Dinamiko Long Table n / 20mg film about 2 pc

$31.71

Dinamiko Long Table n / 20mg film about 2 pc

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Description

Composition
Active substance:
tadalafil 20.00 mg
Excipients:
lactose monohydrate (spray dried) 353.00 mg sodium lauryl sulphate 3.00 mg,
povidone K12 50.00 mg Crospovidone 50.00 mg, 4.00 mg of sodium stearyl fumarate;
film coating:
Opadry II 85F32782 Yellow 15.00 mg (partially hydrolyzed polyvinyl alcohol 6.000 mg macrogol 3350 3.030 mg titanium dioxide (E 171) 2.580 mg, 2.220 mg of talc, iron oxide yellow dye (E 172) 1.170 mg.
Description:
oval biconvex film-coated from light yellow to yellow brownish color, with Valium and marked “2” on the left of the risks and “0” to the right of the risks on one side.
Product form:
2 tablets in a blister made of PVC / Aclar / PVC // aluminum foil (or aluminum (OPA / alu. / PVC) foil, or PVC / Aclar / PVDC / PVC KPMAX // Aluminum Foil). 1 blister together with instructions for use in a cardboard box.
Contraindications
– Increased sensitivity to tadalafil or any substance included in the preparation.
– Reception preparations containing any organic nitrates.
– Age 18 years.
– The presence of contraindications to sexual activity in patients with diseases of the cardiovascular system: myocardial infarction within the past 90 days, unstable angina and the occurrence of angina attack during intercourse, chronic heart failure class II and higher NYHA classification in the last 6 months, uncontrollable arrhythmia, hypotension (blood pressure less than 90/50 mm Hg), uncontrolled hypertension, ischemic stroke within the last 6 months.
– The loss of vision due to the development nearteriitnoy anterior ischemic optic neuropathy (NAPION) (regardless of the connection with the previous reception of PDE-5 inhibitors).
– Concomitant use: with doxazosin; with other PDE5 inhibitors; with other treatment options for erectile dysfunction; guanylate cyclase stimulants such as riotsiguat.
– Application in patients with severe renal failure (creatinine clearance less than 30 mL / min).
– lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
Carefully
Since there is no sufficient data in patients with severe hepatic insufficiency (class C by Child-Pugh classification), caution should be exercised when administering the drug DYNAMIC LONG this group of patients.
Care must be exercised when administering the drug to patients taking alpha1 blockers, since simultaneous application can cause symptomatic hypotension in some patients. In two clinical pharmacology studies in healthy volunteers treated with tadalafil, there was no symptomatic hypotension while the use of tamsulosin, a selective alpha 1-blockers (see. Section “Interaction with other medicinal products”).
The drug should be used with caution in patients with a predisposition to priapism (for sickle cell anemia, multiple myeloma or leukemia), or in patients with anatomical deformation of the penis (angulation, cavernous fibrosis or Peyronie’s disease). Also, caution should be exercised while reception with inhibitors isoenzyme CYP3A4 (ritonavir, saquinavir, ketoconazole, itraconazole, clarithromycin, erythromycin, grapefruit juice), antihypertensive drugs, inhibitors of 5-alpha reductase.
Diagnosis of erectile dysfunction should include the identification of potential primary cause corresponding medical examination and determination of treatment.
Dosage
20 mg
Indications
– Erectile disfunction.
– Lower urinary tract symptoms in patients with benign prostatic hyperplasia (for a dosage of 5 mg).
– Erectile dysfunction in patients with lower urinary tract symptoms on a background of benign prostatic hyperplasia.
Interaction with other drugs
The effect of other drugs on tadalafil
Tadalafil is mainly metabolized with isoenzyme CYP3A4. CYP3A4 isozyme Selective inhibitor ketoconazole (400 mg daily) increases AUC
tadalafil and at 312% of tadalafil Cmax by 22%, and ketoconazole (200 mg daily)
tadalafil AUC increases by 107% of tadalafil Cmax and 15%.
