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Vega Extra Cobra (sildenafil citrate)

Vega Extra Cobra (sildenafil citrate)

$ 1.02 per pill

Quick Overview

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 Vegah Extra 130, 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 Vegah Extra 130 is contraindicated (see "Contraindications").

Vega Extra Cobra® (Signature)

Vega Extra Cobra (Sildenafil citrate) 120 mg

Vega Extra Cobra
Sildenafil citrate
120 mg × 180 pills
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Sildenafil citrate
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Sildenafil citrate
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Vega Extra Cobra
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Information

The pharmacokinetics of Vegah Extra 130 in the recommended dose range is linear.

Suction. After intake of Vegah Extra 130 is rapidly absorbed. Absolute bioavailability averages about 40% (25 to 63%). In vitro Vega Visa 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 120 Vega Extra 100 mg average Cmax free Vegah Extra 130 in plasma men is about 18 ng/ml (38 nm). Cmax when taking Vegah Extra 130 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 Vegah Extra 130 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 Extra 130 (an average of 188 ng) was found in sperm 90 minutes after taking the drug.

Metabolism. Vegah Extra 130 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 Vegah Extra 130, undergoes further metabolism. The selectivity of this metabolite against PDE is comparable to that of Vegah Extra 130, and its activity against PDE-5 in vitro is about 50% of the activity of Vegah Extra 130. The concentration of the metabolite in the blood plasma of healthy volunteers was about 40% of the concentration of Vegah Extra 130. N-demethyl metabolite undergoes further metabolism; its T1/2 is about 4 no.

Breeding. The total clearance of Vegah Extra 130 is 41 l/h, and the final T1/2 — 3-5 h. After oral administration, as well as after I/V, Vegah Extra 130 is excreted as metabolites, mainly by the intestine (about 80% oral dose) and to a lesser extent by the kidneys (about 13% oral dose).

Cardiovascular complications

During the post-marketing use of Vega Extra Cobra 120 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 Vega 120 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 Vegah Extra 130 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 130, 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 Vegah Extra 130 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 Vegah Extra 130, 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 Sildenafil Vega Extra 120

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

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

A single dose of 100 mg of Vega Visa 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 Vegah Extra 130 by 182%.

When co-administered Vegah Extra 130 (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 Vegah Extra 130 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 Sildenafil Vega Extra 130.

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

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 130 Mg in Css (80 mg 3 times a day) showed a decrease in AUC and Cmax Vegab Extra by 62.6 and 52.4%, respectively. Vegah Extra 130 increased the AUC and Cmax of bosentan by 49.8 and 42%, respectively.

It is assumed that the simultaneous use of Vega Extra Cobra 120 with powerful inducers of CYP3A4 isoenzyme, such as rifampicin, can lead to a greater decrease in the concentration of Vegah Cobra 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 Vegah Extra 130.

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

Influence of Vega Extra on other drugs

Vegah Extra 130 is a weak inhibitor of cytochrome P450 — 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 ISOENZYMES (IC50 >150 µmol). When taking Vega Coin in recommended doses, its Cmax is about 1 µmol, so it is unlikely that Vegah Extra 130 can affect the clearance of the substrates of these isoenzymes.

Vegah Extra 130 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 Vegah Extra 130 in combination with nitrates or nitric oxide donators is contraindicated. While taking α-adrenoblocker doxazosin (4 and 8 mg) and Vegah Extra 130 (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 Vegah Extra 130 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.

Vegah Extra 130 (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 Vegah Extra 130 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.

Sildenafil Vega Extra 130 Mg (50 mg) does not cause an additional increase in bleeding time when taking acetylsalicylic acid (150 mg).

Vegah Extra 130 (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 Vegah Extra 130 (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 Vegah Extra 130 in combination with antihypertensive agents does not lead to additional side effects.

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 Vegah Extra 130. 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 Extra 120 Mg, consult a doctor immediately.

Bleedings

Vegah Extra 130 enhances the antiplatelet effect of sodium nitroprusside, a nitric oxide donator, on human platelets in vitro. Data on the safety of Vegah Extra 130 in patients with a tendency to bleeding or exacerbation of gastric ulcer and duodenal ulcer are not available, so the drug Vegah Extra 130 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 Cobra 130 Mg — 12.9%, placebo — 0%) than in patients with primary pulmonary arterial hypertension (Vega Cobra 120 — 3%, placebo — 2.4%). Patients receiving Vega Coin 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 Extra Cobra 120 together with other PDE-5 inhibitors or other drugs for the treatment of pulmonary hypertension containing Vegah Extra 130 (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 Vegah Extra 130 any negative effect on the ability to drive a car or other means was not observed. However, since when taking Vega Extra Cobra 120 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.



Vega Cobra 120

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