Dinamico tabs 50mg #4

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Instruction for use of Dinamico

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Dinamico is a type 5 phosphodiesterase inhibitor (PDE-5), a drug for the treatment of erectile dysfunction.

Release form and composition

Dinamico produced in the form of film-coated tablets: blue, biconvex, at a dose of 25 mg and 50 mg - round, at a dose of 100 mg - oval and with a dividing line on both sides (1 or 4 pcs. In blisters, in cardboard pack 1 blister).
1 film-coated tablet contains:
    active ingredient: sildenafil citrate - 35.12 mg, 70.24 mg or 140.48 mg, this corresponds to the content of 25 mg, 50 mg or 100 mg of sildenafil;
    auxiliary components: microcrystalline cellulose, croscarmellose sodium, hyprolose, colloidal anhydrous silicon dioxide, magnesium stearate;
    composition of the film shell: indigo carmine (E132), opadray II 31F58914 white - macrogol 4000, lactose monohydrate, hypromellose, sodium citrate, titanium dioxide (E171).

Pharmacodynamics

Dinamico is a drug for the treatment of erectile dysfunction, a PDE-5 inhibitor. The mechanism of action is due to an increase in blood flow in the penis under conditions of sexual stimulation.
In the absence of functional disorders, the mechanism of erection occurs as a result of the release of nitric oxide (NO) in the cavernous body against the background of sexual arousal. NO activates the enzyme guanylate cyclase, causing an increase in the concentration of cyclic guanosine monophosphate (cGMP), which promotes relaxation of the smooth muscles of the blood vessels and active blood flow into the corpus cavernosum of the penis.
As a selective inhibitor of cGMP-specific PDE-5, sildenafil in the corpus cavernosum of the penis causes the breakdown of cGMP. The action of the active component of the drug is aimed at enhancing the relaxing effect of NO on the smooth muscles of the corpus cavernosum and increasing blood flow in the penis. Achieving a pharmacological effect is possible only with simultaneous sexual stimulation. When activated by sexual stimulation of the NO - cGMP chain, as a result of inhibition of PDE-5, an increase in cGMP occurs in the corpus cavernosum.
The activity of sildenafil against PDE-5 is 4000 times higher than the activity against PDE-3, which is one of the key enzymes in the regulation of myocardial contractility, 10 times higher than against PDE-6, more than 80 times higher than against PDE-1, more than 700 times - in relation to PDE-2, PDE-4, PDE-7 – PDE-11.
Sildenafil has a hypotensive effect due to a vasodilating effect with an increase in the content of cGMP in the smooth muscle membrane of blood vessels. When Dinamico is taken in recommended doses, it has a mild and short-term form and does not manifest itself clinically.
The efficacy and safety of sildenafil for the treatment of erectile dysfunction of organic, psychogenic or mixed etiology has been confirmed by the results of studies on the use of the drug in 3000 patients aged 19 to 87 years for 6 months. Efficacy was Dinamico assessed using erection diary, international erectile function index and partner survey.
While taking sildenafil, all studies have demonstrated the ability to achieve and maintain an erection sufficient for satisfactory intercourse. In addition, an improvement in the quality of orgasm was noted.

Pharmacokinetics

When used in the recommended dose range, the pharmacokinetics of sildenafil are linear.
After oral administration, the active substance is rapidly absorbed. Cmax (maximum concentration) in blood plasma is reached within 0.5–2 hours when taken on an empty stomach. Bioavailability averages 41%. Reception of Dinamico in combination with fatty foods does not significantly affect the degree of absorption, it only causes a decrease in the rate of absorption: Cmax decreases on average by 29%, AUC - by 11%, the period of reaching Cmax increases by 1 hour.
In vitro, sildenafil at a concentration of about 1.7 ng / ml is able to inhibit the activity of human PDE-5 by 50%.
The apparent Vd (volume of distribution) at equilibrium is 105 liters. Plasma protein binding - 96% of the dose taken.
1.5 hours after taking the drug Dinamico, up to 0.0002% (approximately 188 ng) of the dose of sildenafil is detected in semen.
Metabolism occurs in the liver, mainly by the action of isoenzymes CYP3A4 (main pathway) and CYP2C9 (accessory pathway). The active circulating metabolite is N-demethyl metabolite, which undergoes further metabolism with a half-life (T1 / 2) of 4 hours. When compared with sildenafil, its activity against PDE is 50%, plasma concentration is 40%.
The total clearance of sildenafil is 41 l / h.
T1 / 2 of sildenafil is 3-5 hours. Through the intestines, 80% of the drug is excreted in the form of inactive metabolites, through the kidneys - 13%.
In patients over the age of 65 years, the clearance of the active substance decreases, this causes an increase in the Cmax of sildenafil and its active metabolite by about 90% compared with patients aged 18 to 45 years. In the blood plasma, the content of sildenafil, which is not bound to proteins, is 40%. The incidence of side effects does not depend on the age of the patient.
In mild and moderate renal failure with creatinine clearance (CC) 50-80 ml / min and 30-49 ml / min, respectively, when taking the drug at a dose of 50 mg, the pharmacokinetics of sildenafil does not change, but there is an increase in Cmax (by 73%) and AUC (126%) N-demethylmetabolite. In severe renal failure (CC less than 30 ml / min), there is an increase in Cmax and AUC of the active substance by 88% and 100%, respectively, Cmax and AUC of N-demethylmetabolite - by 79% and 200%, respectively.
With cirrhosis of the liver (classes A and B on the Child-Pugh scale), Cmax increases by 47%, and the total concentration of sildenafil in blood plasma (AUC) - by 84%. In case of class C liver dysfunction (on the Child-Pugh scale), the pharmacokinetic parameters of the drug have not been established.


