Friday, December 16, 2016

Zidena

Description overdue on 07/31/2014

  • Latin name: Zydena
  • ATC code: G04BE
  • Active substance: Udenafil (Udenafil)
  • Manufacturer: Dong-A Pharmaceutical Co. Ltd.. (Korea)
Photos of the drug
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  • Composition
  • Product form
  • Pharmacological action
  • Pharmacodynamics and pharmacokinetics
  • Indications
  • Contraindications
  • Side effects
  • Instructions for use Zideny (method and dosage)
  • Overdose
  • Cooperation
  • Terms of sale
  • Storage conditions
  • Shelf life
  • Cautions
  • Analogs
  • Reviews
  • Price, where to buy

 Zidena

Composition

The composition of each tablet medicament Zidena includes, as active ingredient 100 mg udenafil .

As auxiliary substances tablet contains:

  • 12, 5 mg - colloidal silicon dioxide ;
  • 87, 5 mg - lactose ;
  • 20 mg - corn starch ;
  • 12, 5 mg - Hydroxypropylcellulose-L ;
  • 7, 5 mg - hydroxypropyl-LF ;
  • 2, 5 mg - magnesium stearate ;
  • 7, 5 mg - talc ;

Film-coated tablets, comprising:

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

Product form

Zidena available as film coated tablets, oval. Color light pink with a beige shade, line breaking - white.

On opposite sides of the tablet embossed characters are present: on one side the figure "100" on the other, risk-sharing, the letters " Z "And" Y ".

Pharmacological action

Normalization erectile function .

Pharmacodynamics and pharmacokinetics

Active ingredient Udenafil   It is a selective, reversible specific inhibitor of PDE-5   (enzyme phosphodiesterase 5 ), Which contributes metabolism of cGMP .

It has no direct relaxing effect on the cavernous insulated body But during sexual stimulation increases the relaxing effect of nitric oxide by inhibiting PDE-5 , Responsible, cavernous body For the collapse of cGMP .


As a result of its exposure to relax the smooth muscles of the arteries, which promotes blood flow to the tissues of the penis and as a result leads to erection .

The drug does not work without sexual stimulation.

Results of the study in vitro   proven action udenafil , as Selective PDE5 Inhibitor . This enzyme is present in the vascular smooth muscle of the internal organs as well as the corpus cavernosum, skeletal muscle, platelets Lung, kidney and cerebellum.

Udenafil   10,000 times stronger inhibits PDE-5 Than others phosphodiesterase Localized in the liver, heart, blood vessels, brain and other organs. Also, it is 700 times more potent with respect to PDE-5 Than to PDE-6 Located in the retina and is responsible for the perception of colors.

Udenafil   It does not inhibit PDE-11 That determines the absence of symptoms myalgia , Pain in the lumbar region of the back and cases testicular toxicity .

The drug improves erectile function   and the possibility of successful completion of intercourse.

The effect occurs after 30 minutes after consumption and lasts up to 24 hours (if there is sexual stimulation).

In healthy subjects, the drug does not cause significant changes are detected Systolic blood pressure   (Sad)   and diastolic blood pressure (DBP)   in comparison with the test, the host placebo in the standing position and lying (maximum reduction is statistically average, to 1, 6/0, 8 and 0, 2/4, 6 mm mercury column).

Udenafil   It does not lead to changes in the recognition of the color spectrum (blue / green), this is due to its insignificant effect on PDE-6 . The product does not distort the visual acuity, pupil size, and intraocular pressure , and electroretinogram .

In studies conducted on male volunteers it has not been proven clinically significant effect on the concentration and quantity of sperm as well as the integrity and motility of spermatozoa.

Absorption

When taken orally Udenafil   It absorbed pretty quickly. AT plasma   its maximum concentration is achieved on average over 60 minutes (30 to 90 minutes). T1 / 2 (half life)   about 12 hours.

Characterized by a high binding (93, 9%) of the drug with plasma proteins That significantly increases its effective period of up to 24 hours after a single use (100 mg) dose.

Foods with a high concentration of fat has no significant effect on absorption.

Drinking alcohol (ethanol 40%) in an amount of 112 ml combined with udenafilom 200 mg, no significant effect on its performance.

Metabolism

Metabolism   primarily takes place at the participation CYP3A4 isoenzyme cytochrome P450 .

Withdrawal

In healthy subjects total clearance   equals 755 mL / min.

Following oral administration excreted in the feces in the form of metabolites .

Not accumulates in the body of the patient.

The daily dose of 100 mg - 200 mg taken within 10 days (when tested on healthy people) significant changes in the pharmacokinetics have been found.

Indications

Treatment disorders associated with erectile dysfunction Manifested its inability to create or maintain, for a sufficient time for acceptable sexual intercourse.

Contraindications

  • age 18 years;
  • hypersensitivity to any component of the drug substance;
  • concomitant therapy with reception Nitrate   or drugs that are donators of nitric oxide (NO) .

