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                        117201ATB 
                        18 ¼¼ ¹Ì¸¸  
                        20110227 
                        2011-11-24 
                         
                     
                 
                    
                 
             
            
              
            
             
            
                
                
                
                     
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      1. ȲüÇü¼ºÈ£¸£¸óºÐºñÈ£¸£¸ó(LHRH) À¯»ç¾à¹°°ú º´¿ë ȤÀº °Å¼¼¼ö¼ú°ú º´¿ë½Ã ¼ºÀÎ ³²ÀÚ ¹× °í·ÉÀÚ 
: ºñÄ®·çŸ¹Ìµå·Î¼ 1ÀÏ 1ȸ 50 mgÀ» °æ±¸Åõ¿©ÇÑ´Ù. ÀÌ ¾àÀº ȲüÇü¼ºÈ£¸£¸óºÐºñÈ£¸£¸ó(LHRH) À¯»ç¾à¹°À» Åõ¿©Çϱâ ÃÖ¼ÒÇÑ 3ÀÏ Àü ȤÀº °Å¼¼ ¼ö¼ú°ú µ¿½Ã¿¡ º¹¿ëÀ» ½ÃÀÛÇÑ´Ù. 
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1.  150 mg ´ÜÀÏ¿ä¹ý ȯÀÚ ´Ù¼ö¿¡¼ ¿©¼ºÇü À¯¹æ°ú À¯¹æÅëÁõÀÌ ³ªÅ¸³µ´Ù. ÀÌ·± Áõ»óÀÌ ³ªÅ¸³ ȯÀÚÀÇ ¾à 5 %´Â ÁßÁõÀ¸·Î »ý°¢µÇ¾ú°í, ¿©¼ºÇü À¯¹æÀº Åõ¿©¸¦ Áß´ÜÇÑ ÈÄ¿¡µµ, ƯÈ÷ Àå±â°£ Åõ¿©ÇÑ °æ¿ì ÀÚ¿¬ÀûÀ¸·Î ¼Ò½ÇµÇÁö ¾ÊÀ» ¼öµµ ÀÖ´Ù.
2.  ¿©¼ºÇü À¯¹æ ¹× À¯¹æÆØ¸¸°¨Àº µ¿½Ã¿¡ º´ÇàµÇ´Â °Å¼¼¼ö¼ú ¹× ¾à¹°¿¡ ÀÇÇÑ °Å¼¼È¿°ú¿¡ ÀÇÇØ ¾à鵃 ¼ö ÀÖ´Ù.
3.  °£ÀÇ º¯È(¾Æ¹Ì³ëÀü´ÞÈ¿¼Ò ³óµµ »ó½Â, ´ãÁó¿ïü, Ȳ´Þ)´Â µå¹°°Ô ½É°¢ÇÑ º¯È°¡ ³ªÅ¸³µÀ¸³ª À̰ÍÀº ÀϽÃÀûÀ̾úÀ¸¸ç ¾à¹°Áß´Ü ÈÄ ¶Ç´Â Áö¼ÓÀûÀÎ Ä¡·á¿¡µµ ºÒ±¸ÇÏ°í »ç¶óÁö°Å³ª °³¼±µÇ¾ú´Ù
