Zidena

• Structure
• Release form
• Pharmacological action
• Pharmacodynamics and pharmacokinetics
• Indications to use
• Contraindications
• Side effects
• Application instruction of Zidena (Way and dosage)
• Overdose
• Interaction
• Terms of sale
• Storage conditions
• Period of validity
• Special instructions
• Analogs
• Responses

Structure

Is a part of each tablet of medicine of Ziden, as active agent, 100 mg of an udenafil.

As excipients the tablet of drug contains:

• 12,5 mg — silicon of dioxide colloid;
• 87,5 mg — lactoses;
• 20 mg — starch corn;
• 12,5 mg — L-hydroxypropyl celluloses;
• 7,5 mg — hydroxypropyl celluloses-LF;
• 2,5 mg — stearate magnesium;
• 7,5 mg — talc;

Cover of tablets film, containing:

• 6,9 mg — gidroksipropilmetiltsellyuloza;
• 0,022 mg — talc;
• 0106 mg — iron oxide red;
• 0,0266 mg — iron oxide yellow;
• 1,0408 mg — titanium of dioxide.

Release form

Zidena is issued in the form of tablets in a film cover, an oval form. Color light pink with a beige shade, on the line of demolition — white.

At the different parties of a tablet there are squeezed-out symbols: on one party figure "100", on opposite, divided risky, the letters "Z" and "Y".

Pharmacological action

Normalization of erectile function.

Pharmacodynamics and pharmacokinetics

Udenafit active agent is the selection reversible inhibitor of specific FDE-5 (phosphodiesterase 5 enzyme) which promotes tsGMF metabolism.

Has no the direct weakening effect on the cavernous isolated body, but during sexual stimulation increases the weakening effect of nitrogen oxide, oppressing FDE-5 answering in a cavernous body, for disintegration of tsGMF.

As a result of the influence unstriated muscles of arteries relax that promotes inflow of blood to fabrics of a man's generative organ and as a result leads to an erection.

Medicine does not work without sexual stimulation.

Results of the researches in vitro proved action of an udenafil as selection FDE-5 inhibitor. This enzyme is present at smooth muscles of vessels of internals, and also a cavernous body, at skeleton muscles, thrombocytes, lungs, a cerebellum and kidneys.

Udenafil 10000 times stronger inhibits FDE-5, than other phosphodiesterases which are localized in a liver, heart, blood vessels, a brain and other bodies. Also, it is 700 times more active in relation to FDE-5, than to FDE-6 which is in a retina of an eye and color scale, responsible for perception.

Udenafil does not oppress FDE-11 that predetermines lack of manifestations of a mialgiya, painful feelings in a lower back and cases of testicular toxicity.

Drug improves erectile function and a possibility of successful passing of sexual intercourse.

The effect comes after 30 minutes after the use and proceeds till 24 o'clock (in the presence of sexual stimulation).

Medicine does not cause authentically found change of systolic arterial pressure in healthy examinees (GARDEN) and diastolic arterial costing pressure (DAD) in comparison with the examinees accepting placebo in a position and lying (average maximum lowering makes, respectively 1,6/0,8 and 0,2/4,6 mm of a mercury column).

Udenafil does not lead to changes of recognition of a color range (blue/green), it is a consequence of its insignificant influence on FDE-6. Drug does not distort visual acuity, the size of a pupil and intraocular pressure, and also the electroretinogram.

In the conducted researches on male volunteers its clinically significant action on concentration and amount of sperm, as well as on integrity and mobility of spermatozoa was not proved.

Absorption

At oral administration udenafit it is soaked up quickly enough. In a blood plasma its maximum concentration is reached on average in 60 minutes (from 30 to 90 minutes). T1/2 (elimination half-life) of about 12 hours.

High linkng (93,9%) of drug with proteins of a blood plasma is characteristic that significantly increases the period of its effective action till 24 o'clock, after use single (100 mg) doses.

The food with high concentration of fats does not exert significant impact on absorbability.

Alcohol intake (alcohol of 40%) in number of 112 ml in combination with udenafily in a dose of 200 mg, significantly does not influence its efficiency.

Metabolism

The metabolism generally proceeds with the participation of a P450 cytochrome CYP3A4 isoenzyme.

Removal

At healthy examinees the general clearance equals 755 ml/min.

After oral administration it is removed with a stake, in the form of metabolites.

Does not kumulirut in the patient's organism.

In a daily dose of 100 mg – 200 mg accepted within 10 days (at research on healthy people) serious changes of pharmacokinetics are not revealed.

Indications to use

Therapy of the disturbances connected with an erection, which are shown inability to its emergence or preservation throughout sufficient time for carrying out acceptable sexual intercourse.