Carefully:

  • hypotension   (BP less than 90/50 mm Hg. V.);
  • uncontrolled arterial hypertension   (BP more than 170/100 mm Hg. V);
  • hereditary degenerative diseases of the retina   (including retinitis pigmentosa, diabetic proliferative retinopathy );
  • transferred coronary artery bypass surgery, stroke   or heart attack   (last six months);
  • liver   or kidney disease , Severe;
  • congenital syndrome increase or extension of the interval QT;
  • the patient's disposition to priapism ;
  • anatomical deformation of the penis or implantation;
  • sexual activity in diseases Cardiovascular , Because of the risk of complications.

Side effects

During the passage Zidenoy clinical trials revealed some side effects udenafil Which, depending on the frequency of manifestation divided as follows.

The probability of 10% or more - very often; from 1% to 10% - frequently; from 0% to 1 1% - sometimes.

It is often observed:

  • flushing (redness) of the face.

Often:

  • redness of the eye;
  • discomfort in the abdomen;
  • dyspepsia ;
  • nasal congestion;
  • headache ;
  • feeling hot;
  • discomfort in the chest area.

Sometimes:

  • stiffness in the neck muscles ;
  • 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;
  • breathlessness ;
  • parasynovitis ;
  • pain in the chest and abdomen;
  • feeling thirsty;
  • fatigue.

During further observations were found and other unwanted (adverse) effects:

  • heart palpitations ;
  • noise in ears;
  • nosebleeds;
  • diarrhea ;
  • prolonged erection ;
  • erythema ;
  • rashes on the skin ;
  • general feeling of discomfort;
  • cough ;
  • postural dizziness ;
  • sensation of cold / heat.

Instructions for use Zideny (method and dosage)

Tablets Zidena shown for oral administration.

The drug is taken, regardless of time of day, and meals.

Instructions on Zidenu recommends a single dose, which is 100 mg taken 30 minutes prior to prospective sexual intercourse.

With the ineffectiveness of our recommended single dose may reach 200 mg.

Multiplicity of reception per day - 1 time.

Overdose

When receiving a single dose of 400 mg or more may increase the frequency and severity, as described above, side effects.

Recommended symptomatic therapy.

Cooperation

Strengthening effect udenafil   may preparations: Ketoconazole, ritonavir, itraconazole, indinavir, erythromycin, cimetidine And grapefruit juice.

Ketoconazole Adopted by 400 mg increases bioavailability   single dose udenafil   more than 2-fold (212%) and Cmax in 0, 8 times (85%)

Relaxing effect udenafil Speeding up its metabolism May preparations: Rifampin, dexamethasone, phenytoin, carbamazepine, phenobarbital.

It does not recommend the use of joint and Zideny Nitroglycerin , Because of the risk of blood pressure lowering.

When receiving a patient vasodilator drugs Zidena should be administered in minimal doses.

Terms of sale

The drug Zidena released from pharmacies by prescription.

Storage conditions

It should be stored in a dry place, protected from light and away from children.

Storage temperature - not above 30 ° C.

Shelf life

3 years.

Cautions

The manifestation of sexual activity carries a potential risk for patients with cardiovascular disease . In connection with this holding treatment of erectile dysfunction in patients that do not recommended sexual activity, is undesirable.

Patients with aortic stenosis   may exhibit greater sensitivity to the effects of vasodilators , Including PDE .

In clinical research there were no cases Zideny prolonged   (4 hours) erection   and priapism Nevertheless, these conditions are possible for this class of drugs. If you continue erection   for more than 4 hours you should immediately go to the hospital to assist.

Not recommended intake Zideny men older than 71, because of the lack of reliable clinical data on its effect on patients of this age group.

Udenafil   you should not be administered in combination with other drugs used for the treatment of erectile dysfunction, such as the simultaneous use and Zideny Cialis Which although are composed of different active substance, but have the same effect.

Analogs

Match code ATC 4th level:
  •  Zidena  Papazol
  •  Zidena  Levitra
  •  Zidena  Viagra
  •  Zidena  Impaza
  •  Zidena  Cialis

In the same pharmacological effect as Zidena or Cialis They have other drugs.

Below are some similar, in its action drugs:

  • Viagra ;
  • Konegra ;
  • Cialis ;
  • Dzhenagra ;
  • Lovigra ;
  • Superviga ;
  • Penigra ;
  • Erektil ;
  • Levitra   and etc.

Reviews

Reviews Zidene on user resource purely positive, ranging from the cost of the drug and its action, the virtual absence of negative effects and the possibility of ending the use of a certain amount of alcohol.

Doctors about Zidene more restrained and generally positioning the drug as a good, inexpensive new-generation drug used to treat Erectile Dysfunction While reminding the feasibility survey for the passage of an accurate diagnosis and appropriate treatment.

Price Zideny where to buy

The average price at the pharmacy Zideny (1 tablet of 100 mg) hovers around 600 rubles, depending on the region.

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