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      * Àý´ë ÀÓÀǺ¹¿ëÇÏÁö ¸¶½Ã°í ¹Ýµå½Ã ÀÇ»ç ¶Ç´Â ¾à»ç¿Í »ó´ãÇϽñ⠹ٶø´Ï´Ù. 
    
     
      
      
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      1. ÀϹÝÀûÀÎ ±ÇÀå ¿ë¹ý 
 - ÀÌ ¾àÀº À½½Ä°ú ÇÔ²² º¹¿ëÇØ¾ß ÇÑ´Ù. 
 - ÀÌ ¾àÀÇ ±ÇÀå °æ±¸ º¹¿ë·®Àº ȯÀÚÀÇ Ä¡·á °æ·Â°ú º´¿ë ¾àÁ¦ÀÇ »ç¿ë¿¡ µû¶ó ´Ù¸£´Ù. H2 ¼ö¿ëü ±æÇ×Á¦, ¶Ç´Â ÇÁ·ÎÅæÆßÇÁ ÀúÇØÁ¦¿Í º´¿ë½Ã¿¡´Â µû·Î º¹¿ëÇÒ Çʿ䰡 ÀÖÀ» ¼ö ÀÖ´Ù.(¾Æ·¡ ÂüÁ¶) 
 - ÀÌ ¾àÀ» µð´Ù³ë½Å ¿ÏÃæ ¶Ç´Â Àå¿ëÄÚÆÃ Á¦Á¦¿Í º´¿ë½Ã¿¡´Â µð´Ù³ë½Å º¹¿ë Àü 2½Ã°£ ¶Ç´Â º¹¿ë ÈÄ 1½Ã°£¿¡ À½½Ä°ú ÇÔ²² º¹¿ëÇØ¾ß ÇÑ´Ù.  
 - ÀÌÀü¿¡ Ä¡·á¸¦ ¹ÞÀº °æÇèÀÌ ÀÖÀ¸¸é¼ ¹ÙÀÌ·¯½º ¾ïÁ¦¿¡ ½ÇÆÐÇÑ È¯ÀÚ¿¡¼ ¸®Å䳪ºñ¾î ¾øÀÌ ÀÌ ¾à¸¸ÀÇ »ç¿ëÀº ±ÇÀåµÇÁö ¾Ê´Â´Ù. 
 - 100mg 1ÀÏ 1ȸ ÀÌ»óÀÇ ¸®Å䳪ºñ¾î¿Í ÀÌ ¾à »ç¿ëÀÇ ¾ÈÀü¼º ¹× À¯È¿¼ºÀº È®¸³µÇÁö ¾Ê¾Ò´Ù. À̺¸´Ù ³ôÀº ¿ë·®ÀÇ ¸®Å䳪ºñ¾î´Â ¾ÆÅ¸ÀÚ³ªºñ¾îÀÇ ¾ÈÀü¼º ÇÁ·ÎÆÄÀÏ (½ÉÀå¿¡ ´ëÇÑ ¿µÇâ, °íºô¸®·çºóÇ÷Áõ)À» º¯µ¿½Ãų ¼ö ÀÖ°í, ÀÌ¿¡ µû¶ó ±ÇÀåµÇÁö ¾Ê´Â´Ù. ó¹æÀÚ´Â ¸®Å䳪ºñ¾îÀÇ Àüü ó¹æÁ¤º¸¸¦ Âü°íÇØ¾ß ÇÑ´Ù.
  
2. ¼ºÀÎ ±ÇÀå ¿ë·® 
 1) Ä¡·á °æÇèÀÌ ¾ø´Â ȯÀÚ¿¡ ´ëÇÑ ¿ë¹ý 
 - Ä¡·á °æÇèÀÌ ¾ø´Â ȯÀÚ¿¡ ´ëÇÑ ±ÇÀå ¿ë·®Àº ÀÌ ¾à 300mg ¹× ¸®Å䳪ºñ¾î 100mgÀ» 1ÀÏ 1ȸ º¹¿ëÇÑ´Ù (½Ä»ç¿Í ÇÔ²² ÇѲ¨¹ø¿¡ º¹¿ë). 
	¶Ç´Â 
 - ¸®Å䳪ºñ¾î¿¡ ³»¾à¼ºÀÌ ÁÁÁö ¾ÊÀº Ä¡·á °æÇèÀÌ ¾ø´Â ȯÀÚ¿¡ ´ëÇÑ ±ÇÀå ¿ë·®Àº ÀÌ ¾à 400mg (¸®Å䳪ºñ¾î ¾øÀÌ)À» 1ÀÏ 1ȸ ½Ä»ç¿Í ÇÔ²² º¹¿ëÇÑ´Ù.
  
