#1
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àìïèöèëëèí/ñóëüáàêòàì â ïåäèàòðèè
Çäðàâñòâóéòå, óâàæàåìûå ïåäèàòðû!
Õî÷ó âàì âñåì ñêàçàòü ñïàñèáî çà âàø òðóä - ÿ ñ÷èòàþ åãî ñàìûì òðóäíûì íà ýòîì ôîðóìå.  îïèñàíèè îäíîãî èç ãåíåðèêîâ àìïèöèëëèí/ñóëüáàêòàìà áûëà òàêàÿ ôðàçà: ýôôåêòèâíîñòü è áåçîïàñíîñòü èíòðààáäîìèíàëüíîãî (èíòðàìóñêóëÿðíîãî?) ââåäåíèÿ ó äåòåé íå äîêàçàíà. Òàì æå áûëî íàïèñàíî, ÷òî ðåêîìåíäóåòñÿ âíóòðèâåííîå ââåäåíèå ñ ïîñëåäóþùèì ïåðåõîäîì íà òàáëåòêè. Íèêîãäà íå ñëûøàëà î èíòðààáäîìèíàëüíîì ââåäåíèè àíòèáèîòèêîâ. Èëè íåïðàâèëüíî ïîíÿëà? Ïîèñêàâ, ÿ íå íàøëà ÷åòêîé èíôîðìàöèè î ýôôåêòèâíîñòè /áåçîïàñíîñòè ó äåòåé ðàçíîãî âîçðàñòà. È ïî÷åìó íåò àìïèöèëëèíà â ïîñëåäíåì âûïóñêå PDR Physician Desk Reference- â ÑØÀ åãî íå îäîáðèëè? Àìîêñèöèëëèí, êñòàòè, òàì åñòü. Èìåþùèéñÿ ó ìåíÿ Martindale, ê ñîæàëåíèþ, âûïóñêà 1996 ãîäà. Íå ìîãëè áû âû ïîäñêàçàòü, ãäå ìîæíî áûñòðî ïîëó÷àòü äîñòîâåðíóþ èíôîðìàöèþ î ìåäèêàìåíòàõ, åñëè âðà÷ íå çíàåò íàçâàíèÿ îðèãèíàëà?
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Èñðàôèëîâà Øàõëà Þñèôîâíà. Òåðàïåâò, ïóëüìîíîëîã. |
#2
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[quote=Shahla;588826]
 îïèñàíèè îäíîãî èç ãåíåðèêîâ àìïèöèëëèí/ñóëüáàêòàìà áûëà òàêàÿ ôðàçà: ýôôåêòèâíîñòü è áåçîïàñíîñòü èíòðààáäîìèíàëüíîãî (èíòðàìóñêóëÿðíîãî?) ââåäåíèÿ ó äåòåé íå äîêàçàíà. Òàì æå áûëî íàïèñàíî, ÷òî ðåêîìåíäóåòñÿ âíóòðèâåííîå ââåäåíèå ñ ïîñëåäóþùèì ïåðåõîäîì íà òàáëåòêè. Íèêîãäà íå ñëûøàëà î èíòðààáäîìèíàëüíîì ââåäåíèè àíòèáèîòèêîâ. Èëè íåïðàâèëüíî ïîíÿëà? QUOTE] Óâàæàåìûå ïåäèàòðû, êîíêðåòèçèðóþ ñâîé âîïðîñ. Íàøëà áðåíäîâûé ïðåïàðàò àìïèöèëëèí/ñóëüáàêòàìà (FDA) çäåñü [Ññûëêè äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì ] Brand Name: Unasyn Pediatric Use The safety and effectiveness of Unasyn have been established for pediatric patients one year of age and older for skin and skin structure infections as approved in adults. Use of Unasyn in pediatric patients is supported by evidence from adequate and well-controlled studies in adults with additional data from pediatric pharmacokinetic studies, a controlled clinical trial conducted in pediatric patients and post-marketing adverse events surveillance. The safety and effectiveness of Unasyn have not been established for pediatric patients for intra-abdominal infections. Pediatric Patients 1 Year of Age or Older The recommended daily dose of Unasyn in pediatric patients is 300 mg per kg of body weight administered via intravenous infusion in equally divided doses every 6 hours. This 300 mg/kg/day dosage represents the total ampicillin content plus the sulbactam content of Unasyn, and corresponds to 200 mg ampicillin/100 mg sulbactam per kg per day. The safety and efficacy of Unasyn administered via intramuscular injection in pediatric patients have not been established. ...In clinical trials, most children received a course of oral antimicrobials following initial treatment with intravenous Unasyn. 1.  îïèñàíèè ñêàçàíî, ÷òî ïðèìåíÿþò ó äåòåé îò 1 ãîäà è ñòàðøå. Âû òîæå íå ïðèìåíÿåòå ïðåïàðàò ó äåòåé äî ãîäà? Òî åñòü ìîæíî ëè ïðèìåíÿòü ó äåòåé äî ãîäà? 2. Íàïèñàíî, ÷òî ïðèìåíÿþò âíóòðèâåííî, ýôôåêòèâíîñòü è áåçîïàñíîñòü â/ìûøå÷íîãî ïðèìåíåíèÿ ïðåïàðàòà ó äåòåé íå äîêàçàíà. Âû òîæå ïðèìåíÿåòå åãî òîëüêî âíóòðèâåííî ñ ïîñëåäóþùèì ïåðåõîäîì íà òàáëåòêè? Íàñêîëüêî ÿ çíàþ, ìîãó îøèáàòüñÿ,ìåñòíûå ïåäèàòðû ïðèìåíÿþò àìïèöèëëèí/ñóëüáàêòàì â îñíîâíîì âíóòðèìûøå÷íî. 3. Îáðàòèòå âíèìàíèå, ÷òî ïîêàçàíèÿ ê ïðèìåíåíèþ îãðàíè÷åíû òîëüêî êîæíûìè èíôåêöèÿìè.