4.  ÀÌ ¾à 150 mg ¿ë·® ´Üµ¶Åõ¿© ½ÃÇè(EPC studies)¿¡ »ç¿ëµÈ ÄÚµù(coding) ±ÔÄ¢À¸·Î ÀÎÇØ, ÀÌ»ó¹ÝÀÀ Áß "°ÇÁ¶ÇÑ ÇǺÎ"°¡ "¹ßÁø"¿¡ Æ÷ÇÔµÇ¾î ±¸ºÐµÇ¾ú´Ù. µû¶ó¼ 150 mg ¿ë·®¿¡¼ÀÇ °ÇÁ¶ÇÑ ÇǺÎÀÇ ºóµµ¿¡ ´ëÇÑ º°µµÀÇ ºÐ·ùü°è°¡ ¾øÀ¸³ª, 50 mg ¿ë·®¿¡¼ÀÇ ºóµµ¿Í µ¿ÀÏÇÒ °ÍÀ¸·Î ¿¹»óµÈ´Ù.
5.  ½ÃÆÇÈÄ Á¶»ç °á°ú º¸°íµÈ ÀÌ»ó¹ÝÀÀÀÌ´Ù. ºóµµ´Â ÀÌ ¾à 150 mg ¿ë·® ´Üµ¶Åõ¿© ½ÃÇè(EPC studies)ÀÇ ¹«ÀÛÀ§ Ä¡·á±â°£¿¡ º¸°íµÈ °£Áú¼ºÆóÁúȯ ÀÌ»ó¹ÝÀÀÀÇ ¹ß»ýºóµµ¿¡ µû¶ó ºÐ·ùµÇ¾ú´Ù.
6.  ½ÃÆÇÈÄ Á¶»ç °á°ú º¸°íµÈ ÀÌ»ó¹ÝÀÀÀÌ´Ù. ºóµµ´Â ÀÌ ¾à 150 mg ¿ë·® ´Üµ¶Åõ¿© ½ÃÇè(EPC studies)ÀÇ ¿ÀÇ ¶óº§ Ä¡·á±â°£¿¡ ÀÌ ¾à Åõ¿©±º¿¡¼ º¸°íµÈ °£ºÎÀü ÀÌ»ó¹ÝÀÀÀÇ ¹ß»ýºóµµ¿¡ µû¶ó ºÐ·ùµÇ¾ú´Ù.
7.  °©»ó»ù¾Ï Ä¡·á¸¦ À§ÇØ »ç¿ëµÇ´Â LHRHÀ¯»ç¾à¹° ¹× Ç׾ȵå·Î°ÕÁ¦Á¦¿¡ ´ëÇÑ ¾à¸®ÇÐÀû ¿ªÇבּ¸(pharmaco-epidemiology study)¿¡¼ °üÂûµÇ¾ú´Ù. ÀÌ ¾à 50 mgÀ» LHRHÀ¯»ç¾à¹°°ú º´¿ëÅõ¿©½Ã À§ÇèÀÌ Áõ°¡ÇÏ´Â °ÍÀ¸·Î ³ªÅ¸³µÁö¸¸, ÀÌ ¾à 150 mg ¿ë·®À» ´Üµ¶ Åõ¿©ÇÏ¿´À» ¶§´Â À§ÇèÀÌ Áõ°¡ÇÏÁö ¾Ê´Â °ÍÀ¸·Î ³ªÅ¸³µ´Ù.
2) PT/INRÀÇ Áõ°¡: ÀÌ ¾à°ú Äí¸¶¸°(Ç×ÀÀ°íÁ¦)ÀÇ »óÈ£ÀÛ¿ë¿¡ ´ëÇÑ »ç·Ê°¡ ½ÃÆÇ ÈÄ Á¶»ç¿¡¼ º¸°íµÇ¾ú´Ù.
3) µå¹°°Ô Çù½ÉÁõ, ½ÉºÎÀüÁõ»ó, ½ÉÀüµµ¿¡¼ PR, QT°£°ÝÀÇ ¿¬Àå, ºÎÁ¤¸Æ, ºñƯÀÌÀû ECG º¯È µîÀÇ ½ÉÇ÷°ü°è ÀÌ»ó¹ÝÀÀÀÌ °üÂûµÇ¾ú´Ù.
4) ¶§¶§·Î ¹éÇ÷±¸ °¨¼Ò, Ç÷¼ÒÆÇ °¨¼Ò°¡ ³ªÅ¸³¯ ¼ö ÀÖÀ¸¹Ç·Î °üÂûÀ» ÃæºÐÈ÷ Çϰí ÀÌ»óÀÌ ÀÎÁ¤µÇ´Â °æ¿ì Åõ¿©¸¦ ÁßÁöÇÏ´Â µî ÀûÀýÇÑ Ã³Ä¡¸¦ ÇÑ´Ù.
