Description
Release form
Film-coated tablets.
Packing
In the package 1 pc.
Pharmacological action of
Ziden – a remedy for erectile dysfunction Type 5 phosphodiesterase inhibitor. Udenafil is a selective reversible inhibitor of cyclic guanosine monophosphate (cGMP), a specific type 5 phosphodiesterase (PDE-5).
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 PDE-5, which is responsible for the breakdown of cGMP in the cavernous body. The consequence of this is relaxation of the smooth muscles of the arteries and blood flow to the tissues of the penis, which causes an erection. The drug has no effect in the absence of sexual stimulation.
In vitro studies have shown that udenafil is a selective inhibitor of the PDE-5 enzyme. PDE-5 is present in the smooth muscles of the corpora cavernosa, in the smooth muscles of the vessels of internal organs, in skeletal muscles, platelets, kidneys, lungs and cerebellum. Udenafil is 10,000 times more potent inhibitor in relation to PDE-5 than in relation to PDE-1, PDE-2, PDE-3 and PDE-4, which are localized in the heart, brain, blood vessels, liver and other organs. In addition, Udenafil is 700 times more active in relation to PDE-5 than in relation to PDE-6, which is found in the retina and is responsible for color perception. Udenafil does not inhibit PDE-11, which leads to the absence of cases of myalgia, lower back pain and manifestations of testicular toxicity.
Udenafil improves erection and the possibility of successful sexual intercourse. The effect of the drug has an optimal duration of up to 24 hours. The effect manifests itself already 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 compared with placebo in the supine and standing position (average maximum decrease is 1.6 / 0.8 mm Hg and 0.2 / 4.6 mm Hg. Art., respectively).
Udenafil does not cause color recognition changes (blue / green), due to its low affinity for PDE-6. Udenafil does not affect visual acuity, electroretinogram, intraocular pressure and pupil size.
In a study of udenafil in men, there was no clinically significant effect of the drug on sperm count and concentration, sperm motility and morphology.
Contraindications
hypersensitivity to any of the components of the
preparation while taking nitrates and other nitric oxide donors.
Caution
Caution should be taken in patients with uncontrolled hypertension (arterial pressure> 170/100 mm Hg) and hypotension (arterial pressure) The potential risk of complications during sexual activity in patients with such diseases of the cardiovascular system should be taken as unstable angina pectoris or angina pectoris occurring during intercourse chronic heart failure (II-IV functional class according to NYHA classification (New York Heart Association, New York Heart Association), which has developed over the past 6 months with uncontrolled heart rhythm disturbances.Udenafil should be used with caution in patients with a predisposition to priapism, as well as in patients with anatomical deformation of the penis, in the presence of a penis implant.
Special instructions
Sexual activity has a potential risk for patients with cardiovascular diseases, therefore, treatment of erectile dysfunction, including with the use of udenafil, should not be carried out in men with heart diseases in which sexual activity is not recommended.
Patients with difficulty in outflow of blood from the left ventricle (aortic stenosis) may be more sensitive to the action of vasodilators, including PDE inhibitors. Despite the absence in the course of clinical studies of cases of prolonged erection (more than 4 hours) and priapism (painful erection, lasting more than 6 hours), such phenomena are characteristic of this class of drugs.
In the event of an erection lasting more than 4 hours (regardless 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 age, this drug is not recommended. Udenafil is not recommended in combination with other treatments for erectile dysfunction.
Composition
1 tablet contains:
Active ingredient:
udenafil – 100 mg
Excipients:
lactose,
starch silica,
cloxycloxyc-hydroxycloxyc-hydroxycloxyc-hydroxycloxy-hydroxy
hydroxypropyl methylcellulose,
talc,
iron oxide red,
iron oxide yellow,
titanium dioxide.
Dosage and administration of
The drug is taken orally, regardless of food intake. The recommended dose of the drug is 100 mg, taken 30 minutes before the alleged sexual activity.
Dose may be increased to 200 mg, taking into account the individual effectiveness and tolerability of the drug.
The maximum recommended frequency of use is once a day.
) Side effects of
Side effects observed during clinical trials of udenafil, depending on the frequency of their occurrence: very often -? 10% of cases often – 1-10% sometimes – 0.1–1%.
From the cardiovascular system: very often – flushing of the face
From the central nervous system: sometimes dizziness, stiff neck muscles, paresthesia
From the organs of vision: often – reddening of the eyes sometimes – blurred vision, eye pain, increased lacrimation.
From the skin: in GDS – swelling of the eyelids, swelling of the face, hives
From the digestive system:. often – indigestion, discomfort in the abdomen sometimes – nausea, toothache, constipation, gastritis.
From the respiratory system: often – nasal congestion, sometimes – shortness of breath, dry nose.
From the musculoskeletal system: sometimes – periarthritis.
Organism as a whole: often – headache, chest discomfort, feeling hot sometimes – chest pain, abdominal pain, fatigue, thirst.
In the course of post-marketing observations with the use of udenafil, other adverse events were also described: a strong heartbeat, nosebleeds, tinnitus, diarrhea, allergic reactions (skin rash, erythema), prolonged erection, a feeling of general discomfort, a feeling of cold or heat, postural dizziness coughing.
Drug Interactions
CYP3A4 cytochrome P450 isoenzyme inhibitors (ketoconazole, itraconazole, ritonavir, indinavir, cimetidine, erythromycin, grapefruit juice) may enhance the effect of udenafil.
Ketoconazole (at a dose of 400 mg) increases the bioavailability and Cmax of Udenafil (at a dose of 100 mg) almost twice (212%) and 0.8 times (85%), respectively. Ritonavir and indinavir significantly enhance the effect of udenafil. Dexamethasone, rifampin and anticonvulsants (carbamazepine, phenytoin and phenobarbital) can accelerate the metabolism of udenafil, so co-administration with the above drugs weakens the effect of udenafil.
Co-administration of udenafil (30 mg / kg, oral) and nitroglycerin (2.5 mg / kg once intravenously) did not show any effect on the pharmacokinetics of udenafil in experimental studies, however, the simultaneous use of nitroglycerin and udenafil is not recommended due to a possible decrease blood pressure.
Udenafil and drugs from the group of alpha-blockers are vasodilating agents, therefore, when taken together, they should be prescribed in minimal doses.
Overdose of
With a single dose of the drug at a dose of 400 mg, adverse events were comparable to those observed with udenafil at lower doses, but were more common.
Treatment: symptomatic
. Dialysis does not accelerate the excretion of udenafil.
Storage conditions
In a dry 30 sec.
Expiration
3 years.
active substance
Udenafil
lekarstvennaja form
tablets
