ZYDENA TAB. P ABOUT 100MG #1(1V1)

ZYDENA TAB. P ABOUT 100MG #1(1V1)

Product Code: 12331
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Composition

active substance: udenafil;

1 tablet coated liner contains udenafil 100 mg or 200 mg

Excipients: lactose, corn starch, hydroxypropyl cellulose, silicon colloidal dioxide, talc, magnesium stearate, hypromellose, titanium dioxide (E 171), yellow sunset FCF (e 110).

The

Dosage form

film-coated Tablets.

Basic physical and chemical properties: film coated tablets of pale orange color, oval, embossed 100 mg for dosing and 200 mg for dosing 200 mg on the one hand and Z and Y, separated by a line, on the other.

The

drug description

Preparations for the treatment of erectile dysfunction. Udenafil. ATC code G04B E11.

The

Pharmacological properties

Pharmacological. Udenafil-selective reversible inhibitor of cyclic guanosine monophosphate (cGMP) - specific phosphodiesterase type 5 (FDE-5).

Udenafil has no direct relaxing effect on isolated corpus cavernosum, but enhances sexual stimulation relaxing effect of nitric oxide by inhibiting PDE-5, responsible for the breakdown of cGMP in the cavernous body. The consequence is the relaxation of smooth muscle arteries and blood flow to the tissues of the penis, which causes an erection. The drug is effective in the absence of sexual arousal.

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 cerebellum. Udenafil is 10,000 times stronger than the inhibitor relative to FDE-5 than relatively FDE-1, FDE-2, FDE-3 and FDE-4, which are localized in the heart, brain, blood vessels, liver and other organs.

in addition, udenafil is 700 times more active in relation to PDE5 than in relation to pde6 found in the retina responsible for colour perception. Udenafil is not inhibited by FDE-11, which explains the absence of cases of myalgia, lower back pain and manifestations of testicular toxicity.

the Optimal duration of the drug up to 24 hours. The effect is manifested in 30 minutes after taking the drug in the presence of sexual arousal.

Udenafil in healthy volunteers does not cause a significant change in systolic and diastolic pressure in comparison with placebo in the lying and standing position (the average maximum decrease is 1.6/0.8 mm Hg.article and 0.2/4.6 mm Hg.art . under.) Udenafil does not change the recognition of colors (blue/green), due to its low affinity for PDE-6. Udenafil does not affect visual acuity, electroretinogram, intraocular pressure and pupil size.

there was no clinically significant effect of the drug on sperm quantity and concentration, sperm motility and morphology.

The Pharmacokinetics. Suctions. After oral administration udenafil quickly absorbed. The time to reach the maximum concentration in plasma (t max )  is 30-90 minutes (average - 60 minutes). The elimination half-life (t?) is 12:00, high udenafil tying with blood plasma proteins (93.9 per cent) to extend the period of its effectiveness up to 24 hours after taking just one dose.

food with high fat content does not affect the absorption udenafil. Concomitant intake of 112 ml of alcohol (in terms of 40% ethyl alcohol) with oral administration of udenafil at a dose of 200 mg does not affect the pharmacokinetic profile of udenafil.

Metabolism. Udenafil mainly metabolized with the participation of the enzyme (RMS) 3A4 cytochrome P450.

The Output. In healthy volunteers, total clearance udenafil is 755 ml/min After ingestion udenafil excreted as metabolites with feces.

Udenafil does not accumulate in the body. With a daily intake of healthy volunteers udenafil at a dose of 100 and 200 mg per day for 10 days has not been revealed significant changes of its pharmacokinetics.

Reading

the Treatment of erectile dysfunction characterized by the inability to achieve or maintain penile erection required for successful sexual intercourse.

For effective action Sideny need sexual arousal.

