|
|
|
|
|
À¯·áȸ¿ø °áÀç½Ã¿¡´Â º¸´Ù ´Ù¾çÇÑ ¾à¹°Á¤º¸¸¦
ÀÌ¿ëÇÏ½Ç ¼ö ÀÖ½À´Ï´Ù.
À¯·áÁ¤º¸¸ñ·ÏÀº Àü¹®È¸¿øÀ¸·Î
·Î±×ÀÎ ÇϽøé È®ÀÎ °¡´ÉÇÕ´Ï´Ù.
|
|
|
 | Çã°¡Á¤º¸ |
|
|
| Ç׸ñ |
³»¿ë |
û±¸ÄÚµå(KDÄÚµå) ºñ±Þ¿©Á¡°ËÄÚµå »óÇÑ±Ý¾× |
655403941
[º¸ÇèÄڵ忡 µû¸¥ ¾àǰ±âº»Á¤º¸ Á÷Á¢Á¶È¸]
\12,557 ¿ø/1º´(2024.10.01)(ÇöÀç¾à°¡)
\12,557 ¿ø/1º´(2024.07.01)(º¯°æÀü¾à°¡)
[»óº´ÄÚµåÁ¶È¸]
[Áúº´ÄÚµåÁ¶È¸]
|
| ºü¸¥Á¶È¸ |
|
| Á¦Ç°¼º»ó |
¹é»ö ³»Áö À¯¹é»öÀÇ µ¿°á°ÇÁ¶µÈ °¡·ç°¡ µé¾îÀÖ´Â ¹ÙÀÌ¾Ë [Á¦ÇüÁ¤º¸ È®ÀÎ] |
| Æ÷À塤À¯Åë´ÜÀ§ |
1¹ÙÀ̾Ë/¹Ú½º |
| Æ÷À塤ÄÚµå´ÜÀ§ |
| ¾àǰ±Ô°Ý |
´ÜÀ§ |
Æ÷ÀåÇüÅ |
´ëÇ¥ÄÚµå |
Ç¥ÁØÄÚµå |
ºñ°í |
| 500¹Ð¸®±×·¥ |
1 ¹ÙÀÌ¾Ë |
Vial |
8806554039402 |
8806554039419 |
|
|
| ÁÖ¼ººÐÄÚµå |
134902BIJ
[µ¿ÀÏÇÑ ÁÖ¼ººÐÄڵ带 °¡Áø ¿À¸®Áö³¯ ¶Ç´Â Á¦³×¸¯ ÀǾàǰ Á¶È¸]
|
| Çã°¡»çÇ× ¿ø¹®Á¶È¸ |
[Çã°¡»çÇ× ¿ø¹®Á¶È¸]
|
| È¿´ÉÈ¿°ú |
[ÀûÀÀÁõ º° °Ë»ö]
1. À¯È¿±ÕÁ¾
Ŭ·¡¸®Æ®·Î¸¶À̽ſ¡ °¨¼ö¼ºÀΠȲ»öÆ÷µµ±¸±Õ, Æó·Å¿¬¼â±¸±Õ, ȳ󼺿¬¼â±¸±Õ, ´Ü±¸¼º ¸®½ºÅ׸®¾Æ, ¾ÆÄ®¶ôƼ¾Æ ¿¬¼â±¸±Õ, ³ì»ö¿¬¼â±¸±Õ, Çì¸ðÇʷ罺 ÀÎÇ÷翣ÀÚ, Çì¸ðÇʷ罺 ÆÄ¶óÀÎÇ÷翣ÀÚ, ºê¶õÇϸá¶ó īŸ¶ó¸®½º, ·¹Áö¿À³Ú¶ó ´º¸ðÇʶó, ºê¸£µ¥ÅÚ¶ó ¹éÀÏÇØ, º¸·¼¸®¾Æ ºê¸£±×µµ¸£Æä¸®, Ç츮ÄÚ¹ÚÅÍ ÆÄÀϷθ®, ·¹Áö¿À³Ú¶ó ´º¸ðÇʶó, ÀÓ±Õ, ÆÄ½ºÅð·¼¶ó ¹°Åä½Ã´Ù, Æó·Å, ¹ÌÄÚÇö󽺸¶, Æó·Å Ŭ¶ó¹Ìµð¾Æ, À£Ä¡±Õ, ÆéÅäÄÚÄ¿½º ³ªÀ̰Å, ÇÁ·ÎÇÇ¿À´Ï ¹ÚÅ׸®¿ò ¾ÆÅ©³×½º, ¹ÚÅ×·ÎÀ̵¥½º ¸á¶ó´Ï³ëÁ¦´ÏÄí½º, °èÇü°áÇÙ±º, ³ª±Õ, °ÅºÏ°áÇÙ±º, ¸¶ÀÌÄÚ¹ÚÅ׸®¿ò Ä»ç½Ã, ¸¶ÀÌÄÚ¹ÚÅ׸®¿ò Æ÷ÅõÀÌÅù, ¸¶ÀÌÄÚ¹ÚÅ׸®¿ò ÀÎÆ®¶ó¼¿·ê¶ó
2. ÀûÀÀÁõ
․ Çϱ⵵°¨¿°Áõ : ±â°üÁö¿°, Æó·Å µî
․ »ó±âµµ°¨¿°Áõ : Àεο°, Æíµµ¿°, ºÎºñ°¿° µî
․ ÇǺΠ¹× ÇǺÎÁ¶Á÷ °¨¿°Áõ
․ ¸¶ÀÌÄÚ¹ÚÅ׸®¿ò ¾Æºñ¿ò ¶Ç´Â ¸¶ÀÌÄÚ¹ÚÅ׸®¿ò ÀÎÆ®¶ó¼¿·ê¶ó¿¡ ±âÀÎÇÑ ¸¶ÀÌÄÚ¹ÚÅ׸®¾Æ °¨¿°Áõ
|
| ¾à¹°À½½Ä°£ »óÈ£ÀÛ¿ë |
[Á¶È¸]
|
| ¿ë¹ý¿ë·® |
* Àý´ë ÀÓÀǺ¹¿ëÇÏÁö ¸¶½Ã°í ¹Ýµå½Ã ÀÇ»ç ¶Ç´Â ¾à»ç¿Í »ó´ãÇϽñ⠹ٶø´Ï´Ù.
[󹿾à¾î]
ÀÌ ¾àÀ» 2 ¡ 5ÀÏ µ¿¾È Åõ¿©ÇÑ ´ÙÀ½ °æ±¸¿ë Á¦Á¦·Î ´ëüÇÏ´Â °ÍÀÌ ¹Ù¶÷Á÷ÇÏ´Ù.
¼ºÀο¡°Ô 1ȸ 500 mg(¿ª°¡)À» 1ÀÏ 2ȸ 60ºÐ ÀÌ»ó¿¡ °ÉÃÄ Á¡Àû Á¤¸Æ ÁÖ»çÇÑ´Ù. ÀÌ ¾àÀ» ºí·ç½º(bolus) ÁÖ»çÇϰųª ±ÙÀ°ÁÖ»çÇØ¼´Â ¾È µÈ´Ù. Å©·¹¾ÆÆ¾Ã»¼ÒÀ²ÀÌ 30 mL/min ÀÌÇÏÀÇ ½ÅÀå¾Ö ȯÀÚ¿¡´Â ¿ë·®À» Àý¹ÝÀ¸·Î ÁÙ¿©¾ß ÇÑ´Ù(ÃÑ Ä¡·á±â°£ 14ÀÏ À̳»·Î ÇÑ´Ù).
<ÁÖ»ç¾× Á¶Á¦¹æ¹ý>
1. ÀÌ ¾à 1 ¹ÙÀ̾˿¡ ÁÖ»ç¿ë Áõ·ù¼ö 10 mL¸¦ °¡ÇÏ¿© Èçµé¾î ¿ëÇØÇÑ´Ù(50 mg/mL).
¹Ýµå½Ã ÁÖ»ç¿ë Áõ·ù¼ö¸¦ »ç¿ëÇÏ¿©¾ß ÇÏ¸ç º¸Á¸Á¦³ª ¹«±â¿°À» ÇÔÀ¯ÇÑ Á¦Á¦·Î ¿ëÇØÇØ¼´Â ¾È µÈ´Ù. ÁÖ»ç¿ë¾×Àº 5 ¡ 25 ¡É¿¡¼ º¸°üÇϰí 24½Ã°£ À̳»¿¡ »ç¿ëÇÏ¿©¾ß ÇÑ´Ù.
2. 1.ÀÇ ¿ë¾×À» ¾Æ·¡ÀÇ ¿ë¾× 250 mL¿¡ Èñ¼®ÇÑ´Ù(¾à 2 mg/mL). :
5 % Æ÷µµ´ç in Lactated Ringer's ¾×, 5 % Æ÷µµ´ç, Lactated Ringer's, 5 % Æ÷µµ´ç I in 0.3 % ¿°È³ªÆ®·ý¾×, Normosol-M in 5 % Æ÷µµ´ç, Normosol-R in 5 % Æ÷µµ´ç, 5 % Æ÷µµ´ç in 0.45 % ¿°È³ªÆ®·ý¾×, 0.9 % ¿°È³ªÆ®·ý¾× Èñ¼®¾×(¾à 2 mg/mL)Àº ½Ç¿Â º¸°ü ½Ã 6½Ã°£À̳», 5 ¡É º¸°ü ½Ã 24½Ã°£ À̳»¿¡ ÁÖ»çÇÑ´Ù.