º´¿ë¿ä¹ý 
´ÙÀ½ ¾àÁ¦¿Í º´¿ëÇÑ´Ù¸é ÀÌ ¾à 300mg ¹× ¸®Å䳪ºñ¾î 100mgÀ» 1ÀÏ 1ȸ (½Ä»ç¿Í ÇÔ²² ÇѲ¨¹ø¿¡ º¹¿ë) 
¡Ü Å׳ëÆ÷ºñ¾î 
¡Ü H2 ¼ö¿ëü ±æÇ×Á¦: H2 ¼ö¿ëü ±æÇ×Á¦ ¿ë·®Àº ÆÄ¸ðƼµò 40mg 1ÀÏ 2ȸ ÇØ´ç·®À» ÃʰúÇØ¼´Â ¾ÈµÈ´Ù. ÀÌ ¾à 300mg°ú ¸®Å䳪ºñ¾î 100mgÀ» H2 ¼ö¿ëü ±æÇ×Á¦ Åõ¿©¿Í µ¿½Ã¿¡, ±×¸®°í/¶Ç´Â H2 ¼ö¿ëü ±æÇ×Á¦ Åõ¿© ÈÄ Àû¾îµµ 10½Ã°£ ÀÌÈÄ¿¡ Åõ¿©ÇØ¾ß ÇÑ´Ù. ¸®Å䳪ºñ¾î¿¡ ´ëÇÑ ³»¾à¼ºÀÌ ÁÁÁö ¾ÊÀº ȯÀÚ¿¡ ´ëÇØ¼´Â, ÀÌ ¾à 400mgÀ» 1ÀÏ 1ȸ À½½Ä°ú ÇÔ²² H2 ¼ö¿ëü ±æÇ×Á¦ º¹¿ë ÃÖ¼Ò 2½Ã°£ ÀÌÀü ¹× Àû¾îµµ 10½Ã°£ ÀÌÈÄ¿¡ Åõ¿©ÇØ¾ß ÇÑ´Ù. ÀÌ·¯ÇÑ È¯Àڵ鿡 ÀÖ¾î¼, H2 ¼ö¿ëü ±æÇ×Á¦ÀÇ ÀÏȸ ¿ë·®Àº ÆÄ¸ðƼµò 20mg¿¡ »óÀÀÇÏ´Â ¿ë·®À» ³Ñ¾î¼¼´Â ¾ÈµÇ¸ç, ÀÏÀÏ Ãѿ뷮Àº ÆÄ¸ðƼµò 40mg¿¡ »óÀÀÇÏ´Â ¿ë·®À» ³Ñ¾î¼¼´Â ¾ÈµÈ´Ù. 
¡Ü ÇÁ·ÎÅæ ÆßÇÁ ÀúÇØÁ¦´Â ¿À¸ÞÇÁ¶óÁ¹ 20mg ÇØ´ç·®À» ÃʰúÇÏÁö ¾Ê¾Æ¾ß Çϸç ÀÌ ¾à 300mg°ú ¸®Å䳪ºñ¾î 100mgÀ» º¹¿ëÇϱ⠾à 12½Ã°£ ÀÌÀü¿¡ Åõ¿©µÇ¾î¾ß ÇÑ´Ù.  
¡Ü ¸¸ÀÏ ÀÌ ¾àÀ» ¿¡ÆÄºñ·»Áî¿Í º´¿ë Åõ¿©ÇÑ´Ù¸é, ÀÌ ¾à 400mg (200mg ĸ½¶ 2°³)°ú ¸®Å䳪ºñ¾î 100mgÀ» 1ÀÏ 1ȸ ½Ä»ç¿Í ÇÔ²² ÇѲ¨¹ø¿¡ º¹¿ëÇÏ¿©¾ß Çϸç, ¿¡ÆÄºñ·»Áî´Â °øº¹½Ã, ÁÖ·Î ÀáÀÚ¸®¿¡ µé±â Àü¿¡ º¹¿ëÇÏ¿©¾ß ÇÑ´Ù. 
  
