Zidena - instructions for use, analogs, testimonials and release forms (100 mg tablets) for the treatment of impotence and erectile dysfunction in men. Composition and alcohol
In this article, you can read the instructions for using the drug Zieden. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Zidena in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Zidena in the presence of existing structural analogs. Use to treat impotence and erectile dysfunction in men. Composition and interaction of the drug with alcohol.
Zieden - a drug for the treatment of erectile dysfunction.It is a reversible selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5).
Udenafil does not have a direct relaxing effect on an isolated cavernous body, but with sexual stimulation enhances the relaxing effect of nitric oxide by inhibiting PDE5, responsible for the disintegration of cGMP in the cavernous body. The consequence of this is the relaxation of the smooth muscles of the arteries and the flow of blood to the tissues of the penis, which causes an erection. The drug has no effect in the absence of sexual stimulation.
Studies have shown that udenafil is a selective inhibitor of the PDE5 enzyme. PDE5 is present in the smooth muscles of the cavernous body, in the smooth muscles of the vessels of internal organs, in skeletal muscles, platelets, kidneys, lungs and the cerebellum. Udenafil is 10,000 times more potent inhibitor of PDE5 than with PDE1, PDE2, PDE3 and PDE4, which are localized in the heart, brain, blood vessels, liver and other organs.
In addition, udenafil is 700 times more active against PDE5 than with PDE6, found in the retina and responsible for color perception.Udenafil does not inhibit PDE11, which causes absence of cases of myalgia, back pain and manifestations of testicular toxicity.
Udenafil improves the erection and the possibility of a successful sexual intercourse. The effect of the drug has an optimal duration - up to 24 hours. The effect manifests itself 30 minutes after taking the drug in the presence of sexual arousal.
Udenafil in healthy individuals does not cause a significant change in systolic and diastolic pressure in comparison with placebo in the supine and standing position (the average maximum decrease is 1.6 / 0.8 mmHg and 0.2 / 4.6 mmHg, respectively).
Udenafil does not cause changes in color recognition (blue / green), which is explained by its low affinity with PDE6. Udenafil does not affect visual acuity, electroretinogram, intraocular pressure and pupil size.
In the study of udenafil in men, there was no clinically significant effect of the drug on the number and concentration of sperm, motility and morphology of spermatozoa.
Composition
Udenafil + excipients.
Pharmacokinetics
After intake, Zidena is quickly absorbed.Eating high in fat does not affect the absorption of udenafil. High binding of udenafil with plasma proteins (93.9%) prolongs the period of its effectiveness to 24 hours after taking one dose. Does not accumulate in the body. With daily intake of healthy volunteers of udenafil in doses of 100 mg and 200 mg per day for 10 days, no significant changes in its pharmacokinetics were found. Basically, it is metabolized with the participation of the CYP3A4 isoenzyme. After ingestion, udenafil is excreted as metabolites with feces.
Pharmacokinetics in special clinical cases
The intake of alcohol in the amount of 112 ml (in terms of 40% ethyl alcohol) in combination with the intake of udenafil inside at a dose of 200 mg does not affect the pharmacokinetic profile of udenafil.
Indications
- treatment of erectile dysfunction (impotence), characterized by the inability to achieve or maintain an erection penis sufficient for a satisfactory sexual intercourse.
Forms of release
Tablets coated with 100 mg.
Instructions for use and dosing regimen
The drug is taken orally, regardless of food intake, 30 minutes before the alleged sexual activity.
The recommended dose is 100 mg. If necessary, taking into account individual efficacy and tolerability, the dose may be increased to 200 mg. The maximum recommended frequency of application is 1 time per day.
Side effect
- flushes of blood to the face;
- dizziness;
- stiff neck;
- paresthesia;
- redness of the eyes;
- blurred vision;
- Pain in the eyes;
- increased lacrimation;
- swelling of the eyelids;
- swelling of the face;
- hives;
- dyspepsia;
- discomfort in the abdomen;
- nausea;
- toothache;
- diarrhea, constipation;
- gastritis;
- thirst;
- nasal congestion;
- dyspnea;
- dryness in the nose;
- periarthritis;
- headache;
- discomfort in the chest;
- sensation of heat;
- chest pain;
- stomach ache;
- fatigue;
- nose bleed;
- noise in ears;
- prolonged erection;
- a feeling of general discomfort;
- postural dizziness;
- cough.
Contraindications
- simultaneous reception of nitrates and other donators of nitric oxide;
- hypersensitivity to any of the components of the drug.
