Zydena (Zidena) tabs 100mg #4

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Instruction for Zydena

You can buy Zydena here

Zydena is a drug used in the treatment of erectile dysfunction.

Release form and composition

The dosage form of the release is film-coated tablets: oval, light pink with a beige tint, the symbol "100" is embossed on one side, on the other - the symbols "Z" and "Y" separated by a line; the color of the kernel at the break is white or almost white (1, 2 or 4 pcs. in blisters, 1 or 2 packs in a cardboard box).
Composition of 1 tablet:
    active substance: udenafil - 100 mg;
    additional components: L-hydroxypropyl cellulose - 12.5 mg; magnesium stearate - 2.5 mg; lactose - 87.5 mg; talc - 7.5 mg; corn starch - 20 mg; colloidal silicon dioxide - 12.5 mg; hydroxypropylcellulose-LF - 7.5 mg;
    shell: hydroxypropyl methylcellulose - 6.9 mg; talc - 0.022 mg; titanium dioxide - 1.0408 mg; yellow iron oxide - 0.0266 mg; red iron oxide - 0.0106 mg.

Pharmacodynamics

Zydena has an effect that improves erectile function.
Udenafil is a reversible selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5).
There is no direct relaxing effect on the isolated corpus cavernosum when using udenafil, but with sexual stimulation, the relaxing effect of nitric oxide is enhanced by inhibiting PDE5, which is responsible for the breakdown of cGMP in the corpus cavernosum. The consequence of this is blood flow to the tissues of the penis and relaxation of the smooth muscles of the arteries, which causes an erection. In the absence of sexual stimulation, the drug has no effect.
PDE5 is present in the smooth muscles of the vessels of the internal organs and the corpus cavernosum, in skeletal muscles, kidneys, platelets, cerebellum and lungs. Udenafil is 10,000 times more potent inhibitor against PDE5 than against PDE1, PDE2, PDE3 and PDE4, which are localized in the liver, brain, blood vessels, heart and other organs.
Udenafil is also 700 times more active against PDE5 than against PDE6, which is found in the retina and is responsible for color perception. The substance does not inhibit PDE11, so there are no cases of back pain, myalgia and manifestations of testicular toxicity.
Thanks to the use of udenafil, erection and the possibility of a successful intercourse are improved. The duration of the drug is up to 24 hours. In the presence of sexual arousal, the effect appears within 30 minutes after taking Zydena.
In healthy individuals, udenafil does not cause significant changes in diastolic / systolic pressure compared to placebo in the standing and lying positions.
The substance does not change color recognition (blue / green), which is explained by its low affinity for PDE6. Taking the drug on the electroretinogram, visual acuity, pupil size and intraocular pressure has no effect.
There was no clinically significant effect of udenafil on sperm concentration / number, morphology and sperm motility.

Pharmacokinetics

    absorption: udenafil is absorbed quickly. Tmax is in the range of 30–90 minutes (average - 60 minutes). The absorption of udenafil is not influenced by food intake with a high fat content;
    distribution: due to the high binding of udenafil to blood plasma proteins (93.9%), the period of its effectiveness after a single dose is extended to 24 hours; the accumulation of a substance in the body does not occur;
    metabolism: metabolization of udenafil mainly occurs with the participation of the isoenzyme CYP3A4;
    Elimination: the half-life of the substance is 12 hours. The total clearance of udenafil in healthy volunteers is 755 ml / min. After oral administration, the substance is excreted in the feces in the form of metabolites.


Indications for use

Zydena is prescribed for the treatment of erectile dysfunction, which is characterized by an inability to achieve / maintain an erection of the penis sufficient for satisfactory intercourse.

Contraindications

Absolute:
    combined use with nitrates and other donors of nitric oxide;
    use in women;
    age under 18 and over 71;
    individual intolerance to the components of the drug.
Relative (diseases / conditions in the presence of which caution is required):
    hereditary degenerative diseases of the retina, including proliferative diabetic retinopathy, retinitis pigmentosa;
    severe hepatic / renal failure;
    coronary artery bypass grafting, myocardial infarction or stroke, suffered within the last 6 months;
    uncontrolled arterial hypertension and hypotension (blood pressure> 170/100 or <90/50 mm Hg);
    diseases of the cardiovascular system, including unstable angina pectoris or angina pectoris that occurred during intercourse, chronic heart failure (NYHA classification II-IV functional class), which developed within the last 6 months, uncontrolled heart rhythm disturbances (when prescribing, it is necessary to take into account the potential risk of complications);
    congenital syndrome of prolongation of the QT interval or an increase in the QT interval associated with taking medications;
    predisposition to the development of priapism;
    the presence of a penile implant;
    anatomical deformities of the penis;
    combined use with calcium channel blockers, α-adrenergic blockers or other drugs with hypotensive action (an additional decrease of 7–8 mm Hg in systolic / diastolic pressure is possible).

