Contraindications
hypersensitivity to Vegal Extra 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 Extra Cobra 120 enhances the hypotensive effect of nitrates (see "Interaction»);
the combined use of inhibitors of PDE5, including Vega Cobra 120 Mg, 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 Extra Cobra 120 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.
Clinical data
In a placebo-controlled cross-examination of patients with proven early age macular degeneration (n=9), Vega Extra Cobra 120 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 Sildenafil Vega Extra 130 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 Cobra Vega Extra, 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 Vega Extra Cobra 120 50 mg) and 82% (dose Vega Extra Cobra 120 100 mg) compared to 25% in the placebo group. Analysis of the international index of erectile function showed that in addition to improving erection treatment Vega Extra Cobra 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 120 Mg.
Pharmacokinetics
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 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 Vega Extra Cobra 120, consult a doctor immediately.
Bleedings
Cobra 120 Vega Extra enhances the antiplatelet effect of sodium nitroprusside, a nitric oxide donator, on human platelets in vitro. Data on the safety of Vega Extra Cobra 120 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 Cobra 120 — 12.9%, placebo — 0%) than in patients with primary pulmonary arterial hypertension (Vega Extra Cobra 120 — 3%, placebo — 2.4%). Patients receiving Sildenafil Tablets Vegah Extra Cobra 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 Vegah Extra 120 Indication together with other PDE-5 inhibitors or other drugs for the treatment of pulmonary hypertension containing Vega Extra Cobra 120 (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 120 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.
Side effect
The most common side effects were headache and tides.
Usually the side effects of Vega Extra Cobra 120 are mild or moderate and are transient.
Studies using a fixed dose have shown that the frequency of some adverse events increases with increasing dose.
The frequency of adverse reactions is presented in the following classification: very often — ≥10%; often — ≥1% and <10%; infrequently — ≥0.1% and <1%; rarely — ≥0.01% and <0.1%; very rarely — <0.01%; frequency unknown — cannot be determined based on available data.
Co side of the immune system: infrequently — hypersensitivity reactions (including skin rash), allergic reactions.
On the part of the organ of vision: often — blurred vision, blurred vision, cyanopsia; rarely, eye pain, photophobia, photopsia, chromatopsia, eye redness/injection of the sclera, changing the brightness of cvetovete, mydriasis, conjunctivitis, hemorrhage in the tissue of the eye, cataract, a disorder of the lacrimal apparatus; rarely — swelling of the eyelids and adjacent tissues, a feeling of dryness in the eyes, the presence of iridescent circles in the field of view around the light source, increased fatigue of the eyes, vision of objects in yellow (xanthopsia), vision of objects in red (erythropsia), conjunctival hyperemia, irritation of the mucous membrane of the eyes, unpleasant sensations in the eyes; the frequency is unknown — NPINZN, occlusion of retinal veins, visual field defect, diplopia*, temporary vision loss or decreased visual acuity, increased IHD, edema retina, retinal vascular disease, vitreous detachment/vitreal traction.
On the part of the organ of hearing: infrequent — a sudden decrease or loss of hearing, tinnitus, pain in the ears.
From the CCC: often — tides; infrequently — tachycardia, palpitations, decreased blood PRESSURE, increased heart rate, unstable angina, AV-blockade, myocardial infarction, cerebral thrombosis, cardiac arrest, heart failure, deviations in ECG readings, cardiomyopathy; rarely — atrial fibrillation, sudden cardiac death*, ventricular arrhythmia*.
The blood and lymphatic system: rarely — anemia, leukopenia.
On the part of metabolism and nutrition: infrequently — a feeling of thirst, swelling, gout, uncompensated diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemia, hypernatremia.
From the respiratory system: often — nasal congestion; infrequent — nosebleeds, rhinitis, asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, increased volume of sputum, increased cough; rarely — a feeling of tightness in the throat, dryness of the nasal mucosa, swelling of the nasal mucosa.
From the digestive tract: often — nausea, dyspepsia; uncommon — GERD, vomiting, pain in the abdomen, dryness of the mucous membrane of the mouth, glossitis, gingivitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, rejection of liver function tests from normal, rectal bleeding; rarely, hypesthesia of the mucous membrane of the oral cavity.
On the part of the musculoskeletal system: often — back pain; infrequently — myalgia, pain in the limbs, arthritis, arthrosis, tendon rupture, tenosynovitis, bone pain, myasthenia gravis, synovitis.
From the genitourinary system: infrequently — cystitis, nicturia, breast enlargement, urinary incontinence, hematuria, ejaculation disorders, genital edema, anorgasmia, hematospermia, damage to the tissues of the penis; rarely — prolonged erection and/or priapism.
From the Central and peripheral nervous system: very often — headache; often — dizziness; infrequently — drowsiness, migraine, ataxia, hypertension, neuralgia, neuropathy, paresthesia, tremor, vertigo, symptoms of depression, insomnia, unusual dreams, increased reflexes, hypesthesia; rarely — convulsions*, repeated convulsions*, fainting.
On the part of the skin and subcutaneous tissues: infrequently — skin rash, urticaria, herpes simplex, itching, sweating, skin ulceration, contact dermatitis, exfoliative dermatitis; the frequency is unknown — Stevens-Johnson syndrome, toxic epidermal necrolysis.
Other: infrequently — a feeling of heat, swelling of the face, photosensitivity reaction, shock, asthenia, fatigue, pain of various localization, chills, accidental falls, chest pain, accidental injuries; rarely — irritability.
Vega Cobra 120 Mg
