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 Strong 120 100 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 Vega 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 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 Cobra dose should be reduced to 25 mg.
Hepatic impairment. Since the excretion of Sildenafil Vega Extra 130 Mg Cobra is disturbed in patients with liver damage (in particular, cirrhosis), the dose of Extra 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 Vega Extra Cobra 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 Cobra should be 25 mg (see "Interaction").
To minimize the risk of postural hypotension in patients taking α-blockers, Vega Cobra should be started only after achieving hemodynamic stabilization in these patients. Consideration should also be given to reducing the initial dose of Vega Cobra (see special instructions and Interactions).
Old age. Adjustment of the dose of Vega Visa is not required.
Contraindications
hypersensitivity to Vega 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 Vega Cobra enhances the hypotensive effect of nitrates (see "Interaction»);
the combined use of inhibitors of PDE5, including Vega Cobra, 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 Vega Cobra 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.
Visual impairment
In rare cases, during post-approval use of all of the inhibitors of PDE5, including Vega Cobra, 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 Sildenafil Vega Extra 130 Mg 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 Sildenafil Tablets Vegah Extra Cobra, 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 120 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 Vega Cobra in patients with retinitis pigmentosa absent, so these patients should not be used Vega Cobra (see "Contraindications").
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 Vega Coin. 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 Vega Cobra, consult a doctor immediately.
Bleedings
Vegah Extra 120 Mg enhances the antiplatelet effect of sodium nitroprusside, a nitric oxide donator, on human platelets in vitro. Data on the safety of Vega Cobra in patients with a tendency to bleeding or exacerbation of gastric ulcer and duodenal ulcer are not available, so the drug Cobra Vega Extra 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 (Vegab Extra — 12.9%, placebo — 0%) than in patients with primary pulmonary arterial hypertension (Vegab Extra — 3%, placebo — 2.4%). Patients receiving Cobra Vega 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 Vega Cobra together with other PDE-5 inhibitors or other drugs for the treatment of pulmonary hypertension containing Sildenafil Tablets Vegah Extra Cobra (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 Vega Cobra any negative effect on the ability to drive a car or other means was not observed. However, since when taking Vega Cobra 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.
Vegal Extra