visual impairment. In some patients, 1 h after taking Vegah Cobra at a dose of 100 mg with the Farnsworth-Mansell test 100 revealed a slight and transient violation of the ability to distinguish shades of color (blue/green). After 2 hours after taking the drug, these changes were absent. It is believed that color vision impairment is caused by inhibition of PDE-6, which is involved in the process of color transmission in the retina. Signature Cobra Vega had no effect on visual acuity, contrast perception, electroretinogram, IOP or pupil diameter.

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 Signature Cobra Vega 100 mg, the second tablet of Signature Cobra Vega 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 Sildenafil Tablets Vega Extra Cobra 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 Signature Cobra Vega 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 120 Vega Extra dose should be reduced to 25 mg.

Hepatic impairment. Since the excretion of Signature Cobra Vega is disturbed in patients with liver damage (in particular, cirrhosis), the dose of Signature Cobra Vega 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 Signature Cobra Vega 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 Sildenafil Tablets Vega Extra Cobra should be 25 mg (see "Interaction").

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

Old age. Adjustment of the dose of Sildenafil Vega Extra 130 Mg Cobra is not required.

Clinical data

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

Pharmacokinetics

Sildenafil Vega Extra 130 Mg Cobra