 2) Ä¡·á °æÇèÀÌ Àִ ȯÀÚ¿¡ ´ëÇÑ ¿ë¹ý 
ÀÌ ¾à 300mg ¹× ¸®Å䳪ºñ¾î 100mgÀ» 1ÀÏ 1ȸ (½Ä»ç¿Í ÇÔ²² ÇѲ¨¹ø¿¡ º¹¿ë) 
º´¿ë¿ä¹ý 
¡Ü H2 ¼ö¿ëü ±æÇ×Á¦¸¦ ÀÌ ¾à ¹× ¸®Å䳪ºñ¾î¸¦ º¹¿ëÇϰí Àִ ȯÀÚ¿¡°Ô »ç¿ëÇÒ ¶§¸¶´Ù H2 ¼ö¿ëü ±æÇ×Á¦´Â ÆÄ¸ðƼµò 20mg 1ÀÏ 2ȸ ÇØ´ç·®À» ÃʰúÇØ¼´Â ¾ÈµÈ´Ù. ÀÌ ¾à°ú ¸®Å䳪ºñ¾î´Â H2 ¼ö¿ëü ±æÇ×Á¦ Åõ¿©¿Í µ¿½Ã¿¡, ±×¸®°í/¶Ç´Â H2 ¼ö¿ëü ±æÇ×Á¦ Åõ¿© ÈÄ Àû¾îµµ 10½Ã°£ ÀÌÈÄ¿¡ Åõ¿©ÇØ¾ß ÇÑ´Ù. 
¡Ü H2 ¼ö¿ëü ±æÇ×Á¦¸¦ º¹¿ëÇÑ´Ù¸é, ÀÌ ¾à 300mg ¹× ¸®Å䳪ºñ¾î 100mg 1ÀÏ 1ȸ (½Ä»ç¿Í ÇÔ²² ÇѲ¨¹ø¿¡ º¹¿ë) 
¡Ü Å׳ëÆ÷ºñ¾î¿Í H2 ¼ö¿ëü ±æÇ×Á¦¸¦ ¸ðµÎ º¹¿ëÇÑ´Ù¸é, ÀÌ ¾à 400mg ¹× ¸®Å䳪ºñ¾î 100mg 1ÀÏ 1ȸ (½Ä»ç¿Í ÇÔ²² ÇѲ¨¹ø¿¡ º¹¿ë) 
¡Ü ÇÁ·ÎÅæ ÆßÇÁ ÀúÇØÁ¦´Â Ä¡·á °æÇèÀÌ ÀÖÀ¸¸é¼ ÀÌ ¾àÀ» º¹¿ëÇϰí Àִ ȯÀÚ¿¡°Ô »ç¿ëÇØ¼´Â ¾ÈµÈ´Ù. 
¡Ü ¿¡ÆÄºñ·»Áî: Ä¡·á °æÇèÀÌ Àִ ȯÀÚ¿¡ ´ëÇØ ¿¡ÆÄºñ·»Áî¿Í ÀÌ ¾àÀÇ º´¿ëÀº ¾ÆÀÚŸ³ªºñ¾î ³ëÃâÀ» °¨¼Ò½Ã۱⠶§¹®¿¡ ÇÔ²² Åõ¿©ÇÏÁö ¾Ê´Â´Ù.
  
[ÀÌµé ¾à¹°°ú ±âŸ Ç×·¹Æ®·Î¹ÙÀÌ·¯½º Á¦Á¦¸¦ º´¿ëÇÏ´Â °æ¿ì¿¡´Â ÀûÀýÈ÷ ¿ë·®À» º¯°æÇÒ ¼ö ÀÖ´Ù.(»ç¿ë»ó ÁÖÀÇ»çÇ× 5. »óÈ£ÀÛ¿ë ÂüÁ¶)]
  
3. û¼Ò³â ±ÇÀå¿ë·®(¸¸ 13¼¼ÀÌ»ó, ¸¸ 18¼¼ ÀÌÇÏ) 
ÀÌ ¾àÀÇ ÇÏ·ç ±ÇÀå¿ë·®Àº üÁß¿¡ µû¶ó °áÁ¤Ç쵂 ¼ºÀο뷮À» ÃʰúÁö ¾Ê¾Æ¾ß ÇÑ´Ù. ÀÌ ¾àÀº ¹Ýµå½Ã ½Ä»ç¿Í ÇÔ²² º¹¿ëÇÑ´Ù.  
´ÙÀ½ÀÇ °æ¿ì ÀÌ ¾àÀÇ ±ÇÀå¿ë·®¿¡ ´ëÇÑ ÀÚ·á´Â ÃæºÐÇÏÁö ¾Ê´Ù. 1) ¸®Å䳪ºñ¾î ¾øÀÌ ÀÌ ¾àÀ» Åõ¿©ÇÏ´Â ¸¸ 13¼¼ ¹Ì¸¸ ȯÀÚ, 2) Å׳ëÆ÷ºñ¾î, H2 ¼ö¿ëü ±æÇ×Á¦, ȤÀº ÇÁ·ÎÅæÆßÇÁÀúÇØÁ¦¸¦ º´¿ëÅõ¿©ÇÏ´Â 40kg ¹Ì¸¸ÀÇ È¯ÀÚ
  
Ç¥. ¸®Å䳪ºñ¾î¸¦ º´¿ëÇϴ ȯÀÚ¿¡¼ÀÇ ¿ë·® 
 
  
* üÁß 40kg ÀÌ»ó ȯÀÚ 
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 - Å׳ëÆ÷ºñ¾î, H2 ¼ö¿ëü ±æÇ×Á¦ ȤÀº ÇÁ·ÎÅæ ÆßÇÁ ÀúÇØÁ¦¿Í º´¿ëÅõ¿©Çϴ ȯÀÚ´Â ¸®Å䳪ºñ¾î ¾øÀÌ ÀÌ ¾à¸¸ Åõ¿©ÇÏ¸é ¾ÈµÈ´Ù. 
  
