Dinamico long tabs 20mg #1

Dinamico long instruction

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Indications

Erectile disfunction.

Contraindications

    Hypersensitivity to tadalafil or any other component of Dinamico Long.
    The simultaneous use of tadalafil, nitrates and nitrate-like drugs, since tadalafil enhances the hypotensive effect of nitrates due to the NO / cGMP interaction.
    The presence of contraindications to sexual activity in patients with cardiovascular diseases:
* myocardial infarction in the last 90 days;
* unstable angina or the occurrence of an attack of angina during sexual intercourse;
* chronic heart failure II – IV classes according to the NYHA classification;
* uncontrolled arrhythmias, arterial hypotension (BP less than 90/50 mm Hg), uncontrolled arterial hypertension;
* Ischemic stroke in the last 6 months.
    Loss of vision due to non-arterial anterior ischemic neuropathy of the optic nerve (regardless of the connection with the intake of PDE-5 inhibitors).
    Simultaneous administration of doxazosin, as well as drugs for the treatment of erectile dysfunction.
    Daily (more than 2 times a week) use in patients with severe renal insufficiency (CC less than 30 ml / min).
    Lactase deficiency, lactose intolerance and glucose-galactose malabsorption.
    Children's age up to 18 years.

Carefully

In severe renal failure (CK less than 30 ml / min), severe hepatic failure (on the Child-Pugh class C scale), simultaneous use with alpha-blockers, in patients with predisposition to priapism (with sickle cell anemia, multiple myeloma or leukemia ) or with anatomical deformation of the penis (angular curvature, cavernous fibrosis or Peyronie's disease); with simultaneous use with potent inhibitors of CYP3A4 isoenzyme (ritonavir, saquinavir, ketoconazole, itraconazole, erythromycin), antihypertensives.

special instructions

Before applying tadalafil

Before using Dinamico LONG, it is necessary to diagnose erectile dysfunction, determine the possible causes and selection of adequate treatment methods, evaluate the medical history and conduct a physical examination.
Before starting treatment of erectile dysfunction with DINAMICO LONG, the doctor must examine the patient's cardiovascular system, as there is a certain degree of risk of developing disorders associated with sexual activity. The preparation Dinamico LONG has vasodilating properties, as a result of which a moderate and periodic decrease in blood pressure can be observed, which can enhance the hypotensive effect of nitrates.
The effectiveness of tadalafil in patients undergoing surgical treatment in the pelvic region, pelvic organs or nerve-saving radical prostatectomy is not known.

Cardiovascular complications

Serious adverse reactions of the cardiovascular system, such as: myocardial infarction, sudden death, angina pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations and tachycardia, were registered both in the post-registration period and in time clinical trials. Most of the patients in whom these reactions were observed had previously had cardiovascular risk factors. However, it is impossible to determine the relationship of these reactions with taking tadalafil, cardiovascular risk factors, sexual activity, or a combination of these or other factors.
In patients receiving joint therapy with antihypertensive drugs and DINAMICO LONG, the latter may cause a decrease in blood pressure. With daily use of the drug DINAMICO LONG, you may need a dose correction of the hypotensive
In some patients, the simultaneous use of alpha-blockers with the drug Dinamico LONG can cause a decrease in blood pressure. Simultaneous use of these drugs is not recommended.

Violations by the organ of vision

It was reported on the development of disorders of the organ of vision and ischemic neuropathy of the optic nerve in connection with the use of tadalafil and other PDE-5 inhibitors. It is necessary to discontinue the use of the drug DINAMICO LONG in case of occurrence of signs of a violation by the organ of vision and immediately consult a doctor.

Kidney and liver failure

Due to the increased AUC of tadalafil, the limited clinical experience of its use, as well as the limited effectiveness of hemodialysis to reduce clearance of tadalafil, daily use of the drug Dinamico Long is not recommended in patients with severe renal failure.
There is no data on the daily use of the drug Dinamico LONG in patients with severe hepatic insufficiency (according to the Child-Pugh class C scale). Tadalafil should be used with caution in these patients.

