Visual impairment
In rare cases, during post-approval use of all of the inhibitors of PDE5, including Vega Extra 120, 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 Vega Extra 120 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 Vega Extra 120, 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 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 Extra 120 in patients with retinitis pigmentosa absent, so these patients should not be used Sildenafil Tablets Vega Extra Cobra (see "Contraindications").
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 120 100 mg, the second tablet of Vega Visa 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 Vega Pills 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 Extra 120 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) Extra Vega dose should be reduced to 25 mg.
Hepatic impairment. Since the excretion of Vega Extra 120 is disturbed in patients with liver damage (in particular, cirrhosis), the dose of Vega 120 Mg 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 130 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 Vega Extra 120 Mg should be 25 mg (see "Interaction").
To minimize the risk of postural hypotension in patients taking α-blockers, Vegal Extra should be started only after achieving hemodynamic stabilization in these patients. Consideration should also be given to reducing the initial dose of Signature Cobra Vega (see special instructions and Interactions).
Old age. Adjustment of the dose of Vegab Extra is not required.
The pharmacokinetics of Vega Extra 120 in the recommended dose range is linear.
Suction. After intake of Vega Extra 120 is rapidly absorbed. Absolute bioavailability averages about 40% (25 to 63%). In vitro Vega Extra 120 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 Extra 120 100 mg average Cmax free Vegah Extra 130 in plasma men is about 18 ng/ml (38 nm). Cmax when taking Vega Extra 120 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 Cobra Vega is 105 l. the Association of Vega Extra 120 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 120 Indication 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 Extra 120, undergoes further metabolism. The selectivity of this metabolite against PDE is comparable to that of Vega Extra 120, and its activity against PDE-5 in vitro is about 50% of the activity of Vega Extra 120. The concentration of the metabolite in the blood plasma of healthy volunteers was about 40% of the concentration of Vega Extra 120 Mg. N-demethyl metabolite undergoes further metabolism; its T1/2 is about 4 no.
Breeding. The total clearance of Vega Extra is 41 l/h, and the final T1/2 — 3-5 h. After oral administration, as well as after I/V, Cobra 120 Vega Extra is excreted as metabolites, mainly by the intestine (about 80% oral dose) and to a lesser extent by the kidneys (about 13% oral dose).
Vegah Extra 120 Mg is a weak inhibitor of cytochrome P450 — 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 ISOENZYMES (IC50 >150 µmol). When taking Vega Extra 120 in recommended doses, its Cmax is about 1 µmol, so it is unlikely that Vega Extra 120 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 Extra 120 in combination with nitrates or nitric oxide donators is contraindicated. While taking α-adrenoblocker doxazosin (4 and 8 mg) and Vega Visa (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 Extra 120 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 Extra 120 (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 Cobra Vega 120 Mg 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.
Vega Extra 120 (50 mg) does not cause an additional increase in bleeding time when taking acetylsalicylic acid (150 mg).
Vegah Extra 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 Extra 120 (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 Vega Extra 120 in combination with antihypertensive agents does not lead to additional side effects.
Vegal Extra