4. ½ÅÀå¾Ö ȯÀÚ 
Ç÷¾×Åõ¼®À» ¹ÞÁö ¾Ê´Â ÁßÁõ ½ÅÀå¾Ö ȯÀÚ¸¦ Æ÷ÇÔÇÏ¿©, ½ÅÀå¾Ö ȯÀÚ¿¡ ´ëÇÏ¿©´Â ÀÌ ¾àÀÇ ¿ë·® Á¶Á¤ÀÌ ¿ä±¸µÇÁö ¾Ê´Â´Ù. Ä¡·á°æÇèÀÌ ¾ø°í, Ç÷¾×Åõ¼® ¿ä¹ýÀ» ¹Þ°í ÀÖ´Â ¸»±â ½ÅÁúȯ ȯÀÚ¿¡´Â ÀÌ ¾à 300mg°ú ¸®Å䳪ºñ¾î 100mgÀ» Åõ¿©ÇÑ´Ù. ÀÌ ¾àÀº Ç÷¾×Åõ¼®À» ¹Þ°í ÀÖ´Â ¸»±â ½ÅÁúȯÀÌ¸é¼ HIV Ä¡·á °æÇèÀÌ Àִ ȯÀÚ¿¡°Ô´Â »ç¿ëÇÏÁö ¾Ê¾Æ¾ß ÇÑ´Ù.
  
5. °£Àå¾Ö ȯÀÚ 
°æ¹Ì~ÁߵÀÇ °£ºÎÀü ȯÀÚ ¿¡¼´Â ÁÖÀÇÇØ¼ »ç¿ëÇØ¾ß ÇÑ´Ù. ÀÌÀü¿¡ ¹ÙÀÌ·¯½º ¾ïÁ¦¿¡ ½ÇÆÐÇÑ °æÇèÀÌ ¾ø´Â ÁߵÀÇ °£ºÎÀü ȯÀÚ(Child-Pugh Class B)¿¡ ´ëÇØ¼´Â 300mg 1ÀÏ1ȸ·Î ¿ë·®°¨¼Ò¸¦ °í·ÁÇØ¾ß ÇÑ´Ù. ÀÌ ¾àÀº ÁßÁõ °£ºÎÀü ȯÀÚ¿¡ »ç¿ëÇØ¼´Â ¾ÈµÈ´Ù (Child-Pugh Class C). 
°£Àå¾Ö ȯÀÚ¿¡ ´ëÇÏ¿© ÀÌ ¾à/¸®Å䳪ºñ¾î »ç¿ëÀÌ ¿¬±¸µÈ ¹Ù ¾øÀ¸¹Ç·Î ±ÇÀåµÇÁö ¾Ê´Â´Ù.     
      	
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    1) ÀÌÀü¿¡ ÀÌ ¾àÀÇ ¼ººÐ¿¡ ÀÓ»óÀûÀ¸·Î À¯ÀÇÇÑ °ú¹ÎÁõ (¿¹, ½ºÆ¼ºì-Á¸½¼ ÁõÈıº, ´ÙÇüÈ«¹Ý, ¶Ç´Â µ¶¼º ÇǺΠ¹ßÁø)ÀÌ ÀÖ´Â °ÍÀ¸·Î È®ÀÎµÈ È¯ÀÚ
  
2) û¼ÒÀ²¿¡ ´ëÇØ CYP3A ¶Ç´Â UGT1A1¿¡ ¾ÆÁÖ ÀÇÁ¸ÀûÀ̸ç Ç÷Àå³óµµÀÇ »ó½ÂÀÌ ÁßÁõ ¶Ç´Â Ä¡¸íÀûÀÎ »ç·Ê¿Í °ü·ÃÀÌ ÀÖ´Â ¾à¹°°ú º´¿ëÇÏ¸é ¾ÈµÈ´Ù. ÀÌ·¯ÇÑ ¾à¹°µé°ú ÀÌ¿ÜÀÇ º´¿ëÀÌ ±Ý±âµÈ ¾à¹°Àº Ç¥ 1¿¡ Á¦½ÃÇÏ¿´´Ù. 
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a. ÁÖ»ç¿ë ¹Ì´ÙÁ¹¶÷À» Åõ¿© ½Ã¿¡´Â 5. »óÈ£ÀÛ¿ë, Ç¥ 11À» ÂüÁ¶.
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3) ÀÌ ¾àÀº À¯´çÀ» ÇÔÀ¯Çϰí ÀÖÀ¸¹Ç·Î, °¥¶ôÅä¿À½º ºÒ³»¼º(galactose intolerance), Lapp À¯´çºÐÇØÈ¿¼Ò °áÇÌÁõ(Lapp lactase deficiency) ¶Ç´Â Æ÷µµ´ç-°¥¶ôÅä¿À½º Èí¼öÀå¾Ö(glucose-galactose malabsorption) µîÀÇ À¯ÀüÀûÀÎ ¹®Á¦°¡ Àִ ȯÀÚ¿¡°Ô´Â Åõ¿©ÇÏ¸é ¾ÈµÈ´Ù. | 
   
  
  
  
  
    
  
  
  
  
  