5) ÀÌ ¾à 50 mg°ú LHRHÀ¯»ç¾à¹°ÀÇ º´¿ë¿ä¹ý ¹× ÀÌ ¾à 150 mg ¿ë¹ýÀ» ½Ç½ÃÇÑ ÀÓ»ó½ÃÇè¿¡¼ ´ÙÀ½°ú °°Àº ¸î °ÇÀÇ ÀÌ»ó¹ÝÀÀÀÌ ¹ßÇöµÇ¾úÀ¸³ª À̰ÍÀº ¾à¹°Æ¯ÀÌÀûÀÎ ÀÌ»ó¹ÝÀÀÀº ¾Æ´Ï¾úÀ¸¸ç ÀÌ Áß ¸î °ÇÀº °í·ÉÀÚÃþ¿¡¼ ÀÚÁÖ ¹ß»ýµÇ´Â °ÍÀ̾ú´Ù.
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(2) ÁßÃ߽Űæ°è : ºÒ¸éÁõ, È¥¸ù
(3) È£Èí±â°è : È£Èí°ï¶õ
(4) ºñ´¢»ý½Ä±â°è : ¾ß´¢Áõ
(5) ÇǺΠ¹× ºÎ¼Ó±â°ü : ¶¡
(6) ´ë»ç¿µ¾ç°è : °úÇ÷´çÁõ, üÁß°¨¼Ò, ´ç´¢º´
(7) ±âŸ : µÎÅë, °ñ¹ÝÅë, ¿ÀÇÑ
6) ±¹³» ½ÃÆÇ ÈÄ Á¶»ç¿¡¼ º¸°íµÈ ÀÌ»ó¹ÝÀÀ±¹³»¿¡¼ Àç½É»ç¸¦ À§ÇÏ¿© 6³â µ¿¾È 689¸íÀÇ È¯ÀÚ¸¦ ´ë»óÀ¸·Î ½Ç½ÃÇÑ ½ÃÆÇÈÄ Á¶»ç°á°ú ÀÌ»ó¹ÝÀÀÀÇ ¹ßÇöÁõ·ÊÀ²Àº Àΰú°ü°è ¿©ºÎ¿Í »ó°ü¾øÀÌ 7.98 %(55·Ê/689·Ê)·Î º¸°íµÇ¾ú°í, ÀÌ Áß ÀÌ ¾à°ú Àΰú°ü°è°¡ ÀÖ´Â °ÍÀ¸·Î Á¶»ç µÈ °ÍÀº 6.82 %(47·Ê/689·Ê)ÀÌ´Ù. º¸°íµÈ ÀÌ»ó¹ÝÀÀÀº ¾à°úÀÇ Àΰú°ü°è ¿©ºÎ¿Í »ó°ü¾øÀÌ ¿©¼ºÇü À¯¹æÀÌ 4.64 %(32/689¸í)·Î °¡Àå ¸¹¾ÒÀ¸¸ç, °¡½¿ÅëÁõ, ¾È¸éÈ«Á¶ °¢ 1.31 %(9/689¸í), »çÁ¤Àå¾Ö, ºÎÁ¾(´Ù¸®), ¼³»ç, ¹ßÇÑÁõ°¡ °¢ 0.29 %(2/689¸í), µÎÅë, ¹«·Â, ºÎ°íȯ¿°, ¼ÇýºÎ ºÒÆí°¨, üÁß°¨¼Ò, ±¸Åä, º¯ºñ, AST »ó½Â, ALT »ó½Â, ¼º¿å°¨¼Ò, ¾îÁö·³, °¡·Á¿ò, Æó·Å °¢ 0.15 %(1/689¸í)¿´´Ù. ÀÌ Áß Áß´ëÇÑ ÀÌ»ó¹ÝÀÀÀº Æó·Å 0.15 %(1·Ê)À̾ú°í, ¿¹»óÇÏÁö ¸øÇÑ ÀÌ»ó¹ÝÀÀÀº »çÁ¤Àå¾Ö 2·Ê, ºÎ°íȯ¿°, ¼ÇýºÎ ºÒÆí°¨, Æó·Å °¢ 1·Ê¾¿ ÃÑ 5·Ê(0.73 %)°¡ º¸°íµÇ¾ú´Ù.
          
