Zydena (Udenafil)

Company: Dong-A PharmTech Co., Ltd (South Korea)

Usage: Instruction

Description Zydena (Udenafil)

Udenafil has a trade name Zydena. This is one of the four famous molecules investigated for the treatment of erectile dysfunction (ED). It is well-known with proven clinical efficiency, high safety and acceptability to the patient. The unique qualities of Zydena makes it perfect choice for the user.

Zydena provides quick and strong onset of action, which lasts to twenty-four hours. Zydena does not have testicular toxicity. Certainly, all of these properties will be the best in its segment.
Udenafil comes in oval shaped tablets, film-coated light-pink color with light-yellow shade. There are imprinted symbol “100” on one side and symbols  “Z” and “Y” on another

1 tablet contains 100 mg of udenafil;
There are one or four tablets per pack.

Zydena greatly improves erection and the possibility of successful sexual intercourse. The action of the drug has an optimal duration – up to twenty-four hours. Effect appears after thirty minutes after taking the drug in the presence of sexual arousal.

Pharmacological Group
– Regulators potency

The composition and the form
Tablets, film-coated udenafil 100 mg
Adjuvants: lactose, maize starch, colloidal silicon dioxide; L-hydroxypropylcellulose, hydroxypropyl-LF; talc, magnesium stearate
Jacket: hydroxypropyl methylcellulose, talc, iron oxide red, iron oxide yellow, titanium dioxide
packages stripes 1, 2 or 4 pieces.; in a carton pack 1 (for 1 or 4 pcs.) or 2 (for 2 pcs.) packaging.
Coated tablets light pink color with a tinge yellow, oval imprinted with the symbol “100” on one side and symbols in the form of letters «Z» and «Y», risk-sharing – on the other. At the break – a white or nearly white.
Pharmacological action

– Improves erectile function.
Udenafil Indications
Treatment of erection disorders, characterized by the inability to achieve or maintain penile erection sufficient for satisfactory sexual intercourse.

Pharmacokinetics
Oral udenafil is rapidly absorbed and produces effect in 30-90 minutes (on average – 60 minutes).
Udenafil half-life is 12 hours, due to high binding to plasma proteins (93.9%) effective period extends up to 24 hours after receiving a single dose.
Alcohol and food  have no effect on the udenafil absorbability.
Drinking alcohol at 112 ml (equivalent to 40% ethyl alcohol) in combination with oral udenafil a dose of 200 mg does not affect the pharmacokinetic profile of udenafil.
Udenafil does not accumulate in the body, even continuous intake does not produce significant changes in its pharmacokinetics.
Pharmacodynamics
Udenafil is a selective reversible inhibitor of specific phosphodiesterase type 5-th (PDE-5), promotes metabolism of cyclic guanosine monophosphate (cGMP).
Udenafil no direct relaxing effect on isolated corpus cavernosum, but enhances sexual stimulation relaxing effect of nitric oxide by inhibiting PDE-5, responsible for the breakdown of cGMP in the cavernous body.
The result is relaxation of smooth muscles of arteries and blood flow to the tissues of the penis that causes erections. The drug has no effect in the absence of sexual stimulation.
Research in vitro shown that udenafil is a selective inhibitor of the enzyme PDE-5. PDE-5 is present in smooth muscles of the corpus cavernosum, vascular smooth muscle in internal organs, skeletal muscle, platelets, kidney, lung and cerebellum. Udenafil is 10000 times more potent inhibitor for PDE-5 than for PDE-1, PDE 2, PDE-3 and PDE-4, which are located in the heart, brain, blood vessels, liver and other organs.
In addition, udenafil 700 times more active against PDE-5 than for PDE-6, found in the retina and responsible for color perception. Udenafil not inhibit PDE-11, hence the lack 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 lasts up to 24 h. The effect is manifested as early as 30 minutes after taking the drug in the presence of sexual arousal.
Udenafil in healthy individuals does not cause reliable changes in SBP and DBP compared with placebo in the position of “lying” and “standing up” (mean maximum decrease of 1,6 / 0,8 mmHg and 0,2 / 4,6 mm mmHg, respectively).
Udenafil no effect on recognition of colors (blue / green), which explains its low affinity for PDE-6. Udenafil no effect on visual acuity, elektroretinogrammu, intraocular pressure and pupil size.
In the study of udenafil men revealed no clinically significant effect on the drug quantity and concentration of sperm motility and morphology of spermatozoa.
Prescribed medication Zidena®
Treatment of erection disorders, characterized by the inability to achieve or maintain penile erection sufficient for satisfactory sexual intercourse.
Contraindications
Hypersensitivity to any component of the drug;
simultaneous reception of nitrates and other donor of nitric oxide.
Precautions:
patients with uncontrolled arterial hypertension (blood pressure> 170/100 mm Hg. st), hypotension (BP <90/50 mm Hg. Art.)
patients with hereditary degenerative diseases of the retina (including retinitis pigmentosa, proliferative diabetic retinopathy);
patients who had undergone during the last 6 months of stroke, myocardial infarction, or aorto-coronary bypass surgery;
Patients with severe hepatic or renal insufficiency;
presence of a congenital syndrome of QT prolongation or increase of the QT interval as a result of taking the drugs;
predisposition to priapism;
patients with anatomical deformation of the penis;
presence of penile implant;
during sexual activity in patients with cardio-vascular system, as unstable angina or angina occurring during sexual intercourse, chronic heart failure (II-IV functional class according to the classification NYHA), evolved in the past 6 months, uncontrolled cardiac arrhythmia – should take into account the potential risk for complications;
while receiving of udenafil and CCBs, alpha-blockers or other hypotensive drugs – may mark the additional reduction in SBP and DBP by 7-8 mmHg
The product is not intended for use in children and adolescents under the age of 18 years.
Application of pregnancy and breastfeeding
According to the registered indication the drug is not intended for use in women.
Side effects of Udenafil
Palpitations, prolonged erections, flushing, dizziness eye pain, increased lacrimation, nasal congestion, headache.

