Contraindications
hypersensitivity to Vega Extra Cobra or any other component of the drug;
application in patients receiving constantly or intermittently nitric oxide donators, organic nitrates or nitrites in any form, as Vegah Cobra enhances the hypotensive effect of nitrates (see "Interaction»);
the combined use of inhibitors of PDE5, including Vega Cobra 120 Mg, called guanylate cyclase stimulants such as riociguat, because it can lead to symptomatic hypotension;
concomitant use with other agents for the treatment of erectile dysfunction (safety and efficacy of Vegal Extra when used together has not been studied (see. "Special instructions»);
lactose intolerance, lactase deficiency, glucose-papacosma malabsorption;
severe liver failure (class C classification for child-Pugh);
simultaneous administration of ritonavir;
severe cardiovascular diseases (severe heart failure, unstable angina, stroke or myocardial infarction during the last 6 months, life-threatening arrhythmias, hypertension (BP >170/100 mm Hg). art.) or hypotension (blood PRESSURE <90/50 mm Hg.art.) (see "Special instructions»);
patients with episodes of development partizanai anterior ischemic optic neuropathies (NESN) with loss of vision in one eye;
hereditary retinitis pigmentosa (see special instructions»);
according to the registered indication is not intended for use in women;
according to the registered indication is not intended for use in children under 18 years.
With caution: anatomic deformity of the penis (angulation, cavernous fibrosis or Peyronie's disease) (see "Special instructions"); diseases of, predisposing to the development of priapism (sickle-cell anemia, multiple myeloma, leukemia, thrombocythemia) (see "Special instructions"); diseases accompanied by haemorrhage; ulcer disease of stomach and duodenum in the acute phase; liver dysfunction; severe renal insufficiency (Cl creatinine <30 ml/min); patients with an episode of partizanai development of the anterior ischemic optic neuropathies in history (see "Special instructions); simultaneous reception of blockers α-adrenergic receptors.
Use during pregnancy and breast-feeding
According to the registered indication, the drug is not intended for use in women.
The pharmacokinetics of Signature Cobra Vega in the recommended dose range is linear.
Suction. After intake of Vega Cobra 120 Mg is rapidly absorbed. Absolute bioavailability averages about 40% (25 to 63%). In vitro Vegah Extra 120 Indication 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 Cobra 120 Mg 100 mg average Cmax free Vega Visa in plasma men is about 18 ng/ml (38 nm). Cmax when taking Vega Cobra 120 Mg 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 Cobra 120 Mg is 105 l. the Association of Sildenafil Tablets Vegah Extra Cobra 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. Sildenafil Tablets Vegah 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 Cobra 120 Mg, undergoes further metabolism. The selectivity of this metabolite against PDE is comparable to that of Vega Cobra 120 Mg, and its activity against PDE-5 in vitro is about 50% of the activity of Vegah Cobra. The concentration of the metabolite in the blood plasma of healthy volunteers was about 40% of the concentration of Vega Cobra 120 Mg. N-demethyl metabolite undergoes further metabolism; its T1/2 is about 4 no.
Breeding. The total clearance of Vega Cobra 120 Mg is 41 l/h, and the final T1/2 — 3-5 h. After oral administration, as well as after I/V, Vega 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 Cobra 120 Mg 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 Vegah Extra 130 100 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 Vega 120 Mg 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 Cobra 120 Mg dose should be reduced to 25 mg.
Hepatic impairment. Since the excretion of Vega Cobra 120 Mg is disturbed in patients with liver damage (in particular, cirrhosis), the dose of Vega Extra Strong 120 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 Cobra 120 Mg 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 Vegah Extra Cobra should be 25 mg (see "Interaction").
To minimize the risk of postural hypotension in patients taking α-blockers, Vega Cobra 120 Mg should be started only after achieving hemodynamic stabilization in these patients. Consideration should also be given to reducing the initial dose of Vega Cobra 120 Mg (see special instructions and Interactions).
Old age. Adjustment of the dose of Vega Cobra 120 Mg is not required.
Vega Extra Cobra 130 Mg is a weak inhibitor of cytochrome P450 — 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 ISOENZYMES (IC50 >150 µmol). When taking Vega Cobra 120 Mg in recommended doses, its Cmax is about 1 µmol, so it is unlikely that Vega 120 Mg can affect the clearance of the substrates of these isoenzymes.
Vega Extra 120 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 Vega Cobra 120 Mg in combination with nitrates or nitric oxide donators is contraindicated. While taking α-adrenoblocker doxazosin (4 and 8 mg) and Sildenafil Tablets Vegah Extra Cobra (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 Vega Cobra 120 Mg 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 Cobra 120 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 Sildenafil Vega Extra 120 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).
Vega Cobra 120 Mg (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 Vega Cobra 120 Mg (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 Sildenafil Vega Extra 130 in combination with antihypertensive agents does not lead to additional side effects.
Sildenafil Vega Extra 130