     
   
  
  
    
   
    ÀϹÝÀû ÁÖÀÇ 
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2) ½É°¢ÇÑ °£ÀÇ º¯È ¹× °£ºÎÀüÀÌ µå¹°°Ô °üÂûµÇ¾úÀ¸¸ç »ç¸Á¿¡ À̸¥ °æ¿ì°¡ º¸°íµÇ¾ú´Ù. ¸¸ÀÏ ½É°¢ÇÑ º¯È°¡ ¹ß»ýÇϸé ÀÌ ¾à ¿ä¹ýÀ» Áß´ÜÇØ¾ß ÇÑ´Ù.
3) ÀÌ ¾àÀº CYP-450(CYP3A4)À» ÀúÇØÇÏ´Â °ÍÀ¸·Î ¾Ë·ÁÁ® ÀÖ¾î ÁÖ·Î CYP3A4¸¦ ÅëÇØ ´ë»çµÇ´Â ¾à¹°°ú º´¿ë½Ã ÁÖÀÇÇØ¾ß ÇÑ´Ù.
4) ÀÌ ¾àÀº ¿îÀüÀ̳ª ±â°èÀÛµ¿´É·Â¿¡ ¿µÇâÀ» ¹ÌÄ¡Áö ¾ÊÀ¸³ª È¥¸ùÀÌ ¹ß»ýÇÒ ¼ö ÀÖÀ¸¹Ç·Î ÀÌ·± ȯÀÚµéÀÇ °æ¿ì ÁÖÀǸ¦ ¿äÇÑ´Ù.
5) PSAÀÇ »ó½Â°ú ÇÔ²² ÁúȯÀÇ °´°üÀûÀÎ ÁøÀüÀÌ Àִ ȯÀÚ¿¡¼´Â ÀÌ ¾à ¿ä¹ýÀÇ Áß´ÜÀ» °í·ÁÇØ¾ß ÇÑ´Ù.
6) À¯´ç(lactose) °ú¹Î¼º ȯÀÚÀÇ °æ¿ì, ÀÌ ¾à 150 mg Åõ¿© ½Ã À¯´çÀϼöȹ° ¾à OO* mgÀ» ÇÔÀ¯ÇϹǷΠÁÖÀÇÇØ¾ß ÇÑ´Ù.
*183 mg : ÀÌ¿¬Á¦¾à(ÁÖ), »ïÁøÁ¦¾à(ÁÖ), Çѹ̾àǰ(ÁÖ), Çѱ¹¾Æ½ºÆ®¶óÁ¦³×Ä«(ÁÖ), º¸·ÉÁ¦¾à(ÁÖ), ½ÅdzÁ¦¾à(ÁÖ), ±¤µ¿Á¦¾à(ÁÖ), ±ÙÈÁ¦¾à(ÁÖ)
* 180 mg : ¢ß ¿¤Áö»ý¸í°úÇÐ, ¾¾Á¦ÀÌÁ¦ÀÏÁ¦´ç(ÁÖ)
* 160.5 mg : Ä®·çŸ¹ÌµåÁ¤50mg(¢ß Á¾±Ù´ç)
* 149.25 mg : Ä®·çŸ¹Ìµå150mg(¢ß Á¾±Ù´ç)
7) LHRHÀ¯»ç¾à¹°À» Åõ¿© ¹Þ´Â ³²¼º¿¡¼ Æ÷µµ´ç ³»¼ºÀÇ °¨¼Ò°¡ °üÂûµÇ¾ú´Ù. À̰ÍÀº ¼±À缺 ´ç´¢º´ÀÌ Àִ ȯÀÚ¿¡¼ ´çÁ¶ÀýÀÇ ¼Ò½Ç ¶Ç´Â ´ç´¢º´À¸·Î¼ ¹ßÇöµÉ ¼ö ÀÖÀ¸¹Ç·Î LHRHÀ¯»ç¾à¹°°ú º´¿ëÇÏ¿© ÀÌ ¾àÀ» Åõ¿© ¹Þ°í Àִ ȯÀÚ¿¡¼ Ç÷Áß Æ÷µµ´çÀ» ¸ð´ÏÅ͸µÇÏ´Â °ÍÀ» °í·ÁÇØ¾ß ÇÑ´Ù.
8) ¾Èµå·Î°Õ Â÷´Ü¿ä¹ýÀº QT °£°ÝÀ» ¿¬Àå½Ãų ¼ö ÀÖ´Ù. QT ¿¬ÀåÀÇ º´·ÂÀÌ Àְųª À§ÇèÀÎÀÚ¸¦ °¡Áø ȯÀÚ ¹× QT °£°ÝÀ» ¿¬Àå½Ãų ¼ö ÀÖ´Â ¾à¹°°ú º´¿ë Åõ¿© ¹Þ´Â ȯÀÚÀÇ °æ¿ì, ÀÇ·áÁøÀº ÀÌ ¾àÀ» Åõ¿©Çϱâ Àü¿¡ Torsade de pointes °¡´É¼ºÀ» Æ÷ÇÔÇÏ¿© À¯Àͼº/À§Ç輺À» Æò°¡ÇØ¾ß ÇÑ´Ù.
9) Ç׾ȵå·Î°Õ ¿ä¹ýÀº Á¤ÀÚÀÇ ÇüÅÂÇÐÀû º¯È¸¦ ÃÊ·¡ÇÒ ¼öµµ ÀÖ´Ù. Á¤ÀÚ ÇüÅÂÇп¡ ´ëÇÑ ºñÄ®·çŸ¸¶À̵åÀÇ ¿µÇâÀº Æò°¡µÇÁö ¾Ê¾Ò°í ÀÌ ¾àÀÌ Åõ¿©µÈ ȯÀÚ¿¡¼ ±×·¯ÇÑ º¯È°¡ º¸°íµÇÁö ¾Ê¾ÒÁö¸¸, ȯÀÚ ±×¸®°í/¶Ç´Â ±×µéÀÇ ÆÄÆ®³Ê´Â ÀÌ ¾àÀÇ ¸¶Áö¸· Åõ¿© ÈÄ 130ÀÏ ÀÌÈÄ µ¿¾È ÀûÀýÇÑ ÇÇÀÓ¹ýÀ» µû¶ó¾ß ÇÑ´Ù.
10) ÀÌ ¾à°ú Äí¸¶¸°(Ç×ÀÀ°íÁ¦)À» º´¿ëÇÑ È¯ÀÚ¿¡¼ ÇÁ·ÎÆ®·Òºó ½Ã°£ (PT) ¹× ±¹Á¦Ç¥ÁØÈºñÀ²(INR) Áõ°¡ µî Ç×ÀÀ°í È¿°úÀÇ »ó½ÂÀÛ¿ëÀÌ º¸°íµÇ¾ú´Ù. ¸î¸î »ç·Ê´Â ÃâÇ÷ÀÇ À§Çè°ú °ü·ÃÀÌ ÀÖ¾ú´Ù. PT/INR¿¡ ´ëÇÑ ÁÖÀÇ ±íÀº °üÂûÀÌ ±ÇÀåµÇ¸ç Ç×ÀÀ°íÁ¦ÀÇ ¿ë·® Á¶ÀýÀÌ °í·ÁµÇ¾î¾ß ÇÑ´Ù.
 
