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Zimagra-ODS 50 50 mg 4’s plate dispersible oral




The instruction for medical use of ZIMAGRA-ODS 50 medicine the Trade name of Zimagra-ODS 50 International unlicensed name Sildenafil Lekarstvennaya the Plate form dispersed in an oral cavity, 50 mg Structure One plate contains active agent – sildenafit citrate of 70.24 mg is equivalent a sildenafila of 50 mg, excipients: polyvinyl alcohol, sodium a carbonate, propylene glycol, polysorbate 80, a gipromelloza (5 cps), a gipromelloza (15 cps), a gipromelloza (50 cps), a sucralose, povidone 30, to neota, vanilla fragrance, banana fragrance, FD&C blue dye, the water purified. Description of a squared Plate, blue color, opaque, not sticky. Length is 40.00±1.00 mm, width is 30.00±0.25 mm. Pharmacotherapeutic group Drugs for treatment of urological diseases. Other drugs for treatment of urological diseases, including spasmolysants. Drugs for treatment of disturbances of an erection. Sildenafil. The ATX G04BE03 code the Pharmacological Sildenafil Pharmacokinetics properties is quickly soaked up. The maximum concentration in plasma are reached within 30 – 120 minutes (on average 60 minutes) after oral introduction in a hungry state. The average absolute bioavailability at intake is 41% (range of 25-63%). The average equilibrium volume of distribution (Vd) of a sildenafil averages 105 l that means its penetration into fabrics. After single dose in 100 mg, average maximum general concentration of a sildenafil makes about 440 ng/ml (CV 40%). As sildenafit (and its main circulating Ndesmetilovy a metabolite) for 96% are connected with proteins of plasma, average plasma concentration of free fraction of a sildenafil make 18 ng/ml (38 nanometers). Linking with proteins does not depend on the general concentration of drug. Sildenafil is transformed mainly to CYP3A4 (main way) and CYP2C9 (minor way) in a liver. The main circulating active metabolite is formed as a result of N-demethylation of a sildenafil. This metabolite possesses a selectivity profile to the phosphodiesterases similar to a profile of a sildenafil, and its activity concerning FDE5 is about 50% of activity of the main substance. Concentration of a metabolite in blood plasma makes about 40% of concentration of a sildenafil. N-demetilirovanny a metabolite is exposed to further metabolism, the final period of its semi-removal is about 4 hours. The general clearance of a sildenafil is 41 l/h with the resulting terminal phase of half-decay of 3-5 h. After oral introduction sildenafit it is removed in the form of metabolites mainly with a stake (about 80% of the entered oral dose) and to a lesser extent with urine (about 13% of the entered oral dose). A pharmacodynamics of Zimagra-ODS the 50th drug for treatment of disturbance of an erection. Sildenafil – powerful and selection inhibitor of the tsikloguanozinmonofosfat (tsGMF) – specific phosphodiesterase of the 5th type (FDE5) in a cavernous body where FDE5 is responsible for disintegration of tsGMF, makes peripheral impact on an erection. The researches in vitro showed that sildenafit selektiven concerning FDE5 participating in development of an erection. Its activity concerning FDE5 exceeds activity concerning other known phosphodiesterases. It by 10 times is less effective concerning FDE6 which takes part in phototransfer in a retina. In the maximum recommended doses it by 80 times less selektiven concerning FDE1, by 700 times – concerning FDE 2, 3, 4, 7, 8, 9, 10 and 11. The activity of a sildenafil concerning FDE5 approximately by 4,000 times exceeds its activity concerning FDEZ, tsAMF – the specific phosphodiesterase participating in reduction of heart. Under natural conditions, i.e. in the presence of sexual stimulation, restores the broken erectile function due to strengthening of inflow of blood to a penis. The physiological process which is the cornerstone of a penis erection includes release of nitrogen oxide in a cavernous body under the influence of sexual incentives. Nitrogen oxide activates enzyme guanylate cyclase and increases contents cyclic guanine riboside of monophosphate (tsGMF) which relax smooth muscle cells of a cavernous body and promote its filling by blood. Indications – the erectile dysfunction which is characterized by inability to achievement or preservation of an erection of a penis sufficient for satisfactory sexual intercourse. Drug is effective only in the presence of sexual stimulation. The route of administration and doses place the Plate on language and allow it to be dissolved in a mouth, without washing down with water. The recommended dose makes 50 mg which is accepted if necessary, approximately in one hour prior to expected sexual activity. Depending on efficiency and shipping it is possible to increase a dose to 100 mg or to lower to 25 mg. The maximum recommended dose makes 100 mg. The maximum recommended frequency of intake of medicine is once a day. At reception with food the beginning of activity can be detained in comparison with reception in a hungry state. The renal failure At easy and medium-weight degree of insufficiency of function of kidneys (clearance of creatinine