Ritonavir (200 mg twice daily), an inhibitor of isozyme CYP3A4, 2C9, 2C19 and
2D6, tadalafil AUC increases by 124% unchanged Cmax. Despite the fact that the specific interactions has not been studied, one can assume that other HIV protease inhibitors such as saquinavir, as well as inhibitors of isoenzyme CYP3A4, such as erythromycin, clarithromycin, itraconazole and grapefruit juice –
may increase the concentration of tadalafil in plasma.
The role of vectors (e.g., P-glycoprotein) in the distribution tadalafil unknown.
There is a possibility of drug interactions mediated by inhibition of transporters.
Isozyme selective inducer of CYP3A4, rifampicin (600 mg daily),
It reduces the amount of tadalafil in AUC and 88% of tadalafil Cmax by 46%. It can be assumed that the simultaneous use of other inducers of CYP3A4
(Such as phenobarbital, phenytoin or carbamazepine) may also reduce the concentration of tadalafil in the blood plasma.
Simultaneous reception of antacid (hydroxide / magnesium aluminum hydroxide) and tadalafil reduces the rate of absorption of tadalafil without changing the value AUC tadalafil.
Increased gastric pH as a result of receiving H2-histamine blockers nizatidine receptor had no effect on the pharmacokinetics of tadalafil.
The safety and efficacy of a combination of tadalafil with other treatments for erectile dysfunction or other PDE5 inhibitors have not been studied, so the use of such combinations is not recommended.
Effect of tadalafil on other drugs
It is known that tadalafil enhances hypotensive effects of nitrates. This is due to the additive effect of nitrates and tadalafil on the metabolism of nitric oxide II
(NO) and cGMP, so the use of tadalafil to patients receiving nitrates is contraindicated.
Tadalafil has no clinically significant effect on the clearance of drugs whose metabolism occurs with the participation of cytochrome P450 isoenzymes.
Studies have confirmed that tadalafil does not inhibit or induce isozymes CYP1A2, CYP3A4, CYP2C9, CYP2C19, CYP2D6, CYP2E1.
Tadalafil has no clinically significant effect on AUC S-warfarin or Rvarfarina. Tadalafil did not affect the action of warfarin on prothrombin time.
Tadalafil not potentiate increasing duration of bleeding caused by the intake of acetylsalicylic acid.
Tadalafil has a systemic vasodilating properties and can enhance the effect of antihypertensive drugs, aimed at lowering blood pressure.
Additionally, patients taking multiple antihypertensive agents whose hypertension poorly controlled, there was a slightly greater blood pressure reduction. In most patients, blood pressure reduction was not accompanied by symptoms of hypotension. Patients treated with antihypertensive drugs and receiving tadalafil, should be given appropriate clinical recommendations.
According to the results of two clinical trials no significant reduction in blood pressure while applying healthy volunteers tadalafil and selective alpha1-adrenergic blocker tamsulosin.
The simultaneous use of tadalafil with doxazosin contraindicated. In applying tadalafil healthy volunteers who took alpha 1 adrenergic blocker doxazosin (4-8 mg per day) were increased hypotensive effect of doxazosin. Some patients experienced symptoms associated with a decrease in blood pressure, including syncope.
During clinical studies it was shown that riotsiguat enhances the hypotensive effect of PDE-5 inhibitors. Simultaneous treatment with riotsiguata PDE5 inhibitors,
including tadalafil, are contraindicated.
drug interaction studies tadalafil and inhibitors 5-alfareduktazy not carried out, when the simultaneous reception of caution.
Tadalafil causes increase ethinyl estradiol bioavailability when taken orally.
A similar increase in bioavailability can be expected when taken orally terbutaline.
however, the clinical consequences are not established.
Tadalafil does not affect the concentration of ethanol as well as ethanol does not affect the concentration of tadalafil. At high doses of ethanol (0.7 g / kg) receiving tadalafil does not cause a statistically significant reduction in the average blood pressure value.
Some patients experienced postural dizziness and orthostatic hypotension. At reception of tadalafil in conjunction with lower doses of ethanol (0.6 g / kg)
blood pressure decrease was not observed, and dizziness occurred with the same frequency as that at reception of ethanol.
Tadalafil has no clinically meaningful effect on the pharmacokinetics or pharmacodynamics of theophylline.