Instructions for use of Zydena: method and dosage

Zydena tablets are taken orally, regardless of the meal.
The recommended dose is 100 mg, which should be taken half an hour before the expected sexual activity. In some cases, taking into account individual efficacy / tolerance, it is possible to increase the dose by 2 times.
The drug can be taken only once a day.

Side effects

Possible side reactions (> 10% - very often;> 1% and <10% - often;> 0.1% and <1% - sometimes):
    musculoskeletal system: sometimes - periarthritis;
    respiratory system: often - nasal congestion; sometimes - dry nose, shortness of breath;
    central nervous system: sometimes - stiff neck muscles, dizziness, paresthesia;
    cardiovascular system: very often - flushing of the face;
    digestive system: often - abdominal discomfort, dyspepsia; sometimes - gastritis, nausea, constipation, toothache;
    skin: sometimes - swelling of the face / eyelids, urticaria;
    organ of vision: often - redness of the eyes; sometimes - increased lacrimation, eye pain, blurred vision;
    others: often - chest discomfort, headache, feeling of heat; sometimes - stomach / chest pain, thirst, fatigue.
During post-registration observations, the following disorders were noted: diarrhea, palpitations, tinnitus, nosebleeds, allergic reactions (in the form of skin rash, erythema), prolonged erection, cough, general discomfort, postural dizziness, feeling of heat / cold.

Overdose

Adverse events with a single dose of Zydena tablets at a dose of 400 mg were comparable to those observed with the use of the drug at lower doses, but occurred more often.
Therapy: symptomatic; dialysis does not accelerate the elimination of udenafil.


Special instructions

This class of drugs is characterized by cases of prolonged erection and priapism (painful erection lasting more than 4/6 hours). In cases of the development of such symptoms during the use of Zydena, medical advice is required, since the lack of timely therapy can lead to the development of irreversible damage to erectile function and erectile tissue.
Since sexual activity has a potential risk for patients with cardiovascular diseases, therapy for erectile dysfunction, including Zydena, should not be carried out for heart disease in which sexual activity is not recommended.
If there is difficulty in the outflow of blood from the left ventricle (aortic stenosis), there may be a greater sensitivity to the action of vasodilators, including Zydena's drug.
Combined use with other erectile dysfunction therapies is not recommended.

Influence on the ability to drive vehicles and complex mechanisms

The ability to drive vehicles should be determined individually based on the patient's response to therapy.

Application during pregnancy and lactation

According to the instructions, Zydena is not intended for use in women.

Childhood use

For patients under 18 years of age, the drug is not prescribed.

With impaired renal function

In patients with renal insufficiency, therapy should be carried out with caution.

For violations of liver function

In patients with hepatic impairment, therapy should be carried out with caution.

Use in the elderly

Patients over 71 years of age should not use udenafil due to the lack of necessary clinical data.

Drug interactions

Possible interactions with the simultaneous use of certain drugs / substances:
    inhibitors of cytochrome CYP3A4 isoenzymes (grapefruit juice, cimetidine, itraconazole, ketoconazole, ritonavir, indinavir, erythromycin): increased action of udenafil;
    ketoconazole (dose - 400 mg): increased bioavailability and Cmax of udenafil;
    indinavir, ritonavir: a significant increase in the action of udenafil;
    drugs with an anticonvulsant effect (carbamazepine, phenobarbital, phenytoin), rifampicin, dexamethasone: accelerating the metabolism of udenafil, and therefore, when used together, its effectiveness decreases;
    nitroglycerin: lowering blood pressure (combination not recommended);
    drugs from the group of alpha-blockers: the likelihood of mutual enhancement of effects; if necessary, the combined use of drugs should be prescribed in the lowest effective doses.

Terms and conditions of storage

Store in a place protected from light and moisture at temperatures up to 30 ° C. Keep out of the reach of children.
Shelf life is 3 years.

Reviews about Zydena

Reviews about Zydena are in most cases positive. Its low cost and good tolerance are noted without the development of adverse reactions. Another advantage of the drug is the absence of a prohibition on drinking alcohol while taking the drug.

Terms of sell

You don't need a prescription to buy Zydena.