   
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Ç¥2. Ä¡·á°æÇèÀÌ ¾ø´Â ¼ºÀÎȯÀÚbÀÇ 2% À̻󿡼 º¸°íµÈ Áߵ ¶Ç´Â ÁßÁõÀÇ Ä¡·á°¡ ÇÊ¿äÇÑ ÀÀ±Þ ÀÌ»ó¹ÝÀÀa, ÀÓ»ó½ÃÇè AI424-138 
 
  
Ç¥3. Ä¡·á°æÇèÀÌ ¾ø´Â ¼ºÀÎȯÀÚbÀÇ 2% À̻󿡼 º¸°íµÈ Áߵ ¶Ç´Â ÁßÁõÀÇ Ä¡·á°¡ ÇÊ¿äÇÑ ÀÀ±Þ ÀÌ»ó¹ÝÀÀa, Studies AI424-034, AI424-007, ¹× AI424-008 
 
  
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Ç¥4. Ä¡·á°æÇèÀÌ ÀÖ´Â ¼ºÀÎȯÀÚbÀÇ 2% À̻󿡼 º¸°íµÈ Áߵ ¶Ç´Â ÁßÁõÀÇ Ä¡·á°¡ ÇÊ¿äÇÑ ÀÀ±Þ ÀÌ»ó¹ÝÀÀa, ÀÓ»ó½ÃÇè AI424-045 
 
  
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   Ä¡·á°æÇèÀÌ ¾ø´Â ¼ºÀÎȯÀÚ°¡ ÀÌ ¾à (¾ÆÀÚŸ³ªºñ¾îȲ»ê¿°) 300mg°ú ¸®Å䳪ºñ¾î 100mg ¶Ç´Â ÀÌ ¾à 400mg (¸®Å䳪ºñ¾î¿Í º´¿ëÇÏÁö ¾ÊÀ½)À» Æ÷ÇÔÇÏ¿© º´¿ëÄ¡·á¸¦ ¹Þ°í 3-4µî±ÞÀÇ ÀÓ»ó°Ë»çÄ¡ ÀÌ»óÀ» ³ªÅ¸³½ ¹éºÐÀ²À» Ç¥5¿Í 6¿¡ °¢°¢ ³ªÅ¸³Â´Ù. 
  
Ç¥5. Ä¡·á°æÇèÀÌ ¾ø´Â ¼ºÀÎȯÀÚÀÇ 2% À̻󿡼 º¸°íµÈ 3-4µî±ÞÀÇ ÀÓ»ó°Ë»çÄ¡ ÀÌ»óa, AI424-138 
 
  
Ç¥ 6. Ä¡·á°æÇèÀÌ ¾ø´Â ¼ºÀÎȯÀÚÀÇ 2% À̻󿡼 º¸°íµÈ 3-4µî±ÞÀÇ ÀÓ»ó°Ë»çÄ¡ ÀÌ»óa, Studies AI424-034, AI424-007, ¹× AI424-008 
 
  
   
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Ç¥ 8.  ÁöÁú°ª, °³½Ã°ªÀ¸·ÎºÎÅÍ Æò±Õ º¯È, Study AI424-138 
 
  
Ç¥ 9.  ÁöÁú°ª, °³½Ã°ªÀ¸·ÎºÎÅÍ Æò±Õ º¯È, Study AI424-034 
 
  
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    ¿¬±¸AI424-045¿¡¼, °øº¹½Ã LDL-ÄÝ·¹½ºÅ×·Ñ, HDL-ÄÝ·¹½ºÅ×·Ñ, ÃÑÄÝ·¹½ºÅ×·Ñ ¹× °øº¹½Ã Áß¼ºÁö¹æÀÇ °³½Ã°ªÀ¸·ÎºÎÅÍ º¯È¸¦ Ç¥10¿¡ ³ªÅ¸³Â´Ù. ÁöÁúÀÌ»óÁõÀº ·ÎÇdzªºñ¾î/¸®Å䳪ºñ¾î¿¡ ºñÇÏ¿© ÀÌ ¾à/¸®Å䳪ºñ¾î¿¡¼ Àû°Ô °üÂûµÇ¾ú´Ù. ±×·¯³ª, ÀÌ·¯ÇÑ °üÂû °á°úÀÇ ÀÓ»óÀû ¿µÇâÀº È®ÀεÇÁö ¾Ê¾Ò´Ù.
  