Overdose
With single assignment tadalafil healthy volunteers at a dose of 500 mg and patients with erectile dysfunction – repeatedly to 100 mg / day, adverse effects were the same as when using lower doses. In case of overdose should be carried out standard symptomatic treatment. Hemodialysis tadalafil virtually displayed.
pharmachologic effect
Pharmacological group:
erectile dysfunction treatment agent – PDE5 inhibitor.
Pharmacodynamics:
Tadalafil is a reversible, selective inhibitor of specific phosphodiesterase type 5 (PDE5), cyclic guanosine monophosphate (cGMP). When sexual stimulation causes local release of nitric oxide, inhibition of PDE5 tadalafil leads to an increase in cGMP concentration in the corpus cavernosum penis. The consequence of this is the relaxation of smooth muscles of arteries and blood flow to the tissues of the penis that causes erections. Tadalafil has no effect in the absence of sexual stimulation.
Studies in vitro have shown that tadalafil is a selective inhibitor of PDE5. PDE5 is an enzyme found in corpus cavernosum smooth muscle, smooth muscle in blood vessels internal organs, skeletal muscle, platelets, kidneys, lungs and cerebellum. Effects of tadalafil is more pronounced against PDE5 than for other phosphodiesterase. Tadalafil is 10 000 times more active blocks
PDE5 than PDE-1 PDE-2, PDE 4 and PDE 7 enzymes that are found in the heart, brain, blood vessels, liver, leukocytes, skeletal muscle and in other organs. Tadalafil 10 000 times more active blocks PDE5 than PDE-3 enzyme that is found in the heart and blood vessels. This selectivity for PDE5 as compared to PDE-3 is significant, because 3-PDE is an enzyme participating in the reduction of the heart muscle. Furthermore, tadalafil is about 700 times more active blocks PDE5 than enzyme PDE-6, which is found in the retina and is responsible for fotoperedachu. Tadalafil is 9000 times more active blocks PDE5 than enzymes PDE-8, 9-PDE and PDE-10 and 14 times more active blocks PDE5 than PDE-11. Tissue distribution and physiological effects of inhibiting PDE-PDE-8 and 11 have not yet been studied.
Tadalafil improves erection and increases the possibility of successful sexual intercourse.
Tadalafil in healthy volunteers did not cause significant changes in systolic and diastolic blood pressure compared to placebo in the supine position (mean maximum decrease of 1.6 / 0.8 mm Hg. V., Respectively), and standing (mean maximum decrease of 0, 2 / 4.6 mm Hg. v., respectively). Tadalafil does not cause significant changes in heart rate.
Tadalafil does not cause changes in the recognition of colors (blue / green), due to its low affinity PDE-6. In addition, there is no effect of tadalafil on visual acuity, electroretinogram, intraocular pressure and pupil size.
In order to evaluate the effect of daily use of tadalafil on spermatogenesis have been several studies. None of the studies was not observed undesirable effects on sperm morphology and motility. In one study showed a reduction in the average sperm concentration as compared to placebo. Decrease of sperm concentration was associated with a higher incidence of ejaculation. Furthermore, there was no adverse effect on the average concentration of the sex hormones, testosterone, luteinizing hormone and follicle-stimulating hormone while taking Cialis, compared to placebo.
The efficacy and safety of Cialis (in doses of 2.5 mg, 5.0 mg) was studied in clinical trials. It was noted improved erections in patients with erectile dysfunction of all severities when taking tadalafil once a day.
In studies of primary efficacy application 5 mg tadalafil, 62% and 69% of attempts were successful intercourse compared with 34% and 39% of patients taking placebo. Admission 5 mg tadalafil significantly improved erectile function within 24 hours between doses.
The mechanism of action in patients with benign prostatic hyperplasia (BPH)
The inhibition of PDE5 tadalafil, resulting in increased cGMP concentration in the corpus cavernosum of the penis, is also observed in the smooth muscle of the prostate, bladder and blood vessels that supply blood to them.
Relaxation of vascular smooth muscle leads to an increased blood perfusion in these organs, and, as a consequence, to a decrease in severity of symptoms of BPH. Relaxation of smooth muscle of prostate and bladder may further exacerbate vascular effects.