Priapism and anatomical deformities of the penis

Patients who have an erection lasting more than 4 hours should immediately consult a doctor. Late treatment of priapism can lead to damage to the tissues of the penis and loss of potency.
DINAMICO LONG should be used with caution in patients with anatomical deformation of the penis (angulation, cavernous fibrosis, Peyronie's disease), or in patients with risk factors for developing priapism (sickle cell anemia, multiple myeloma, leukemia).

Use with inhibitors of an isoenzyme CYP3A4

It should be used with caution the drug DINAMICO LONG simultaneously with powerful inhibitors of the isoenzyme CYP3A4 (ritonavir, saquinavir, ketoconazole, itraconazole and erythromycin), due to the possible increase in AUC of tadalafil.

Use simultaneously with other treatments for erectile dysfunction

Not recommended simultaneous use of the drug Dinamico LONG with other drugs used to treat erectile dysfunction, because efficacy and safety of the combined treatment has not been studied.

Influence on ability to drive vehicles and mechanisms

Caution should be exercised when using the drug Dinamico LONG due to the fact that dizziness may develop, which may affect the ability to drive and work with potentially dangerous machinery.

Composition

1 tablet contains: active ingredient: tadalafil 2.50 mg / 5.00 mg / 10.00 mg / 20.00 mg; excipients: lactose monohydrate (spray dried) 44.125 mg / 88.25 mg / 176.50 mg / 353.00 mg, sodium lauryl sulfate 0.375 mg / 0.75 mg / 1.50 mg / 3.00 mg, Povidone-K12 6.25 mg / 12.50 mg / 25.00 mg / 50.00 mg, crospovidone 6.25 mg / 12.50 mg / 25.00 mg / 50.00 mg, sodium fumarate 0.50 mg / 1, 00 mg / 2.00 mg / 4.00 mg; film coat: Opadry II 85F32782 yellow 2.00 mg / 4.00 mg / 7.00 mg / 15.00 mg (polyvinyl alcohol partially hydrolyzed 0.800 mg / 1.600 mg / 2.800 mg / 6,000 mg, macrogol-3350 0.404 mg / 0.808 mg / 1.414 mg / 3.030 mg, titanium dioxide (E 171) 0.344 mg / 0.688 mg / 1.204 mg / 2.580 mg, talc 0.296 mg / 0.592 mg / 1.036 mg / 2.220 mg, iron dye yellow oxide (E 172) 0.156 mg / 0.312 mg / 0.546 mg / 1.170 mg.

Dosage and administration

Inside, regardless of the meal.

erectile disfunction

The recommended dose is 10 mg before the intended sexual intercourse.
In patients in whom the drug DINAMICO LONG at a dose of 10 mg is not effective, apply a dose of 20 mg. The drug DINAMICO LONG must be taken at least 30 minutes before sexual activity.
The maximum frequency of taking the drug DINAMICO LONG is 1 time per day.
Doses of 10 mg and 20 mg are used immediately before sexual activity and are not recommended for daily use. For patients with frequent sexual activity (more than twice a week) the use of the drug DINAMICO LONG in a dose of 5 mg daily, once a day at the same time is recommended. The daily dose may be reduced to 2.5 mg depending on the individual sensitivity. For patients with infrequent sexual activity (less than 2 times a week), the use of the drug DINAMICO LONG in a dose of 20 mg immediately before sexual activity is recommended. The maximum daily dose of 20 mg.

Special patient group

In elderly patients, dose adjustment is not required.
In patients with mild or moderate renal insufficiency, dose adjustment is not required. The maximum dose in patients with severe renal insufficiency is 10 mg. Daily use (more than 2 times per week) of the drug Dinamico LONG in patients with severe renal failure is not recommended.
In patients with mild and moderate liver failure, the recommended dose of Dinamico LONG is 10 mg. The use of a dose of more than 10 mg in patients with impaired liver function has not been evaluated. Not enough data on the use of the drug Dinamico LONG in severe liver failure (on the scale of Child-Drink class C). Caution must be exercised when using the drug Dinamico LONG in this group of patients.
Patients with diabetes
When used in patients with diabetes, dose adjustment is not required.

