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 120 Vega Extra 100 mg, the second tablet of Cobra Vega Extra 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 Cobra 120 Vega Extra 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 Cobra 120 Vega Extra 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 120 dose should be reduced to 25 mg.
Hepatic impairment. Since the excretion of Cobra 120 Vega Extra is disturbed in patients with liver damage (in particular, cirrhosis), the dose of Cobra 120 Vega 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 Extra 120 Indication 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 Cobra 120 Vega Extra should be 25 mg (see "Interaction").
To minimize the risk of postural hypotension in patients taking α-blockers, Vega Extra Cobra should be started only after achieving hemodynamic stabilization in these patients. Consideration should also be given to reducing the initial dose of Cobra Vega 120 (see special instructions and Interactions).
Old age. Adjustment of the dose of Vegah Extra 120 Indication is not required.
Cobra 120 Vega Extra is a potent selective inhibitor of cGMP-specific PDE-5.
Mechanism of action
The implementation of the physiological mechanism of erection is associated with the release of nitric oxide (NO) in the cavernous body during sexual stimulation. This, in turn, leads to an increase in the level of cGMP, the subsequent relaxation of smooth muscle tissue of the cavernous body and an increase in blood flow.
Cobra 120 Vega Extra does not have a direct relaxing effect on the isolated cavernous human body, but enhances the effect of nitric oxide by inhibiting PDE-5, which is responsible for the disintegration of cGMP.
Selective Vega Extra Strong 120 against PDE5 in vitro, its activity against PDE5 superior activity against other known PDE isoenzymes: PDE-6 — 10 times; PDE-1 more than 80 times; PDE-2, PDE-4, PDE-7 PDE–11 more than 700 times. Cobra Vega 120 is 4000 times more selective for PDE-5 than PDE-3, which is crucial because PDE-3 is one of the key enzymes in the regulation of myocardial contractility.
A prerequisite for the effectiveness of Cobra Vega Extra is sexual stimulation.
Cobra 120 Vega Extra restores impaired erectile function in conditions of sexual stimulation by increasing blood flow to the cavernous bodies of the penis.
Clinical data
In a placebo-controlled cross-examination of patients with proven early age macular degeneration (n=9), Sildenafil Vega Extra 130 Mg 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 Sildenafil Tablets Vegah Extra Cobra, 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 Visa 25 mg), 74% (dose Vega Coin 50 mg) and 82% (dose Cobra 120 Vega Extra 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 Vegah Extra 120 Indication 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 Vegab Extra.
Pharmacokinetics
The pharmacokinetics of Vegal Extra in the recommended dose range is linear.
Suction. After intake of Cobra 120 Vega Extra 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 Vega 120 Mg 100 mg average Cmax free Vega 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 Vega Extra Cobra 120 is 105 l. the Association of Vega Extra 120 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 Cobra (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 Cobra 120 Vega Extra, undergoes further metabolism. The selectivity of this metabolite against PDE is comparable to that of Cobra Vega Extra Strong 120mg, 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 Cobra 120 Vega Extra. 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, Sildenafil Vega Extra 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).
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