Contra

Hypersensitivity to the drug component of Zydena; regular or intermittent use of nitrates and other donators of nitrogen oxide uncontrolled arterial hypertension (HELL>170/100 mm Hg. art.),

arterial hypotension (blood pressure>90/50 mm Hg. art.)

uncontrolled arrhythmia;

hereditary degenerative retinal disorders (including retinitis pigmentosa)

severe hepatic or renal failure

presence of congenital syndrome of prolongation OF Qt interval or increase of QT interval due to taking drugs;

unstable angina or severe heart failure

stroke, myocardial infarction or coronary artery bypass grafting in the last 6 months

the use of strong cytochrome P450 inhibitors (HIV protease inhibitor indinavir or ritonavir, concomitant use of the drug Zidena with other drugs for the treatment of erectile dysfunction.

loss of vision per eye due to nonarterial ischemic neuropathy.

Zidene contains lactose, so the drug should not be taken in patients with hereditary diseases such as galactose intolerance, lactase deficiency or glucose-galactose absorption disorder.

the Age of 18.

The

Interaction with other medicinal products and other forms of interaction

cytochrome P450 SURZA4 (ketoconazole, Itraconazole, ritonavir, indinavir, cimetidine, erythromycin, grapefruit juice) Inhibitors may increase the plasma concentration of the drug Zidene.

Concomitant use of ketoconazole (400 mg dose) and udenafil (100 mg dose) increases bioavailability and maximum concentration almost twice (212%) and 0.8 times (85%) respectively.

HIV protease Inhibitors ritonavir and indinavir significantly increase the systemic concentration of the drug.

Dexamethasone, rifampicin and anticonvulsants (carbamazepine, phenytoin and phenobarbital) accelerate the metabolism of udenafil, therefore, with simultaneous use, a decrease in the concentration of the drug is expected.

the Simultaneous introduction udenafil (30 mg/kg orally) and nitroglycerin (2.5 mg/kg single I. V.) in experiments on rats showed no effect on the pharmacokinetics of udenafil, however, the simultaneous use of nitroglycerin and udenafil not recommended due to possible reduction in blood pressure by acting on udenafil vasodilation.

Udenafil and preparations of alpha-blockers is vasodilators, so during coadministration should assign the minimum recommended dose.

Patients with obstruction of outflow of blood from the left ventricle (aortic stenosis) may be more sensitive to the action of vasodilators, including PDE inhibitors.

while drinking a large amount of alcohol and the drug Zidene, the doctor should report that there may be symptoms such as more frequent pulse, lower blood pressure, dizziness, headache and orthostatic phenomena.

application Features

in order to diagnose erectile dysfunction and assess potential risks, it is necessary to conduct a survey and carefully examine the patient's history. The use of zidene should be limited to patients who require clinical treatment based on objective diagnostic data. Before using Zidene, it is necessary to thoroughly examine the state of the cardiovascular system, since sexual activity is a potential risk for patients with cardiovascular diseases. Therefore, treatment of erectile dysfunction, including with the use of udenafil, should not be undertaken in men with heart disease, in which sexual activity is not recommended. Drug Zidena should not be prescribed to patients who are within 6 months of stroke, brain hemorrhage or myocardial infarction.

Zidena Drug is contraindicated to patients who previously received or are currently receiving any form of nitrates or other donors of nitric oxide (nitroglycerin, amyl nitrite, isosorbide dinitrate, etc.) Because of Zidena may enhance their hypotensive action. Therefore, before administration of the drug Zidene should determine whether the patient takes nitrates or other nitric oxide donators. Also, patients should be warned about banning the use of nitrates or other nitric oxide donators during and after treatment of Zidene.

udenafil should be used with caution in patients with a tendency to priapism, as well as in patients with anatomical deformity of the penis, in the presence of a penile implant.

in the event of an erection lasting more than 4:00 (regardless of the presence of pain), patients should immediately seek medical attention. In the absence of timely treatment, priapism can lead to irreversible damage to erectile tissue and violation of erectile function.

Not recommended for use udenafil in combination with other drugs for the treatment of erectile dysfunction.

caution should be used udenafil patients with diabetic retinopathy and with the active form of gastroesophageal reflux disease or hernia hiatal.

