Dinamico pills film 50mg N1
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Description
Dispersing film Dynamic - a means of treating erectile dysfunction. It is used to treat erectile dysfunction, restores impaired erectile function under sexual stimulation by increasing blood flow in the penis.
Active ingredients
Sildenafil
Composition
1 film contains the active substance: Sildenafil 100 mg.
Pharmacological effect
The implementation of the physiological mechanism of erection is associated with the release of nitric oxide (NO) in the cavernous body due to sexual arousal. N0 activates the enzyme guanylate cyclase, which leads to an increase in the concentration of cyclic guanosine monophosphate (cGMP). In turn, cGMP causes relaxation of the smooth muscles of blood vessels and, accordingly, blood flow to the cavernous body of the penis. Sildenafil is a selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5), which causes the disintegration of cGMP in the cavernous body of the penis. It does not have a direct relaxing effect on the smooth muscles of the cavernous body, but enhances the relaxing effect of N0 on this tissue and increases blood flow in the penis. When activated, the chain N0 - cGMP. observed during sexual stimulation, inhibition of PDE5 leads to an increase in cGMP in the cavernous body. The pharmacological effect is achieved only in the presence of sexual stimulation. The activity of sildenafil with respect to PDE5 exceeds the activity with respect to other known phosphodiesterase isoenzymes: PDE6 - by 10 times, PDE1 - by more than 80 times, PDE2 - PDE4, PDE7 - PDE11 - by more than 700 times. Sildenafil is 4,000 times more selective for PDE5 than PDEZ, which is of great importance, since PDEZ is one of the key enzymes regulating myocardial contractility. Sildenafil has a mild and short-term antihypertensive effect, in most cases without clinical manifestation when taken in recommended doses. The antihypertensive effect is associated with the vasodilating effect of sildenafil due to an increase in the concentration of cGMP in the vascular smooth muscle membrane.
Pharmacokinetics
Suction. After ingestion is rapidly absorbed. The maximum concentration in the blood plasma (Cax) when taken on an empty stomach is reached within 30-120 minutes, the bioavailability averages 41% (25-63%).The area under the concentration-time curve (AUC) and Stax increase in proportion to the dose when used in the therapeutic range (25-100 mg). With food intake, Stach is reduced by 29%, and the time to reach Stach is increased by 60 minutes. Distribution. The apparent volume of distribution in the equilibrium state is 105 liters. The relationship of sildenafil and its main circulating N-demethylmetabolite with plasma proteins is 96% of the administered dose and is not dose-dependent. 90 minutes after a single dose of 100 mg of sildenafil, less than 0.0002% of the dose (average 188 ng) was found in the ejaculate. Metabolism. Sildenafil is mainly metabolized by the action of CYP3A4 isoenzymes (main route) and CYP2C9 (additional route) of microsomal liver isoenzymes. The main circulating active metabolite is N-demethylmetabolite, whose activity in relation to phosphodiesterase is 50% of the activity of sildenafil, and its plasma concentration reaches 40% of the concentration of sildenafil. N-demethylmetabolite undergoes further metabolism with a half-life (T> / 2) of 4 hours. Excretion. The total clearance of sildenafil is 41 l / h, and the final T / 2 is 3-5 hours. After oral administration or intravenous administration, sildenafil is excreted as metabolites with feces (about 80% of the ingested dose) and kidneys (about 13% of the accepted inside dose).
Indications
Treatment of erectile dysfunction, characterized by the inability to achieve or maintain an erection of the penis, sufficient for satisfactory sexual intercourse. Effective only with sexual stimulation.
Contraindications
Hypersensitivity to sildenafil or any other component of the drug. With the continuous or intermittent use of nitric oxide donors (such as amyl nitrite), organic nitrates or nitrates in any dosage form, as sildenafil enhances the hypotensive effect of nitrates. Use in patients for whom sexual activity is undesirable (for example, with severe cardiovascular diseases, such as severe heart failure, unstable angina). Transferred in the last six months of cerebral circulation or myocardial infarction. Simultaneous administration of ritonavir. Chronic renal failure severe.Hereditary degenerative diseases of the retina, including retinitis pigmentosa (the smaller part of such patients has a genetic disorder of retinal phosphodiesterase), due to the fact that the safety of use has not been studied. Arterial hypotension (BP less than 90/50 mm Hg). It is not recommended to be used simultaneously with other drugs for the treatment of erectile dysfunction (the safety and efficacy of combination therapy has not been studied). According to the registered indication is not intended for use in women and children under 18 years.
