Zydena® [Udenafil]

Brand Dong-A Pharmaceutical

In stock 1812 Items

Available since: 2019-09-19

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Clinical Pharmacology

Zydena - a treatment for erectile dysfunction. Inhibitor of phosphodiesterase-5 type. Udenafil is a selective reversible inhibitor of cyclic guanosine monophosphate (cGMP) —specific phosphodiesterase type 5 (PDE-5).

Udenafil does not have a direct relaxing effect on the isolated cavernous body, but during sexual stimulation it enhances the relaxing effect of nitric oxide by inhibiting PDE-5, which is responsible for the decay of cGMP in the cavernous body. The result is a relaxation of 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 enzyme PDE-5. PDE-5 is present in the smooth muscles of the cavernous body, in the smooth muscles of the vessels of the internal organs, in skeletal muscles, platelets, kidneys, lungs and cerebellum. Udenafil is 10,000 times more potent inhibitor against PDE-5 than 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, found in the retina and responsible for color perception. Udenafil does not inhibit PDE-11, which leads to the absence of cases of myalgia, back pain and manifestations of testicular toxicity.
Udenafil improves erection and the possibility of successful sexual intercourse. The action of the drug has an optimal duration of up to 24 hours. The effect is already 30 minutes after taking the drug in the presence of sexual arousal.
Udenafil in healthy individuals does not cause significant changes in systolic and diastolic pressure in comparison with placebo in the supine and standing position (the average maximum decrease is 1.6 / 0.8 mm Hg and 0.2 / 4.6 mm Hg ., respectively).
Udenafil does not cause color recognition changes (blue / green), which is explained by its low affinity with PDE-6. Udenafil does not affect visual acuity, electroretinogram, intraocular pressure and pupil size.
In the study of udenafil in men, no clinically significant effect of the drug on the amount and concentration of sperm, mobility and morphology of spermatozoa was revealed.

Indications

Treatment of erectile dysfunction, characterized by the inability to achieve or maintain an erection of the penis, sufficient for satisfactory sexual intercourse.

Composition

1 tablet contains:
active substance: udenafil - 100 mg
Excipients: lactose, corn starch, colloidal silicon dioxide, L-hydroxypropylcellulose hydroxypropylcellulose-LF, talc, magnesium stearate;
shell: hydroxypropyl methylcellulose, talc, red iron oxide, yellow iron oxide, titanium dioxide.

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Dosage and Administration

The drug is taken orally, regardless of the meal. The recommended dose of the drug is 100 mg, taken 30 minutes before the intended sexual activity.
The dose can be increased to 200 mg, taking into account the individual efficacy and tolerability of the drug.
The maximum recommended frequency of use is once a day.

Adverse reactions

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%.

Since the cardiovascular system: very often - hot flashes to the face.

From the side of the central nervous system: sometimes dizziness, stiff neck muscles, paresthesia.

From the organs of vision: often - redness of the eyes; sometimes - blurred vision, pain in the eyes, increased tearing.

From the skin: sometimes - swelling of the eyelids, swelling of the face, hives.

From the digestive system: often - dyspepsia, abdominal discomfort; sometimes nausea, toothache, constipation, gastritis.

On the part of the respiratory system: often - nasal congestion; sometimes - shortness of breath, dry nose.

From the musculoskeletal system: sometimes - periarthritis.

The body as a whole: often - headache, chest discomfort, heat sensation; sometimes - chest pain, abdominal pain, fatigue, thirst.

In the process of post-marketing observations when using udenafil, other adverse events were also described: heart palpitations, nose bleeding, tinnitus, diarrhea, allergic reactions (skin rash, erythema), prolonged erection, feeling of general discomfort, feeling cold or fever, postural dizziness, cough.

Contraindications

Carefully
Caution should be taken with udenafil in patients with uncontrolled hypertension (blood pressure> 170/100 mmHg), hypotension (blood pressure) Consider the potential risk of complications during sexual activity in patients with cardiovascular diseases such as unstable angina or angina occurring during intercourse; chronic heart failure (NYHA Class II-IV functional class (New York Heart Association, New York Heart Association), azvivshayasya during the last 6 months. uncontrolled heart rhythm disorders Caution should be used udenafil in patients with predisposition to priapism, as well as in patients with anatomical deformation of the penis, in the presence of the implant of the penis.

Drug interactions

Cytochrome P450 CYP3A4 isoenzyme inhibitors (ketoconazole, itraconazole, ritonavir, indinavir, cimetidine, erythromycin, grapefruit juice) can enhance the effect of udenafil.
Ketoconazole (at a dose of 400 mg) increases bioavailability and C_max udenafil (at a dose of 100 mg) is almost twice (212%) and 0.8 times (85%), respectively. Ritonavir and indinavir significantly enhance the effect of udenafil. Dexamethasone, rifampin and anticonvulsant drugs (carbamazepine, phenytoin and phenobarbital) can speed up the metabolism of udenafil, so co-administration with the above drugs weakens the effect of udenafil.
Combined 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 the possible reduction of arterial pressure.
Udenafil and drugs from the group of alpha-blockers are vasodilators, therefore, when administered jointly, should be administered in minimal doses.

Special instructions

Sexual activity has a potential risk for patients with cardiovascular diseases, therefore, treatment of erectile dysfunction, including the use of udenafil, should not be carried out in men with heart disease, in which sexual activity is not recommended.
Patients with impaired 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 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 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 age in this category of patients, this drug is not recommended. It is not recommended to use udenafil in combination with other types of treatment for erectile dysfunction.

Overdosage

With a single dose of 400 mg, the adverse events were comparable to those observed with lower doses of udenafil, but were more common.
Treatment: symptomatic. Dialysis does not accelerate the removal of udenafil.