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 Extra. 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 Cobra 120 Vega Extra, consult a doctor immediately.

Bleedings

Sildenafil Vega Extra 130 Mg enhances the antiplatelet effect of sodium nitroprusside, a nitric oxide donator, on human platelets in vitro. Data on the safety of Vegal Extra in patients with a tendency to bleeding or exacerbation of gastric ulcer and duodenal ulcer are not available, so the drug Sildenafil Vega Extra 130 Mg 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 (Sildenafil Vega Extra 130 Mg — 12.9%, placebo — 0%) than in patients with primary pulmonary arterial hypertension (Cobra Vega Extra — 3%, placebo — 2.4%). Patients receiving Sildenafil Vega Extra 130 Mg 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 Sildenafil Vega Extra 130 together with other PDE-5 inhibitors or other drugs for the treatment of pulmonary hypertension containing Sildenafil Vega Extra 130 Mg (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 Extra Cobra any negative effect on the ability to drive a car or other means was not observed. However, since when taking Sildenafil Vega Extra 130 Mg 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.

Visual impairment

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

Cardiovascular complications

During the post-marketing use of Sildenafil Vega Extra 130 Mg for the treatment of erectile dysfunction, adverse events such as severe cardiovascular complications (including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, hemorrhagic stroke, transient ischemic attack, hypertension and hypotension) were reported, which had a temporary connection with the use of Sildenafil Vega Extra 130 Mg. Most of these patients, but not all of them, had risk factors for cardiovascular complications. Many of these adverse events were observed shortly after sexual activity, and some were observed after taking Cobra Vega Extra Strong 120 Mg without subsequent sexual activity. It is not possible to establish a direct link between the reported adverse events and those or other factors.

Hypotension

Sildenafil Vega Extra 130 Mg has a systemic vasodilating effect, leading to a transient decrease in blood PRESSURE, which is not clinically significant and does not lead to any consequences in most patients. However, before prescribing Sildenafil Vega Extra 130 Mg, the doctor should carefully assess the risk of possible undesirable manifestations of vasodilating action in patients with relevant diseases, especially against the background of sexual activity. Increased susceptibility to vasodilators is observed in patients with obstruction of the output tract of the left ventricle (aortic stenosis, GOCMP), as well as with the rare syndrome of multiple systemic atrophy, manifested by a severe violation of the regulation of blood PRESSURE from the autonomic nervous system.

Since the combined use of Cobra 120 Vega Extra and α-blockers can lead to symptomatic hypotension in some sensitive patients, Vega 120 Mg should be used with caution in patients taking α-blockers (see "Interaction"). To minimize the risk of postural hypotension in patients taking α-blockers, the drug Sildenafil Vega Extra 130 Mg should be started only after achieving stabilization of hemodynamic parameters in these patients. It should also consider reducing the initial dose of Sildenafil Vega Extra 130 Mg (see. "Dosage and administration"). The doctor should inform patients about what actions should be taken in case of symptoms of postural hypotension.

Cardiovascular complications

During the post-marketing use of Sildenafil Vega Extra 130 Mg for the treatment of erectile dysfunction, adverse events such as severe cardiovascular complications (including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, hemorrhagic stroke, transient ischemic attack, hypertension and hypotension) were reported, which had a temporary connection with the use of Sildenafil Tablets Vegah Extra Cobra. Most of these patients, but not all of them, had risk factors for cardiovascular complications. Many of these adverse events were observed shortly after sexual activity, and some were observed after taking Vega Extra Strong 120 without subsequent sexual activity. It is not possible to establish a direct link between the reported adverse events and those or other factors.

Visual impairment

In rare cases, during post-approval use of all of the inhibitors of PDE5, including Sildenafil Vega Extra 130 Mg, 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 of developing 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 Pills 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 Vega Extra 130 Mg, in such patients should be used with caution and only in situations where the expected benefit outweighs the risk.

When using the drug Sildenafil Vega Extra 130 Mg in doses exceeding the recommended, adverse events were similar to those noted above, but usually more common.

*Side effects identified during post-marketing studies.