   
  
  
  
    
   
    »óÈ£ÀÛ¿ë 
    1) ÀÌ ¾àÀÌ LHRHÀ¯»ç¾à¹°°ú ¾à¸®ÇÐÀûÀ¸·Î³ª ¾à¹°µ¿·ÂÇÐÀûÀ¸·Î »óÈ£ÀÛ¿ëÀ» ÀÏÀ¸Å²´Ù´Â Áõ°Å´Â ¾ø´Ù.
2) »ýü¿Ü ¿¬±¸¿¡¼ R-ºñÄ®·çŸ¸¶À̵å´Â CYP 2C9, 2C19 ¹× 2D6ÀÇ È°¼º ¾ïÁ¦ÀÛ¿ëÀÌ ÀûÀº CYP3A4ÀúÇØÁ¦ÀÎ °ÍÀ¸·Î ³ªÅ¸³µ´Ù. ±×·¯³ª ÀÌ ¾àÀº ÈçÈ÷ º´¿ëµÇ´Â ´Ù¸¥ ¾à¹°°ú »óÈ£ÀÛ¿ëÀ» ÀÏÀ¸Å°Áö ¾ÊÀ¸¸ç ¸ÅÀÏ 150 mg±îÁö Åõ¿©ÇÏ¿©µµ È¿¼ÒÀ¯µµ³ª ¾ÈƼÇǸ° ´ë»çÀúÇØÀÇ Áõ°Å´Â ¾ø´Ù.
3) ºñ·Ï, CYP-450 Ȱ¼ºÀÇ Ç¥½ÄÀ¸·Î ¾ÈƼÇǸ°À» »ç¿ëÇÑ ÀÓ»ó½ÃÇè¿¡¼ ÀÌ ¾àÀÌ ¾à¹°»óÈ£ÀÛ¿ëÀÇ °¡´É¼ºÀ» º¸ÀÌÁö ¾Ê¾ÒÁö¸¸ 28Àϰ£ ÀÌ ¾à°ú º´¿ë ÈÄ Æò±Õ ¹Ì´ÙÁ¹¶÷ ³ëÃâ(AUC)À» 80 %±îÁö Áõ°¡½ÃÄ×´Ù. Ä¡·á ¾ÈÀü¿ªÀÌ Á¼Àº ¾à¹°ÀÇ °æ¿ì¿¡´Â ÀÌ·± Áõ°¡°¡ ÀÓ»óÀûÀ¸·Î À¯ÀǼºÀÌ ÀÖÀ» ¼öµµ ÀÖÀ¸¹Ç·Î Å׸£Æä³ªµò, ¾Æ½ºÅ×¹ÌÁ¹, ½Ã»çÇÁ¶óÀ̵å¿ÍÀÇ º´¿ëÀº ±Ý±âÀÌ¸ç ½ÃŬ·Î½ºÆ÷¸°, Ä®½·±æÇ×Á¦¿Í °°Àº ¾à¹°µé°ú º´¿ë½Ã¿¡´Â ÁÖÀǸ¦ ¿äÇÑ´Ù. ÀÌµé ¾à¹°°úÀÇ º´¿ë½Ã ƯÈ÷ ¾àÈ¿ÀÇ Áõ°¡³ª ÀÌ»ó¹ÝÀÀÀÇ Áõ°Å°¡ ÀÖ´Â °æ¿ì, ¾à¹°°¨·®ÀÌ ÇÊ¿äÇÒ ¼öµµ ÀÖ´Ù. ½ÃŬ·Î½ºÆ÷¸°ÀÇ °æ¿ì ÀÌ ¾à ¿ä¹ýÀ» ½ÃÀÛÇϰųª Áß´ÜÇÑ ÈÄ Ç÷Áß³óµµ¿Í ÀÓ»ó»óŸ¦ ¸é¹ÐÈ÷ ¸ð´ÏÅ͸µÇÏ´Â °ÍÀÌ ÁÁ´Ù.
4) ¾à¹°ÀÇ »êȸ¦ Â÷´ÜÇÏ´Â ½Ã¸ÞƼµòÀ̳ª ÄÉÅäÄÚ³ªÁ¹°ú´Â º´¿ëÇÒ ¶§ ÁÖÀǸ¦ ¿äÇÑ´Ù. ÀÌ·ÐÀûÀ¸·Î ÀÌ ¾àÀÇ Ç÷Àå³óµµ¸¦ Áõ°¡½ÃÄÑ ÀÌ»ó¹ÝÀÀÀ» ³ªÅ¸³¾ ¼ö ÀÖ´Ù.
5) ½ÃÇè°ü³» ½ÃÇè°á°ú, ÀÌ ¾àÀÌ Äí¸¶¸°(Ç×ÀÀ°íÁ¦), ¿ÍÆÄ¸°°úÀÇ ´Ü¹é°áÇÕÀ» °æÀï, ġȯÇÒ ¼ö ÀÖ´Ù. ÀÌ ¾à°ú ¿ÍÆÄ¸°, ´Ù¸¥ Äí¸¶¸°(Ç×ÀÀ°íÁ¦)¿Í º´¿ë Åõ¿©½Ã Ç×ÀÀ°íÈ¿°úÀÇ Áõ°¡°¡ º¸°íµÇ¾ú´Ù. µû¶ó¼, Äí¸¶¸°(Ç×ÀÀ°íÁ¦)¿Í º´¿ëÅõ¿© ¹Þ´Â ȯÀÚ´Â PT/INR¿¡ ´ëÇÑ ÁÖÀÇ ±íÀº °üÂûÀÌ ±ÇÀåµÇ¸ç Ç×ÀÀ°íÁ¦ÀÇ ¿ë·® Á¶ÀýÀÌ °í·ÁµÇ¾î¾ß ÇÑ´Ù.
6) ¾Èµå·Î°Õ Â÷´Ü¿ä¹ýÀº QT °£°ÝÀ» ¿¬Àå½Ãų ¼ö Àֱ⠶§¹®¿¡, ÀÌ ¾à°ú QT °£°ÝÀ» ¿¬Àå½ÃŰ´Â °ÍÀ¸·Î ¾Ë·ÁÁø ¾à¹°À̳ª Class IA(¿¹. Äû´Ïµò, µð¼ÒÇǶó¹Ìµå) ¶Ç´Â Class III(¿¹. ¾Æ¹Ì¿À´Ù·Ð, ¼ÒŸ·Ñ, µµÆäÆ¿¶óÀ̵å, ÀÌºÎÆ¿¶óÀ̵å) Ç׺ÎÁ¤¸Æ ¾à¹°, ¸ÞŸµ·, ¸ñ½ÃÇ÷ϻç½Å, Ç×Á¤½Åº´¾à µî Torsade de pointes¸¦ À¯¹ß ÇÒ ¼ö ÀÖ´Â ¾à¹°°ú º´¿ë Åõ¿©½Ã ½ÅÁßÇÏ°Ô Æò°¡µÇ¾î¾ß ÇÑ´Ù.
 
