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                                          ÃëÇÏ                   
                                          
                              (2021.01.28) 
                                          
                       
                     
                    
                     
                        
	    				   BIT ¾àÈ¿ºÐ·ù 
                        
                          Ç×È÷½ºÅ¸¹Î & Ç׾˷¯Áö¾à (Antihistamines & antiallergics)
                         
                     
                    
                    
                      
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                      149[±âŸÀÇ ¾Ë·¹¸£±â¿ë¾à                                             ] 
                     
                    
                      
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644805170Àú°¡¾à ´ëü Àμ¾Æ¼ºê Áö±Þ ´ë»ó   \0 ¿ø/1Á¤(2020.11.01) (ÇöÀç¾à°¡) \457 ¿ø/1Á¤(2017.02.01) (º¯°æÀü¾à°¡) 
                         
                        
						     
						     
                         
                      
                     
                       
                     
                     
                    
                       ATCÄÚµå 
                      Epinastine  / R06AX24 
                     
                    
                    
                       NDCÄÚµå 
                      
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2. ¾Ë·¹¸£±âºñ¿°
3. µÎµå·¯±â, ½ÀÁø¤ýÇǺο°, ÇǺΰ¡·Á¿ò, °¡·Á¿ò¹ßÁø(åÊòÖ), °¡·Á¿òÀ» µ¿¹ÝÇÑ º¸Åë°Ç¼±
      
     
   
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
    
  
  
  
  
  
   
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2. ¾Ë·¹¸£±âºñ¿°
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2) 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 ¾È µÈ´Ù.
 
   
  
  
  
  
   
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10) ºóµµºÒ¸íÀÇ ¿©¼ºÇü À¯¹æ, À¯¹æÁ¾´ë, µå¹°°Ô ¿ù°æÀÌ»ó, Ȳö°Å¸², ¾´¸À, ¹Ì°¢ÀúÇÏ, °¡½¿ÅëÁõ µîÀÌ ³ªÅ¸³¯ ¼ö ÀÖ´Ù.
      
     
   
        
  
  
    
   
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2) ÁøÁ¤È¿°ú°¡ ¾ø´Â ´Ù¸¥ Ç×È÷½ºÅ¸¹ÎÁ¦µé°ú´Â ´Þ¸® ÀÌ ¾àÀº ÁÖ·Î ºñ´ë»çü·Î ¹è¼³µÈ´Ù. ÀÌ ¾àÀº CYP1A2, CYP2C9, CYP2D6, CYP2E1, CYP3A4 ¿Í »óÈ£ÀÛ¿ëÀ» ÀüÇô ÇÏÁö ¾Ê°Å³ª °ÅÀÇ ÇÏÁö ¾Ê´Â´Ù. µû¶ó¼ CYP-450¿¡ ÀÇÁ¸ÇÏ¿© ¹è¼³µÇ´Â ´Ù¸¥ ¾à¹°µéÀÇ ´ë»ç¿¡ ¿µÇâÀ» ¹ÌÄ¡Áö ¾ÊÀ» °ÍÀ¸·Î ±â´ëµÈ´Ù.
 
   
  
    
  
  
       	
  
     
  
  
  
  
  
  
 
    
   
  
    
       
      
        
          
            
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	          ÀüüÀӽŠ±â°£º°·Î ¿©·¯µî±ÞÀÌ Á¸ÀçÇÒ ¼ö ÀÖÀ¸¸ç °¡Àå À§Çèµµ°¡ ³ôÀº Á¤º¸¸¸ º¸¿©Áý´Ï´Ù. ´Ü, º¹ÇÕÁ¦ÀÇ °æ¿ì ¸ðµç º¹ÇÕÁ¦¼ººÐ¿¡ ´ëÇÑ ÀÓºÎÅõ¿©µî±ÞÀÌ Ç¥½ÃµÈ°ÍÀº Àý´ë ¾Æ´Ï¸ç Ç¥½ÃµÈ°ÍÁß¿¡ °¡Àå À§Çèµµ°¡ ³ôÀº Á¤º¸¸¸ ³ªÅ¸³³´Ï´Ù. 
	          
	         
	      
	       
	   
	  
	      
	   
	  
	    
	     FDA : Cµî±Þ 
				        
				         (epinastine; )
				        
	   
	  
	  
	  
	     
	     
	     
	     
	     
	     
	   
	 
	
	  
	      
	      
	        *   
	        
	          »ó±â ÀÓºÎÅõ¿©¿¡ ´ëÇÑ Á¤º¸´Â Àü»êó¸® µÇ¸é¼ ÀÔ·Â ¿À·ù °¡´É¼ºÀÌ Á¸ÀçÇÕ´Ï´Ù. ¿À·ù °¡´É¼ºÀ» ÃÖ¼ÒÈÇϱâ À§ÇÏ¿© ¸¹Àº ³ë·ÂÀ» ±â¿ïÀ̰í ÀÖÀ¸³ª, ±× Á¤È®¼º¿¡ ´ëÇÏ¿© È®½ÅÀ» µå¸± ¼ö ¾ø½À´Ï´Ù. ÀÌ¿¡ ´ëÇØ ȸ»ç´Â Ã¥ÀÓÀ» ÁöÁö ¾Ê½À´Ï´Ù. 
	         
	         
	      
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	          ¹Ýµå½Ã °ø½Å·Â ÀÖ´Â ¹®ÇåÀ» ´Ù½Ã Çѹø Âü°í  ÇϽñ⠹ٶó¸ç ÀÇ»ç ¶Ç´Â ¾à»çÀÇ ÆÇ´Ü¿¡ µû¶ó Åõ¿©¿©ºÎ°¡ °áÁ¤µÇ¾î¾ß ÇÕ´Ï´Ù. 
	         