Interaction

Effect of other drugs on the pharmacokinetics of Cobra Vega Extra

The metabolism of Vegah Cobra occurs mainly under the action of CYP3A4 isoenzyme (main pathway), so inhibitors of this isoenzyme can reduce the clearance of Sildenafil Vega Extra 130 Mg, and inducers, respectively, increase the clearance of Cobra Vega. A decrease in the clearance of Sildenafil Vega Extra 130 Mg with simultaneous use of inhibitors of CYP3A4 isoenzyme (ketoconazole, erythromycin, cimetidine).

Cimetidine (800 mg), a nonspecific inhibitor of CYP3A4 isoenzyme, when taken together with Sildenafil Vega Extra 130 Mg (50 mg) causes an increase in the concentration of Sildenafil Vega Extra 130 Mg in plasma by 56%.

A single dose of 100 mg of Sildenafil Tablets Vega Extra Cobra together with erythromycin (500 mg/day 2 times a day for 5 days), a moderate inhibitor of CYP3A4 isoenzyme, while achieving a constant concentration of erythromycin in the blood, leads to an increase in the AUC of Sildenafil Vega Extra 130 Mg Cobra by 182%.

When co-administered Cobra 120 Vega Extra (once 100 mg) and saquinavir (1200 mg/day 3 times daily), an inhibitor of HIV protease and of CYP3A4, on the background to achieve a constant concentration of saquinavir in the blood, Cmax of Sildenafil Vega Extra 120 was increased by 140% and the AUC increased by 210%.

Stronger inhibitors of CYP3A4 isoenzyme, such as ketoconazole and Itraconazole, can cause more pronounced changes in the pharmacokinetics of Vegab Extra.

The simultaneous use of Sildenafil Vega Extra 130 Mg (100 mg once) and ritonavir (500 mg 2 times a day), an inhibitor of HIV protease and a strong inhibitor of cytochrome P450, on the background to achieve a constant concentration of ritonavir in the blood leads to an increase in Cmax of Vega Pills by 300% (4 times), a AUC by 1000% (11-fold). After 24 h, the concentration of Sildenafil Vega Extra 130 Mg in blood plasma is about 200 ng/ml (after a single application of one Vegal Extra — 5 ng/ml). This is consistent with the ritonavir effect on a wide range of cytochrome P450 substrates. Cobra Vega Extra Strong 120 Mg does not affect the pharmacokinetics of ritonavir. Given these data, the simultaneous reception of ritonavir and Sildenafil Vega Extra 130 Mg is not recommended. In any case, the maximum dose of Vegal Extra under any circumstances should not exceed 25 mg for 48 hours. If Sildenafil Vega Extra 130 Mg is taken in the recommended doses, patients receiving strong inhibitors of CYP3A4 isoenzyme at the same time, then Cmax free Extra Vega does not exceed 200 nm, and the drug is well tolerated.

Single administration of antacid (magnesium hydroxide/aluminum hydroxide) does not affect the bioavailability of Vegal Extra.

Studies involving healthy volunteers with simultaneous use of endothelin receptor antagonist, bosentan (CYP3A4 isoenzyme inducer (moderate), CYP2C9, and possibly CYP2C19) in Css (125 mg 2 times a day) and Vega Extra Cobra in Css (80 mg 3 times a day) showed a decrease in AUC and Cmax Extra Vega by 62.6 and 52.4%, respectively. Sildenafil Vega Extra 130 Mg increased the AUC and Cmax of bosentan by 49.8 and 42%, respectively.

It is assumed that the simultaneous use of Sildenafil Vega Extra 130 Mg with powerful inducers of CYP3A4 isoenzyme, such as rifampicin, can lead to a greater decrease in the concentration of Sildenafil Vega Extra 130 Mg in blood plasma.

CYP2D6 isoenzyme inhibitors (SSRIs, tricyclic antidepressants), thiazide and thiazide-like diuretics, ACE inhibitors and calcium antagonists have no effect on the pharmacokinetics of Vega Extra.

Azithromycin (500 mg/day for 3 days) has no effect on AUC, Cmax, Tmax, excretion rate constant and T1/2 Vega Visa or its main circulating metabolite.

Vega Extra Cobra