|
| ÁÖ¿ä¾à¹° »óÈ£ÀÛ¿ë |
[Á¶È¸]
|
| ±Ý±â |
1) ÀÌ ¾àÀÇ Ã·°¡Á¦¿¡ °ú¹Î¹ÝÀÀÀÌ Àִ ȯÀÚ
2) Ŭ·¡¸®Æ®·Î¸¶À̽Å, ¿¡¸®Æ®·Î¸¶À̽Š¶Ç´Â ¸¶Å©·Î¶óÀ̵å°è Ç×»ý¹°Áú¿¡ °ú¹Î¹ÝÀÀÀÇ º´·ÂÀÌ Àִ ȯÀÚ
3) Å׸£Æä³ªµò, ½Ã»çÇÁ¸®µå, ÇǸðÁöµå, ¾Æ½ºÅ×¹ÌÁ¹, µ¼Æä¸®µ·À» Åõ¿© ¹Þ°í Àִ ȯÀÚ(Ŭ·¡¸®Æ®·Î¸¶À̽й×(¶Ç´Â) ¿¡¸®Æ®·Î¸¶À̽Űú º´¿ëÅõ¿© ½Ã QT ¿¬Àå ¹× ½ÉºÎÁ¤¸Æ(QT ¿¬Àå, ½É½Ç¼º ºó¸Æ, ½É½Ç¼¼µ¿, Torsades de pointesÆ÷ÇÔ)ÀÌ ³ªÅ¸³ª°í À̴ Ŭ·¡¸®Æ®·Î¸¶À̽Š¹× ¿¡¸®Æ®·Î¸¶À̽ſ¡ ÀÇÇØ ÀÌµé ¾à¹°ÀÇ °£´ë»ç°¡ ¹æÇظ¦ ¹Þ±â ¶§¹®ÀÎ °ÍÀ¸·Î ¿Ü±¹ÀÇ ½ÃÆÇ ÈÄ Á¶»ç°á°ú º¸°íµÇ¾ú´Ù. Ä¡¸íÀûÀÎ »ç·Êµµ º¸°íµÇ¾ú´Ù)(¡®5.»óÈ£Àۿ롯ÂüÁ¶)
4) QT ¿¬Àå(¼±ÃµÀû ¶Ç´Â ¹®¼·Î ±â·ÏµÈ ÈÄõÀû QT ¿¬Àå) ¶Ç´Â ½É½Ç¼º ½ÉºÎÁ¤¸Æ(Torsades de pointes Æ÷ÇÔ)ÀÇ º´·ÂÀÌ Àִ ȯÀÚ
5) ÁßÁõ °£Àå¾Ö ȯÀÚ
6) ¸Æ°¢¾ËÄ®·ÎÀÌµå ¹× ±× À¯µµÃ¼(¿¡¸£°íŸ¹Î, µðÈ÷µå·Î¿¡¸£°íŸ¹Î µî)¸¦ Åõ¿© ¹Þ°í Àִ ȯÀÚ(¸Æ°¢ µ¶¼ºÀÌ ³ªÅ¸³¯ ¼ö ÀÖ´Ù)
7) ÀӺΠ¶Ç´Â ÀÓ½ÅÇϰí ÀÖÀ» °¡´É¼ºÀÌ ÀÖ´Â ¿©¼º ¹× ¼öÀ¯ºÎ
8) ÁßÃ߽Űæ°è °¨¿° ȯÀÚ
9) ¹ÌÁ¹¶ó½ºÆ¾, º£ÇÁ¸®µôÀ» Åõ¿© ¹Þ°í Àִ ȯÀÚ
10) ·Î¹Ù½ºÅ¸Æ¾ ¶Ç´Â ½É¹Ù½ºÅ¸Æ¾((HMG-CoA ȯ¿øÈ¿¼Ò ¾ïÁ¦Á¦)À» Åõ¿© ¹Þ°í Àִ ȯÀÚ(¡®5.»óÈ£Àۿ롯ÂüÁ¶)
11) Ƽī±×·¼·Î(ticagrelor)¸¦ Åõ¿© ¹Þ°í Àִ ȯÀÚ
12) ÄÝŰ½Å(colchicine)À» Åõ¿© ¹Þ°í Àִ ȯÀÚ
13) ÀúÄ®·ýÇ÷Áõ ȯÀÚ(QT¿¬Àå°ú °ü·Ã µÊ)
14) ¹Ì´ÙÁ¹¶÷(°æ±¸¿ë)À» º¹¿ë ÁßÀΠȯÀÚ(¡®5.»óÈ£Àۿ롯ÂüÁ¶)
|
| ½ÅÁßÅõ¿© |
1) °£Àå¾Ö ȯÀÚ(ÁÖ·Î °£À» ÅëÇØ ¹è¼³µÈ´Ù)
2) Áߵ¿¡¼ ÁßÁõÀÇ ½ÅºÎÀü ȯÀÚ(Ç÷Áß ³óµµ°¡ »ó½ÂÇÒ ¼ö ÀÖÀ½)
3) °ü»óµ¿¸ÆÁúȯ, ÀüµµÀå¾Ö ¶Ç´Â ÀÓ»óÀûÀ¸·Î °ü·Ã ÀÖ´Â ¼¸Æ°ú °°Àº ½ÉÁúȯ ȯÀÚ(QT ¿¬Àå, ½É½Ç¼º ºÎÁ¤¸Æ(Torsades de pointes Æ÷ÇÔ)À» ÀÏÀ¸Å³ ¼ö ÀÖÀ½)
4) °í·ÉÀÚ
5) ´Ù¸¥ Ç×»ý¹°Áú(¸¶Å©·Î¶óÀ̵å°è, ¸°ÄÚ¸¶À̽Å, Ŭ¸°´Ù¸¶À̽Å, Ŭ·Î¶÷Æä´ÏÄÝ)µîÀ» Åõ¿© ¹Þ°í Àִ ȯÀÚ(±³Â÷³»¼º¿¡ ÁÖÀÇÇÑ´Ù)
6) ºê·Î¸ðÅ©¸³Æ¾, Ä«º£°ñ¸°, Æä¸£°ñ¸®µå, ¿¡ ¹Ù½ºÆ¾, Ÿũ·Î¸®¹«½º, ÅçÅͷεò, ÇÒ·ÎÆÇµå¸°À» Åõ¿© ¹Þ°í Àִ ȯÀÚ
7) ¾à¹°¿¡ ´ëÇÑ ¾Ë·¹¸£±â°¡ Àִ ȯÀÚ¿¡ Åõ¿©½Ã(ƯÈ÷ ÀÌ ¾àÀÇ ¼ººÐ°ú À¯»çÇÑ ±¸Á¶¸¦ °¡Áø ¾à¹° Åõ¿© ½Ã)¿¡´Â ½ÅÁßÇÏ°Ô Åõ¿©ÇÑ´Ù.
8) Æ®¸®¾ÆÁ¹¶÷°ú °°Àº Æ®¸®¾ÆÁ¹·Îº¥Á¶µð¾ÆÁ¦ÇÉ·ù³ª ¹Ì´ÙÁ¹¶÷(ÁÖ»çÁ¦)À» Åõ¿© ¹Þ°í Àִ ȯÀÚ
9) Àú¸¶±×³×½·Ç÷Áõ°ú °°Àº ÀüÇØÁú ºÒ±ÕÇü ȯÀÚ
|
| ÀÌ»ó¹ÝÀÀ |
1) ¼îÅ©, ¾Æ³ªÇʶô½Ã½º ¸ð¾ç Áõ»ó : µå¹°°Ô ¼îÅ©, ¾Æ³ªÇʶô½Ã½º ¸ð¾ç Áõ»ó(È£Èí °ï¶õ, °æ·Ã, ¹ßÀû µî)À» ÀÏÀ¸Å³ ¼ö ÀÖÀ¸¹Ç·Î °üÂûÀ» ÃæºÐÈ÷ Çϰí ÀÌ»ó¹ÝÀÀÀÌ ³ªÅ¸³ª´Â °æ¿ì¿¡´Â Åõ¿©¸¦ ÁßÁöÇϰí ÀûÀýÇÑ Ã³Ä¡¸¦ ÇÑ´Ù.
2) °ú¹Î¹ÝÀÀ : ¶§¶§·Î ¹ßÁø, µå¹°°Ô °¡·Á¿ò, µÎµå·¯±â, °æÁõÀÇ ÇǺΠ¹ßÀû, Ç÷°üºÎÁ¾, °üÀý ºÎÁ¾, ¾à¹° ¹ßÁø µîÀÌ ³ªÅ¸³¯ ¼ö ÀÖ´Ù.
3) ¼Òȱâ°è : ¶§¶§·Î º¹ºÎ ÆØ¸¸°¨, ±¸¿ª, ±¸Åä, ¼ÒȺҷ®, º¹Åë/ºÒÄè°¨, °¡½º Âü, ¼³»ç, ±¸°³»¹Ì¶õ, »óº¹ºÎ ÅëÁõ(µå¹°°Ô °æ·ÃÇüÅÂ), ±¸°¥, Àϰú¼º Ä¡¾Æº¯»ö, µå¹°°Ô ÃéÀå¿°, ¾Æ¹Ð¶óÁ¦ Áõ°¡, ¹Ì°¢ ÀÌ»ó, ½Ä¿åºÎÁø, º¯ºñ, ¼³º¯»ö µîÀÇ À§Àå°ü Àå¾Ö°¡ ³ªÅ¸³µ´Ù´Â º¸°í°¡ ÀÖ´Ù. À§¸·¼º´ëÀå¿°, ÃâÇ÷¼º´ëÀå¿° µî Ç÷º¯À» µ¿¹ÝÇÑ ´ëÀå¿°ÀÌ ³ªÅ¸³¯ ¼ö ÀÖÀ¸¹Ç·Î º¹Åë, ºó¹øÇÑ ¼³»ç°¡ ³ªÅ¸³ª´Â °æ¿ì¿¡´Â Åõ¿©¸¦ ÁßÁöÇϰí ÀûÀýÇÑ Ã³Ä¡¸¦ ÇÑ´Ù.
4) È£Èí±â°è : ¹ß¿, ±âħ, È£Èí°ï¶õ, ÈäºÎ X¼± ÀÌ»ó, È£»ê±¸ Áõ°¡ µîÀ» ¼ö¹Ý Çϴ ȣ»ê±¸¼ºÆóħÀ±, °£Áú¼ºÆó·Å µîÀÌ »ý±æ ¼ö ÀÖÀ¸¹Ç·Î ÀÌ¿Í °°Àº Áõ»óÀÌ ¹ß»ýÇϸé Åõ¿©¸¦ ÁßÁöÇϰí ÄÚ¸£Æ¼ÄÚÀ̵åÀÇ Åõ¿© µî ÀûÀýÇÑ Ã³Ä¡¸¦ ½Ç½ÃÇÑ´Ù. ¸¸¼º±â°üÁö¿° ¹× ±Þ¼º »ó¾Çµ¿¿°ÀÇ ±Þ¼º ¾Çȵµ °üÂûµÇ¾ú´Ù.
5) Ç÷¾×°è : ¶§¶§·Î È£»ê±¸ Áõ°¡, Ç÷¼ÒÆÇ °¨¼Ò, ¹üÇ÷±¸ °¨¼Ò, ¿ëÇ÷¼º ºóÇ÷, ¹éÇ÷±¸ °¨¼Ò, ¹«°ú¸³±¸Áõ µîÀÌ ³ªÅ¸³ª±âµµ ÇϹǷΠÁ¤±âÀûÀ¸·Î °Ë»çÇÏ¿© ÃæºÐÈ÷ °üÂûÀ» Çϰí ÀÌ»ó¹ÝÀÀÀÌ ³ªÅ¸³ª¸é Åõ¿©¸¦ ÁßÁöÇÏ´Â µî ÀûÀýÇÑ Ã³Ä¡¸¦ ÇÑ´Ù.
6) ÁßÃ߽Űæ°è : ¾îÁö·¯¿ò, ¿ì¿ï, ¹Ì°¢¼Ò½Ç , Èİ¢»ó½Ç, ºÒ¾È, µå¹°°Ô ºÒ¸é, ¾Ç¸ù, À̸í, Âø¶õ, Áö³²·ÂÀå¾Ö, ȯ°¢, Á¤½Åº´, ÀÌÀÎÁõ, °æ·Ã(°Á÷°£´ë¼º, °£´ë¼º±Ù°æ·ÃÁõ, ÀǽļҽǹßÀÛ µî), ¶³¸², ¸¶ºñ°¨ µî Àϰú¼º ÁßÃ߽Űæ°è ÀÌ»ó¹ÝÀÀÀÌ ³ªÅ¸³µ´Ù´Â º¸°í°¡ ÀÖÀ¸³ª ÀÌ ¾à°úÀÇ °ü·Ã ¿©ºÎ´Â ¹àÇôÁöÁö ¾Ê¾Ò´Ù. Çൿº¯È, Á¶ÁõÇൿÀÌ ³ªÅ¸³µÀ¸³ª ¾à¹°Åõ¿©¸¦ Áß´ÜÇÏ¸é ¼Ò½ÇµÈ´Ù. ¿©·¯ °¡Áö ÀÌ»ó¹ÝÀÀÀÌ ³ªÅ¸³¯ ¼ö ÀÖÀ¸¹Ç·Î °üÂûÀ» ÃæºÐÈ÷ Çϰí ÀÌ»ó¹ÝÀÀÀÌ ³ªÅ¸³ª´Â °æ¿ì¿¡´Â Åõ¿©¸¦ ÁßÁöÇϰí ÀûÀýÇÑ Ã³Ä¡¸¦ ÇÑ´Ù.
7) ÇǺΠ: ½ºÆ¼ºì½¼-Á¸½¼ÁõÈıº, µ¶¼ºÇ¥ÇDZ«»ç¿ëÇØ µîÀÌ ¹ß°ßµÇ±âµµ ÇϹǷΠÀß °üÂûÇϰí ÀÌ»ó ¹ÝÀÀÀÌ ³ªÅ¸³ª´Â °æ¿ì¿¡´Â Åõ¿©¸¦ ÁßÁöÇÏ°í ºÎ½Å ÇÇÁú È£¸£¸óÁ¦ÀÇ Åõ¿© µî ÀûÀýÇÑ Ã³Ä¡¸¦ ½Ç½ÃÇÑ´Ù. ¾Ë·¹¸£±â¼º Àڹݺ´ÀÌ ³ªÅ¸ ³¯ ¼ö ÀÖÀ¸¹Ç·Î °üÂûÀ» ÃæºÐÈ÷ Çϰí ÀÌ»ó¹ÝÀÀÀÌ ³ªÅ¸³ª´Â °æ¿ì¿¡´Â Åõ¿©¸¦ ÁßÁöÇϰí ÀûÀýÇÑ Ã³Ä¡¸¦ ÇÑ´Ù. ½ÃÆÇ ÈÄ °æÇè Áß ¡®È£»ê±¸ Áõ°¡¿Í Àü½Å¼º Áõ»óÀ» µ¿¹ÝÇÑ ¾à¹° ¹ßÁø(DRESS ; drug rash with eosinophilla and systemic symptoms)'ÀÌ ³ªÅ¸³µ´Ù.
