3582910069706

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3582910069706

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Farmakologicheskoye deystviye Feksofenadin (farmakologicheski aktivnyy metabolit terfenadina) yavlyayetsya antigistaminnym sredstvom s selektivnoy antagonisticheskoy aktivnost’yu k N1-retseptoram bez antikholinergicheskogo i blokiruyushchego al’fa-adrenergicheskiye retseptory deystviya. Krome etogo u feksofenadina ne nablyudayetsya sedativnogo deystviya i drugikh effektov so storony tsentral’noy nervnoy sistemy. V issledovaniyakh u cheloveka po otsenke vyzyvayemykh gistaminom voldyrey i giperemii antigistaminnoye deystviye feksofenadina, prinimayemogo vnutr’ odin ili dva raza v sutki, proyavlyayetsya cherez 1 chas, dostigayet maksimuma cherez 6 chasov, i prodolzhayetsya v techeniye 24 chasov posle yego priyema. Dazhe posle 28 dney priyema feksofenadina ne vyyavleno razvitiya tolerantnosti k preparatu. Pri odnokratnom priyeme feksofenadina vnutr’ nablyudayetsya dozozavisimoye uvelicheniye antigistaminnogo effekta pri uvelichenii dozy ot 10 mg do 130 mg. Pri ispol’zovanii toy zhe modeli antigistaminnogo deystviya bylo ustanovleno, chto dlya postoyannogo v techeniye 24 chasov deystviya byla neobkhodima doza ne meneye 130 mg. Maksimal’noye podavleniye obrazovaniya voldyrey i giperemii kozhi sostavlyayet boleye 80%. U patsiyentov s sezonnym allergicheskim rinitom, poluchavshikh do 240 mg feksofenadina 2 raza v sutki v techeniye 2-kh nedel’ prodolzhitel’nost’ intervala QTc (QT skorrigirovannogo) ne otlichalas’ ot takovoy pri priyeme platsebo. Takzhe ne nablyudalos’ izmeneniy QTc pri priyeme feksofenadina zdorovymi dobrovol’tsami po 60 mg 2 raza v sutki v techeniye 6 mesyatsev, po 400 mg 2 raza v sutki v techeniye 6.5 dney i 240 mg v sutki v techeniye 1 goda po sravneniyu s prodolzhitel’nost’yu QTc pri priyeme platsebo. Dazhe pri plazmennoy kontsentratsii v 32 raza prevyshayushchey terapevticheskiye kontsentratsii u cheloveka feksofenadin ne okazyval vliyaniya na kaliyevyye kanaly zaderzhannogo vypryamleniya v chelovecheskom serdtse

Pharmacological action Fexofenadine (a pharmacologically active metabolite of terfenadine) is an antihistamine with selective antagonistic activity to H1 receptors without anticholinergic and blocking alpha-adrenergic action receptors. In addition, fexofenadine is not observed sedation and other effects from the central nervous system. In human studies, according to the assessment of histamine-induced blisters and hyperemia, the anti-histamine effect of fexofenadine ingested once or twice a day manifests itself after 1 hour, reaches a maximum after 6 hours, and lasts for 24 hours after its administration. Even after 28 days of fexofenadine, there was no development of tolerance to the drug. With a single administration of fexofenadine, a dose-related increase in antihistamine effect is observed with an increase in the dose from 10 mg to 130 mg. Using the same model of antihistamine action, it was found that a dose of at least 130 mg was required for a 24-hour action that was constant. The maximum suppression of blistering and hyperemia of the skin is more than 80%. In patients with seasonal allergic rhinitis who received up to 240 mg of fexofenadine twice a day for 2 weeks, the duration of the QTc interval (QT corrected) did not differ from that with placebo. There were also no QTc changes with fexofenadine taken by healthy volunteers at 60 mg twice daily for 6 months, 400 mg twice daily for 6.5 days and 240 mg per day for 1 year compared with the duration of QTc when taking placebo . Even with a plasma concentration 32 times higher than the therapeutic concentration in humans fexofenadine had no effect on the potassium channels of delayed rectification in the human heart

Dosage The tablets are for oral use. The recommended dose of fexofenadine for seasonal allergic rhinitis for adults and children 12 years and older is 120 mg 1 time a day before meals. The recommended dose of fexofenadine for chronic urticaria for adults and children 12 years and older is 180 mg once a day before meals. Patients at risk groups Studies in special risk groups (elderly patients, patients with renal and hepatic insufficiency) have shown that they do not require correction of the dosing regimen