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Vega Extra Cobra (sildenafil citrate)

Vega Extra Cobra (sildenafil citrate)

$ 1.02 per pill

Quick Overview

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

Vega Extra Cobra® (Signature)

Vega Extra Cobra (Sildenafil citrate) 120 mg

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Information

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 Cobra Vega 120 Mg. 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 Signature Cobra Vega, consult a doctor immediately.

Bleedings

Signature Cobra Vega enhances the antiplatelet effect of sodium nitroprusside, a nitric oxide donator, on human platelets in vitro. Data on the safety of Cobra Vega Extra Strong 120mg in patients with a tendency to bleeding or exacerbation of gastric ulcer and duodenal ulcer are not available, so the drug Vegal 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 (Vega Extra Strong 120 — 12.9%, placebo — 0%) than in patients with primary pulmonary arterial hypertension (Cobra 120 Vega Extra — 3%, placebo — 2.4%). Patients receiving Cobra Vega Extra Strong 120mg 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 Cobra Vega Extra Strong 120mg together with other PDE-5 inhibitors or other drugs for the treatment of pulmonary hypertension containing Cobra Vega Extra Strong 120mg (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 120 Mg any negative effect on the ability to drive a car or other means was not observed. However, since when taking Cobra Vega Extra Strong 120mg 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.

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 Vega Extra Strong 120mg 100 mg, the second tablet of Vega Pills 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 Extra Strong 120mg 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 Vega Extra Strong 120mg 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) Sildenafil Vega Extra 130 Mg Cobra dose should be reduced to 25 mg.

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

To minimize the risk of postural hypotension in patients taking α-blockers, Cobra Vega Extra Strong 120mg should be started only after achieving hemodynamic stabilization in these patients. Consideration should also be given to reducing the initial dose of Cobra Vega Extra Strong 120mg (see special instructions and Interactions).

Old age. Adjustment of the dose of Cobra 120 Vega Extra is not required.

Clinical data

In a placebo-controlled cross-examination of patients with proven early age macular degeneration (n=9), Cobra Vega Extra Strong 120mg 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 Vega Extra Strong 120mg 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 Vegah Extra 120 Indication, 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 Vegah Extra 120 Indication 25 mg), 74% (dose Cobra Vega Extra Strong 120mg 50 mg) and 82% (dose Cobra Vega Extra Strong 120mg 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 Sildenafil Vega Extra 120 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 Cobra Vega Extra Strong 120mg.

Pharmacokinetics

Cardiovascular complications

During the post-marketing use of Cobra Vega 120 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 Cobra Vega Extra Strong 120mg. 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 120mg 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 Vegah Extra 120 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 Cobra 120 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 Cobra Vega Extra Strong 120mg, in such patients should be used with caution and only in situations where the expected benefit outweighs the risk.

When using the drug Vega Extra 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 Strong 120mg

The metabolism of Cobra Vega Extra Strong 120mg occurs mainly under the action of CYP3A4 isoenzyme (main pathway), so inhibitors of this isoenzyme can reduce the clearance of Cobra Vega Extra Strong 120mg, and inducers, respectively, increase the clearance of Cobra Vega Extra Strong 120mg. A decrease in the clearance of Vega Extra Strong 120 with simultaneous use of inhibitors of CYP3A4 isoenzyme (ketoconazole, erythromycin, cimetidine).

Cimetidine (800 mg), a nonspecific inhibitor of CYP3A4 isoenzyme, when taken together with Cobra Vega Extra Strong 120mg (50 mg) causes an increase in the concentration of Cobra Vega in plasma by 56%.

A single dose of 100 mg of Vega Extra Cobra 120 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 Cobra Vega 120 by 182%.

When co-administered Cobra Vega Extra Strong 120mg (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 Tablets Vega Extra Cobra 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 Cobra Vega Extra Strong 120mg.

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

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 Sildenafil Tablets Vega Extra Cobra in Css (80 mg 3 times a day) showed a decrease in AUC and Cmax Cobra Vega Extra Strong 120mg by 62.6 and 52.4%, respectively. Vega Cobra 120 Mg increased the AUC and Cmax of bosentan by 49.8 and 42%, respectively.

It is assumed that the simultaneous use of Cobra Vega Extra Strong 120mg with powerful inducers of CYP3A4 isoenzyme, such as rifampicin, can lead to a greater decrease in the concentration of Cobra Vega Extra Strong 120mg 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 Cobra Vega Extra Strong 120mg.

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



Cobra Vega Extra

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