   
  
  
  
   
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2) ÀϹÝÀûÀ¸·Î °í·ÉÀÚ¿¡¼´Â ½ÉÀ塤¼øÈ¯±â°èÀÇ ±â´ÉÀÇ ÀúÇϰ¡ ¸¹À¸¸ç, ½ÉÀ塤¼øÈ¯±â°èÀÇ ÀÌ»ó¹ÝÀÀ ¹ßÇö ºóµµ°¡ ÀþÀº Ãþº¸´Ù ³ô°Ô ³ªÅ¸³¯ ¼ö ÀÖÀ¸¹Ç·Î °í·ÉÀÚ¿¡ Åõ¿©½Ã ȯÀÚÀÇ »óŸ¦ °üÂûÇÏ¸é¼ ½ÅÁßÇÏ°Ô Åõ¿©ÇÑ´Ù.
 
   
  
  
  
  
  
  
  
  
  
  
  
  
   
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2) ÀÌ ¾àÀº ´Ü¹é°áÇÕÀ²ÀÌ ³ô°í ¼Òº¯¿¡¼ ´ë»çµÇÁö ¾ÊÀº ¾à¹°ÀÌ È¸¼öµÇÁö ¾ÊÀ¸¹Ç·Î °ú·®Åõ¿©½Ã Ç÷¾×Åõ¼®ÀÌ µµ¿òÀÌ µÇÁö ¾ÊÀ» ¼öµµ ÀÖ´Ù. ±×¸®°í È£Èí¼ö, ½É¹Úµ¿¼ö µîÀÇ vital signÀ» ºó¹øÈ÷ ÃøÁ¤ÇÏ¸é¼ ÀϹÝÀûÀ̰í Áö¼ÓÀûÀÎ °ü½ÉÀ» ȯÀÚ¿¡°Ô ±â¿ïÀ̵µ·Ï ÇÏ¿©¾ß ÇÑ´Ù.
 
   
  
  
  
  		
  
  
   
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      Bicalutamide Brand Names/Synonyms  
Bicalutamide [Usan:Ban:Inn] 
 Casodex   Brand Name Mixtures  Not AvailableChemical IUPAC Name  N-[4-cyano-3-(trifluoromethyl)phenyl]-3-(4-fluorophenyl)sulfonyl-2-hydroxy-2-methyl- propanamide
     
   
   
 
	  
	 
	
	  
       
	    
	      
	        
            
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    DUR (ÀǾàǰ»ç¿ëÆò°¡) 
    º´¿ë±Ý±â :
     
	     [domperidone]  
	     
	     [domperidone maleate (as domperidone)]  
	     
	 [»óÈ£ÀÛ¿ë/º´¿ë±Ý±â°Ë»ö]  										
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    Mechanism of Action 
    
      Bicalutamide¿¡ ´ëÇÑ Mechanism_Of_Action Á¤º¸  Bicalutamide competes with androgen for the binding of androgen receptors, consequently blocking the action of androgens of adrenal and testicular origin which stimulate the growth of normal and malignant prostatic tissue. 
     