Contraindications

• age till 18 flyings;
• hypersensitivity to any of the making medicine substances;
• the accompanying therapy with reception of nitrates or drugs, being donators of nitrogen oxide (NO).

With care:

• hypotonia (ABP less than 90/50 mm of mercury.);
• uncontrollable arterial hypertension (ABP bolee170/100 mm of mercury);
• hereditary degenerative pathologies of a retina of an eye (including pigmental retinitis, diabetic proliferative retinopathy);
• the postponed aortocoronary shunting, stroke or heart attack (for the last half a year);
• hepatic or renal pathologies, in a severe form;
• inborn syndrome of increase or lengthening of an interval of QT;
• predisposition of the patient to a priapism;
• anatomic deformation of a man's generative organ or its implantation;
• sexual activity at diseases of cardiovascular system, because of risk of emergence of complications.

Side effects

During passing of clinical trials by Zidena some side effects of an udenafil which depending on the frequency of manifestation subdivide as follows were revealed.

Probability of emergence of 10% and more — it is very frequent; from 1% to 10% — it is frequent; from 0,1% to 1% — sometimes.

Very often observed:

• rushes of blood (reddening) to the person.

Often:

• reddening of eyes;
• discomfort in a stomach;
• dyspepsia;
• nose congestion;
• headache;
• feeling of heat;
• discomfort in a pectus.

Sometimes:

• rigidity of cervical muscles;
• dizziness;
• paresthesia;
• the obscured sight;
• the raised dacryagogue;
• pain in organs of sight;
• face edema;
• the century swelled;
• small tortoiseshell;
• nausea;
• lock;
• gastritis;
• dentagra;
• feelings of dryness in a nose;
• asthma;
• periarthritis;
• pain in a breast and in a stomach;
• feeling of thirst;
• fatigue.

In the course of further supervision also other undesirable (negative) effects were found:

• cardiopalmus;
• sonitus;
• nasal bleedings;
• diarrhea;
• long erection;
• erythema;
• rash on integuments;
• feeling of the general discomfort;
• cough;
• postural dizziness;
• feeling of cold/heat.

Application instruction of Zidena (Way and dosage)

Ziden's tablets are shown for oral administration.

Drug is accepted irrespective of time of day and meal.

The instruction recommends a single dose which makes 100 mg and is accepted in 30 minutes prior to expected sexual intercourse for Zidena.

At the inefficiency recommended the single dose can make 200 mg.

Frequency rate of reception in days – 1 time.

Overdose

At reception in a single dose of 400 mg and strengthening of frequency of emergence and the weight described above, side effects is more possible.

Symptomatic therapy is recommended.

Interaction

Drugs can strengthen effect of an udenafil: Ketokonazol, Ritonavir, Itrakonazol, Indinavir, Erythromycin, Cimetidinum, and also grapefruit juice.

Ketokonazol accepted in a dose of 400 mg increases biological availability of a single dose of an udenafil more than twice (212%) and Cmax by 0,8 times (85%)

To weaken action of an udenafil, accelerating its metabolism, drugs can: Rifampinum, Dexamethasone, Phenytoinum, Carbamazepine, Phenobarbital.

Do not recommend combined use of Zidena and Nitroglycerine, because of risk of decrease in the ABP.

At reception by the patient of vasodilating medicines, Zidena has to be appointed in the minimum doses.

Terms of sale

Medicine of Ziden is released from drugstores according to the recipe.

Storage conditions

It is necessary to store in dry, protected from light and the place, unavailable to children.

Storage temperature — is not above 30 °C.

Period of validity

3 years.

Special instructions

Manifestation of sexual activity bears potential risk for patients with cardiovascular pathologies. In this regard carrying out therapy of erectile dysfunction at persons to whom sexual activity is not recommended it is undesirable.

Patients, with an aortal stenosis can show big sensitivity to effects of vazodilatator including to FDE inhibitors.

During clinical researches of Zidena there were no cases prolonged (more than 4 hours) an erection and a priapism, nevertheless, these phenomena are possible for this class of medicines. In case of continuation of an erection for more than 4 hours it is necessary to address immediately to medical institution for assistance.

Do not recommend Zidena's reception to men 71 years are more senior, due to the lack of reliable clinical data about its action on patients of this age category.

Udenafil you should not appoint in a combination with the other drugs used for therapy of erectile dysfunction, for example Zidena and Sialis's simultaneous use which though incorporate different active ingredient, but possess identical action.

Analogs

The same pharmacological action as Zidena or Sialis, also other medicines possess.

Some are given similar, on the action drugs below:

• Viagra;
• Konegra;
• Sialis;
• Dzhenagra;
• Lovigra;
• Superwhig;
• Penigra;
• Erektil;
• Levitra, etc.