Zidena - instructions for use, dose, side effects, contraindications

Active substanceUdenafilUdenafil

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Ziden®

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Mezzon Pharma Co., Ltd. The Republic of Korea

Dosage form: & nbspfilm-coated tablets

Composition:

1 tablet contains:

active substance: Udenafil - 100 mg

Excipients:

lactose 87.5 mg, corn starch-20.0 mg, silicon colloidal dioxide 12.5 mg, L-hydroxypropyl cellulose 12.5 mg, hydroxypropyl cellulose-LF 7.5 mg, talc 7.5 mg, stearate magnesium - 2.5 mg;

shell: hydroxypropylmethylcellulose - 6,9000 mg, talc - 0,0220 mg, iron oxide red - 0,0106 mg, iron oxide yellow - 0,0266 mg, titanium dioxide -1,0408 mg.

Description:Tablets covered with a light pink color with a beige tint, oval with a squashed symbol 100 on one side and symbols in the form of letters Z and Y, separated by a risk, on the other side. On the fracture is white or almost white.

Pharmacotherapeutic group:Means for the treatment of erectile dysfunction. The phosphodiesterase-5 type inhibitor

ATX: & nbsp

G.04.B.E Drugs for the treatment of erectile dysfunction

G.04.B.E.11 Udenafil

Pharmacodynamics:

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, 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.

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 internal organs, in skeletal muscles, platelets, kidneys, lungs and the cerebellum. Udenafil is 10,000 times more potent inhibitor against PDE-5 than with PDE-1, PDE-2, PDE-3 and PDE-4, which are located in the heart, brain, blood vessels, liver and other organs.

Besides, udenafil 700 times more active against PDE-5 than in relation to PDE-6, found in the retina and responsible for color perception. Udenafil does not inhibit PDE-11, which causes absence of cases of myalgia, low back pain and manifestations of testicular toxicity.

Udenafil improves the erection and the possibility of a successful sexual intercourse. The drug has an optimal duration of up to 24 hours. The effect manifests itself after 30 minutes after taking the drug in the presence of sexual arousal. Udenafil in healthy persons does not cause a significant change in systolic and diastolic pressure compared to 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 changes in color recognition (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, there was no clinically significant effect of the drug on the number and concentration of sperm, motility and morphology of spermatozoa.

Pharmacokinetics:

Suction:

After oral administration udenafil quickly absorbed. Time to reach the maximum concentration in the blood plasma (t_max) is 30-90 minutes (on the average - 60 minutes). The half-life period (t_1/2) is 12 hours, high binding of udenafil with plasma proteins (93.9%) prolongs the period of its effectiveness up to 24 hours after taking only one dose.

Eating high in fat does not affect the absorption of udenafil.

The intake of alcohol in amounts of 112 ml of alcohol (in terms of 40% ethyl alcohol) in combination with oral administration of udenafil at a dose of 200 mg does not affect the pharmacokinetic profile of udenafil.

Metabolism:

Udenafil is mainly metabolized with the participation of the isoenzyme (SUR) ZA4 cytochrome P450.

Excretion:

In healthy people, the total clearance of udenafil is 755 ml / min. After oral administration udenafil is excreted in the form of metabolites with feces.

Udenafil does not accumulate in the body. With daily intake of healthy volunteers, uadenafil in a dose of 100 mg and 200 mg per day for 10 days, there were no significant changes in its pharmacokinetics.

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

Contraindications:

- Hypersensitivity to any of the components of the drug;

- simultaneous reception of nitrates and other "donators" of nitrogen oxide.

Carefully:

Caution should be taken udenafil patients with uncontrolled arterial hypertension (arterial pressure> 170/100 mm Hg), hypotension (arterial pressure <90/50 mm Hg); patients with hereditary degenerative diseases of the retina (including retinitis pigmentosa, proliferative diabetic retinopathy); patients,who suffered a stroke, myocardial infarction or aortocoronary 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 (II-IV functional class according to the NYHA classification (New York Heart Association, New York Heart Association), developed during the last 6 months, uncontrolled disturbances of the heart rate.