   
  
   
    Pharmacology 
     
      Bicalutamide¿¡ ´ëÇÑ Pharmacology Á¤º¸  Bicalutamide is an antineoplastic hormonal agent primarily used in the treatment of prostate cancer. Bicalutamide is a pure, nonsteroidal anti-androgen with affinity for androgen receptors (but not for progestogen, estrogen, or glucocorticoid receptors). Consequently, Bicalutamide blocks the action of androgens of adrenal and testicular origin which stimulate the growth of normal and malignant prostatic tissue. Prostate cancer is mostly androgen-dependent and can be treated with surgical or chemical castration. To date, antiandrogen monotherapy has not consistently been shown to be equivalent to castration. 
     
   
  
   
    Protein Binding 
    
      Bicalutamide¿¡ ´ëÇÑ ´Ü¹é°áÇÕ Á¤º¸  96% 
     
   
  
   
    Half-life 
    
      Bicalutamide¿¡ ´ëÇÑ ¹Ý°¨±â Á¤º¸  5.9 days 
     
   
  
   
    Absorption 
    
      Bicalutamide¿¡ ´ëÇÑ Absorption Á¤º¸  Bicalutamide is well-absorbed following oral administration, although the absolute bioavailability is unknown. 
     
   
  
   
    Pharmacokinetics 
    
      BicalutamideÀÇ ¾à¹°µ¿·ÂÇÐÀÚ·á  
 ÃÖ´ë È¿°ú ¹ßÇö : Áõ»ó °³¼± : 2-4 ÁÖ, °´°üÀûÀÎ °Ë»ç»óÀÇ °³¼± : 12ÁÖ
  Èí¼ö : °æ±¸ : Àß Èí¼öµÊ
  ´Ü¹é°áÇÕ : 96%
  ´ë»ç : ´ëºÎºÐÀÌ ´ë»çµÊ : (S)-À̼ºÃ¼(ºñȰ¼ºÇü)°¡ ¢ç-À̼ºÃ¼(Ȱ¼ºÇü)¿¡ ºñÇØ ºü¸£°Ô ¼Ò½ÇµÈ´Ù. ½É°¢ÇÑ °£±â´É ÀúÇϽÿ¡¸¸ ¼Ò½Ç¼Óµµ°¡ ÀúÇϵÊ
  ¹Ý°¨±â : 7-10 ÀÏ
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    Biotransformation 
    
      Bicalutamide¿¡ ´ëÇÑ Biotransformation Á¤º¸  Bicalutamide undergoes stereo specific metabolism. The S (inactive) isomer is metabolized primarily by glucuronidation. The R (active) isomer also undergoes glucuronidation but is predominantly oxidized to an inactive metabolite followed by glucuronidation. 
     
   
  
   
    Toxicity 
    
      Bicalutamide¿¡ ´ëÇÑ Toxicity Á¤º¸  Not Available 
     
   
  
   
    Drug Interactions 
    
      Bicalutamide¿¡ ´ëÇÑ Drug_Interactions Á¤º¸  Not Available 
     
   
  
   
    CYP450  Drug Interaction 
    
      [CYP450 TableÁ÷Á¢Á¶È¸]  
     
   
  
   
    Food Interaction 
    
      Bicalutamide¿¡ ´ëÇÑ Food Interaction Á¤º¸  Take without regard to meals, at the same time everyday. 
     
   
  
   
    Drug Target 
    
      
      [Drug Target]  
     
   
  
   
    Description 
    
      Bicalutamide¿¡ ´ëÇÑ Description Á¤º¸  Bicalutamide is an oral non-steroidal anti-androgen for prostate cancer. It binds to the androgen receptor. 
     
   
  
   
    Dosage Form 
    
      Bicalutamide¿¡ ´ëÇÑ Dosage_Form Á¤º¸  Tablet	Oral 
     
   
  
   
    Drug Category 
    
      Bicalutamide¿¡ ´ëÇÑ Drug_Category Á¤º¸  Androgen AntagonistsAntineoplastic Agents 
     
   
  
   
    Smiles String Canonical 
    
      Bicalutamide¿¡ ´ëÇÑ Smiles_String_canonical Á¤º¸  CC(O)(CS(=O)(=O)C1=CC=C(F)C=C1)C(=O)NC1=CC(=C(C=C1)C 
     
   
  
   
    Smiles String Isomeric 
    
      Bicalutamide¿¡ ´ëÇÑ Smiles_String_isomeric Á¤º¸  C[C@](O)(CS(=O)(=O)C1=CC=C(F)C=C1)C(=O)NC1=CC(=C(C=C1)C 
     
   
  
