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

Suction. After intake of Vega Extra 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 Vega Extra 100 mg average Cmax free Vega Coin in plasma men is about 18 ng/ml (38 nm). Cmax when taking 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 Vega Extra is 105 l. the Association of Cobra 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 Vega Extra (an average of 188 ng) was found in sperm 90 minutes after taking the drug.

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

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

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

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

To minimize the risk of postural hypotension in patients taking α-blockers, Vegal Extra should be started only after achieving hemodynamic stabilization in these patients. Consideration should also be given to reducing the initial dose of Sildenafil Vega Extra 130 (see special instructions and Interactions).

Old age. Adjustment of the dose of Cobra Vega is not required.

Visual impairment

In rare cases, during post-approval use of all of the inhibitors of PDE5, including Vega Visa, 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 Vega Extra 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 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 Vega Extra 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 130 Mg Cobra in patients with retinitis pigmentosa absent, so these patients should not be used Vega Extra (see "Contraindications").

Clinical data

Cardiac studies. The use of Vega Extra 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 Cobra Vega Extra Strong 120 Mg 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 Vega Extra 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 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 Vega Extra 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 Vegah Extra 130 (up to 100 mg) in men (n=568) with erectile dysfunction and hypertension, taking more than two antihypertensive drugs, was studied. Vega Extra Cobra 120 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 Vega Extra 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. Vega Extra had no effect on visual acuity, contrast perception, electroretinogram, IOP or pupil diameter.

Vegah Cobra