Caution should be applied udenafil in patients with predisposition to priapism, as well as in patients with an anatomical deformation of the penis, in the presence of an implant of the penis.

With the simultaneous administration of udenafil and calcium channel blockers, alpha-blockers or other antihypertensive agents, an additional decrease in systolic and diastolic blood pressure by 7-8 mmHg may be noted.

Pregnancy and lactation:

According to the registered indication the drug is not intended for use in women.

Pediatric Use

Udenafil is not intended for use in children and adolescents under the age of 18 years.

Dosing and Administration:

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.

The dose can be increased to 200 mg, taking into account the individual efficacy and tolerability of the drug. The maximum recommended frequency of application is once a day.

Side effects:The table below lists the side effects observed in the clinical studies of udenafil, depending on the frequency of their occurrence.

Organs and organ systems	Adverse Events
	Often	often	sometimes
	≥10%	1 %-10%	0,1 %-1%
Cardiovascular system	Tides of blood to the face
central nervous system			Dizziness, stiff neck muscles, paresthesia.
The organs of sight		Redness of the eyes	Blurred vision, pain in the eyes, increased lacrimation
Leather			Edema of the eyelids, edema of the face, urticaria
Digestive system		Dyspepsia, abdominal discomfort	Nausea, toothache, constipation, gastritis
Endocrine system			Thirst
Respiratory system		Nasal congestion	Shortness of breath, dryness in the nose
Musculoskeletal system			Periarthritis
Organism as a whole		Headache, discomfort in groovedand, a feeling of heat	Chest pain, abdominal pain, fatigue

In the process of postmarketing observations, other undesirable effects were also described with the use of udenafil: severe palpitation, nosebleeds, tinnitus, diarrhea, allergic reactions (skin rash, erythema), prolonged erections, a feeling of general discomfort, a feeling of cold or heat, postural dizziness, cough.

Overdose:

At a single administration of the drug at a dose of 400 mg, adverse events were comparable to those observed with the use of uadenafil in lower doses, but were more common.

Treatment: symptomatic. Dialysis does not accelerate the excretion of udenafil.

Interaction:

Inhibitors of cytochrome P450 isoenzymes CYP3A4 (ketoconazole, itraconazole, ritonavir, indinavir, cimetidine, erythromycin, grapefruit juice) can enhance the action of udenafil.

Ketoconazole (400 mg dose) increases bioavailability and C_max udenafil (in a dose of 100 mg) almost doubled (212%) and in 0.8 times (85%), respectively.

Ritonavir and indinavir significantly enhance the action 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 action of udenafil.

The simultaneous administration of udenafil (30 mg / kg, orally) and nitroglycerin (2.5 mg / kg once intravenously) showed no effect on the pharmacokinetics of udenafil in experimental studies, however, concomitant use of nitroglycerin and udenafil is not recommended because of a possible reduction in arterial pressure.

Udenafil and drugs from the group of alpha-blockers are vasodilators, therefore, when combined, should be given in minimal doses.

Special instructions:

Sexual activity has a potential risk for patients with cardiovascular disease, so treatment of erectile dysfunction, including with the use of udenafil, should not be performed in men with heart disease, where 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) during clinical trials, such phenomena are typical for 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.

Effect on the ability to drive transp. cf. and fur:Before operating machinery and vehicles, patients should be aware of how they respond to Zygensa®.

Form release / dosage:Tablets, film-coated 100 mg.

Packaging:

For 1, 2 or 4 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

1 contour cell package for 1, 2 or 4 tablets, or 2 contour packs for 1, 2 or 4 tablets, or 4 contour packs of 2 tablets each, or 5 loop packs of 2 tablets together with instructions for use are placed in a pack from cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-006071/08

Date of registration:31.07.2008 / 01.09.2014

Expiration Date:Unlimited

The owner of the registration certificate:Mezzon Pharma Co., Ltd.Mezzon Pharma Co., Ltd. The Republic of Korea

Manufacturer: & nbsp

DONG-A ST CO., LTD. The Republic of Korea

Representation: & nbspVALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Information update date: & nbsp13.10.2017

Illustrated instructions

Instructions

Ziden® (Zydena®)