8) °£Àå : ´Ù¸¥ ¸¶Å©·Î¶óÀ̵å°è Ç×»ý¹°Áú°ú ¸¶Âù°¡Áö·Î µå¹°°Ô Ȳ´ÞÀ» µ¿¹ÝÇϰųª ¶Ç´Âµ¿¹ÝÇÏÁö ¾Ê´Â °£¼¼Æ÷¼º ¶Ç´Â ´ãÁó¿ïü¼º °£¿°, °£È¿¼ÒÄ¡ÀÇ Áõ°¡¸¦ Æ÷ÇÔÇÑ °£±â´ÉÀå¾Ö°¡ ³ªÅ¸³µ´Ù´Â º¸°í°¡ ÀÖ´Ù. ÀÌ·¯ÇÑ °£ ±â´É Àå¾Ö´Â ÁßÁõÀÏ ¼ö ÀÖÀ¸¸ç, ´ëü·Î °¡¿ªÀûÀÌ´Ù. ¸î¸î °æ¿ì, »ç¸Á(fatal outcome)À» µ¿¹ÝÇÑ °£ºÎÀüÀÌ º¸°íµÈ ¹Ù ÀÖÀ¸¸ç ÀÌ´Â ´ëü·Î ÁßÁõÀÇ ±âÀúÁúȯ ¹×/¶Ç´Â º´¿ë Åõ¿©µÈ ¾àÁ¦¿Í °ü·ÃÀÌ ÀÖ¾ú´Ù. Àü°Ý¼º°£¿°, AST, ALT, ¥ã-GTP, LDH, ALP »ó½Â, ÃÑ ºô¸®·çºó Áõ°¡ µîÀ» µ¿¹ÝÇÑ °£±â´É Àå¾Ö, Ȳ´Þ, °£ºÎÀüÀÌ ³ªÅ¸³¯ ¼ö ÀÖÀ¸¹Ç·Î °üÂûÀ» ÃæºÐÈ÷ ÇÏ°í ½Ä¿åºÎÁø, Ȳ´Þ, ÁøÇÑ »öÀÇ ´¢, °¡·Á¿òÁõ ¶Ç´Â º¹ºÎ¾ÐÅë µî°ú °°Àº °£¿°ÀÇ Áõ»ó°ú ¡Èİ¡ ³ªÅ¸³¯ °æ¿ì Åõ¿©¸¦ ÁßÁöÇϰí ÀûÀýÇÑ Ã³Ä¡¸¦ ÇÑ´Ù.
9) ½ÅÀå : µå¹°°Ô Ç÷ûũ·¹¾ÆÆ¼´Ñ »ó½ÂÀÌ ÀϾ´Ù´Â º¸°í°¡ ÀÖÀ¸³ª, ÀÌ ¾à°úÀÇ °ü·Ã¿©ºÎ´Â ¹àÇôÁöÁö ¾Ê¾Ò´Ù. µå¹°°Ô º¹¿ë·®ÀÌ ¸¹À» ¶§ BUNÀÌ »ó½ÂÇÑ´Ù´Â º¸°í°¡ ÀÖ´Ù. °£Áú¼º½Å¿°, ½ÅºÎÀü, ÃéÀå¿° µîÀÌ º¸°íµÇ¾ú´Ù. ±ÙÀ°Åë, ¹«·Â°¨, Å©·¹¾ÆÆ¾Å°³ª¾ÆÁ¦(CK) »ó½Â, Ç÷Áß ¹× ¿äÁß ¹Ì¿À±Û·Îºó »ó½ÂÀ» Ư¡À¸·Î Çϴ Ⱦ¹®±ÙÀ¶ÇØÁõÀÌ ³ªÅ¸³¯ ¼ö ÀÖÀ¸¹Ç·Î °üÂûÀ» ÃæºÐÈ÷ ½Ç½ÃÇϰí ÀÌ»ó¹ÝÀÀÀÌ ³ªÅ¸³ª´Â °æ¿ì¿¡´Â Åõ¿©¸¦ ÁßÁöÇϰí ÀûÀýÇÑ Ã³Ä¡¸¦ ÇÏ´Â µî Ⱦ¹®±ÙÀ¶ÇØÁõ¿¡ ÀÇÇÑ ±Þ¼º½ÅºÎÀüÀÌ ³ªÅ¸³¯ ¼ö ÀÖÀ¸¹Ç·Î ÁÖÀÇÇÑ´Ù. ÇÌ´¢ µîÀÇ Áõ»óÀ̳ª Ç÷ûũ·¹¾ÆÆ¼´ÑÄ¡ »ó½Â µî ½Å±â´É ÀúÇϰ¡ ³ªÅ¸³ª´Â °æ¿ì¿¡´Â Åõ¿©¸¦ ÁßÁöÇϰí ÀûÀýÇÑ Ã³Ä¡¸¦ ÇÑ´Ù.
10) ±Õ±³´ëÁõ : µå¹°°Ô Çô¿°, ±¸³»¿°, ±¸°Äµð´ÙÁõÀÌ ³ªÅ¸³µ´Ù´Â º¸°í°¡ ÀÖ´Ù.
11) ¼øÈ¯±â°è : ´Ù¸¥ ¸¶Å©·Î¶óÀ̵å°è¿Í °°ÀÌ µå¹°°Ô QT ¿¬Àå, ½É½Ç¼ººó¸Æ ¹× Torsades de Pointes°¡ µå¹°°Ô º¸°íµÇ¾ú´Ù.
12) ±âŸ : µå¹°°Ô ±Çۨ, µÎÅë, ¹Ì°¢µµÂø, °¡¿ªÀûÀΠû°¢»ó½Ç, ÀÌ»ó °¨°¢Áõ, °üÀýÅë, ±ÙÀ°Åë, Èİ¢Àå¾Ö°¡ ³ªÅ¸³µ´Ù´Â º¸°í°¡ ÀÖ´Ù. À̸í, û°¢Àå¾ÖÀÎ °æ¿ì ÀϹÝÀûÀ¸·Î Åõ¿©¸¦ Áß´ÜÇÏ¸é °¨¼ÒµÉ ¼ö ÀÖÀ¸³ª, Åõ¿© ¿¬Àå±â°£ µ¿¾È 1ÀÏ 1 gÀÌ»ó Åõ¿© ½Ã ´Ù½Ã ³ªÅ¸³¯ ¼ö ÀÖ´Ù. °æ±¸ ÀúÇ÷´ç¾à¹° ¶Ç´Â Àν¶¸°À» Åõ¿© ¹Þ´Â ȯÀÚ¿¡°Ô¼ µå¹°°Ô ÀúÇ÷´çÁõÀÌ ³ªÅ¸³µ´Ù´Â º¸°í°¡ ÀÖ´Ù. ½ÃÆÇ ÈÄ °æÇè Áß È¾¹®±ÙÀ¶ÇØÁõÀÌ º¸°íµÇ¾ú´Ù. ÀϺΠȾ¹®±ÙÀ¶ÇØÁõÀÇ º¸°í¿¡¼ Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀº ½ºÅ¸Æ¾°è, ÇǺ극ÀÌÆ®°è, ÄÝŰ½Å ¶Ç´Â ¾Ë·ÎǪ¸®³î°ú º´¿ë Åõ¿© µÇ¾ú¾ú´Ù.
13) ÄÝŰ½Å°ú º´¿ë Åõ¿© ½Ã ƯÈ÷ °í·ÉÀÚ¿Í ÀϺΠ½ÅºÎÀü ȯÀÚ¿¡¼ ÄÝŰ½Å µ¶¼ºÀÌ ³ªÅ¸³µ´Ù´Â ½ÃÆÇ ÈÄ º¸°í°¡ ÀÖ¾ú´Ù. À̵é ȯÀÚ Áß ÀϺο¡¼´Â »ç¸Á »ç·Êµµ º¸°íµÇ¾ú´Ù. ÀÌ ¾à°ú ÄÝŰ½ÅÀº º´¿ëÅõ¿© ÇÏÁö ¾Ê´Â´Ù.
14) Ŭ·¡¸®Æ®·Î¸¶À̽Űú °ü·ÃÀÌ ÀÖÀ» ¼ö ÀÖ´Ù°í ÆÇ´ÜµÇ´Â ÀÌ»ó¹ÝÀÀÀ» Àü½ÅÁ¶Á÷ºÐ·ù¿Í ´ÙÀ½°ú °°Àº ºóµµºÐ·ù¿¡ µû¶ó ¾Æ·¡ Ç¥·Î ³ªÅ¸³»¾ú´Ù : ¸Å¿ì ÈçÇϰÔ(¡Ã 1/10), ÈçÇϰÔ(¡Ã 1/100 ¡ < 1/10), ÈçÇÏÁö ¾Ê°Ô(¡Ã 1/1000 ¡ 1/100), ±×¸®°í not known(½ÃÆÇÈÄ Á¶»ç¿¡¼ ³ªÅ¸³ ÀÌ»ó¹ÝÀÀÀ¸·Î µ¥ÀÌÅͷκÎÅÍ ÃßÁ¤ÇÒ ¼ö ¾øÀ½). °¢ Ä¿¡¼ ÀÌ»ó¹ÝÀÀÀº Áß´ëÇÔÀÌ Æò°¡ °¡´ÉÇÒ °æ¿ì Áß´ëÇÔÀÌ Å« ¼ø¼ºÎÅÍ ±âÀçÇÏ¿´´Ù.
| Ŭ·¡¸®Æ®·Î¸¶À̽ſ¡ ´ëÇØ º¸°íµÈ ÀÌ»ó¹ÝÀÀ |
| Àü½ÅÁ¶Á÷ºÐ·ù |
¸Å¿ì ÈçÈ÷ ¡Ã 1/10 |
ÈçÈ÷ ¡Ã 1/100~< 1/10 |
µå¹°°Ô ¡Ã 1/1000~1/100 |
not known* (µ¥ÀÌÅͷκÎÅÍ ÃßÁ¤ÇÒ ¼ö ¾øÀ½) |
| °¨¿° ¹× ±â»ýÃæÄ§ÀÔ |
|
|
¿¬Á¶Á÷¿°1, ĵð´ÙÁõ, À§Àå¿°2, °¨¿°3, Áú°¨¿° |
À§¸·¼º´ëÀå¿°, ´Üµ¶, ¾èÀº¿¬Á¶Á÷¿°, È«»öÀ½¼± |
| Ç÷¾× ¹× ¸²ÇÁ°è |
|
|
¹éÇ÷±¸°¨¼ÒÁõ, È£Áß±¸°¨¼ÒÁõ4, °íÇ÷¼ÒÆÇÁõ3, È£»ê±¸Áõ°¡Áõ4 |
¹«°ú¸³±¸Áõ, ÀúÇ÷¼ÒÆÇÁõ |
| ¸é¿ª°è Àå¾Ö |
|
|
¾Æ³ªÇʶô½Ã½º¾ç ¹ÝÀÀ1, °ú¹Î¼º |
¾Æ³ªÇʶô½Ã½º¹ÝÀÀ, Ç÷°üºÎÁ¾ |
| ´ë»ç ¹× ¿µ¾ç Àå¾Ö |
|
|
½Ä¿åºÎÁø, ½Ä¿å°¨¼Ò |
ÀúÇ÷´çÁõ |
| Á¤½Å Àå¾Ö |
|
ºÒ¸éÁõ |
ºÒ¾È, ½Å°æ°ú¹Î3, ¼Ò¸®Áö¸§3 |
Á¤½Åº´¼º Àå¾Ö, È¥µ· »óÅÂ, ÀÌÀÎÁõ, ¿ì¿ïÁõ, Áö³²·ÂÀå¾Ö, ȯ°¢, ºñÁ¤»óÀûÀÎ ²Þ(abnormal dreams), Á¶Áõ |
| ½Å°æ°è Àå¾Ö |
|
¹Ì°¢ÀÌ»ó, µÎÅë, ¹Ì°¢µµÂø |
ÀǽĻó½Ç1, ¿îµ¿ÀÌ»óÁõ1, ºñÀüÁ¤¼º Çö±âÁõ, Á¹À½, ÁøÀü |
°æ·Ã, ¹Ì°¢¼Ò½Ç, ÀÌ»óÈİ¢, Èİ¢»ó½Ç |
| ±Í ¹× ¹Ì·Î Àå¾Ö |
|
|
ÀüÁ¤¼º Çö±âÁõ, û·ÂÀå¾Ö, À̸í |
³Ã» |
| ½É Àå¾Ö |
|
|
½ÉÀåÁ¤Áö1, ½É¹æ¼¼µ¿1, ½ÉÀüµµQT¿¬Àå, ÁÖ±â¿Ü¼öÃà1, ½É°èÇ×Áø |
Torsade de pointes, ½É½Ç¼ººó¸Æ, ½É½Ç¼¼µ¿ |
| Ç÷°ü Àå¾Ö |
|
Ç÷°üÈ®Àå1 |
|
ÃâÇ÷ |
| È£Èí±â, ÈäºÎ ¹× Á¾°Ý Àå¾Ö |
|
|