Caution should be given to Ziden patients with uncontrolled arterial hypertension (blood pressure more than 170/100 mm Hg), arterial hypotension (blood pressure less than 90/50 mm Hg); patients with hereditary degenerativeretinal diseases (including retinitis pigmentosa, proliferative diabetic retinopathy); patients who have had stroke, myocardial infarction, or coronary artery bypass in the last 6 months; patients with severe hepatic or renal insufficiency; if there is a congenital syndrome of prolongation of the QT interval or with an increase in the QT interval due to drug administration.
The potential risk of developing complications associated with sexual activity in patients with cardiovascular diseases such as unstable angina or angina arising during intercourse should be considered; chronic heart failure 2-4 functional class (according to the NYHA classification), developed during the last 6 months; uncontrolled disturbances of the heart rhythm.
Caution should be applied to udenafil in patients with a predisposition to priapism, as well as in patients with an anatomical deformation of the penis, if there is an implant of the penis.
With simultaneous administration of udenafil and calcium channel blockers, alpha-blockers or other antihypertensive agents, an additional decrease in systolic anddiastolic blood pressure by 7-8 mm Hg.
Application in pregnancy and lactation
According to the registered indication the drug is not intended for use in women.
Use in children
Not applicable.
Application in elderly patients
Due to the lack of clinical data on the use of udenafil in patients older than 71 years of this category of patients, this drug is not recommended.
special instructions
Sexual activity has a potential risk for patients with cardiovascular diseases, so the treatment of erectile dysfunction, incl. with the use of Ziden, should not be performed in men with heart disease, in which sexual activity is not recommended.
Patients with difficulty in bleeding from the left ventricle (aortic stenosis) may be more sensitive to the action of vasodilators, including PDE inhibitors. Despite the absence of prolonged erections (more than 4 hours) and priapism (a painful erection lasting more than 6 hours) in clinical trials, such phenomena are peculiar to this class of drugs. In the case of an erection lasting more than 4 hours (regardless of the presence of pain) patients should immediately seek medical help.In the absence of timely treatment, priapism can lead to irreversible damage to erectile tissue and erectile function.
Due to the lack of clinical data on the use of udenafil in patients older than 71 years of this category of patients, this drug is not recommended. It is not recommended to use udenafil in combination with other treatments for erectile dysfunction.
Impact on the ability to drive vehicles and manage mechanisms
Patients whose activities are associated with driving vehicles and managing mechanisms, should determine the individual response to taking the drug.
Drug Interactions
Inhibitors of cytochrome isoenzymes CYP3A4 (ketoconazole, itraconazole, ritonavir, indinavir, cimetidine, erythromycin, grapefruit juice) can enhance the effect of Zidena.
Ketoconazole (400 mg dose) increases bioavailability and Cmax of udenafil (at a dose of 100 mg) by almost 2 times (212%) and by 0.8 times (85%), respectively.
Ritonavir and indinavir significantly enhance the action of udenafil.
Dexamethasone, rifampicin and anticonvulsants (carbamazepine, phenytoin and phenobarbital) can accelerate the metabolism of Zydena, therefore, when combined, the effectiveness of udenafil decreases.
In experimental studies with combined administration of udenafil (30 mg / kg orally) and Nitroglycerin (2.5 mg / kg once intravenously) there was no effect on the pharmacokinetics of udenafil, but the simultaneous clinical use of nitroglycerin and udenafil is not recommended because of the possible reduction in blood pressure.
Udenafil and drugs from the group of alpha-blockers are vasodilators, therefore, if simultaneous application is necessary, both drugs should be prescribed in the minimum effective doses.
Analogues of the drug Ziden
Zidena does not have structural analogs for the active substance. Similar generics were not found.
Analogues on the pharmacological group (regulators of potency in men):
- Alisat;
- Allikor;
- Andriol;
- Bromocriptine;
- Vazoton (L arginine);
- Verona;
- Viagra;
- Viardot;
- Viardot forte;
- Vizarsin;
- Dynaman;
- Dynamics;
- The Impaza;
- Iohimbine;
- Yohimbe;
- Carinate;
- Karinat Forte;
- Koprivit;
- Levitra;
- Leuseya;
- Milife;
- Muse;
- Omnadren 250;
- Optinat;
- Proviron;
- Simpletons;
- Reilis;
- Cialis;
- Sildenafil;
- Stalon;
- Super Yohimbe Plus;
- Sustanon;
- Tentex forte;
- Testalamine;
- Testis compositum;
- Tornethis;
- Tribestan;
- Himkoline;
- Edex;
- Eifitol;
- Erbisol;
- Erexel.
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