Ç¥ 10.  ÁöÁú°ª, °³½Ã°ªÀ¸·ÎºÎÅÍ Æò±Õ º¯È, Study AI424-045 
 
  
2) ¼Ò¾ÆÈ¯ÀÚ 
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3) BÇü °£¿° ¹×/¶Ç´Â CÇü °£¿° ¹ÙÀÌ·¯½º¿Í µ¿½Ã¿¡ °¨¿°µÈ ȯÀÚ 
  BÇüÀ̳ª CÇü °£¿°ÀÇ º´·ÂÀÌ Àִ ȯÀÚ´Â °£±â´É °Ë»ç¸¦ ½Ç½ÃÇÏ¿©¾ß ÇÑ´Ù. 
  AI424-138 ¿¬±¸¿¡¼, Å׳ëÆ÷ºñ¾î-¿¥Æ®¸®½ÃŸºó °íÁ¤¿ë·®°ú ÇÔ²² ÀÌ ¾à/¸®Å䳪ºñ¾î 300mg/100mg 1ÀÏ 1ȸ Åõ¿©ÇÑ 60¸í, ·ÎÇdzªºñ¾î/¸®Å䳪ºñ¾î 400mg/100mg 1ÀÏ 2ȸ Åõ¿©ÇÑ 51¸íÀº ¿¬±¸ °³½Ã½Ã¿¡ BÇü ¹×/¶Ç´Â CÇü °£¿°¿¡ ´ëÇØ Ç÷û¹ÝÀÀ¿¡ ¾ç¼ºÀ» ³ªÅ¸³Â´Ù. ÀÌ ¾à/¸®Å䳪ºñ¾î Ä¡·á ȯÀÚÀÇ 8% (5/60)¿Í ·ÎÇdzªºñ¾î/¸®Å䳪ºñ¾î Ä¡·á ȯÀÚÀÇ 6% (3/50)°¡ ALT ¼öÄ¡°¡ Á¤»ó »óÇѼ±ÀÇ 5¹è¸¦ ÃʰúÇÏ¿´´Ù. ÀÌ ¾à/¸®Å䳪ºñ¾î Ä¡·á ȯÀÚÀÇ 8% (5/60)´Â AST ¼öÄ¡°¡ Á¤»ó »óÇѼ±ÀÇ 5¹è¸¦ ÃʰúÇÏ¿´À¸¸ç ·ÎÇdzªºñ¾î/¸®Å䳪ºñ¾î Ä¡·á ȯÀÚ Áß ¾Æ¹«µµ (0/50) ÇØ´çµÇÁö ¾Ê¾Ò´Ù. 
  AI424-008°ú AI424-034 ¿¬±¸¿¡¼, ÀÌ ¾à 400mgÀ» 1ÀÏ1ȸ Åõ¿©ÇÑ 74¸í, ¿¡ÆÄºñ·»Á Åõ¿© ¹ÞÀº 58¸í, ³ÚÇdzªºñ¾î¸¦ Åõ¿© ¹ÞÀº 12¸í¿¡¼ ¿¬±¸ °³½Ã½Ã¿¡ BÇü ¹×/¶Ç´Â CÇü °£¿°¿¡ ´ëÇØ Ç÷û¹ÝÀÀ¿¡ ¾ç¼ºÀ» ³ªÅ¸³Â´Ù. ÀÌ ¾àÀ¸·Î Ä¡·á¹ÞÀº ȯÀÚÀÇ 9%, ¿¡ÆÄºñ·»Áî·Î Ä¡·á¹ÞÀº ȯÀÚÀÇ 5%, ³ÚÇdzªºñ¾î·Î Ä¡·á¹ÞÀº ȯÀÚÀÇ 17%¿¡¼ AST ³óµµ°¡ Á¤»ó »óÇѼ±ÀÇ 5¹è¸¦ ÃʰúÇÏ¿´´Ù. ÀÌ ¾àÀ¸·Î Ä¡·á¹ÞÀº ȯÀÚÀÇ 15%, ¿¡ÆÄºñ·»Áî·Î Ä¡·á¹ÞÀº ȯÀÚÀÇ 14%, ³ÚÇdzªºñ¾î·Î Ä¡·á¹ÞÀº ȯÀÚÀÇ 17%¿¡¼ ALT ³óµµ°¡ Á¤»ó »óÇѼ±ÀÇ 5¹è¸¦ ÃʰúÇÏ¿´´Ù. ÀÌ ¾à°ú ´ëÁ¶ ¾àÁ¦±º¿¡¼, Ç÷û¹ÝÀÀ¿¡¼ ¾ç¼ºÀΠȯÀÚ¿Í À½¼ºÀΠȯÀÚ °£¿¡ ºô¸®·çºó »ó½ÂÀÇ ºóµµ¿¡´Â Â÷À̰¡ ¾ø¾ú´Ù.  
  AI424-045 ¿¬±¸¿¡¼, ÀÌ ¾à/¸®Å䳪ºñ¾î 300mg/100mgÀ» ÇÏ·ç Çѹø Åõ¿©¹ÞÀº 20¸íÀÇ È¯ÀÚ¿Í ·ÎÇdzªºñ¾î/¸®Å䳪ºñ¾î 400mg/100mgÀ» ÇÏ·ç µÎ ¹ø Åõ¿©¹ÞÀº 18¸íÀÇ È¯ÀÚµéÀº ¿¬±¸ °³½Ã½Ã¿¡ BÇü ±×¸®°í/¶Ç´Â CÇü °£¿°¿¡ ´ëÇØ Ç÷û¹ÝÀÀ ¾ç¼ºÀ» ³ªÅ¸³Â´Ù. ÀÌ ¾à/¸®Å䳪ºñ¾î Ä¡·á ȯÀÚÀÇ 25% (5/20)¿Í ·ÎÇdzªºñ¾î/¸®Å䳪ºñ¾î Ä¡·á ȯÀÚÀÇ 6% (1/18)´Â ALT ³óµµ°¡ Á¤»ó»óÇѼ±ÀÇ 5¹è¸¦ ÃʰúÇÏ¿´´Ù. ÀÌ ¾à/¸®Å䳪ºñ¾î Ä¡·á ȯÀÚÀÇ 10% (2/20)¿Í ·ÎÇdzªºñ¾î/¸®Å䳪ºñ¾î Ä¡·á ȯÀÚÀÇ 6% (1/18)´Â AST ³óµµ°¡ Á¤»ó»óÇѼ±ÀÇ 5¹è¸¦ ÃʰúÇÏ¿´´Ù. 
  