õ½Ä1, ºñÃâÇ÷2, Æó»öÀüÁõ1 |
|
| À§Àå°ü Àå¾Ö |
|
¼³»ç, ±¸Åä, ¼ÒȺҷ®, ±¸¿ª, º¹Åë |
½Äµµ¿°1, À§½Äµµ¿ª·ùº´2, À§¿°, Á÷ÀåÅëÁõ2, ±¸³»¿°, ¼³¿°, º¹ºÎÆØ¸¸4, º¯ºñ, ±¸°¥, Æ®¸², °íâ |
±Þ¼ºÃéÀå¿°, Çô º¯»ö, Ä¡¾Æ º¯»ö |
| °£±â´É Àå¾Ö |
|
°£±â´É°Ë»ç ÀÌ»ó |
´ãÁóÁ¤Ã¼4, °£¿°4, ¾Ë¶ó´Ñ ¾Æ¹Ì³ëÆ®·£½ºÆÛ¶ó¾ÆÁ¦ »ó½Â, ¾Æ½ºÆÄÅ×ÀÌÆ® ¾Æ¹Ì³ëÆ®·£½ºÆÛ¶ó¾ÆÁ¦ »ó½Â, °¨¸¶-±Û·çŸ¹ÐÆ®·£½ºÆÛ¶ó¾ÆÁ¦ »ó½Â4 |
°£ºÎÀü, °£¼¼Æ÷¼º Ȳ´Þ |
| ÇǺΠ¹× ÇÇÇÏÁ¶Á÷ Àå¾Ö |
|
¹ßÁø, ´ÙÇÑÁõ |
¼öÆ÷¼º ÇǺο°1, °¡·Á¿ò, µÎµå·¯±â, ¹Ý±¸Áø¼º ¹ßÁø3 |
½ºÆ¼ºì½º-Á¸½¼ ÁõÈıº, µ¶¼ºÇ¥ÇǼº±«»ç¿ëÇØ, È£»ê±¸Áõ°¡¿Í Àü½Å¼º Áõ»óÀ» µ¿¹ÝÇÑ ¾à¹° ¹ßÁø (DRESS : drug rash with eosinophilla and systemic symptoms), ¿©µå¸§, Henoch-Schonlein ÀÚ¹ÝÁõ |
| ±Ù°ñ°Ý ¹× °áÇÕÁ¶Á÷ Àå¾Ö |
|
|
±ÙÀ°¿¬Ãà3, ±Ù°ñ°Ý °æÁ÷1, ±ÙÀ°Åë2 |
Ⱦ¹®±ÙÀ¶ÇØ2, ±ÙÀ°º´Áõ |
| ½ÅÀå ¹× ºñ´¢±â Àå¾Ö |
|
|
Ç÷ÁßÅ©·¹¾ÆÆ¼´Ñ »ó½Â1, Ç÷Áß¿ä¼Ò »ó½Â1 |
½ÅºÎÀü, ½ÅÀå¿° |
| ÀϹÝÀû Àå¾Ö ¹× Åõ¿©ºÎÀ§»óÅ |
ÁÖ»çºÎÀ§Á¤¸Æ¿°1 |
ÁÖ»çºÎÀ§ÅëÁõ1, ÁÖ»çºÎÀ§¿°Áõ1 |
±Çۨ4, ¹ß¿3, ¹«·ÂÁõ, ÈäÅë4, ¿ÀÇÑ4, ÇÇ·Î4 |
|
| °Ë»ç¼öÄ¡ÀÌ»ó |
|
|
¾ËºÎ¹Î±Û·ÎºÒ¸°ºñ ÀÌ»ó1, Ç÷Áß ¾ËÄ®¸®¼º Æ÷½ºÆÄŸ¾ÆÁ¦ »ó½Â4, Ç÷Áß ¶ôÆ®»êÅ»¼ö¼ÒÈ¿¼Ò »ó½Â4 |
±¹Á¦Ç¥ÁØÈºñÀ²(INR) Áõ°¡, ÇÁ·ÎÆ®·Òºó½Ã°£ ¿¬Àå, ´¢ »ö ÀÌ»ó |
| * ÀÌ Ç×ÀÇ ÀÌ»ó¹ÝÀÀµéÀº ºÒ¸íÈ®ÇÑ Å©±âÀÇ Áý´ÜÀ¸·ÎºÎÅÍ ÀÚ¹ßÀûÀ¸·Î º¸°íµÈ °ÍÀ̹ǷÎ, ±× ºóµµ¸¦ ½Å·ÚÇÒ ¼ö ÀÖµµ·Ï È®¸³Çϰųª, ÀÌ»ó¹ÝÀÀ°ú ¾à¹°³ëÃâ°úÀÇ Àΰú°ü°è¸¦ È®¸³ÇÏ´Â °ÍÀÌ Ç×»ó °¡´ÉÇÑ °ÍÀº ¾Æ´Ï´Ù. ȯÀÚ³ëÃâ(patient exposure)Àº Ŭ·¡¸®Æ®·Î¸¶À̽ſ¡ ´ëÇØ 10¾ï patient treatment days¸¦ ÃʰúÇÒ °ÍÀ¸·Î ¿¹»óµÈ´Ù. 1 ÁÖ»çÁ¦Çü¿¡ ´ëÇØ¼¸¸ º¸°íµÈ ÀÌ»ó¹ÝÀÀ 2 ¼¹æÁ¦Çü¿¡ ´ëÇØ¼¸¸ º¸°íµÈ ÀÌ»ó¹ÝÀÀ 3 °ÇÁ¶½Ã·´Á¦Çü¿¡ ´ëÇØ¼¸¸ º¸°íµÈ ÀÌ»ó¹ÝÀÀ 4 ¼Ó¹æÁ¦Çü¿¡ ´ëÇØ¼¸¸ º¸°íµÈ ÀÌ»ó¹ÝÀÀ |
|
| »óÈ£ÀÛ¿ë |
1) ±âŸ ³»À̵¶¼ºÀÌ ÀÖ´Â ¾à¹°, ƯÈ÷ ¾Æ¹Ì³ë±Û¸®ÄÚ»çÀ̵å¿Í´Â º´¿ëÅõ¿©ÇÏÁö ¾Ê´Â´Ù.
2) Å׿ÀÇʸ° ¶Ç´Â Ä«¸£¹Ù¸¶Á¦Çɰú º´¿ë Åõ¿©ÇÏ´Â °æ¿ì¿¡´Â ÀÌµé ¾à¹°ÀÇ Ç÷û³óµµ°¡ Áõ°¡ÇÑ´Ù´Â º¸°í°¡ ÀÖÀ¸¹Ç·Î °í¿ë·®ÀÇ Å׿ÀÇʸ°À» Åõ¿©Çϰųª Å׿ÀÇʸ° ±âÀú ³óµµ°¡ »óÀ§ Ä¡·á³óµµ¹üÀ§ÀÎ °æ¿ì Å׿ÀÇʸ°ÀÇ Ç÷Áß ³óµµ ¸ð´ÏÅ͸µÀ» °í·ÁÇØ¾ß Çϸç Ä«¸£¹Ù¸¶Á¦Çɰú º´¿ëÅõ¿© ½Ã Ç÷Áß³óµµ ¸ð´ÏÅ͸µÀ» °í·ÁÇÒ ¼ö ÀÖ´Ù. Å׿ÀÇʸ°¼¹æÁ¤ 6.5 mg/kg ¶Ç´Â 12 mg/kg°ú 12½Ã°£¸¶´Ù ÀÌ ¾à 250 mg ¶Ç´Â 500 mgÀ» º´¿ëÅõ¿©ÇÑ ÀÓ»ó½ÃÇè¿¡¼ Å׿ÀÇʸ°ÀÇ Ç×Á¤»óÅ Cmax, Cmin°ú Ç÷Áß°î¼±ÇϸéÀû(AUC)ÀÌ ¾à 20 %Áõ°¡Çß´Ù.
3)
(1) CYP-450°è·Î ´ë»çµÇ´Â ¾à¹°(¿ÍÆÄ¸°, ¸Æ°¢¾ËÄ®·ÎÀ̵å, Æ®¸®¾ÆÁ¹¶÷, ¹Ì´ÙÁ¹¶÷, ·Î¹Ù½ºÅ¸Æ¾, ½É¹Ù½ºÅ¸Æ¾, ¾ÆÅ丣¹Ù½ºÅ¸Æ¾, µð¼ÒÇǶó¹Ìµå, Æä´ÏÅäÀÎ, »çÀÌŬ·Î½ºÆ÷¸°, Çí¼Ò¹Ù¸£ºñÅ», ¾ËÆæÅ¸´Ò, ºê·Î¸ðÅ©¸³Æ¾, ¹ßÇÁ·Î¿¡ÀÌÆ®, ¸ÞÆ¿ÇÁ·¹µå´Ï¼Ö·Ð, ½Çµ¥³ªÇÊ, ºóºí¶ó½ºÆ¾, ¾ËÇÁ¶óÁ¹¶÷, ¾Æ½ºÅ×¹ÌÁ¹, Ä«¸£¹Ù¸¶Á¦ÇÉ, ½Ç·Î½ºÅ¸Á¹, ½Ã»çÇÁ¸®µå, ¿À¸ÞÇÁ¶óÁ¹, ÇǸðÁöµå, Äû´Ïµò, ¸®ÆÄºÎƾ, Ÿũ·Î¸®¹«½º, Å׸£Æä³ªµò, µ¼Æä¸®µ·)°ú º´¿ë Åõ¿©ÇÏ´Â °æ¿ì¿¡´Â ´Ù¸¥ ¸¶Å©·Î¶óÀ̵å°è Ç×»ý¹°Áú°ú °°ÀÌ ÀÌµé ¾à¹°ÀÇ Ç÷û³óµµ¸¦ »ó½Â½Ãų ¼ö ÀÖ´Ù.
(2) ¿¡ÆÄºñ·»Áî, ³×ºñ¶óÇÉ, ¸®ÆÊÇǽÅ, ¸®ÆÄºÎƾ ¹× ¸®ÆÄÆæÆ¾°ú °°Àº CYP-450 ´ë»ç°èÀÇ °·ÂÇÑ À¯µµÁ¦µéÀº Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀÇ ´ë»ç¸¦ ÃËÁøÇÏ¿© Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀÇ Ç÷Àå ³óµµ¸¦ ³·Ãß´Â ¹Ý¸é, ¹Ì»ý¹°ÇÐÀûÀ¸·Î Ȱ¼ºÀÌ ÀÖ´Â ´ë»çüÀÎ 14-OH-clarithromycinÀÇ Ç÷Àå ³óµµ¸¦ »ó½Â½ÃŲ´Ù. Ŭ·¡¸®Æ®·Î¸¶À̽Űú 14-OH-clarithromycinÀÇ ¹Ì»ý¹°ÇÐÀû Ȱ¼ºÀº ´Ù¸¥ ¼¼±Õ¿¡ ´ëÇØ ´Ù¸£°Ô ³ªÅ¸³ª¹Ç·Î, À§ÀÇ È¿¼Ò À¯µµÁ¦µé°ú Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀ» º´¿ë Åõ¿©Çϸé ÀǵµÇÑ Ä¡·áÈ¿°ú¸¦ ³ªÅ¸³»Áö ¸øÇÒ ¼ö ÀÖ´Ù.
(3) CYP3AÀÇ À¯µµÁ¦°¡ µÇ´Â ¾à¹°µé(¿¹, ¸®ÆÊÇǽÅ, Æä´ÏÅäÀÎ, Ä«¸£¹Ù¸¶Á¦ÇÉ, Æä³ë¹Ù¸£ºñÅ», St. John's wort)ÀÌ ÀÌ ¾àÀÇ ´ë»ç¸¦ À¯µµÇÒ ¼ö ÀÖ´Ù. ÀÌ´Â ÀÌ ¾àÀÇ Ä¡·á³óµµ¹üÀ§¾Æ·¡ ³óµµ(sub-therapeutic level)·Î À̾îÁ® ¾àÈ¿°¨¼Ò°¡ ÀϾ ¼ö ÀÖ´Ù. ¶ÇÇÑ, ÀÌ ¾àÀÇ CYP3A ¾ïÁ¦ÀÛ¿ë¿¡ ±âÀÎÇÏ¿© CYP3A À¯µµÁ¦ÀÇ Ç÷Àå³óµµ°¡ Áõ°¡µÉ ¼ö ÀÖÀ¸¹Ç·Î À̸¦ ¸ð´ÏÅ͸µÇÏ´Â °ÍÀÌ ÇÊ¿äÇÒ ¼öµµ ÀÖ´Ù(Åõ¿©µÈ CYP3A À¯µµÁ¦¿¡ °ü·ÃµÈ Çã°¡»çÇ×µµ ÂüÁ¶Çϵµ·Ï ÇÑ´Ù).