While admission udenafil and calcium channel blockers, alpha-blockers or other antihypertensives may be an additional decrease in systolic and diastolic blood pressure.

Patients with obstruction of the outflow tract of the left ventricle (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) can article be particularly sensitive to the action of vasodilators.

In the case of sudden loss of vision, hearing, or deafness (which may be accompanied by tinnitus and dizziness), you should immediately seek medical help.

use during pregnancy or lactation. The drug is not intended for use by women.

Ability to influence the reaction rate when driving motor transport or operating other mechanisms. Before driving vehicles, patients should know how they react to the reception Sydeny. Keep in mind the possibility of dizziness, blurred vision.

Method of application and doses

Used adult men inside, regardless of the meal. Administered orally one tablet of 100 mg a day approximately 30 minutes - 12:00 prior to the expected sexual activity. The dose can be increased with caution to 200 mg, after careful evaluation of all adverse events that occur after taking 100 mg of the drug. The maximum recommended number of applications is 1 time per day.

For men of elderly age (over 65 years) dose adjustment is not required.

men with mild renal insufficiency dose adjustment is not required.

Patients with mild hepatic insufficiency dose adjustment is not required (class a on child-Pugh).

Children. Not apply.

Overdose

studies of the use of one dose of the drug in healthy volunteers when applying udenafil 400 mg once daily had no major adverse reactions. When increasing the dose increased frequency of adverse events (headache, redness of the face), but most of them had a slight degree of severity and passed without additional treatment. In case of overdose, General symptomatic therapy should be prescribed. The drug Zidene has a high binding rate with plasma proteins and is not excreted in the urine, so after dialysis, the renal clearance does not increase.

Side effects

Adverse reactions listed in the table, occurred during clinical trials using the drug zidena of 100 or 200 mg on demand patients before sexual activity. In General, adverse reactions were transient and had mild or moderate severity. The most common adverse reactions include headache and redness of the face.

The The The The The The The The The The The
The
Side effects frequency
The
 
THE
[?10%]
The
[?1%, <10%]
The
[?0,1%,<1.0%]
The
common disorders
The
 
The
 
The
headache
The
 
The
pain in the chest, abdominal pain, fatigue, flushing, discomfort in the chest
The
 
The
From the nervous system
The
 
The
 
The
 
dizziness, neck muscle rigidity, paresthesia
The
From the cardiovascular system
The
 
The
 
The
redness
The
 
The
 
The
on view
The
 
The
 
redness of eyes
The
 
The
blurred vision, eye pain, chromatopsia
The
 
from the respiratory system
The
 
The
 
The
stuffy nose
The
 
The
 
The
shortness of breath, dryness of the nasal mucosa
The
 
The
 
from the gastrointestinal tract
The
 
The
 
The
dyspepsia
nausea, toothache, constipation, gastritis, stomach discomfort
on the part of the skin and subcutaneous tissue
The
 
The
 
The
swelling of the face or eyes, hives, itching,
The
 
The
Metabolic and endocrine disorders
The
 
The
 
The
 
disorders of the excretory system, thirst
The
From the side of musculoskeletal system
The
 
The
 
The
periarthritis

the following adverse reactions were not observed during pre-registration studies of the drug, but were recorded during additional clinical studies, so their cause-effect relationships can not be excluded: heaviness in the head, feeling cold, drowsiness, severe palpitation, orthostatic dizziness, lethargy, numbness of the ear, eye discomfort, rash, erythema, vomiting, diarrhea, shortness of breath during physical exercises, cough, nasal bleeding, increased erection and hypotension.

in patients taking a dose of 200 mg per day, observed an increase in the frequency and types of adverse reactions compared with the use of a dose of 100 mg.