Indications for use

According to the instructions, Dinamico is indicated for men for the treatment of erectile dysfunction, the characteristic feature of which is the inability of the penis to achieve or maintain an erection sufficient for satisfactory intercourse.
Effectiveness Dinamico manifests itself only against the background of sexual stimulation.

Contraindications

    severe cardiovascular diseases (including life-threatening arrhythmias, unstable angina pectoris, severe heart failure), concomitant therapy with riociguat (guanylate cyclase stimulator) - due to an increased risk of developing symptomatic arterial hypotension, other conditions in which sexual activity is undesirable;
    arterial hypotension - the patient's blood pressure (BP) is less than 90/50 mm Hg;
    arterial hypertension - blood pressure above 170/100 mm Hg;
    condition after a recent myocardial infarction or cerebrovascular accident;
    concomitant use of ritonavir, nitric oxide donors, organic nitrates, nitrates as part of other drugs;
    loss of vision in one eye as a result of anterior ischemic optic neuropathy of non-arterial genesis, which occurred as a result of taking a PDE-5 inhibitor or for another reason;
    hereditary degenerative diseases of the retina, including retinitis pigmentosa (including the genetic disease PDE of the retina);
    severe liver failure;
    lactose intolerance, glucose-galactose malabsorption syndrome, lactase deficiency;
    simultaneous use with PDE-5 inhibitors, other agents for the treatment of erectile dysfunction;
    female;
    age under 18;
    hypersensitivity to the components of the drug.
It should be taken with caution in patients with anatomical deformity of the penis (cavernous fibrosis or Peyronie's disease, angulation), severe renal failure (CC less than 30 ml / min), impaired liver function, an indication in the history of the development of anterior non-arteritis ischemic neuropathy of the optic nerve, concomitant therapy with alpha-adrenergic receptor blockers, with multiple myeloma, thrombocythemia, leukemia, during an exacerbation of gastric ulcer and duodenal ulcer, with bleeding diseases, pathologies (including sickle cell anemia), predisposing to the development of priapism.

Instructions for use Dinamico: method and dosage

Dinamico tablets are taken orally.
Recommended dosage: first dose - 50 mg 1 hour before sexual activity. Depending on the efficacy and tolerability, the dose is then selected individually, increasing it to 100 mg or decreasing it to 25 mg. The maximum frequency of application is 1 time per 24 hours. The maximum daily dose is 100 mg.
No dose adjustment is required for elderly patients; it is recommended to start taking the drug with a dose of 25 mg.
In renal failure with a CC of 30–80 ml / min, dose adjustment is not required. In severe renal failure (CC less than 30 ml / min), the first dose should be 25 mg of sildenafil. In case of good tolerance, it can be increased, if necessary, to 50 mg and 100 mg.
For cirrhosis and other liver diseases, the dose of Dinamico is 25 mg.
When combined with erythromycin, saquinavir, ketoconazole, itraconazole (inhibitors of the cytochrome CYP3A4 isoenzyme), sildenafil should be taken with a dose of 25 mg.
With concomitant therapy with alpha-blockers, it is recommended to start taking sildenafil only after stabilizing hemodynamics with a minimum dose (25 mg).
The concomitant use of Dinamico with ritonavir is contraindicated. If these recommendations are not followed, the maximum dose of sildenafil should not exceed 25 mg once every 48 hours.