Side effects

The most frequent adverse reactions in patients with erectile dysfunction using Tadalafil are headache, dyspepsia, myalgia, back pain, most often they were intermittent and mostly mild or moderate. The most frequent reports of the appearance of headache were observed in patients using tadalafil daily for 10-30 days from the start of the drug.
Adverse reactions are classified with the following frequency: very often (≥1 / 10); often - (≥1 / 100 to
On the part of the immune system: infrequently - hypersensitivity reactions; rarely - angioedema.
From the nervous system: often - headache; infrequently - dizziness; rarely, stroke1 (including hemorrhagic), syncope, transient ischemic attack1, migraine2, cluster convulsions, transient amnesia.
On the part of the organs of sight: infrequently - blurred vision, pain in the eyes; rarely, visual field defects, eyelid edema, conjunctival hyperemia, optic nerve ischemic neuropathy2, retinal vascular occlusion2.
From the side of the heart1: infrequently - tachycardia, palpitations; rarely - myocardial infarction, unstable stenocardia2, ventricular arrhythmia2.
From the side of blood vessels: often - “flushing” of blood to the face; infrequently, hypotonia 3, hypertension.
On the part of the respiratory system: often - nasal congestion; infrequently - shortness of breath, epistaxis.
From the gastrointestinal tract: often - dyspepsia, gastroesophageal reflux; infrequently - abdominal pain.
On the part of the skin and subcutaneous tissues: infrequently - skin rash, hyperhidrosis (sweating); rarely - urticaria, Stevens-Johnson syndrome2, exfoliative dermatitis2.
From the musculoskeletal and connective tissue: often - back pain, myalgia, pain in the limbs.
On the part of the kidneys and urinary tract: infrequently - hematuria.
On the part of the genitals: infrequently - bleeding from the penis, hematospermia; rarely - prolonged erection, priapism2.
Other: infrequently - chest pain; rarely - swelling of the face2, sudden death1,2.
(1) Most patients had previously had cardiovascular risk factors.
(2) Side effects are registered in the post-registration period.
(3) Reports of adverse reactions in patients taking tadalafil concomitantly with antihypertensive drugs.

Description of individual unwanted reactions

It was reported about changes in the electrocardiogram (sinus bradycardia) in patients who used tadalafil daily. These changes were not associated with adverse reactions.

Drug interaction

Inhibitors of the cytochrome P450 system
Tadalafil is mainly metabolized with the participation of CYP3A4 isoenzyme. The selective CYP3A4 isoenzyme inhibitor ketoconazole (200 mg / day) increases AUC of tadalafil (10 mg once) by 2 times and Cmax by 15%, and ketoconazole (400 mg / day) increases AUC of tadalafil (20 mg once) by 4 times and Cmax by 22% compared with taking only tadalafil in the same dose.
Ritonavir (200 mg twice a day), which is an inhibitor of CYP3A4, CYP2С9, CYP2С19 and CYP2D6 isoenzymes, increased Tadalafil AUC (20 mg) twice without changing Cmax. Although specific interactions have not been studied, it can be assumed that
other protease inhibitors, such as saquinavir and other inhibitors of the CYP3A4 isoenzyme, such as erythromycin, clarithromycin, itraconazole and grapefruit juice can increase the concentration of tadalafil in the blood plasma, as well as increase the likelihood of adverse reactions, so you should be careful to use them simultaneously with tadalafil .
Selective inducer of the CYP3A4 isoenzyme rifampicin while used with tadalafil reduces the AUC of tadalafil (10 mg once) by 88%. This can reduce the effects of tadalafil and reduce its effectiveness. The degree of efficacy loss is unknown. It can be assumed that other inducers of the CYP3A4 isoenzyme, such as carbamazepine, phenytoin, phenobarbital, can also reduce the concentration of tadalafil in the blood plasma.

Other medications

It is known that tadalafil (5 mg, 10 mg and 20 mg) enhances the hypotensive effect of nitrates. This occurs as a result of the additive effect of nitrates and tadalafil on the metabolism of NO and cGMP. Therefore, the use of tadalafil on the background of the use of nitrates is contraindicated. However, if necessary, nitrates can be used at least 48 hours after taking the last dose of tadalafil. In this situation, nitrates should be taken only under the supervision of a physician and be accompanied by monitoring hemodynamic parameters.