During the post-marketing surveillance is rarely mentioned temporary appearance partizanai anterior ischemic neuropathy of the optic nerve (NASN), although in clinical trials Sideny had no data about it and the causes of visual loss in connection with the use of phosphodiesterase type 5 inhibitors (PDE-5), including preparation of Sedena. Most of these patients, but not all, had underlying anatomic or vascular risk factors NAINAN, including, among others: low ratio of the diameters of the Cup and disk of optic nerve (stagnant disc), age 50, diabetes, hypertension, coronary heart disease, hyperlipidemia and Smoking. It is not possible to determine whether these adverse events are directly related to the use of PDE-5 inhibitors, concomitant vascular risk factors or anatomical pathologies of the patient, or a combination of these factors or other reasons.

during post-registration follow-up, patients taking PDE-5 inhibitors, including the drug Zidene, no cases of sudden decrease or loss of hearing were recorded. At the same time, it was reported that sometimes health and other factors can affect the appearance of adverse events on the part of hearing organs. Often information about further medical supervision is limited. It is not possible to determine whether these adverse events are directly related to the use of the drug Zidene, associated risk factors for hearing loss or a combination of these factors or other reasons.

the Results of post-marketing studies udenafil 100 and 200 mg. During post-marketing studies for re-examination in Korea lasted 6 years, the frequency of adverse reactions without regard to causality made up 2.20%; the frequency of adverse events where it is impossible to exclude a connection with the drug of Zidena, were 2.03%.

adverse reactions Recorded included: blood flushes (1.04%), headache (0.76%), dizziness (0.11%), nasal congestion (0.11%), dyspepsia, reddening of the eyes (0.06%) , visual impairment, gastroesophageal reflux disease, increased heartbeat (0.03%). Among all the phenomena gastroesophageal reflux disease was an unpredictable adverse reaction.

The

shelf Life

3 years.

storage Conditions

Store at a temperature not exceeding 25 ° C to protect against moisture and light store in its original packaging. Keep out of reach of children.

The

Packaging

1 or 2 film-coated tablets in a blister, 1 blister with 1 tablet, 1 blister with 2 tablets or 2 blisters with 2 tablets in a cardboard bundle.

The

Category vacation

According to the recipe.

The

Manufacturer

Dong-A ST Co., Ltd./Dong - a ST co., Ltd.

location of the manufacturer and address of the place of business

2F Section B, DF, 4F Section B, 200-23, Pacakged 1-ro, Sobuk-GU, Cheonan-si, chungcheongnam-do, South Korea/(Section B 2F, 3F, 4F Section B), 200-23, Baekseokgongdan 1-ro, Seobuk-gu, Cheonan-si, Chungcheongnam-do, Republic of Korea.

The

The Applicant

Dong-A ST Co., Ltd./Dong - a ST co., Ltd.

location of the applicant

2F Section B, DF, 4F Section B, 200-23, Pacakged 1-ro, Sobuk-GU, Cheonan-si, chungcheongnam-do, South Korea/(Section B 2F, 3F, 4F Section B), 200-23, Baekseokgongdan 1-ro, Seobuk-gu, Cheonan-si, Chungcheongnam-do, Republic of Korea.

DROPS FOR ORAL administration GENTOS 50ML

Gentos drops for oral administration 50 ml vial on the body have not only anti-edema, but also anti-exudative and excellent anti-inflammatory effect. The drug reduces various types of stagnation in the pelvis, while improving the circulation process.

Pharmacological action

the Product restores the natural urination process, increasing the urine flow, reducing delay and reducing the frequency of urinations. The drug improves erectile function in patients with chronic prostatitis. It also significantly reduces the risk of impotence in men and infertility in women.

Dosage

children 12 years of age and adults are prescribed the drug in its pure or diluted form (1 tablespoon 9 drops). Take the drops three times a day for 25-30 minutes before meals.

for the fastest possible relief of pain symptoms, it is recommended to use the tool after 30-35 minutes before the disappearance of painful symptoms (up to 8 times during the day). In such doses, the drops can be taken no more than 3 days, after which drink up to 3 times a day. 

to increase the efficacy of the drug, the drug should be held for 20 seconds in the mouth before swallowing. In the acute form of prostatitis or cystitis is a course of treatment should be 14 days.

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