Side effects

    from the immune system: infrequently - allergic reactions, hypersensitivity reactions (including skin rash);
    on the part of the organ of vision: often - visual impairment, blurred vision, cyanopsia; infrequently - redness of the eyes or sclera injections, photophobia, photopsia, pain in the eyes, chromatopsia, hemorrhage in the eye tissue, impaired brightness of light perception, mydriasis, conjunctivitis, disruption of the lacrimal apparatus, cataract; rarely - a feeling of dryness in the eyes, swelling of the eyelids and adjacent tissues, conjunctival hyperemia, increased eye fatigue, the presence of rainbow circles in the field of vision around the light source, xanthopsia (seeing objects in yellow light), erythropsia (seeing objects in red), an unpleasant sensation in the eyes, irritation of the mucous membrane of the eyes; frequency not established - retinal vein occlusion, non-arteritis anterior ischemic neuropathy of the optic nerve (NPINZN), visual field defect, decreased visual acuity, temporary loss of vision, increased intraocular pressure, retinal edema, retinal vascular disease, vitreous detachment (vitreous traction), diplopia ;
    on the part of the organ of hearing: infrequently - tinnitus, sudden decrease or loss of hearing, pain in the ears;
    on the part of the cardiovascular system: often - hot flashes; infrequently - lowering blood pressure, tachycardia, unstable angina, palpitations, increased heart rate, atrioventricular block, heart failure, cardiomyopathy, abnormalities in electrocardiogram readings, myocardial infarction, cardiac arrest, thrombosis of cerebral vessels; rarely - atrial fibrillation, ventricular arrhythmia, sudden cardiac death;
    from the hematopoietic system: infrequently - leukopenia, anemia;
    from the side of metabolism: infrequently - thirst, gout, edema, hyperglycemia, uncompensated diabetes mellitus, hypoglycemia, hyperuricemia, hypernatremia, peripheral edema;
    from the respiratory system: often - nasal congestion; infrequently - epistaxis, laryngitis, pharyngitis, rhinitis, sinusitis, dyspnoea, bronchitis, increased cough, increased sputum volume, asthma; rarely - dryness and / or swelling of the nasal mucosa, a feeling of tightness in the throat;
    from the digestive system: often - dyspepsia, nausea; infrequently - dry mouth, stomatitis, abdominal pain, gastroesophageal reflux disease, vomiting, colitis, dysphagia, glossitis, gingivitis, esophagitis, gastritis, gastroenteritis, rectal bleeding, abnormal liver function tests; rarely - hypesthesia of the oral mucosa;
    from the musculoskeletal system: often - back pain; infrequently - pain in the limbs, bone pain, myalgia, arthritis, arthrosis, tendosynovitis, myasthenia gravis, synovitis, tendon rupture;
    from the urinary system: infrequently - urinary incontinence, cystitis, nocturia, hematuria;
    on the part of the reproductive system: infrequently - violation of ejaculation, enlargement of the mammary glands, edema of the genitals, hematospermia, anorgasmia, damage to the tissues of the penis; rarely - priapism (prolonged erection);
    from the nervous system: very often - headache; often - dizziness; infrequently - insomnia, drowsiness, neuralgia, neuropathy, migraine, ataxia, paresthesia, tremor, hypertonicity, vertigo, unusual dreams, symptoms of depression, hypoesthesia, increased reflexes; rarely - fainting, convulsions, repeated convulsions;
    dermatological reactions: infrequently - itching, rash, urticaria, increased sweating, skin ulceration, herpes simplex, contact dermatitis, photosensitivity reaction, exfoliative dermatitis; frequency unknown - toxic epidermal necrolysis, Stevens-Johnson syndrome;
    others: infrequently - increased fatigue, chest pain, fever, chills, asthenia, facial swelling, accidental falls, pain of various localization, accidental trauma, shock; rarely - irritability.

Overdose

Symptoms: after a single dose of Dinamico in a dose of up to 800 mg - headache, dizziness, hot flashes, dyspepsia, blurred vision, nasal congestion in a more pronounced form than when taking the usual dose. While taking up to 200 mg, the incidence of adverse reactions increases, but not their severity.
Treatment: the appointment of symptomatic therapy. The use of hemodialysis is ineffective.