4) CYP3A È¿¼Ò¿Í ¿¬°üµÈ ¾à¹°»óÈ£ÀÛ¿ëÀÌ ¾Æ·¡¿Í °°ÀÌ ¿¡¸®Æ®·Î¸¶À̽мººÐ ¹×(¶Ç´Â) Ŭ·¡¸®Æ®·Î¸¶À̽мººÐ¿¡¼µµ º¸°íµÇ¾ú´Ù.
Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀº CYP3A¸¦ ÀúÇØÇÏ´Â °ÍÀ¸·Î ¾Ë·ÁÁ® ÀÖÀ¸¸ç, CYP3A·Î ÁÖ·Î ´ë»çµÇ´Â ¾à¹°°úÀÇ º´¿ëÅõ¿©´Â ¾à¹°³óµµÀÇ »ó½Â°ú ¿¬°üµÇ¾î º´¿ë Åõ¿©ÇÑ ¾à¹°ÀÇ Ä¡·áÈ¿°ú¿Í ÀÌ»ó¹ÝÀÀÀÇ Áõ°¡ ¹× ¿¬ÀåÀ» ÀÏÀ¸Å³ ¼ö ÀÖ´Ù. Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀº CYP3A È¿¼ÒÀÇ ±âÁú·Î ¾Ë·ÁÁø ¾à¹°, ƯÈ÷ Á¼Àº ¾ÈÀü¿ª (¿¹, Ä«¸£¹Ù¸¶Á¦ÇÉ)À» °¡Áö°í/¶Ç´Â ÀÌ È¿¼Ò¿¡ ÀÇÇØ ÁÖ·Î ´ë»çµÇ´Â ´Ù¸¥ ¾à¹°À» Åõ¿© ¹Þ°í Àִ ȯÀÚÀÇ °æ¿ì ÁÖÀÇ ±í°Ô »ç¿ëµÇ¾î¾ß ÇÑ´Ù. °¡´ÉÇÑ °æ¿ì ¿ë·® Á¶ÀýÀÌ °í·ÁµÉ ¼ö ÀÖÀ¸¸ç, Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀ» Åõ¿© ¹Þ°í Àִ ȯÀÚµéÀº CYP3A¿¡ ÀÇÇØ ÁÖ·Î ´ë»çµÇ´Â ¾à¹°ÀÇ Ç÷û ³óµµ¸¦ ÁÖÀÇ ±í°Ô ¸ð´ÏÅ͸µ ÇÏ¿©¾ß ÇÑ´Ù.
µ¿ÀÏÇÑ CYP3A È¿¼Ò¿¡ ÀÇÇØ ´ë»çµÇ´Â °ÍÀ¸·Î ¾Ë·ÁÁö°Å³ª ÀǽɵǴ ¾à¹° ¶Ç´Â ¾à¹°·ù·Î¼ ¾ËÇÁ¶óÁ¹¶÷, ¾Æ½ºÅ×¹ÌÁ¹, Ä«¸£¹Ù¸¶Á¦ÇÉ, ½Ç·Î½ºÅ¸Á¹ ½Ã»çÇÁ¸®µå, »çÀÌŬ·Î½ºÆ÷¸°, µð¼ÒÇǶó¹Ìµå, ¸Æ°¢¾ËÄ®·ÎÀ̵å, ·Î¹Ù½ºÅ¸Æ¾, ¸ÞÆ¿ÇÁ·¹µå´Ï¼Ö·Ð, ¹Ì´ÙÁ¹¶÷, ¿À¸ÞÇÁ¶óÁ¹, °æ±¸¿ë Ç×ÀÀ°íÁ¦ (¿¹, ¿ÍÆÄ¸°), ºñÁ¤Çü Ç×Á¤½Åº´¾à¹° (¿¹, Äí¿¡Å¸ÇÉ), ÇǸðÁöµå, Äû´Ïµò, ¸®ÆÄºÎƾ, ½Çµ¥³ªÇÊ, ½É¹Ù½ºÅ¸Æ¾, Ÿũ·Î¸®¹«½º, Å׸£Æä³ªµò, Æ®¸®¾ÆÁ¹¶÷, ºóºí¶ó½ºÆ¾ÀÌ ÀÖÀ¸³ª, ¸ðµç ¾à¹°À» Æ÷ÇÔÇÏ´Â °ÍÀº ¾Æ´Ï¸ç, CYP-450°èÀÇ ´Ù¸¥ È¿¼Ò¿¡ ÀÇÇÑ ºñ½ÁÇÑ ±âÀüÀÇ ¾à¹° »óÈ£ÀÛ¿ëÀ¸·Î Æó´ÏÅäÀÎ, Å׿ÀÇʸ°, ¹ßÇÁ·Î¿¡ÀÌÆ®¸¦ Æ÷ÇÔÇÑ´Ù.
(1) Å׸£Æä³ªµò°ú º´¿ëÅõ¿©ÇÏ´Â °æ¿ì¿¡´Â µå¹°°Ô QT ¿¬Àå, ½É½Ç¼º ºÎÁ¤¸Æ(Torsades de pointes Æ÷ÇÔ), ½ÉÁ¤Áö(»ç¸Á Æ÷ÇÔ), ½É½Ç¼º ºó¸Æ, ½É½Ç¼¼µ¿ µîÀÇ ½ÉÇ÷°ü°è ÀÌ»ó¹ÝÀÀÀÌ ³ªÅ¸³µ´Ù´Â º¸°í°¡ ÀÖÀ¸¹Ç·Î º´¿ëÅõ¿©ÇÏÁö ¾Ê´Â´Ù. ¾Æ½ºÅ×¹ÌÁ¹°ú ´Ù¸¥ ¸¶Å©·Î¶óÀ̵å°è Ç×»ý¹°ÁúÀ» º´¿ëÅõ¿©ÇÏ´Â °æ¿ì¿¡µµ À¯»çÇÑ °á°ú°¡ ³ªÅ¸³µ´Ù´Â º¸°í°¡ ÀÖ´Ù.
(2) ½Ã»çÇÁ¸®µå¸¦ º´¿ëÅõ¿©ÇÏ´Â °æ¿ì¿¡´Â ½Ã»çÇÁ¸®µå ³óµµ°¡ Áõ°¡ÇÏ¿´´Ù´Â º¸°í°¡ ÀÖ´Ù. ÀÌ·Î ÀÎÇØ QT ¿¬Àå°ú ½É½Ç¼º ºó¸Æ, ½É½Ç¼¼µ¿ ¹× Torsades de pointes¸¦ Æ÷ÇÔÇÑ ºÎÁ¤¸ÆÀ¸·Î µÉ ¼ö ÀÖ´Ù. À¯»çÇÑ È¿°ú°¡ ÇǸðÁöµå¿Í º´¿ëÅõ¿©½Ã ³ªÅ¸³µ´Ù´Â º¸°í°¡ ÀÖÀ¸¹Ç·Î º´¿ëÅõ¿©ÇÏÁö ¾Ê´Â´Ù.
(3) ÀÌ ¾à°ú ·Î¹Ù½ºÅ¸Æ¾ ¶Ç´Â ½É¹Ù½ºÅ¸Æ¾°úÀÇ º´¿ëÅõ¿©´Â ±Ý±âÀÌ´Ù. ´Ù¸¥ ¸¶Å©·Î¶óÀ̵å°è ¾à¹°°ú °°ÀÌ, ÀÌ ¾àµµ HMG-CoA reductase inhibitorÀÇ ³óµµ¸¦ Áõ°¡½ÃŰ´Â °ÍÀ¸·Î º¸°íµÇ¾ú´Ù. ÀÌ ¾àµé°ú º´¿ë Åõ¿©Çϴ ȯÀڵ鿡°Ô¼ µå¹°Áö¸¸ Ⱦ¹®±ÙÀ¶ÇØÁõÀÌ º¸°íµÇ¾ú´Ù. ȯÀÚµéÀº ±ÙÀ°º´ÁõÀÇ Â¡ÈÄ¿Í Áõ»ó µîÀ» ¸ð´ÏÅ͸µ ÇØ¾ß ÇÑ´Ù. ÀÌ ¾à°ú ¾ÆÆ®·Î¹Ù½ºÅ¸Æ¾ ¶Ç´Â ·Î¼ö¹Ù½ºÅ¸Æ¾À» º´¿ëÅõ¿© Çϴ ȯÀڵ鿡°Ô¼µµ ¶ÇÇÑ È¾¹®±ÙÀ¶ÇØÁõÀÌ µå¹°°Ô º¸°íµÇ¾ú´Ù. Ŭ·¡¸®Æ®·Î¸¶À̽Űú º´¿ëÇÒ ¶§, ¾ÆÆ®·Î¹Ù½ºÅ¸Æ¾ ¶Ç´Â ·Î¼ö¹Ù½ºÅ¸Æ¾ÀÇ °¡Àå °¡´ÉÇÑ ÃÖÀú ¿ë·®À» Åõ¾àÇØ¾ß ÇÑ´Ù. ½ºÅ¸Æ¾ ¿ë·®ÀÇ Á¶ÀýÀ̳ª CYP3A ´ë»ç¿¡ ¿µÇâÀÌ ¾ø´Â ½ºÅ¸Æ¾(¿¹, Ç÷ç¹Ù½ºÅ¸Æ¾ ¶Ç´Â ÇÁ¶ó¹Ù½ºÅ¸Æ¾)ÀÇ »ç¿ëÀ» °í·ÁÇØ¾ß ÇÑ´Ù.
(4) ¹Ì´ÙÁ¹¶÷°ú Ŭ·¡¸®Æ®·Î¸¶À̽ŠÁ¤Á¦(500 mg 1ÀÏ 2ȸ Åõ¿©)¸¦ º´¿ëÅõ¿© ÇßÀ» ¶§, ¹Ì´ÙÁ¹¶÷ AUC´Â Á¤¸Æ Åõ¿© ÈÄ 2.7¹è, °æ±¸ Åõ¿© ÈÄ 7¹è Áõ°¡µÇ¾ú´Ù. ¹Ì´ÙÁ¹¶÷°ú Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀ» °æ±¸·Î º´¿ëÅõ¿©Çؼ´Â ¾È µÈ´Ù. ¹Ì´ÙÁ¹¶÷°ú Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀ» Á¤¸ÆÀ¸·Î º´¿ëÅõ¿© ÇßÀ» ¶§, ¿ë·® Á¶ÀýÀ» À§ÇÏ¿© ȯÀÚ¸¦ ¸é¹ÐÈ÷ ¸ð´ÏÅ͸µ ÇÏ¿©¾ß ÇÑ´Ù. Æ®¸®¾ÆÁ¹¶÷°ú ¾ËÇÁ¶óÁ¹¶÷À» Æ÷ÇÔÇÑ, CYP3A·Î ´ë»çµÇ´Â ´Ù¸¥ º¥Á¶µð¾ÆÁ¦ÇÉ·ùµé¿¡µµ °°Àº ÁÖÀÇ»çÇ×ÀÌ Àû¿ëµÈ´Ù. CYP3A¿¡ ÀÇÇØ ´ë»çµÇÁö ¾Ê´Â º¥Á¶µð¾ÆÁ¦ÇÉ·ùµé (Å׸¶Á¦ÆÊ, ´ÏÆ®¶óÁ¦ÆÊ, ·Î¶óÁ¦ÆÊ)¿¡´Â Ŭ·¡¸®Æ®·Î¸¶À̽ŰúÀÇ »óÈ£ÀÛ¿ëÀº ÀÓ»óÀûÀ¸·Î Áß¿äÇÏÁö ¾Ê´Ù.
¿Ü±¹ÀÇ ½ÃÆÇ ÈÄ Á¶»ç¿¡¼ ÀÌ ¾à°ú Æ®¸®¾ÆÁ¹¶÷ º´¿ëÅõ¿© ½Ã Á¹À½, Âø¶õ°ú °°Àº ÁßÃ߽Űæ°è ¿µÇâÀÌ º¸°íµÇ¾ú´Ù. ÁßÃ߽Űæ°èÀÇ ¾à¸®ÇÐÀû Ȱ¼ºÀÌ Áõ°¡µÈ ȯÀÚ´Â ¸ð´ÏÅ͸µÀÌ ¿ä¸ÁµÈ´Ù.
