Udenafyl | Ziden tablets 100 mg, 4 pcs.

Release form

Film-coated tablets.

Packaging

In the package 4 pcs.

ФармакологичРскоРдРйствимbr>
ЗидРна - срРдство для лРчРния эрРктильной дисфункции. Ингибитор фосфодиэстРраз -5 типа.УдРнафил - сРлРктивн й обратим й ингибитор цикличРского гуанозинмонофосфата (цГМФ) - спРцифичРской фосфодиэстРраз 5-го типа (ФДЭ-5).

УдРнафил нРоказ ваРт прямого расслабляющРго дРйствия на изолированноРкавРрнозноРтРло, но при сРксуальной стимуляции усиливаРт расслабляющий эффРкт оксида азота посрРдством ингибирования ФДЭ-5, отвРтствРнной за распад цГМФ в кавРрнозном тРлР. СлРдствиРм этого являРтся рРлаксация гладких м шц артРрий и приток крови к тканям полового члРна, что и в з ваРт эрРкцию. ПрРпарат нРоказ ваРт эффРкта в отсутствии сРксуального стимулирования.

ИсслРдования in vitro показали, что удРнафил являРтся сРлРктивн м ингибитором фРрмРнта ФДЭ-5. ФДЭ-5 присутствуРт в гладких м шцах кавРрнозного тРла, в гладких м шцах сосудов внутрРнних органов, в скРлРтн х м шцах, тромбоцитах, почках, лРгких и мозжРчкР.

УдРнафил являРтся в 10 000 раз болРРмощн м ингибитором в отношРнии ФДЭ-5, чРм в отношРнии ФДЭ-1, ФДЭ-2, ФДЭ-3 и ФДЭ-4, котор Рлокализуются в сРрдцР, головном мозгР, кровРносн х сосудах, пРчРни и других органах. КромРтого, удРнафил в 700 раз активнРРв отношРнии ФДЭ-5, чРм в отношРнии ФДЭ-6, обнаружРнной в сРтчаткРи отвРтствРнной за цвРтовосприятиР. УдРнафил нРингибируРт ФДЭ-11 , что обуславливаРт отсутствиРслучаРв миалгии, болРй в поясницРи проявлРний тРстикулярной токсичности.

УдРнафил улучшаРт эрРкцию и возможность провРдРния успРшного полового акта. ДРйствиРпрРпарата имРРт оптимальную продолжитРльность до 24 часов. ЭффРкт проявляРтся ужРчРрРз 30 минут послРприРма прРпарата при наличии сРксуального возбуждРния.

УдРнафил у здоров х лиц нРв з ваРт достовРрного измРнРния систоличРского и диастоличРского давлРния в сравнРнии с плацРбо в положРнии лРжа и стоя (срРднРРмаксимальноРснижРниРсоставляРт 1,6/0,8 мм рт.ст. и 0,2/4,6 мм рт.ст., соотвРтствРнно).

УдРнафил нРв з ваРт измРнРний распознавания цвРтов (голубой/зРлРн й), что объясняРтся Рго низким сродством с ФДЭ-6. УдРнафил нРвлияРт на остроту зрРния, элРктрорРтинограмму, внутриглазноРдавлРниРи размРр зрачка.

При исслРдовании удРнафила у мужчин нРв явлРно клиничРски значимого влияния прРпарата на количРство и концРнтрацию спРрм , подвижность и морфологию спРрматозоидов.

Indications

Treatment of erectile dysfunction characterized by an inability to achieve or maintain an erection of the penis sufficient for satisfactory intercourse.

Special instructions

Sexual activity has a potential risk for patients with cardiovascular diseases, therefore, treatment of erectile dysfunction, including the use of udenafil, should not be performed in men with heart diseases in which sexual activity is not recommended.

Patients with difficulty in outflow of blood from the left ventricle (aortic stenosis) may be more sensitive to the action of vasodilators, including PDE inhibitors. Despite the absence in the course of clinical studies of cases of prolonged erection (more than 4 hours) and priapism (painful erection, lasting more than 6 hours), such phenomena are characteristic of this class of drugs.

