Zydena tabs 100mg #4

Zydena user manual

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Composition

Each tablet of the drug Zydena contains, as an active substance, 100 mg of udenafil.
As auxiliary substances, the tablet of the preparation contains:
    12.5 mg - silicon dioxide colloidal;
    87.5 mg - lactose;
    20 mg corn starch;
    12.5 mg of L-hydroxypropylcellulose;
    7.5 mg of hydroxypropyl cellulose-LF;
    2.5 mg - magnesium stearate;
    7.5 mg - talc;
A film-coated tablet shell containing:
        6.9 mg of hydroxypropylmethylcellulose;
        0.022 mg is talc;
        0106 mg - iron oxide red;
        0,0266 mg - iron oxide yellow;
        1,0408 mg is titanium dioxide.

Form of issue

Zydena is available in the form of tablets in a film shell, oval. The color is light pink with a beige tint, on the scrap line is white.
On the different sides of the tablet there are squeezed symbols: on one side there is a number "100", on the opposite side, separated by a risk, the letters "Z" and "Y".

pharmachologic effect

Normalization of erectile function.

Pharmacodynamics and pharmacokinetics

The active substance udenafil is a selective reversible inhibitor of specific PDE-5 (phosphodiesterase 5 enzyme), which promotes the metabolism of cGMP.
It does not have a direct relaxing effect on the cavernous isolated body, but during sexual stimulation it increases the relaxing effect of nitric oxide, inhibiting PDE-5, responsible, in the cavernous body, for the disintegration of cGMP.
As a result of their action, the smooth muscles of the arteries relax, which contributes to the flow of blood to the tissues of the male sexual organ and, as a consequence, leads to an erection.
The drug does not work without sexual stimulation.
The results of in vitro studies have shown the action of udenafil as a selective inhibitor of PDE-5. This enzyme is present in the smooth muscles of the vessels of the internal organs, as well as the cavernous body, in the muscles of the skeleton, platelets, lungs, cerebellum and kidneys.
Udenafil 10,000 times more inhibits PDE-5 than other phosphodiesterases, localized in the liver, heart, blood vessels, brain and other organs. Also, it is 700 times more active in relation to PDE-5 than to PDE-6, located in the retina of the eye and responsible for the perception of the color scale.
Udenafil does not inhibit PDE-11, which predetermines the absence of manifestations of myalgia, painful sensations in the lumbar spine and cases of testicular toxicity.
The drug improves erectile function and the possibility of successful passage of sexual intercourse.
The effect occurs after a lapse of 30 minutes after ingestion and lasts up to 24 hours (with the presence of sexual stimulation).
In healthy subjects, the drug does not cause a significantly detectable change in systolic blood pressure (SAD) and diastolic blood pressure (DAD) compared to placebo and prone placebo (the mean maximum decrease is 1.6 / 0.8 and 0.2 / 4.6 mm mercury column).
Udenafil does not lead to changes in the recognition of the color spectrum (blue / green), this is a consequence of its insignificant effect on PDE-6. The drug does not distort visual acuity, pupil size and intraocular pressure, as well as electroretinogram.
In the studies conducted on male volunteers, its clinically significant effect on the concentration and quantity of sperm, as well as on the integrity and motility of the spermatozoa, was not proved.

Suction

When taken orally, udenafil is absorbed rather quickly. In plasma, its maximum concentration is achieved in an average of 60 minutes (from 30 to 90 minutes). T1 / 2 (half-life) is approximately 12 hours.
Characteristically high binding (93.9%) of the drug with blood plasma proteins, which significantly increases the period of its effective effect up to 24 hours, after applying a single dose (100 mg).
Food with a high concentration of fats does not have a significant effect on absorption.
The consumption of alcohol (ethyl alcohol 40%) in the amount of 112 ml in combination with udenafil at a dose of 200 mg does not significantly affect its effectiveness.

Metabolism

Metabolism mainly occurs with the participation of cytochrome P450 isoenzyme CYP3A4.

Excretion

In healthy subjects, the total clearance is 755 ml / min.
After oral administration, it is excreted with feces, in the form of metabolites.
Do not cumulate in the patient's body.
In a daily dose of 100 mg - 200 mg, taken within 10 days (when tested in healthy people), no significant changes in pharmacokinetics were detected.

Indications for use

Therapy of violations associated with erection, manifested by the inability to create or maintain it, for a sufficient time to conduct an acceptable sexual intercourse.

Contraindications

    age to 18 years;
    hypersensitivity to any of the constituent substances of the drug;
    concomitant therapy with the use of nitrates or preparations that are donators of nitric oxide (NO).