(5) Äû´Ïµò ¶Ç´Â µð¼ÒÇǶó¹Ìµå¿Í º´¿ëÅõ¿©ÇÏ´Â °æ¿ì Torsades de Pointes°¡ ¹ß»ýÇß´Ù´Â ½ÃÆÇ ÈÄ º¸°í°¡ ÀÖ¾ú´Ù. ÀÌµé ¾à¹°ÀÇ Ç÷Áß³óµµ¿Í QT ¿¬Àå¿¡ ´ëÇØ ½ÉÀüµµ¸¦ ¸ð´ÏÅ͸µ ÇÑ´Ù. ½ÃÆÇ ÈÄ Á¶»ç¿¡¼ µð¼ÒÇǶó¹Ìµå¿Í º´¿ëÅõ¿© ÇÏ´Â °æ¿ì ÀúÇ÷´çÁõÀÌ ¹ß»ýÇß´Ù´Â º¸°í°¡ ÀÖ¾ú´Ù. µû¶ó¼ Åõ¿© Áß Ç÷´çÀ» ¸ð´ÏÅ͸µ ÇÏ¿©¾ß ÇÑ´Ù.
(6) ¿¡¸£°íŸ¹Î ¶Ç´Â µðÈ÷µå·Î¿¡¸£°íŸ¹Î°ú º´¿ë Åõ¿©ÇÏ´Â °æ¿ì »çÁö ¹× ÁßÃ߽Űæ°è¸¦ Æ÷ÇÔÇÑ Á¶Á÷ÀÇ Ç÷°ü°æ·Ã ¹× ÇãÇ÷°ú °°Àº Áõ»óÀ» Ư¡À¸·Î ÇÏ´Â ±Þ¼º ¿¡¸£°íÆ® µ¶¼ºÀÌ ³ªÅ¸³¯ ¼ö ÀÖ´Ù. Ŭ·¡¸®Æ®·Î¸¶À̽Űú ÀÌ ¾àµé°úÀÇ º´¿ëÅõ¿©´Â ±Ý±âÀÌ´Ù.
(7) ½Çµ¥³ªÇÊ, Ÿ´Þ¶óÇÊ, ¹Ùµ¥³ªÇÊ ;
ÀÌµé °¢°¢ÀÇ Æ÷½ºÆ÷µð¿¡½ºÅͶóÁ¦ ÀúÇØÁ¦µéÀº Àû¾îµµ ÀϺκРCYP3A¿¡ ÀÇÇØ ´ë»çµÇ¸ç, CYP3A´Â º´¿ëÅõ¿© µÈ Ŭ·¡¸®Æ®·Î¸¶À̽ſ¡ ÀÇÇØ ÀúÇØµÈ´Ù. À§ ¾à¹°µé°ú Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀÇ º´¿ëÅõ¿©´Â Æ÷½ºÆ÷µð¿¡½ºÅͶóÁ¦ ÀúÇØÈ°µ¿ÀÇ »ó½ÂÀ» ¾ß±âÇÒ °ÍÀÌ´Ù. Ŭ·¡¸®Æ®·Î¸¶À̽Űú À§ ¾à¹°µéÀ» º´¿ë Åõ¿©ÇÏ´Â °æ¿ì, À§ ¾à¹°µéÀÇ ¿ë·® °¨¼Ò¸¦ °í·ÁÇÏ¿©¾ß ÇÑ´Ù.
5) µð°î½ÅÀº À¯Ãâ¿î¹ÝÀÚ(efflux transporter)ÀÎ P-glycoprotein(Pgp)ÀÇ ±âÁú·Î ¿©°ÜÁø´Ù. Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀº PgpÀ» ÀúÇØÇÏ´Â °ÍÀ¸·Î ¾Ë·ÁÁ® ÀÖ´Ù. Ŭ·¡¸®Æ®·Î¸¶À̽Űú µð°î½ÅÀ» º´¿ë Åõ¿©ÇßÀ» ¶§, Ŭ·¡¸®Æ®·Î¸¶À̽ſ¡ ÀÇÇÑ PgpÀÇ ÀúÇØ´Â µð°î½Å ¼öÄ¡ÀÇ »ó½ÂÀ» ¾ß±âÇÑ´Ù. µð°î½ÅÀÇ Ç÷û³óµµ¸¦ »ó½Â½ÃŲ´Ù´Â º¸°í°¡ ÀÖÀ¸¹Ç·Î µð°î½Å°ú º´¿ëÅõ¿©¸¦ ÇÏ´Â °æ¿ì¿¡´Â µð°î½ÅÀÇ Ç÷û³óµµ¸¦ ¸ð´ÏÅ͸µÇÑ´Ù. ÀϺΠȯÀÚ¿¡¼´Â Ä¡¸íÀûÀÏ ¼ö ÀÖ´Â ºÎÁ¤¸ÆÀ» Æ÷ÇÔÇÑ µð°î½Å µ¶¼º°ú ÀÏÄ¡ÇÏ´Â ÀÓ»óÁõ»óÀÌ ³ªÅ¸³µ´Ù.
6) ¶õ¼ÒÇÁ¶óÁ¹°ú º´¿ëÅõ¿©ÇÏ´Â °æ¿ì¿¡´Â Ç÷û ³óµµ°¡ °æ¹ÌÇÏ°Ô »ó½ÂÇÑ´Ù´Â º¸°í°¡ ÇÑ °ÇÀÌ ÀÖ¾úÀ¸³ª, ¿ë·® Á¶Àý µî¿¡ ´ëÇÑ °á°ú¸¦ µÞ¹ÞħÇÒ¸¸ÇÑ ÀÚ·á´Â ¾ø´Ù. °Ç°ÇÑ ¼ºÀο¡ ´ëÇØ 8½Ã°£¸¶´Ù Ŭ·¡¸®Æ®·Î¸¶À̽Š500 mg°ú 1ÀÏ 1ȸ ¿À¸ÞÇÁ¶óÁ¹ 40 mgÀ» º´¿ëÅõ¿© ÇÏ¿´À» ¶§ Ç×Á¤»óÅ ¿À¸ÞÇÁ¶óÁ¹ÀÇ Cmax, AUC0-24¿Í T1/2ÀÌ °¢°¢ 30 %, 89 %, 34 % Áõ°¡Çß´Ù. Æò±Õ 24½Ã°£ ³» À§Àå pH°¡ ¿À¸ÞÇÁ¶óÁ¹ ´Üµ¶Åõ¿© ½Ã´Â 5.2À̰í ÀÌ ¾à°ú º´¿ë Åõ¿©ÇßÀ» ¶§´Â 5.7À̾ú´Ù.
7) ¸®ÆÄºÎƾ ¶Ç´Â ¸®ÆÊÇɰú º´¿ëÅõ¿©ÇÏ´Â °æ¿ì Ŭ·¡¸®Æ®·Î¸¶À̽г󵵰¡ °¨¼ÒµÈ´Ù. Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀº ¸®ÆÄºÎƾÀÇ Ç÷û ¹× Á¶Á÷ ³» ³óµµ¸¦ Áõ°¡½ÃÄÑ µ¶¼ºÀ» Áõ°¡½Ãų ¼ö ÀÖ°í, Æ÷µµ¸·¿°ÀÇ À§Ç輺ÀÇ Áõ°¡¸¦ ÃÊ·¡ÇÏ¿´´Ù.
8) ½ÅºÎÀü ȯÀÚ¿¡¼ ¸®Å䳪ºñ¸£¸¦ ´Ù¸¥ HIV ÇÁ·ÎÅ×¾ÆÁ¦ ¾ïÁ¦Á¦(¾ÆÅ¸ÀÚ³ªºñ¸£, »çÄû³ªºñ¸£ Æ÷ÇÔ)¿¡ ´ëÇÑ ¾àµ¿ÇÐ °ÈÁ¦(pharmacokinetic enhancer)·Î¼ »ç¿ëÇÒ °æ¿ì, ¿ë·®Á¶Á¤À» °í·ÁÇÏ¿©¾ß ÇÑ´Ù.
9) Ÿũ·Î¸®¹«½º¿Í º´¿ëÅõ¿©ÇÏ´Â °æ¿ì¿¡´Â Ÿũ·Î¸®¹«½ºÀÇ Ç÷Àå³óµµ¸¦ Áõ°¡½ÃÄѼ µ¶¼ºÀ» Áõ°¡½Ãų ¼ö ÀÖ´Ù.
10) ¾Æ¸ñ½Ã½Ç¸° ¹×(¶Ç´Â) ¿À¸ÞÇÁ¶óÁ¹°ú º´¿ë Åõ¿©ÇÏ´Â °æ¿ì¿¡´Â °¢ ¾à¹°¿¡ ´ëÇÑ »ç¿ë»óÀÇ ÁÖÀÇ»çÇ×, ¾à¹°»óÈ£ÀÛ¿ë µîÀ» Âü°íÇÑ´Ù.
11) Å©·¹¾ÆÆ¼´Ñû¼ÒÀ²ÀÌ 25 mL/min ÀÌÇÏÀΠȯÀÚ¿¡°Ô ¶ó´ÏƼµòºñ½º¹«Æ®½ÃÆ®¸£»ê ¿ä¹ý°ú º´¿ëÇÏ´Â °ÍÀº ¹Ù¶÷Á÷ÇÏÁö ¾Ê´Ù. ±Þ¼º Æ÷¸£ÇǸ°ÁõÀÇ º´·ÂÀÌ Àִ ȯÀÚ¿¡°Ô´Â ¶ó´ÏƼµòºñ½º¹«Æ®½ÃÆ®¸£»ê°ú º´¿ëÇÏÁö ¾Ê´Â´Ù. ¶ó´ÏƼµòºñ½º¹«Æ®½ÃÆ®¸£»ê°ú º´¿ëÅõ¿© ½Ã Ç÷Áß ¶ó´ÏƼµòÀÇ ³óµµ´Â 57 % »ó½Â, Ç÷Áß ºñ½º¹«Æ® ÃÖÀú ³óµµ´Â 48 % »ó½ÂÇßÀ¸¸ç 14-ÇÏÀ̵å·Ï½Ã-Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀÇ ³óµµ´Â 31 % Áõ°¡ÇßÀ¸³ª ÀÌ´Â ÀÓ»óÀû Àǹ̰¡ ¾ø´Ù.
12) Ŭ·¡¸®Æ®·Î¸¶À̽Űú ÀÌÆ®¶óÄÚ³ªÁ¹Àº CYP3AÀÇ ±âÁúÀÌ¸é¼ ¶ÇÇÑ ÀúÇØÁ¦À̸ç, ¾ç¹æÇ⠾๰ »óÈ£ÀÛ¿ëÀ» ÀÏÀ¸Å²´Ù. Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀº ÀÌÆ®¶óÄÚ³ªÁ¹ÀÇ Ç÷Àå ³óµµ¸¦ Áõ°¡½Ã۸ç, ÀÌÆ®¶óÄÚ³ªÁ¹Àº Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀÇ Ç÷Àå ³óµµ¸¦ Áõ°¡½ÃŲ´Ù. ÀÌÆ®¶óÄÚ³ªÁ¹°ú Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀ» º´¿ë Åõ¿© ¹Þ´Â ȯÀÚ´Â ¾à¹°ÇÐÀû Ȱ¼ºÀÇ Áõ°¡ ¶Ç´Â ¿¬ÀåÀÇ Â¡ÈÄ¿¡ ´ëÇØ ÁÖÀÇ ±í°Ô ¸ð´ÏÅ͸µ µÇ¾î¾ß ÇÑ´Ù.
13) °æ±¸¿ë Ç÷´ç°ÇÏÁ¦(¿¹, ¼³Æ÷´ÒÀ¯¸®¾Æ°è ¾à¹°) ±×¸®°í/¶Ç´Â Àν¶¸°°ú º´¿ë Åõ¿© ÇÏ´Â °æ¿ì¿¡´Â ÇöÀúÇÏ°Ô ÀúÇ÷´çÀÌ ³ªÅ¸³¯ ¼ö ÀÖ´Ù. ³ªÅ×±Û¸®³ªÀ̵å, ÇÇ¿À±Û¸®Å¸Á¸, ·¹ÆÄ±Û¸®³ªÀ̵å, ·ÎÁö±Û¸®Å¸Á¸°ú º´¿ë½Ã, Ŭ·¡¸®Æ®·Î¸¶À̽ſ¡ ÀÇÇØ CYP3A È¿¼Ò°¡ ÀúÇØµÉ ¼ö ÀÖÀ¸¸ç, ÀúÇ÷´çÀ» ÀÏÀ¸Å³ ¼ö ÀÖ´Ù. Ç÷´çÀ» ÁÖÀÇ ±í°Ô ¸ð´ÏÅ͸µ Çϵµ·Ï ÇÑ´Ù.
14) Æç·ÎµðÇɰú º´¿ë Åõ¿©ÇÏ´Â °æ¿ì¿¡´Â ¾à¹°¹è¼³ÀÌ Áö¿¬µÇ¾î ¾à¹°È¿°ú°¡ »ó½ÂµÉ ¼ö ÀÖÀ¸¹Ç·Î ÁÖÀÇÇÑ´Ù.