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Èñðàôèëîâà Øàõëà Þñèôîâíà. Òåðàïåâò, ïóëüìîíîëîã. |
#3
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Çäðàâñòâóéòå!
Ýòîò ïðåïàðàò ïðèìåíÿåòñÿ íå òîëüêî ïàðåíòåðàëüíî,è íå òîëüêî ïðèìåíèòåëüíî ê èíôåêöèÿì êîæè. [Ññûëêè äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì ] Ïðèìåð ãåíåðèê "àìïèñèä", âûïóñêàåòñÿ â ñóñïåíçèè, íàçíà÷àåòñÿ ñ ðîæäåíèÿ(FDA ãðóïïà B). ÌÍÍ-Ñóëüòàìèöèëëèí. |
#4
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Ðèíà, ñïàñèáî çà îòâåò, íî ÿ ñîâñåì çàïóòàëàñü.  ññûëêå, êîòîðóþ âû äàëè, àìåðèêàíöû ðåêîìåíäóþò àìïèöèëëèí/ñóëüáàêòàì äåòÿì, ïðè÷åì íå òîëüêî â/âåííî, íî è â/ìûøå÷íî: Use of ampicillin/sulbactam and sultamicillin in pediatric infections: a re-evaluation. Ïðàâäà, ñòàòüÿ çà 2001ãîä.
 [Ññûëêè äîñòóïíû òîëüêî çàðåãèñòðèðîâàííûì ïîëüçîâàòåëÿì ], ãäå äàåòñÿ îïèñàíèå óíàçèíà, êàê ÿ ïîíÿëà, îðèãèíàëüíîãî ïðåïàðàòà àìïèöèëëèí/ñóëüáàêòàì, òå æå àìåðèêàíöû: äåòÿì äî ãîäà íå äîêàçàíî, â/ìûøå÷íî íå äîêàçàíî, è âîîáùå ýôôåêòèâåí òîëüêî ïðè èíôåêöèÿõ êîæè. À âîò ÷òî ïèøåò up-to-date (âñå-òàêè FDA äåòÿì äî 12 ëåò ïðåïàðàò íå îäîáðèë, êàê ÿ ïîíèìàþ èç-çà ñóëüáàêòàìà? õîòÿ äîçèðîâêè äàþò äëÿ íîâîðîæäåííûõ òîæå: U.S. BRAND NAMES*—*Unasyn® CANADIAN BRAND NAMES*—*Unasyn® INDEX TERMS*—*Sulbactam and Ampicillin I.M., I.V.: **Infants ≥ 1 month: 100-150 mg ampicillin/kg/day divided every 6 hours ****Meningitis: 200-300 mg ampicillin/kg/day divided every 6 hours **Children: 100-200 mg ampicillin/kg/day divided every 6 hours ADMINISTRATION*—*Parenteral: May be administered by slow I.V. injection over 10-15 minutes at a final concentration for administration not to exceed 45 mg Unasyn® (30 mg ampicillin and 15 mg sulbactam)/mL or by intermittent infusion over 15-30 minutes USE*—*Treatment of susceptible bacterial infections involved with skin and skin structure, intra-abdominal infections, gynecological infections; spectrum is that of ampicillin plus organisms producing beta-lactamases such as S. aureus, H. influenzae, E. coli, Klebsiella, Acinetobacter, Enterobacter, and anaerobes WARNINGS:not FDA approved for children <12 years of age Êîìó âåðèòü? Êàê ðàçáèðàòüñÿ â ýòîì ïðîñòûì ñìåðòíûì âðà÷àì?
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Èñðàôèëîâà Øàõëà Þñèôîâíà. Òåðàïåâò, ïóëüìîíîëîã. |
#5
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Öèòàòà:
 Ðîññèè íåò îôèöèàëüíîãî îãðàíè÷åíèÿ èñïîëüçîâàíèÿ ó äåòåé. Âîîáùå, ïðîáëåìà ïåäèàòðè÷åñêîãî ïðèìåíåíèÿ ëåêàðñòâ î÷åíü ñåðüåçíàÿ ïî ïð÷èíå ìàëîãî ÷èñëà àäåêâàòíûõ êëèíè÷åñêèõ èñïûòàíèé. FDA ïðè îäîáðåíèè èñõîäèò èç ðåçóëüòàòîâ ïðîâåäåííûõ èñïûòàíèé, ïîýòîìó ïîêàçàíèÿ î÷åíü îãðàíè÷åíû. |
#6
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ß âîîáùå ïðåäïî÷èòàþ àìîêñèöèëëèí àìïèöèëëèíó, è â çàùèùåííûõ ïåíèöèëëèíàõ òîæå( åñëè, ÷åñòíî)
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