4) ½ÃÆÇÈÄ º¸°í »ç·Ê 
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    | Mechanism of Action | 
    
       atazanavir¿¡ ´ëÇÑ Mechanism_Of_Action Á¤º¸ Atazanavir selectively inhibits the virus-specific processing of viral Gag and Gag-Pol polyproteins in HIV-1 infected cells, thus preventing formation of mature virions. 
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    | Pharmacology | 
     
       atazanavir¿¡ ´ëÇÑ Pharmacology Á¤º¸ Atazanavir (ATV) is an azapeptide HIV-1 protease inhibitor (PI). It is a protease inhibitor with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Protease inhibitors block the part of HIV called protease. HIV-1 protease is an enzyme required for the proteolytic cleavage of the viral polyprotein precursors into the individual functional proteins found in infectious HIV-1. Atazanavir binds to the protease active site and inhibits the activity of the enzyme. This inhibition prevents cleavage of the viral polyproteins resulting in the formation of immature non-infectious viral particles. Protease inhibitors are almost always used in combination with at least two other anti-HIV drugs. 
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    | Absorption | 
    
       atazanavir¿¡ ´ëÇÑ Absorption Á¤º¸ Atazanavir is rapidly absorbed with a Tmax of approximately 2.5 hours. Administration of atazanavir with food enhances bioavailability and reduces pharmacokinetic variability. Oral bioavailability is 60-68%. 
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    | Drug Interactions | 
    
       atazanavir¿¡ ´ëÇÑ Drug_Interactions Á¤º¸ Aluminium	This gastric pH modifier decreases the levels/effects of atazanavirAmiodarone	Increased risk of cardiotoxicity and arrhythmiasAmitriptyline	Increases the effect and toxicity of tricyclicsAmoxapine	Increases the effect and toxicity of tricyclicsAnisindione	The protease inhibitor increases the anticoagulant effectAtorvastatin	Increases the effect and toxicity of the statinBepridil	Increases the effect and toxicity of bepridilBismuth Subsalicylate	This gastric pH modifier decreases the levels/effects of atazanavirCalcium	This gastric pH modifier decreases the levels/effects of atazanavirCimetidine	This gastric pH modifier decreases the levels/effects of atazanavirCisapride	Increased risk of cardiotoxicity and arrhythmiasClarithromycin	Increases levels of clarithromycinClomipramine	Increases the effect and toxicity of tricyclicsCyclosporine	Increases the effect and toxicity of immunosuppressantDesipramine	Increases the effect and toxicity of tricyclicsDicumarol	The protease inhibitor increases the anticoagulant effectDihydroergotamine	Increases the effect and toxicity of ergot derivativeDihydroquinidine barbiturate	Increased risk of cardiotoxicity and arrhythmiasDihydroxyaluminium	This gastric pH modifier decreases the levels/effects of atazanavirDiltiazem	Increases the effect and toxicity of diltiazemDoxepin	Increases the effect and toxicity of tricyclicsEfavirenz	Efavirenz decreases the levels/effects of atazanavirErgotamine	Increases the effect and toxicity of ergot derivativeErlotinib	This CYP3A4 inhibitor increases levels/toxicity of erlotinibEsomeprazole	This gastric pH modifier decreases the levels/effects of atazanavirFamotidine	This gastric pH modifier decreases the levels/effects of atazanavirImipramine	Increases the effect and toxicity of tricyclicsIndinavir	Increased risk of hyperbilirubinemia with this associationIrinotecan	Increases levels/effect of irinotecanLansoprazole	This gastric pH modifier decreases the levels/effects of atazanavirLidocaine	Increased risk of cardiotoxicity and arrhythmiasLovastatin	Increased risk of myopathy/rhabdomyolysisMagnesium oxide	This gastric pH modifier decreases the levels/effects of atazanavirMagnesium	This gastric pH modifier decreases the levels/effects of atazanavirMagnesium Sulfate	This gastric pH modifier decreases the levels/effects of atazanavirMethylergonovine	Increases the effect and toxicity of ergot derivativeMidazolam	Increases the effect and toxicity of benzodiazepineNevirapine	Nevirapine decreases levels/effect of atazanavirAcenocoumarol	The protease inhibitor increase the anticoagulant effectNizatidine	This gastric pH modifier decreases the levels/effects of atazanavirNortriptyline	Increases the effect and toxicity of tricyclicsOmeprazole	This gastric pH modifier decreases the levels/effects of atazanavirPantoprazole	This gastric pH modifier decreases the levels/effects of atazanavirPimozide	The protease inhibitor increases the effect and toxicity of pimozideProtriptyline	Increases the effect and toxicity of tricyclicsQuinidine	Increased risk of cardiotoxicity and arrhythmiasQuinidine barbiturate	Increased risk of cardiotoxicity and arrhythmiasRabeprazole	This gastric pH modifier decreases the levels/effects of atazanavirRanitidine	This gastric pH modifier decreases the levels/effects of atazanavirRanolazine	Increased levels of ranolazine- risk of toxicityRifabutin	Increases levels/toxicity of rifabutinRifampin	Rifampin reduces levels and efficacy of atazanavirRitonavir	Association with dose adjustmentSildenafil	Increases the effect and toxicity of sildenafilSimvastatin	Increased risk of myopathy/rhabdomyolysisSirolimus	Increases the effect and toxicity of immunosuppressantSt. John's Wort	St. John's Wort decreases the levels/effects of atazanavirSunitinib	Possible increase in sunitinib levelsTacrolimus	Increases the effect and toxicity of immunosuppressantTriazolam	Increases the effect and toxicity of benzodiazepineTrimipramine	Increases the effect and toxicity of tricyclicsWarfarin	The protease inhibitor increases the anticoagulant effectSodium bicarbonate	This gastric pH modifier decreases the levels/effect of atazanavirTenofovir	Tenofovir decreases the levels/effects of atazanavir 
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    CYP450  Drug Interaction | 
    