15) º£ÇÁ¸®µô, ¹ÌÁ¹¶ó½ºÆ¾, ¿¡¹Ù½ºÆ¾°ú º´¿ëÅõ¿©ÇÏ´Â °æ¿ì¿¡´Â ½É½Ç¿îµ¿, ƯÈ÷ Torsades de pointes Àå¾ÖÀÇ À§ÇèÀÌ ÀÖ´Ù.
16) Ä«¹ö°ñ¸°, Æä¸£°ñ¸®µå¿Í º´¿ë Åõ¿©ÇÏ´Â °æ¿ì¿¡´Â °ú´ÙÅõ¿© ½Ã ÀÛ¿ëÀÌ Áõ°¡Çϰí Ç÷Àå³óµµ°¡ Áõ°¡µÉ ¼ö ÀÖ´Ù.
17) ÅçÅͷεò°ú º´¿ë Åõ¿©ÇÏ´Â °æ¿ì ÅçÅͷεòÀ» ½ÅÁø´ë»ç°¡ ´À¸° ȯÀÚ¿¡°Ô °ú´ÙÅõ¿© ½Ã ÅçÅͷεòÀÇ Ç÷û³óµµ°¡ Áõ°¡ÇÒ ¼ö ÀÖ´Ù. ÅçÅͷεòÀÇ ÁÖ¿ä ´ë»ç °æ·Î´Â CYP-450ÀÇ 2D6 isoform(CYP2D6)À̳ª, CYP2D6°¡ °á¿©µÈ Áý´Ü¿¡¼´Â CYP3A·Î ´ë»çµÇ´Â °ÍÀ¸·Î È®ÀεǾú´Ù. ÀÌ·¯ÇÑ Áý´Ü¿¡¼ CYP3A¸¦ ÀúÇØÇϸé, ÅçÅͷεò Ç÷û³óµµÀÇ Áß´ëÇÑ »ó½ÂÀÌ ¾ß±âµÇ¾ú´Ù. CYP2D6¿¡ ´ëÇØ ¾àÇÑ ´ë»ç´ÉÀ» °¡Áø Áý´Ü(CYP2D6 poor metabolizer)¿¡°Ô Ŭ·¡¸®Æ®·Î¸¶À̽Űú °°Àº CYP3A ÀúÇØÁ¦¸¦ º´¿ëÇÏ´Â °æ¿ì, ÅçÅͷεòÀÇ ¿ë·® °¨¼Ò°¡ ¿ä±¸µÈ´Ù.
18) ÇÒ·ÎÆÇÆ®¸°°ú º´¿ë Åõ¿©ÇÏ´Â °æ¿ì¿¡´Â ½É½Ç¿îµ¿, ƯÈ÷ Torsades de pointes Àå¾ÖÀÇ À§ÇèÀÌ ÀÖÀ¸¹Ç·Î °¡´ÉÇϸé QT °Ë»ç¸¦ ¹Ì¸® ½Ç½ÃÇϰųª ½ÉÀüµµ¸¦ ¸ð´ÏÅ͸µ °¨µ¶ÇÑ´Ù.
19) INR(±¹Á¦Á¤»óȺñÀ²)ÀÇ º¯È : ÀÌ ¾àÀ» Æ÷ÇÔÇÑ Ç×»ý¹°ÁúÀ» Ç×ÀÀ°íÁ¦¿Í µ¿½Ã¿¡ Åõ¿© ¹ÞÀº ȯÀÚ¿¡¼ Ç×ÀÀ°í Ȱ¼ºÀÇ Áõ°¡°¡ º¸°íµÇ¾ú´Ù. °¨¿°¼ºÁúȯ(±×¸®°í ¿°Áõ¼º °úÁ¤À» µ¿¹ÝÇÑ), ȯÀÚÀÇ ¿¬·É°ú ÀϹÝÀûÀÎ »óÅ´ À§Çè¿ä¼Ò°¡ µÈ´Ù. ÀÌ ¾à°ú ¿ÍÆÄ¸°À» º´¿ëÅõ¿© ÇßÀ» ¶§, ½É°¢ÇÑ ÃâÇ÷ÀÇ À§ÇèÀÌ ÀÖ°í, INR°ú ÇÁ·ÎÆ®·Òºó ½Ã°£ÀÇ ÇöÀúÇÑ Áõ°¡°¡ ÀÖ¾ú´Ù. ÀÌ ¾à°ú °æ±¸¿ë Ç×ÀÀ°íÁ¦¸¦ º´¿ëÅõ¿© ÇÒ ¶§´Â INR°ú ÇÁ·ÎÆ®·Òºó ½Ã°£À» ÀÚÁÖ ¸ð´ÏÅ͸µ ÇØ¾ß ÇÑ´Ù. ÇÊ¿äÇÑ °æ¿ì °æ±¸¿ë Ç×ÀÀ°íÁ¦ÀÇ ¿ë·®À» ÀûÀýÈ÷ Á¶ÀýÇÑ´Ù. Ç×»ý¹°ÁúÀÇ ÀϺΠÁ¾·ùµé, ƯÈ÷ Ç÷ç¿À·ÎÄû³î·Ð, ¸¶Å©·Î¶óÀ̵å, »çÀÌŬ¸°, ÄÚÆ®¸®¸ñ»çÁ¹°ú ÀϺΠ¼¼ÆÈ·Î½ºÆ÷¸°ÀÇ °æ¿ì´Â ´õ ½ÉÇÏ´Ù.
20) Ä®½· ±æÇ×Á¦(´ÏÆäµðÇÉ, º£¶óÆÄ¹Ð¿°»ê¿° µî)¿Í º´¿ë ½Ã ÁÖÀÇÇÑ´Ù. Ŭ·¡¸®Æ®·Î¸¶À̽Űú º£¶óÆÄ¹ÐÀ» º´¿ëÇϴ ȯÀÚ¿¡°Ô¼ ÀúÇ÷¾Ð, ¼¸Æ¼ººÎÁ¤¸Æ ¹× À¯»êÁõ(lactic acidosis)ÀÌ °üÂûµÇ¾ú´Ù.
21) °Ç°ÇÑ Áö¿øÀÚ¿¡ ´ëÇØ Ç÷çÄÚ³ªÁ¹ 200 mg 1ÀÏ 1ȸ¿Í Ŭ·¡¸®Æ®·Î¸¶À̽Š500 mg 1ÀÏ 2ȸ º´¿ë Åõ¿© ÇßÀ»¶§ ÀÌ ¾àÀÇ Æò±Õ Ç×Á¤»óÅ Cmin¿Í AUC°¡ °¢°¢ 33 %, 18 % Áõ°¡ÇßÀ¸³ª 14-OH-Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀÇ ³óµµ´Â ÇöÀúÇÑ ¿µÇâÀ» ¹ÞÁö ¾Ê¾Ò´Ù. Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀÇ ¿ë·®Á¶ÀýÀº ¿ä±¸µÇÁö ¾Ê´Â´Ù.
22) ÄÝŰ½Å°ú º´¿ëÅõ¿© ½Ã, ƯÈ÷ °í·ÉÀÚ¿Í ÀϺΠ½ÅºÎÀüȯÀÚ¿¡¼ ÄÝŰ½Å µ¶¼ºÀÌ º¸°íµÇ¾úÀ¸¸ç ÀϺο¡¼´Â »ç¸Á»ç·Êµµ º¸°íµÇ¾ú´Ù. ÄÝŰ½ÅÀº CYP3A ¹× À¯Ãâ¿î¹ÝÀÚ(efflux transporter)ÀÎ P-glycoprotein(Pgp)ÀÇ ±âÁúÀÌ´Ù. Ŭ·¡¸®Æ®·Î¸¶À̽Űú ´Ù¸¥ ¸¶Å©·Î¶óÀ̵å°è Ç×»ý¹°ÁúÀº CYP3A ¹× Pgp¸¦ ¾ïÁ¦ÇÏ¿© ÄÝŰ½Å¿¡ ´ëÇÑ ³ëÃâÀÌ Áõ°¡µÉ ¼ö ÀÖÀ¸¹Ç·Î ÄÝŰ½Å°ú ÀÌ ¾àÀ» º´¿ëÅõ¿©Çؼ´Â ¾È µÈ´Ù.
23) Ŭ·¡¸®Æ®·Î¸¶À̽Űú ¾ÆÅ¸ÀÚ³ªºñ¸£´Â CYP3AÀÇ ±âÁúÀÌ¸é¼ ¶ÇÇÑ ÀúÇØÁ¦À̸ç, ¾ç¹æÇâ(bi-directional) ¾à¹°»óÈ£ÀÛ¿ë¿¡ ´ëÇÑ ±Ù°ÅµéÀÌ Á¸ÀçÇÑ´Ù. Ŭ·¡¸®Æ®·Î¸¶À̽Å(500 mg 1ÀÏ 2ȸ)°ú ¾ÆÅ¸ÀÚ³ªºñ¸£(400 mg 1ÀÏ 1ȸ)¸¦ º´¿ëÅõ¿©Çϸé, Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀÇ ¼öÄ¡´Â 2¹è Áõ°¡Çϸç 14-OH-Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀº 70 % °¨¼ÒÇϰí, ¾ÆÅ¸ÀÚ³ªºñ¸£ÀÇ AUC´Â 28 % Áõ°¡ÇÑ´Ù. Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀÇ ³ÐÀº Ä¡·á¹üÀ§(therapeutic window)·Î ÀÎÇÏ¿©, Á¤»óÀûÀÎ ½Å±â´ÉÀ» °¡Áø ȯÀÚ¿¡°Ô Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀÇ ¿ë·® °¨¼Ò´Â ¿ä±¸µÇÁö ¾Ê´Â´Ù. ¿Â°ÇÇÑ ½Å±â´É(Å©·¹¾ÆÆ¼´Ñû¼ÒÀ² 30 ¡ 60 mL/min)À» °¡Áø ȯÀÚÀÇ °æ¿ì, Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀÇ ¿ë·®Àº 50 % ±îÁö °¨¼ÒµÇ¾î¾ß ÇÑ´Ù. Å©·¹¾ÆÆ¼´Ñû¼ÒÀ²ÀÌ 30 mL/min ¹Ì¸¸ÀΠȯÀÚÀÇ °æ¿ì, Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀÇ ¿ë·®Àº ÀûÀýÇÑ Å¬·¡¸®Æ®·Î¸¶À̽Šó¹æ¿¡ µû¶ó 75 % ±îÁö °¨¼ÒµÇ¾î¾ß ÇÑ´Ù. Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀÇ 1ÀÏ ¿ë·®ÀÌ 1,000 mgÀ» ÃʰúÇÏ´Â °æ¿ì, ÇÁ·ÎÅ×¾ÆÁ¦ ÀúÇØÁ¦¿Í º´¿ëÅõ¿©Çؼ´Â ¾È µÈ´Ù.
24) Ŭ·¡¸®Æ®·Î¸¶À̽Űú »çÄû³ªºñ¸£´Â CYP3AÀÇ ±âÁúÀÌ¸é¼ ¶ÇÇÑ ÀúÇØÁ¦À̸ç, ¾ç¹æÇâ(bi-directional) ¾à¹°»óÈ£ÀÛ¿ë¿¡ ´ëÇÑ ±Ù°ÅµéÀÌ Á¸ÀçÇÑ´Ù. °Ç°ÇÑ 12¸íÀÇ Áö¿øÀÚ¸¦ ´ë»óÀ¸·Î Ŭ·¡¸®Æ®·Î¸¶À̽Å(500 mg 1ÀÏ 2ȸ)°ú »çÄû³ªºñ¸£(¿¬Áúĸ½¶ 1,200 mg 1ÀÏ 3ȸ)¸¦ º´¿ëÅõ¿© ÇÑ °á°ú, »çÄû³ªºñ¸£ÀÇ Ç×Á¤»óÅÂÀÇ AUC ¿Í Cmax ¼öÄ¡´Â ´Üµ¶ Åõ¿© ½Ã º¸´Ù 177 % ¹× 187 % »ó½ÂÇÏ¿´´Ù. Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀÇ AUC ¿Í Cmax ¼öÄ¡´Â ´Üµ¶ Åõ¿© ½Ã º¸´Ù ¾à 40 % »ó½ÂÇÏ¿´´Ù. ½ÃÇè¿¡ »ç¿ëµÈ ¿ë·®/Á¦Çü ¿¡¼ µÎ ¾à¹°ÀÇ ¿ë·®Á¶ÀýÀº ¿ä±¸µÇÁö ¾Ê´Â´Ù. »çÄû³ªºñ¸£ ¿¬Áú ĸ½¶ Á¦ÇüÀ» ÀÌ¿ëÇÑ ¾à¹°»óÈ£ÀÛ¿ë ½ÃÇèÀÇ °á°ú´Â °æÁú ĸ½¶ Á¦ÇüÀ» »ç¿ëÇßÀ» ¶§ÀÇ È¿°ú¸¦ ´ëÇ¥ÇÏÁö ¾Ê´Â´Ù. »çÄû³ªºñ¸£¸¦ ´Üµ¶ Åõ¿©ÇÏ¿© ¼öÇàÇÑ ¾à¹° »óÈ£ÀÛ¿ë ½ÃÇèÀÇ °á°ú´Â, »çÄû³ªºñ¸£/¸®Å䳪ºñ¸£¸¦ Åõ¿©ÇßÀ» ¶§ÀÇ È¿°ú¸¦ ´ëÇ¥ÇÏÁö ¾Ê´Â´Ù. »çÄû³ªºñ¸£¸¦ ¸®Å䳪ºñ¾î¿Í º´¿ëÇÏ¿© Åõ¿©ÇßÀ» ¶§¿¡´Â, ¸®Å䳪ºñ¸£ÀÇ Å¬·¡¸®Æ®·Î¸¶À̽ſ¡ ´ëÇÑ ÀáÀçÀûÀÎ ¿µÇâ¿¡ ´ëÇÑ °í·Á¸¦ ÇÏ¿©¾ß ÇÑ´Ù.