Special instructions

Appointment of adequate therapy for erectile dysfunction is made by the doctor on the basis of a complete medical history and the results of diagnostic studies, including examination of the state of the cardiovascular system. In patients with arterial hypotension, the doctor should assess the possible risk of developing undesirable manifestations of the vasodilating effect of Dinamico against the background of sexual activity.
Patients taking alpha-blockers should be informed about the increased risk of postural hypotension during Dinamico therapy and about the actions to be taken if it occurs.
If, while taking the drug, an erection persists for more than 4 hours, you should seek prompt medical attention. Prolonged erection can cause damage to the tissues of the penis and irreversible loss of potency.
The development of adverse events in the form of severe cardiovascular conditions (including arterial hypertension and arterial hypotension, unstable angina pectoris, ventricular arrhythmia, transient ischemic attack, myocardial infarction, sudden cardiac death, hemorrhagic stroke), detected during post-marketing studies, more often occurred in patients with risk factors for cardiovascular complications. Many of the adverse events were observed immediately after sexual activity, some after taking Dinamico without subsequent sexual activity.
If you suddenly deteriorate or lose your hearing or vision while taking sildenafil, you should immediately consult a doctor.

Influence on the ability to drive vehicles and complex mechanisms

Due to the risk of developing adverse events that affect the speed of psychomotor reactions (including dizziness, low blood pressure, chromatopsia, visual impairment), caution should be exercised when performing potentially hazardous activities, including driving and driving complex mechanisms.

Childhood use

The use of Dinamico is contraindicated in children and adolescents under 18 years of age.

With impaired renal function

With caution, you should take Dinamico tablets in case of severe renal failure (CC less than 30 ml / min). The first dose should be 25 mg of sildenafil. In case of good tolerance, it can be increased, if necessary, to 50 mg and 100 mg.
In renal failure with a CC of 30–80 ml / min, dose adjustment is not required.

For violations of liver function

The use of the drug Dinamico is contraindicated in patients with severe hepatic insufficiency.
It should be taken with caution in case of liver dysfunction.
In case of liver diseases (including cirrhosis of the liver), the dose of the drug should not exceed 25 mg.

Use in the elderly

No dose adjustment is required for elderly patients.
You should start taking Dinamico with a dose of 25 mg, with good tolerance, it can be increased to 50 mg or 100 mg.

Drug interactions

With the simultaneous use of Dinamico:
    ritonavir (HIV protease inhibitor, strong inhibitor of cytochrome P450): contributes to a significant increase in the concentration of sildenafil in blood plasma;
    inhibitors of cytochrome CYP3A4 isoenzymes (erythromycin, ketoconazole, cimetidine, itraconazole) and CYP2C9: may cause a decrease in clearance and marked changes in the pharmacokinetics of sildenafil;
    inducers of cytochrome CYP3A4 and CYP2C9 isoenzymes: an increase in the clearance of sildenafil is possible;
    magnesium hydroxide, aluminum hydroxide (antacids): with a single dose, they do not affect the bioavailability of sildenafil;
    rifampicin (a powerful inducer of the isoenzyme CYP3A4): may cause a significant decrease in the concentration of sildenafil in blood plasma;
    tricyclic antidepressants, selective serotonin reuptake inhibitors, tolbutamide, warfarin, thiazide-like and thiazide diuretics, calcium antagonists, angiotensin-converting enzyme inhibitors, azithromycin: do not affect the pharmacokinetics of sildenafil;
    nitrates: there is an increase in the hypotensive effect of nitrates, regardless of the period of their use;
    alpha-blockers, including doxazosin: can contribute to the development of symptomatic hypotension, including, in rare cases, symptomatic postural (orthostatic) hypotension;
    acetylsalicylic acid: at a dose of 150 mg does not cause an additional increase in bleeding time while taking 50 mg of sildenafil;
    ethanol: does not enhance its hypotensive effect while taking 50 mg of sildenafil;
    amlodipine: does not interact with sildenafil at a dose of 100 mg, the combination with antihypertensive drugs does not cause additional side effects.

Terms and conditions of storage

Keep out of the reach of children.
Store at temperatures up to 25 ° C.
Shelf life is 3 years.

Reviews about Dinamico

Reviews about Dinamico are positive. Patients indicate the effectiveness of the drug for erectile dysfunction, even with the use of low doses. Describing its tolerability, they report facial flushing, nasal congestion, increased pressure. Adverse events appear to a small extent and quickly disappear. Dinamico action can last for 9 hours. Comparing with expensive analogs, they note an acceptable price.

Terms of sell

You don't need a prescription to buy Dinamico.