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

Due to the lack of clinical data on the use of udenafil in patients older than 71 years of age, this drug is not recommended. Udenafil is not recommended in combination with other treatments for erectile dysfunction.

Composition

1 tablet contains:

active substance:

udenafil - 100 mg

excipients:

lactose,

corn starch,

silicon dioxide colloid,

L-hydroxypropyl l-hydroxypropyl l-hydroxypropyl l-hydroxypropyl l-hydroxypropyl l-hydroxypropyl hydroxypropyl

magnesium stearate

shell:

hydroxypropyl methylcellulose,

talc,

iron oxide red,

iron oxide yellow,

titanium dioxide.

Dosage and administration of

The drug is taken orally, regardless of food intake. The recommended dose of the drug is 100 mg, taken 30 minutes before the alleged sexual activity.

Dose may be increased to 200 mg, taking into account the individual effectiveness and tolerability of the drug.

The maximum recommended frequency of use is once a day.

Side effects

Side effects observed during clinical trials of udenafil, depending on the frequency of their occurrence: very often -? 10% of cases often - 1-10% sometimes - 0.1-1%.

From the cardiovascular system: very often - flushing of the face.

From the side of the central nervous system: sometimes - dizziness, stiff neck muscles, paresthesia.

From the side of the organs of vision: often - redness of the eyes sometimes - blurred vision, pain in the eyes, increased lacrimation.

From the skin: sometimes - swelling of the eyelids, swelling of the face, urticaria.

From the digestive system: often - dyspepsia, discomfort in the abdomen, sometimes - nausea, toothache, constipation, gastritis.

From the respiratory system: often - nasal congestion, sometimes - shortness of breath, dry nose.

From the musculoskeletal system: sometimes - periarthritis.

Organism as a whole: often - headache, chest discomfort, fever sometimes - chest pain, abdominal pain, fatigue, thirst.

In the course of post-marketing observations with the use of udenafil, other adverse events were also described: a strong heartbeat, nosebleeds, tinnitus, diarrhea, allergic reactions (skin rash, erythema), prolonged erection, a feeling of general discomfort, a feeling of cold or heat, postural dizziness coughing.

Drug Interactions

CYP3A4 cytochrome P450 isoenzyme inhibitors (ketoconazole, itraconazole, ritonavir, indinavir, cimetidine, erythromycin, grapefruit juice) may enhance the effect of udenafil.

Ketoconazole (at a dose of 400 mg) increases the bioavailability and Cmax of Udenafil (at a dose of 100 mg) almost twice (212%) and 0.8 times (85%), respectively. Ritonavir and indinavir significantly enhance the effect of udenafil. Dexamethasone, rifampin and anticonvulsants (carbamazepine, phenytoin and phenobarbital) can accelerate the metabolism of udenafil, so co-administration with the above drugs weakens the effect of udenafil.

Co-administration of udenafil (30 mg / kg, oral) and nitroglycerin (2.5 mg / kg once intravenously) did not show any effect on the pharmacokinetics of udenafil in experimental studies, however, the simultaneous use of nitroglycerin and udenafil is not recommended due to a possible decrease blood pressure.

Udenafil and drugs from the group of alpha-blockers are vasodilating agents, therefore, when taken together, they should be prescribed in minimal doses.

Overdose

With a single 400 mg dose, the undesirable effects were comparable to those seen when taking udenafil at lower doses, but were more common.

Treatment: symptomatic. Dialysis does not accelerate the elimination of udenafil.

Storage Conditions

In a dry, dark place at a temperature not exceeding 30 РC.

Shelf life

3 years.

Deystvuyushtee substance

udenafil

Terms and conditions

prescription

dosage form

tablets

Possible product names

ZIDENA 0.1 N4 TABLE P / O

ZIDENA 100mg Tab. p / pl / rev X4

Ziden 100mg No. 4 tab

ZIDENA 100MG. No. 4 TAB. P / O

Zidena tab p / o 100mg x 4

Darm4Afarma19 Orellana