Precautionary measures
Be wary of anatomical deformation of the penis (angulation, cavernous fibrosis, Peyronie's disease), in patients with risk factors of priapism (sickle-cell anemia, multiple myeloma, leukemia) patients with episodes of the front nearteriitnoy ischemic optic neuropathy in history, diseases, accompanied by bleeding, exacerbations of gastric ulcer and duodenal ulcer, heart failure, unstable angina, suffered in the last 6 months Myocardial infarction, stroke, severe, life-threatening arrhythmias, hypertension (BP more than 170/100 mm Hg).
Dosage and administration
Inside, about 1 hour before planned sexual activity. The film is removed from the sachet (bag) with dry hands, immediately placed on the tongue and held until completely dissolved, then swallowed. When taken with meals, the onset of action of the drug DINAMIKO FORWARD may be delayed compared with taking the drug on an empty stomach. The recommended dose for most adult patients is 50 mg. Given the effectiveness and tolerability of the dose of the drug Dinamico pills can be increased to 100 mg or reduced to 25 mg (in this case, you should use another dosage form at a dose of 25 mg). The maximum recommended dose is 100 mg. The maximum recommended frequency of use 1 time per day.
Side effects
The most common adverse events are headache and hot flashes. Usually, the side effects of the application are mild or moderate and are transient. With a fixed dose, the frequency of some adverse events increases with increasing dose.Side effects are classified according to the following frequency: very often -> 10%, often -> 1%, but <10%, infrequently -> 0.1%, but <1%, rarely -> 0.01%, but <0, 1%, very rarely - <0.01%, frequency unknown - impossible to determine based on available data. On the part of the immune system: rarely - hypersensitivity reactions (including skin rash), allergic reactions. From the side of blood and lymphatic system: infrequently - anemia, leukopenia. Metabolism and nutrition: infrequently - feeling of thirst, edema, gout, uncompensated diabetes mellitus, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemia, hypernatremia. From the nervous system: very often - headache, often - dizziness, rarely - drowsiness, migraine, ataxia, hypertonia, neuralgia, neuropathy, paresthesia, tremor, vertigo, depression symptoms, insomnia, unusual dreams, increased reflexes, hypoesthesia, rarely - convulsions, repeated convulsions, syncope.
Interaction with other drugs
The influence of other drugs on the pharmacokinetics of sildenafil Sildenafil metabolism occurs mainly under the action of cytochrome CYP3A4 isoenzymes (primary pathway) and CYP2C9, therefore inhibitors of these isoenzymes can reduce the clearance of sildenafil, and inductors, respectively, increase sildenafil. A marked decrease in the clearance of sildenafil with simultaneous use of CYP3A4 isoenzyme inhibitors (ketoconazole, erythromycin, cimetidine). Cimetidine (800 mg), a non-specific inhibitor of the isoenzyme CYP3A4, when taken together with sildenafil (50 mg) causes an increase in plasma concentration of sildenafil by 56%. A single dose of 100 mg of sildenafil together with erythromycin (500 mg / day, 2 times a day for 5 days), a moderate inhibitor of the cytochrome CYP3A4 isoenzyme, while achieving a constant concentration of erythromycin in the blood plasma, leads to an increase in AUC of sildenafil by 182%. When coadministration of sildenafil (once 100 mg) and saquinavir (1200 mg / day 3 times a day), HIV protease inhibitor and CYP3A4 isoenzyme, while reaching a constant concentration of saquinavir in the blood plasma, Staden sildenafil increased by 140%, and AUC increased by 210%. Sildenafil has no effect on the pharmacokinetics of saquinavir. More potent inhibitors of the CYP3A4 isoenzyme, such as ketoconazole and itraconazole, can also cause stronger changes in the pharmacokinetics of sildenafil.The simultaneous use of sildenafil (once 100 mg) and ritonavir (500 mg 2 times a day), an HIV protease inhibitor and a strong inhibitor of cytochrome P450, while achieving a constant concentration of ritonavir in the blood plasma leads to an increase in Stadena sildenafil by 300% (in 4 times), a AUC by 1000% (11 times). After 24 h, the concentration of sildenafil in the blood plasma is about 200 ng / ml (after a single application of sildenafil alone - 5 ng / ml).
special instructions
For the diagnosis of erectile dysfunction, the determination of their possible causes and the choice of adequate treatment, it is necessary to gather a full medical history and conduct a thorough physical examination. Erectile dysfunction treatments 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 priapism (sickle cell anemia, multiple myeloma, leukemia).