Antihypertensive drugs, including blockers "slow" calcium channel

The simultaneous use of doxazosin (4 mg and 8 mg daily) with tadalafil (5 mg daily and 20 mg once) significantly increases the hypotensive effect of alpha-blockers. This effect lasts a minimum of 12 hours and may be accompanied by appropriate symptoms, including fainting, and therefore the simultaneous use of these drugs is not recommended. With the simultaneous use of alfuzosin or tamsulosin with tadalafil, these reactions were not reported, however, tadalafil should be used with caution in patients treated with alpha-blockers, especially in elderly patients. Treatment should begin with a minimum dose and further adjust the dose.
Tadalafil has a systemic vasodilating property and can enhance the antihypertensive effect of antihypertensive drugs, including such groups of antihypertensive drugs as blockers of “slow” calcium channels (amlodipine), angiotensin converting enzyme inhibitors (enalapril), beta-adrenoblockers (metoprolol), and in-quotas; and angiotensin II receptor antagonists (various types and doses, alone or in combination with thiazide diuretics, calcium channel blockers, beta-blockers and and / or alpha-blockers).
Additionally, in patients taking several antihypertensive drugs in which hypertension was poorly controlled, there was a slightly greater decrease in blood pressure. In the vast majority of patients, this reduction was not associated with the hypotensive syndrome. Patients receiving simultaneous treatment of antihypertensive drugs with tadalafil should be given appropriate clinical guidelines.

5 alpha reductase inhibitor

With the simultaneous use of tadalafil (5 mg) with finasteride (5 mg) to alleviate the symptoms of benign prostatic hyperplasia, no additional adverse reactions have been reported. However, the interaction of these drugs has not been fully studied and at the same time they should be used with caution.

CYP1A2 isoenzyme substrate (eg, theophylline)

With the simultaneous use of tadalafil (10 mg) and theophylline (a non-selective phosphodiesterase inhibitor), no adverse reactions were reported, but a slight change in pharmacodynamic properties was observed: an increase in heart rate of 3.5 beats per minute. This effect is regarded as insignificant and has no clinical significance; however, it should be taken into account with the simultaneous use of these drugs.

Ethinyl estradiol and terbutaline

An increase in the bioavailability of ethinyl estradiol for oral administration has been reported with simultaneous use with tadalafil; Such an increase can be expected with the use of terbutaline for oral administration, although the clinical significance of this effect is not significant.

Alcohol

Tadalafil did not affect the concentration of alcohol, just as alcohol did not affect the concentration of tadalafil. Tadalafil (20 mg) did not increase the decrease in blood pressure caused by alcohol (0.7 g / kg). Some patients experienced postural dizziness and orthostatic hypotension. When taking tadalafil in combination with lower doses of alcohol (0.6 g / kg), a decrease in blood pressure was not observed, and dizziness occurred with the same frequency as when taking alcohol without tadalafil. The effect of alcohol on cognitive function does not change when used simultaneously with tadalafil.

Drugs metabolized by the cytochrome P450 system

Tadalafil does not have a clinically significant effect on the clearance of drugs metabolized with the participation of the CYP450 isoenzyme. Studies have confirmed that tadalafil does not inhibit and does not induce CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9, and CYP2C19 isoenzymes.

CYP2C19 isoenzyme substrate (for example, R-warfarin)

Tadalafil in a dose of 10 mg and 20 mg has no clinically significant effect on the AUC of S-warfarin or R-warfarin. Tadalafil also does not affect the effect of warfarin on prothrombin time.

Acetylsalicylic acid

Tadalafil in a dose of 10 mg and 20 mg does not increase the duration of bleeding caused by acetylsalicylic acid.

Antidiabetic drugs

Specific studies on the interaction with antidiabetic drugs have not been conducted.

Overdose

With a single use of tadalafil in a dose of 500 mg in healthy volunteers and in patients with erectile dysfunction (many times up to 100 mg / day), the undesirable effects were the same as with the use of lower doses.
In case of overdose, standard symptomatic treatment is necessary. With hemodialysis, tadalafil is practically not excreted.

Storage conditions

Store at a temperature not higher than 25 ° С.
Keep out of the reach of children.
Shelf life - 2 years.
Active substance - Tadalafil

Pharmacy sales terms

You can buy Dinamico long without a prescription.