of 30-80 ml/min.) correction of the recommended dose is not required. Because at patients with a heavy renal failure (clearance of creatinine & lt, 30 ml/min.) the clearance of a sildenafil is reduced, it is necessary to consider the possibility of use of drug in a dose of 25 mg. Proceeding from efficiency and tolerance of drug, it is possible to increase its dose step by step to 50 mg and up to 100 mg as necessary. A liver failure Because the clearance of a sildenafil is reduced at patients with an abnormal liver function (for example, cirrhosis), it is necessary to consider the possibility of use of drug in a dose of 25 mg. Proceeding from efficiency and tolerance of drug, it is possible to increase its dose step by step to 50 mg and up to 100 mg as necessary. Elderly patients it is not required From patients of advanced age of dose adjustment of drug. Patients of children’s age of Zimagra-ODS 50 it is not shown for use for patients by age 18 years are younger. Side effects Very often (≥ 1/10) – a headache Often (≥ from 1/100 to & lt, 1/10) – dizziness – disorders of vision, disturbance of color perception, the obscured sight, change of light sensitivity (it is necessary to stop reception of a sildenafil and to see a doctor) – hyperaemia of the person – congestion of a nose – indigestions, nausea Infrequently (≥ from 1/1000 to & lt, 1/100) – disorders from a conjunctiva, eyes, a slyozoobrazovaniye, other disorders of eyes – drowsiness, a spatial disorientation, sonitus – heart consciousness, tachycardia – vomiting, nausea, dryness in a mouth – skin rash – a giposteziya Seldom – hypersensitivity reaction – an acute disorder of cerebral circulation, to a syncope – deafness – a myocardial infarction, fibrillation of auricles – hypertensia, hypotension – Does not know nasal bleeding – passing ischemic attacks, spasms, the repeating spasms – a front nearteriitny ischemic neuropathy of an optic nerve (NAION), occlusion of vessels of a retina, defect of a field of vision – ventricular arrhythmia, unstable stenocardia, a sudden cardiac death – Stephens-Johnson’s syndrome, a toxic epidermal necrolysis of the Contraindication – hypersensitivity to active agent or to any of excipients – a concomitant use of drugs, being donators of nitrogen oxide (amyle nitrite) or nitrates in any form – a heavy liver failure – hereditary degenerative diseases of a retina of an eye (for example, a hereditary pigmentary retinitis (the small number of these patients has inherited disorders of functions of phosphodiesterases of a retina)) – loss of sight on one eye owing to front nearteriitny ischemic neuropathy of an optic nerve, regardless of whether this episode was connected with the previous use of FDE-5 inhibitor or not – arterial hypotension (the ABP & lt, 90/50 mm Hg.) – a serious cardiovascular illness (for example, heavy heart failure, unstable stenocardia) – the myocardial infarction postponed to the last 6 months – the stroke which is had in the last 6 months On the registered indication drug is not intended for use for children and teenagers aged up to 18 years and women. Medicinal interactions Influence of other medicines on sildenafit the Researches in Vivo At a concomitant use of a sildenafil with CYP3A4 inhibitors (such as ketokonazol, erythromycin and Cimetidinum) decrease in clearance of a sildenafil is observed. At this group of patients the increased frequency of side effects is not observed, nevertheless, it is necessary to begin Zimagra-ODS drug treatment 50 in an initial dose of 25 mg. The concomitant use of inhibitor of HIV protease of the ritonavir which is strong inhibitor of P450 cytochrome in an equilibrium state (two times a day) with sildenafily (100 mg a single dose) leads 500 mg to increase in the maximum concentration (Cmax) in a sildenafil by 300% (4-hkratno) and also to increase in AUC of a sildenafil in blood plasma for 1000% (11-multiply). In 24 hours the levels of a sildenafil in blood plasma are about 200 ng/ml in comparison with about 5 ng/ml after reception only sildenafit. These data will be agreed with the significant effects of a ritonavir on a wide range of substrates of P450 cytochrome. Based on the above-stated data, simultaneous use of a sildenafil with ritonaviry is not recommended, and under any circumstances, the maximum dose of Sildenafil should not exceed 25 mg within 48 hours at all. Zimagra-ODS 50 does not influence pharmacokinetics of a ritonavir. The concomitant use of inhibitor of HIV protease of the sakvinavir which is CYP3A4 inhibitor in an equilibrium state (three times a day) with sildenafily (100 mg a single dose) leads 1200 mg to increase in Cmax of a sildenafil by 140% and also increase in AUC of a sildenafil by 210%. Sildenafil does not influence pharmacokinetics of a sakvinavir. Stronger CYP3A4 inhibitors, such as ketokonazol and itrakonazol, have more significant effect. At single dose of a sildenafil in a dose of 100 mg together with the erythromycin moderated by CYP3A4 inhibitor in an equilibrium state (500 mg two times a day within 5 days), increase in system influence of a sildenafil by 182% (is determined by AUC). value &
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