Carefully:

    hypotension (blood pressure less than 90/50 mm Hg);
    uncontrolled arterial hypertension (blood pressure more than 170/100 mm Hg);
    hereditary degenerative pathologies of the retina (including pigment retinitis, diabetic proliferative retinopathy);
    transferred aortocoronary bypass, stroke or heart attack (for the last six months);
    hepatic or renal pathologies, in severe form;
    congenital syndrome of increased or prolonged QT interval;
    predisposition of the patient to priapism;
    anatomical deformation of the male sexual organ or its implantation;
    sexual activity in diseases of the cardiovascular system, because of the risk of complications.

Side effects

During the passage of Zydena clinical studies, some side effects of udenafil have been identified, which, depending on the frequency of manifestation of the sub-division, are as follows.
The probability of occurrence of 10% or more is very frequent; from 1% to 10% - often; from 0.1% to 1% - sometimes.
Very often observed:
    flushes of blood (redness) to the face.
Often:
    redness of the eyes;
    discomfort in the abdomen;
    dyspepsia;
    nasal congestion;
    headache;
    sensation of heat;
    discomfort in the thoracic region.
Sometimes:
    stiff neck;
    dizziness;
    paresthesia;
    blurred vision;
    increased lacrimation;
    pain in the organs of vision;
    swelling of the face;
    swelling of the eyelids;
    hives;
    nausea;
    constipation;
    gastritis;
    toothache;
    sensation of dryness in the nose;
    dyspnea;
    periarthritis;
    pain in the chest and abdomen;
    feeling of thirst;
    fatigue.
In the course of further observations, other undesirable (negative) effects were also observed:
    cardiopalmus;
    noise in ears;
    nasal bleeding;
    diarrhea;
    prolonged erection;
    erythema;
    rash on the skin;
    a feeling of general discomfort;
    cough;
    postural dizziness;
    feeling of cold / heat.

Instructions for use Zydena (Method and dosage)

Zydena tablets are indicated for oral administration.
The drug is taken regardless of the time of day and food intake.
Instruction for Zydena recommends a one-time dose, which is 100 mg and taken 30 minutes before the alleged sexual intercourse.
If the recommended dose is ineffective, a single dose may be 200 mg.
Multiplicity of administration per day - 1 time.

Overdose

When taken in a single dose of 400 mg or more, it is possible to increase the incidence and severity described above, side effects.
Symptomatic therapy is recommended.

Interaction

Strengthen the effect of udenafil drugs: ketoconazole, ritonavir, Itraconazole, indinavir, erythromycin, cimetidine, and grapefruit juice.
Ketoconazole taken at a dose of 400 mg increases the bioavailability of a single dose of udenafil by more than 2 times (212%) and Cmax by 0.8 times (85%)
To weaken the action of udenafil, speeding up its metabolism, can drugs: Rifampin, Dexamethasone, Phenytoin, Carbamazepine, Phenobarbital.
Do not recommend the joint use of Zydena and Nitroglycerin, because of the risk of lowering blood pressure.
When taking a patient with vasodilating drugs, Zydena should be given in minimal doses.

Storage conditions

It should be stored in a dry place, protected from light and out of reach of children.
Storage temperature - not higher than 30 ° C.
Shelf life - 3 years.

special instructions

The manifestation of sexual activity carries a potential risk for patients with cardiovascular pathologies. Therefore, the treatment of erectile dysfunction in individuals who are not recommended for sexual activity is undesirable.
Patients with aortic stenosis may be more sensitive to the effects of vasodilators, including PDE inhibitors.
During the clinical studies of Zydena there were no cases of prolonged (more than 4 hours) erection and priapism, however, these phenomena are possible for this class of drugs. If the erection continues for more than 4 hours, you should immediately contact the medical institution for assistance.
Do not recommend Zydena's intake of men older than 71 years, due to the lack of reliable clinical data on its effect on patients of this age category.
Udenafil should not be prescribed in combination with other drugs used to treat erectile dysfunction, for example, simultaneous application of Zydena and Cialis, which, although they have different active substance in their composition, have the same effect.

Reviews

Reviews about Zydena on user resources are purely positive, ranging from the cost of the drug, its action, the practical absence of negative effects and ending with the possibility of consuming a certain amount of alcohol.
The doctors' comments about Zydena are more restrained and mainly position this drug as a good, inexpensive drug of the new generation used to treat erectile dysfunction, while recalling the advisability of undergoing a checkup for an accurate diagnosis and the appointment of an adequate treatment.