Pharmacokinetics:
Suction
After oral administration of tadalafil is rapidly absorbed. The average maximum concentration (Cmax) in plasma is achieved at a mean of 2 hours after ingestion. The rate and extent of absorption of tadalafil are not dependent on the time of the meal, and the drug DYNAMIC LONG can be used regardless of the meal. Hours (morning or evening) had no clinically significant effect on the rate and extent of absorption.
Tadalafil pharmacokinetics in healthy subjects is linear with respect to time and dose. In the dose range from 2.5 to 20 mg of the area under the curve “concentration-time» (AUC) increased in proportion to dose. The equilibrium concentration in plasma is reached within 5 days while taking the drug once a day.
The pharmacokinetics of tadalafil in patients with erectile dysfunction is similar to the pharmacokinetics of the drug in patients without erectile dysfunction.
Distribution
The average volume of distribution is around 63 liters, indicating that tadalafil is distributed in body tissues. At therapeutic concentrations, 94% of tadalafil in plasma binds to the protein. Protein binding is not changed by impaired renal function.
In healthy volunteers, less than 0.0005% of the administered dose is found in semen.
Metabolism
Tadalafil is mainly metabolized involving CYP3A4 isoenzyme of cytochrome P450. The main circulating metabolite is metilkateholglyukuronid. This metabolite is at least 13 000 times less active against PDE5 than tadalafil. Consequently, the concentration of this metabolite is not clinically significant.
breeding
In healthy volunteers the average clearance of tadalafil ingestion of 2.5 l / h, and the average half-life – 17.5 hours. Tadalafil is excreted mainly in the form of inactive metabolites, mainly through the intestine (about 61% of the dose) and, to a lesser extent, the kidneys (approximately 36% of the dose).
Special patient groups
Age over 65 years
Healthy volunteers aged 65 and older had a lower clearance of tadalafil when taken orally, which was reflected in an increase in AUC by 25% compared with healthy volunteers aged 19 to 45 years. This difference is not clinically significant and does not require a dose adjustment.
kidney failure
In patients with renal mild impairment (creatinine clearance of 51 to 80 ml / min) and moderate (creatinine clearance of 31 to 50 ml / min), and in patients with end stage renal failure, hemodialysis, exposure tadalafil (AUC) approximately doubled.
In patients on hemodialysis, Cmax was 41% higher compared with healthy volunteers. Excretion of tadalafil by hemodialysis is negligible.
Liver failure
The pharmacokinetics of tadalafil in patients with mild to moderate hepatic insufficiency (class A and B for the classification of Child-Pugh) is comparable to that in healthy volunteers. For patients with severe hepatic insufficiency (class C by Child-Pugh classification) data are insufficient. When administering the drug DYNAMIC LONG patients with severe liver failure previously conduct a risk assessment need and use of the drug.
Patients with diabetes mellitus
Patients with diabetes mellitus during treatment with tadalafil AUC was lower by about 19% compared with healthy volunteers. This difference does not require dose adjustment.
Pregnancy and breast-feeding
The drug is not intended for use in women.
Conditions of supply of pharmacies
Prescription.
side effects
The most common adverse events in patients with erectile dysfunction
BPH are: headache, dyspepsia, and back pain and myalgia.
Ниже приведены побочные эффекты, которые были зарегистрированы во время клинических исследований и при пострегистрационном применении препарата.
Зарегистрированные побочные эффекты обычно были слабо или умеренно выражены и носили преходящий характер. В соответствии с классификацией ВОЗ все реакции распределены по системам органов и частоте развития: очень часто (>1/10); common (> 1/100,
special instructions
Сексуальная активность имеет потенциальный риск для пациентов с сердечнососудистыми заболеваниями, поэтому лечение эректильной дисфункции, в том числе с препаратом ДИНАМИКО ЛОНГ, не следует проводить у мужчин с такими заболеваниями сердца, при которых сексуальная активность не рекомендована.
Имеются сообщения о возникновении приапизма при применении ингибиторов ФДЭ-5, включая тадалафил. Пациенты должны быть проинформированы о необходимости немедленного обращения за медицинской помощью в случае возникновения эрекции, продолжающейся 4 часа и более. Несвоевременное лечение приапизма ведет к повреждению тканей полового члена, в результате чего может наступить необратимая импотенция.