There is no research for its side effects for the men over 71 y.o.

There are no side effects on sperm quality.
Interaction

Inhibitors of cytochrome P450 isoenzyme CYP3A4 (ketoconazole, itraconazole, ritonavir, indinavir, cimetidine, erythromycin, grapefruit juice) may enhance the action of udenafil.
Ketoconazole (400 mg) increases the bioavailability and Cmax of udenafil (100 mg) almost 2-fold (212%) and 0.8-fold (85%), respectively.
Ritonavir and indinavir substantially increases the effects of udenafil.
Dexamethasone, rifampin, and anticonvulsants drugs (carbamazepine, phenytoin and phenobarbital) may accelerate the metabolism of udenafil, so joint application with the above medications weakens the effect of udenafil.
The joint application of udenafil (30 mg / kg orally) and nitroglycerin (2.5 mg / kg once, w / w) did not reveal any effect on the pharmacokinetics of udenafil in experimental studies, but the simultaneous use of nitroglycerin and of udenafil is not recommended because of possible reduce blood pressure.
Udenafil and drugs from the group of alpha-blockers are vasodilator, therefore, in the joint admission should be appointed at the minimum doses.
Overdose

Symptoms: with single dose of the drug in a dose of 400 mg of adverse events were comparable to those observed when receiving of udenafil at lower doses, but occurred more frequently.
Treatment: symptomatic. Dialysis does not accelerate the elimination of udenafil.
Dosing and Administration
Inside, regardless of the meal.
Recommended dose- 100 mg, taken 30 minutes before anticipated sexual activity.
The dose may be increased to 200 mg given individual efficacy and tolerability.
The maximum recommended frequency of application – 1 times per day.
Cautions
Sexual activity is a potential risk for patients with cardiovascular disease, so treatment of erectile dysfunction, including using of udenafil, should not hold for men with heart disease, in which sexual activity is not recommended.
Patients with obstruction of blood outflow from the left ventricle (aortic stenosis) may be more sensitive to the action of vasodilators, including inhibitors of PDE. Despite the lack of clinical trials of cases of prolonged erection (longer than 4 hours) and priapism (painful erections lasting more than 6 h), such phenomena are peculiar to 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 of priapism can lead to irreversible damage to the erectile tissue and erectile function.
In the absence of clinical data on the use of udenafil in patients older than 71 года this category of patients receiving the drug is not recommended. Do not use udenafil in combination with other treatments for erectile dysfunction.
Effects on ability to drive and operate machinery. Before you manage the equipment and vehicles, patients need to know how they react to the reception of Zidena®.
Shelf-life drug Zidena® / Zydena

3 years
Storage conditions Zidena® / Zydena
In dry, dark place at temperatures not above 30 ° C.