      [CYP450 TableÁ÷Á¢Á¶È¸] 
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    | Drug Target | 
    
      
      [Drug Target]
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    | Description | 
    
       atazanavir¿¡ ´ëÇÑ Description Á¤º¸ Atazanavir (formerly known as BMS-232632) is an antiretroviral drug of the protease inhibitor (PI) class. Like other antiretrovirals, it is used to treat infection of human immunodeficiency virus (HIV). Atazanavir is distinguished from other PIs in that it can be given once-daily (rather than requiring multiple doses per day) and has lesser effects on the patient's lipid profile (the amounts of cholesterol and other fatty substances in the blood). Like other protease inhibitors, it is used only in combination with other HIV medications. The U.S. Food and Drug Administration (FDA) approved atazanavir on June 20, 2003. [Wikipedia] 
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    | Dosage Form | 
    
       atazanavir¿¡ ´ëÇÑ Dosage_Form Á¤º¸ Capsule	Oral 
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    | Drug Category | 
    
       atazanavir¿¡ ´ëÇÑ Drug_Category Á¤º¸ Anti-HIV AgentsHIV Protease InhibitorsProtease Inhibitors 
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    | Smiles String Canonical | 
    
       atazanavir¿¡ ´ëÇÑ Smiles_String_canonical Á¤º¸ COC(=O)NC(C(=O)NC(CC1=CC=CC=C1)C(O)CN(CC1=CC=C(C=C1)C1=CC=CC=N1)NC(=O)C(NC(=O)OC)C(C)(C)C)C(C)(C)C 
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    | Smiles String Isomeric | 
    
       atazanavir¿¡ ´ëÇÑ Smiles_String_isomeric Á¤º¸ COC(=O)N[C@H](C(=O)N[C@@H](CC1=CC=CC=C1)[C@@H](O)CN(CC1=CC=C(C=C1)C1=CC=CC=N1)NC(=O)[C@@H](NC(=O)OC)C(C)(C)C)C(C)(C)C 
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    | InChI Identifier | 
    
       atazanavir¿¡ ´ëÇÑ InChI_Identifier Á¤º¸ InChI=1/C38H52N6O7/c1-37(2,3)31(41-35(48)50-7)33(46)40-29(22-25-14-10-9-11-15-25)30(45)24-44(43-34(47)32(38(4,5)6)42-36(49)51-8)23-26-17-19-27(20-18-26)28-16-12-13-21-39-28/h9-21,29-32,45H,22-24H2,1-8H3,(H,40,46)(H,41,48)(H,42,49)(H,43,47)/t29-,30-,31+,32+/m0/s1/f/h40-43H 
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    | Chemical IUPAC Name | 
    
       atazanavir¿¡ ´ëÇÑ Chemical_IUPAC_Name Á¤º¸ methyl N-[(2S)-1-[[(2S,3S)-3-hydroxy-4-[[[(2S)-2-(methoxycarbonylamino)-3,3-dimethylbutanoyl]amino]-[(4-pyridin-2-ylphenyl)methyl]amino]-1-phenylbutan-2-yl]amino]-3,3-dimethyl-1-oxobutan-2-yl]carbamate 
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                          ÀüÈ: 02-3486-1061 ¤Ó À̸ÞÀÏ: webmaster@druginfo.co.kr
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