   
    InChI Identifier 
    
      Bicalutamide¿¡ ´ëÇÑ InChI_Identifier Á¤º¸  InChI=1/C18H14F4N2O4S/c1-17(26,10-29(27,28)14-6-3-12(19)4-7-14)16(25)24-13-5-2-11(9-23)15(8-13)18(20,21)22/h2-8,26H,10H2,1H3,(H,24,25)/t17-/m0/s1/f/h24H 
     
   
  
   
    Chemical IUPAC Name 
    
      Bicalutamide¿¡ ´ëÇÑ Chemical_IUPAC_Name Á¤º¸  (2R)-N-[4-cyano-3-(trifluoromethyl)phenyl]-3-(4-fluorophenyl)sulfonyl-2-hydroxy-2-methylpropanamide 
     
   
    
 
	  
	   
	
	  
       
	    
	      
	        
            
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                      µå·°ÀÎÆ÷ ÀǾàÇмúÁ¤º¸´Â ½ÄǰÀǾàǰ¾ÈÀüóÀÇ Á¦Ç°Çã°¡»çÇ×, Çмú¹®Çå, Á¦¾àȸ»ç Á¦°øÁ¤º¸ µîÀ» ±Ù°Å·Î ÀÛ¼ºµÈ Âü°í Á¤º¸ÀÔ´Ï´Ù. 
                          Á¤º¸ÀÇ Á¤È®¼ºÀ» À§ÇØ ³ë·ÂÇϰí ÀÖÀ¸³ª ÆíÁý»óÀÇ ¿À·ù, Çã°¡»çÇ× º¯°æ, Ãß°¡ÀûÀÎ Çмú¿¬±¸ ¶Ç´Â Àӻ󿬱¸ ¹ßÇ¥ µîÀ¸·Î ÀÎÇØ ¹ß»ýÇÏ´Â ¹®Á¦¿¡ ´ëÇØ µå·°ÀÎÆ÷´Â 
                          Ã¥ÀÓÀ» ÁöÁö ¾Ê½À´Ï´Ù. ÀÚ¼¼ÇÑ ³»¿ëÀº ¡°Ã¥ÀÓÀÇ ÇÑ°è ¹× ¹ýÀû°íÁö¡± ¸¦ ÂüÁ¶ÇØ ÁֽʽÿÀ.
                            ¹Ýµå½Ã Á¦Á¶¡¤¼öÀÔ»ç, ÆÇ¸Å»ç, ÀÇ»ç, ¾à»ç¿¡°Ô ÃÖÁ¾ÀûÀ¸·Î È®ÀÎÇϽñ⠹ٶø´Ï´Ù. 
                          ÀüÈ: 02-3486-1061 ¤Ó À̸ÞÀÏ: webmaster@druginfo.co.kr
 
                    
                  
 
               
  
  
    ¾Æ·¡ÀÇ ³»¿ëÀ» Æ÷ÇÔÇÑ Àüü µ¥ÀÌÅ͸¦ º¸½Ã·Á¸é 
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  The database contains the following fields:
The generic name of each chemical
For module A10 (liver enzyme composite module):
Overall activity category for each compound (A for active, M for marginally active, or I for inactive) based on the number of active and marginally active scores for each compound at the five individual endpoints (see research article for full description of method)
Number of endpoints at which each compound is marginally active (M)
Number of endpoints at which each compound is active (A)
For modules A11 to A15 (alkaline phosphatase increased, SGOT increased, SGPT increased, LDH increased, and GGT increased, respectively):
Overall activity category for each compound (A for active, M for marginally active, or I for inactive) based on the RI and ADR values (see the research article for full description of method)
Number of ADR reports for each compound, given as <4 or ¡Ã4
Reporting Index value for each compound, except where no shipping units were available (NSU)
Group 1 comprises of compounds for which ADR data were available for the first five years of marketing, so when no ADR reports were listed during this period the compounds were evaluated as inactive. Group 2 comprises of compounds for which a 'steady state' period of ADR data were available (1992-1996). In cases where no ADR reports were filed during this period, the compounds were scored as 'NA' (data not available) since they may have had one or more ADR reports during their first five years of marketing which should not be negated by a lack of ADR reports during the steady-state period.
BICALUTAMIDE [GGT Increase] [Composite Activity] (Score)   A  (Marginal)   0 (Active)   3 [Alkaline Phosphatase Increase] (Activity Score)   A  (Number of Rpts)   ¡Ã4 (Index value)   8.5 [SGOT Increase] (Activity Score)   A  (Number of Rpts)   ¡Ã4 (Index value)   13.6 [SGPT Increase] (Activity Score)   A  (Number of Rpts)   ¡Ã4 (Index value)   11.9 [LDH Increase] (Activity Score)   I  (Number of Rpts)   <4 (Index value)   5.1 [GGT Increase] (Activity Score)   I  (Number of Rpts)   <4 (Index value)   1.7 
 
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