	         
	      
	   
	 
      
     
   
  
  
  	   
  
  	   
  
  	   
  
  
     
      Pharmacokinetics 
      
       
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    DUR (ÀǾàǰ»ç¿ëÆò°¡) 
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	 °í½ÃµÈ º´¿ë±Ý±â ³»¿ëÀº ¾ø½À´Ï´Ù.
	 
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    Mechanism of Action 
    
      Epinastine¿¡ ´ëÇÑ Mechanism_Of_Action Á¤º¸  Epinastine has a multiaction effect that inhibits the allergic response in 3 ways: 1. stabilizes mast cells by preventing mast cell degranulation to control the allergic response, 2. prevents histamine binding to both the H1- and H2 -receptors to stop itching and provide lasting protection, and 3. prevents the release of proinflammatory chemical mediators from the blood vessel to halt progression of the allergic response. 
     
   
  
   
    Pharmacology 
     
      Epinastine¿¡ ´ëÇÑ Pharmacology Á¤º¸  Epinastine is an antihistamine and an inhibitor of histamine release from the mast cell for topical administration to the eyes. Epinastine is indicated for the prevention of itching associated with allergic conjunctivitis. Epinastine is a topically active, direct H1 -receptor antagonist and an inhibitor of the release of histamine from the mast cell. Epinastine is selective for the histamine H1 -receptor and has affinity for the histamine H2 receptor. Epinastine also possesses affinity for the a1-, a2-, and 5-HT2  -receptors. Epinastine does not penetrate the blood/brain barrier and, therefore, is not expected to induce side effects of the central nervous system. 
     
   
  
   
    Protein Binding 
    
      Epinastine¿¡ ´ëÇÑ ´Ü¹é°áÇÕ Á¤º¸  64% 
     
   
  
   
    Half-life 
    
      Epinastine¿¡ ´ëÇÑ ¹Ý°¨±â Á¤º¸  12 hours 
     
   
  
   
    Absorption 
    
      Epinastine¿¡ ´ëÇÑ Absorption Á¤º¸  The absolute bioavailability of epinastine is about 40%. 
     
   
  
   
    Pharmacokinetics 
    
      Epinastine HClÀÇ ¾à¹°µ¿·ÂÇÐÀÚ·á  
Èí¼öÀ² : ¾à 40%
 »ýü³»ÀÌ¿ë·ü : ¾à 39%
 ¹Ý°¨±â : 9.2 ½Ã°£
 Ç÷ÁßÃÖ°í³óµµ µµ´Þ½Ã°£ : 1.9 ½Ã°£
 ¼Ò½Ç : ¼Òº¯ (¾à 25%)°ú ´ëº¯ (¾à 70%)À» ÅëÇØ ¹è¼³µÈ´Ù.
  
     
   
  
   
    Biotransformation 
    
      Epinastine¿¡ ´ëÇÑ Biotransformation Á¤º¸  Mainly excreted unchanged, less than 10% metabolized. 
     
   
  
   
    CYP450  Drug Interaction 
    
      [CYP450 TableÁ÷Á¢Á¶È¸]  
     
   
  
   
    Drug Target 
    
      
      [Drug Target]  
     
   
  
   
    Description 
    
      Epinastine¿¡ ´ëÇÑ Description Á¤º¸  Epinastine is used for the prevention of itching associated with allergic conjunctivitis. It has a multi-action effect that inhibits the allergic response in 3 ways: 1. stabilizes mast cells by preventing mast cell degranulation to control the allergic response, 2. prevents histamine binding to both the H1- and H2-receptors to stop itching and provide lasting protection, and 3. prevents the release of proinflammatory chemical mediators from the blood vessel to halt progression of the allergic response. 
     
   
  
   
    Dosage Form 
    
      Epinastine¿¡ ´ëÇÑ Dosage_Form Á¤º¸  Solution / drops	Ophthalmic 
     
   
  
   
    Drug Category 
    
      Epinastine¿¡ ´ëÇÑ Drug_Category Á¤º¸  AntihistaminesHistamine H1 AntagonistsOphthalmics 
     
   
  
   
    Smiles String Canonical 
    
      Epinastine¿¡ ´ëÇÑ Smiles_String_canonical Á¤º¸  NC1=NCC2N1C1=CC=CC=C1CC1=CC=CC=C21 
     
   
  
   
    Smiles String Isomeric 
    
      Epinastine¿¡ ´ëÇÑ Smiles_String_isomeric Á¤º¸  NC1=NC[C@H]2[N@]1C1=CC=CC=C1CC1=CC=CC=C21 
     
   
  
   
    InChI Identifier 
    
      Epinastine¿¡ ´ëÇÑ InChI_Identifier Á¤º¸  InChI=1/C16H15N3/c17-16-18-10-15-13-7-3-1-5-11(13)9-12-6-2-4-8-14(12)19(15)16/h1-8,15H,9-10H2,(H2,17,18)/f/h17H2 
     
   
  
   
    Chemical IUPAC Name 
    
      Epinastine¿¡ ´ëÇÑ Chemical_IUPAC_Name Á¤º¸  Not Available 
     
   
    
 
    
     
  
    
       
      
        
          
            
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                          ÀüÈ: 02-3486-1061 ¤Ó À̸ÞÀÏ: webmaster@druginfo.co.kr
 
  
                  
 
               
  
  
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