Безопасность и эффективность комбинации тадалафила с другими ингибиторами ФДЭ-5 и видами лечения эректильной дисфункции не изучались, поэтому применение подобных комбинаций не рекомендуется.
Как и другие ФДЭ-5 ингибиторы, тадалафил обладает системными сосудорасширяющими свойствами, что может приводить к транзиторному снижению артериального давления.
Перед назначением препарата ДИНАМИКО ЛОНГ врач должен тщательно рассмотреть вопрос, не будут ли пациенты с сердечно-сосудистым заболеванием подвергаться нежелательному воздействию за счёт таких сосудорасширяющих эффектов.
НАПИОН является причиной нарушения зрения, включая полную потерю зрения.
Имеются редкие постмаркетинговые сообщения о случаях развития НАПИОН, по времени связанных с приёмом ингибиторов ФДЭ-5. Анализ данных эпизодического применения ингибиторов ФДЭ-5 в течение от 1 до 4 дней у мужчин с эректильной дисфункцией дает основания предполагать повышение риска развития острой НАПИОН.
Врач должен рекомендовать пациентам в случае внезапной потери зрения прекратить приём тадалафила и обратиться за медицинской помощью. Врач также должен сообщить пациентам, что риск повторного развития НАПИОН выше у пациентов, ранее перенёсших НАПИОН.
Пациенты с предполагаемым диагнозом ДГПЖ должны пройти обследование для исключения рака предстательной железы.
Эффективность препарата ДИНАМИКО ЛОНГ у пациентов, перенесших хирургическую операцию на органах малого таза или радикальную простатэктомию без сохранения сосудисто-нервных пучков, неизвестна.
Effect on the ability to drive mechanisms and
Несмотря на то, что частота возникновения головокружения на фоне плацебо и тадалафила одинакова, в период лечения необходимо соблюдать осторожность при вождении автотранспорта и занятиями другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Storage conditions
Store at a temperature not higher than 25 ° C.
Keep out of the reach of children
Dosing and Administration
For oral administration.
Применение препарата ДИНАМИКО ЛОНГ по показанию эректильная дисфункция (ЭД).
Для пациентов с частой сексуальной активностью (более двух раз в неделю): рекомендованная частота приёма – ежедневно, один раз в сутки 5 мг, в одно и то же время, вне зависимости от времени приёма пищи. Суточная доза может быть снижена до 2,5 мг в зависимости от индивидуальной чувствительности.
Для пациентов с нечастой сексуальной активностью (реже двух раз в неделю): рекомендованная доза составляет 10 мг перед предполагаемой сексуальной активностью, независимо от приёма пищи. У пациентов, у которых препарат в дозе 10 мг недостаточно эффективен, применяют дозу 20 мг. Препарат следует принимать как минимум за 16 минут до предполагаемой сексуальной активности. Пациенты могут осуществлять попытку полового акта в любое время в течение 36 часов после приёма препарата для того, чтобы установить оптимальное время ответа на приём препарата.
Рекомендованная максимальная суточная доза препарата ДИНАМИКО ЛОНГ составляет 20 мг.
Максимальная рекомендованная частота приёма – 1 раз в сутки.
Дозы 10 мг и 20 мг применяют непосредственно перед сексуальной активностью и не рекомендуются для ежедневного применения.
Применение препарата ДИНАМИКО ЛОНГ по показанию доброкачественная гиперплазия предстательной железы (ДГПЖ) или ЭД/ДГПЖ.
Рекомендуемая доза препарата ДИНАМИКО ЛОНГ при ежедневном применении один раз в сутки составляет 5 мг; препарат следует принимать приблизительно в одно и то же время дня, независимо от времени сексуальной активности. Продолжительность лечения устанавливается врачом индивидуально.
У пациентов с почечной недостаточностью легкой степени тяжести (клиренс креатинина от 51 до 80 мл/мин) и умеренной степени тяжести (клиренс креатинина от 31 до 50 мл/мин) коррекция дозы не требуется. У пациентов с тяжёлой степенью почечной недостаточности (клиренс креатинина
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

TEVA

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