25) Ŭ·¡¸®Æ®·Î¸¶À̽гëÃâÀº ¿¡Æ®¶ó¸®ºó¿¡ ÀÇÇØ °¨¼ÒµÇ¾úÀ¸³ª, Ȱ¼º´ë»çü 14-OH-Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀÇ ³óµµ´Â Áõ°¡µÇ¾ú´Ù. 14-OH-Ŭ·¡¸®Æ®·Î¸¶À̽ÅÀº Mycobacterium avium complex(MAC)¿¡ ´ëÇØ °¨¼ÒµÈ Ȱ¼ºÀ» °¡Áö¹Ç·Î, ÀÌ º´¿ø±Õ¿¡ ´ëÇÑ ÃÑ È°¼ºÀÌ º¯°æµÉ ¼öµµ ÀÖ´Ù. µû¶ó¼, MACÀÇ Ä¡·á¿¡ ÀÖ¾î¼ ÀÌ ¾àÀÇ ´ëüÁ¦¸¦ °í·ÁÇÏ¿©¾ß ÇÑ´Ù.
|
| Off-label Usage |
[Á¶È¸]
|
| Related FDA Approved Drug |
|
|
|
 | Á¤º¸¿ä¾à |
|
|
|
µå·°ÀÎÆ÷ ÀǾàǰ ¿ä¾à/»ó¼¼Á¤º¸
|
|
 | ÄÚµå ¹× ºÐ·ùÁ¤º¸ |
|
|
| |
|
 | Á¦Ç°Á¤º¸ |
|
|
|
|
 | º¹¾àÁ¤º¸ |
|
|
| Ç׸ñ |
³»¿ë |
| LACTmed ¹Ù·Î°¡±â |
[¹Ù·Î°¡±â]
|
| ¾à¸®ÀÛ¿ë |
À¯·áÁ¤º¸ÀÔ´Ï´Ù.
|
| º¹¾àÁöµµ |
À¯·áÁ¤º¸ÀÔ´Ï´Ù.
|
| ÀӺο¡´ëÇÑÅõ¿© |
| * |
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
|
|
| * |
»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.
|
| * |
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.
|
|
|
½ÅÀå¾Ö, °£Àå¾Ö½Ã ¿ë·®Á¶Àý |
À¯·áÁ¤º¸ÀÔ´Ï´Ù.
|
| Pharmacokinetics |
À¯·áÁ¤º¸ÀÔ´Ï´Ù.
|
| º¹¾à¶óº§ |
| À̹ÌÁö |
º¹¾à¼³¸í |
 |
¾îÁö·¯¿òÀÌ ÀÖÀ»¼ö ÀÖ½À´Ï´Ù. |
|
|
| * |
º¹¾àÀ̹ÌÁö´Â ¸ðµç º¹¾àÁöµµ »çÇ×À» Ç¥½ÃÇѰÍÀº ¾Æ´Ï¸ç, Ãß°¡ÀûÀ¸·Î ¾÷µ¥ÀÌÆ®µÇ°Å³ª ¼öÁ¤µÉ ¼ö ÀÖ½À´Ï´Ù. |
| * |
º¹¾àÀ̹ÌÁöÀÇ Ç¥½Ã¿©ºÎ´Â ½ÇÁ¦ ¾à¹°º¹¿ë½Ã Á߿䵵¿¡ µû¸¥°ÍÀº ¾Æ´Ï¸ç ´Ü¼øÈ÷ Çã°¡Á¤º¸»ó Ű¿öµå¸¦ ±âÁØÀ¸·Î µî·ÏµÇ¾ú½À´Ï´Ù. |
| * |
±ÍÇϰ¡ º¹¾àÀ̹ÌÁö Á¤º¸¸¦ ½Å·ÚÇÔÀº ÀüÀûÀ¸·Î ±ÍÇÏÀÇ Ã¥ÀÓÀÔ´Ï´Ù. µå·°ÀÎÆ÷´Â ÀÌ¿¡ ´ëÇÑ ¾î¶°ÇÑ º¸Áõµµ ÇÏÁö ¾Ê½À´Ï´Ù. |
|
|
| º¸°ü»ó ÁÖÀÇ |
|
| Á¶Á¦½Ã ÁÖÀÇ |
|
|
|
 | ½É»çÁ¤º¸ |
|
|
| Ç׸ñ |
³»¿ë |
| ½É»çÁöħ°Ë»ö |
[½ÉÆò¿ø ½É»çÁöħ¿¶÷]
|
| ½É»ç»ç·Ê |
¸¸¼ºÈ£Èí±âÁúȯ¿¡ Àå±â Åõ¿©µÈ macrolide °è¿ Á¦Á¦¿¡ ´ëÇÏ¿©
¡á ½ÉÀÇ¹è°æ
ÇöÀç macrolide°è¿(clarithromycin, erythromycin, roxithromycin, azithromycin) Á¦Á¦¸¦ ¸¸¼ºÈ£Èí±â Áúȯ¿¡¼ Àå±â Åõ¿©ÇÏ´Â »ç·Ê°¡ ¹ß»ýÇϰí ÀÖ¾î ÀÌÀÇ ÀÇÇÐÀû Ÿ´ç¼º¿¡ ´ëÇØ ½ÉÀÇÇÔ.
¡á Âü°í
¡Û Clarithromycin °æ±¸Á¦ (ǰ¸í:Ŭ·¡¸®½ÃµåÇʸ§ÄÚÆÃÁ¤250mg µî) ÀÎÁ¤±âÁØ (º¸°Çº¹ÁöºÎ°í½Ã Á¦2010-20È£, 2010.05.01)
¡Û ½ÄǰÀǾàǰ¾ÈÀüû Çã°¡»çÇ×
¡Û ±èÁ¾¼±. À̺ñÀÎÈİúÇÐ(´ëÇÑÀ̺ñÀÎÈİúÇÐȸ Æí). ÀÏÁ¶°¢. 2002.
¡Û ´ëÇѰ¨¿°ÇÐȸ. Ç×»ýÁ¦ÀÇ ±æÀâÀÌ, Á¦3ÆÇ. 2008.
¡Û ±è¿µÈ¯ ¿Ü. ±â°üÁöÈ®ÀåÁõ¿¡¼ ErythromycinÀÇ ¼Ò·® Àå±âÅõ¿© È¿°ú. °áÇÙ ¹× È£Èí±âÁúȯ
¡á ½ÉÀdz»¿ë
Macrolide°è¿(clarithromycin, erythromycin, roxithromycin, azithromycin)Á¦Á¦°¡ ¸¸¼ºÈ£Èí±â Áúȯ¿¡¼ Àå±â Åõ¿©µÇ´Â »ç·Ê°¡ ¹ß»ýÇϰí ÀÌ¿Í °ü·ÃÇÑ ³í¹®µéÀÌ ³ª¿À°í ÀÖÀ¸³ª, Àú¿ë·® Àå±â¿ä¹ýÀÇ °æ¿ì Ç×»ýÁ¦ ³»¼º À¯¹ß µîÀÇ ½É°¢ÇÑ ¹®Á¦¸¦ ¾ß±âÇÒ ¼ö ÀÖ´Â Á¡À» °í·ÁÇØº¼ ¶§ chronic sinusitis, bronchiectasis, COPD µî¿¡¼ macrolide°è Á¦Á¦ÀÇ Àå±â»ç¿ë¿¡ ´ëÇÑ Ä¡·áÈ¿°ú ¹× ÀÇÇÐÀû Ÿ´ç¼º¿¡ ´ëÇÏ¿© ü°èÀû ¹®Çå°íÂûÀÌ ÇÊ¿äÇÏ´Ù´Â ÀǰßÀÌ Á¦±âµÇ¾î(¡®08.3.28 ³»°ú¥³ºÐÀ§) EBH¿¡ ¹®Çå°íÂûÀ» ¿äûÇÏ¿© ³íÀÇÇÑ °á°ú
¡®¸¸¼ºÈ£Èí±âÁúȯ¿¡ Àú¿ë·® Àå±â Åõ¿©(low-dose, long-term therapy)µÈ macrolides°è¿ Á¦Á¦ÀÇ ÀÓ»óÀû À¯¿ë¼º ¹× ¾ÈÀü¼ºÀ» ÀÔÁõÇÒ ¸¸ÇÑ ±Ù°Å´Â ÇöÀç±îÁö ÃæºÐÇÏÁö ¾Ê´Ù°í ÆÇ´ÜµÈ´Ù.¡¯´Â EBH º¸°í¼¸¦ ÂüÁ¶½Ã Â÷ÈÄ macrolides°è Á¦Á¦ÀÇ Àú¿ë·® Àå±â Åõ¿©·Î ÀÎÇÑ ³»¼º±Õ ÃâÇöÀ̳ª ±Õ±³´ëÇö»ó µî ¾ÈÀü¼º ¹× À¯È¿¼º¿¡ ´ëÇÑ ÃæºÐÇÑ ±Ù°Å°¡ È®¸³µÉ ¶§±îÁö ¸¸¼ºÈ£Èí±âÁúȯ¿¡ macrolides°è¿ Á¦Á¦ÀÇ Àú¿ë·® Àå±âÅõ¿©´Â ÇöÇà´ë·Î ½Ä¾àû Çã°¡»çÇ×(¿ë¹ý¿ë·®) µîÀ» ÃʰúÇÑ °æ¿ì·Î º¸¾Æ ÀÎÁ¤ÇÏÁö ¾Æ´ÏÇÔ.
[2010.06.07 Áø·á½É»çÆò°¡À§¿øÈ¸]
|
| DUR °ü·Ã °í½Ã |
[º´¿ë¿¬·É±Ý±â ÀǾàǰ / ÀӺαݱâ ÀǾàǰ / ºñ¿ëÈ¿°úÀû ÇÔ·® ÀǾàǰ / ¾ÈÀü¼º °ü·Ã ±Þ¿©ÁßÁö ÀǾàǰ]
|
|
|
 | ÇмúÁ¤º¸ |
|
|
| Ç׸ñ |
³»¿ë |
| DUR (ÀǾàǰ»ç¿ëÆò°¡) |
º´¿ë±Ý±â :
[caffeine anhydrous+ergotamine tartrate]
[colchicine]
[domperidone]
[domperidone maleate (as domperidone)]
[dronedarone]
[ezetimibe+simvastatin]
[ezetimibe+simvastatin]
[finerenone]
[haloperidol]
[haloperidol decanoate (as haloperidol)]
[haloperidol decanoate (as haloperidol)]
[ivabradine hydrochloride (as ivabradine)]
[lurasidone hydrochloride]
[mizolastine]
[palbociclib]
[pimozide]
[silodosin]
[simvastatin]
[ticagrelor]
[tolvaptan]
[tolvaptan]
[tolvaptan SD powder (as tolvaptan)]
[trastuzumab emtansine (as trastuzumab)]
[»óÈ£ÀÛ¿ë/º´¿ë±Ý±â°Ë»ö]
¿¬·É´ë±Ý±â :
°í½ÃµÈ ¿¬·É±Ý±â ³»¿ëÀº ¾ø½À´Ï´Ù.
[¿¬·É´ë±Ý±â»ó¼¼°Ë»ö]
|
| Mechanism of Action |
Clarithromycin¿¡ ´ëÇÑ Mechanism_Of_Action Á¤º¸ Clarithromycin is first metabolized to 14-OH clarithromycin. Like other macrolides, it then binds to the 50 S subunit of the 70 S ribosome of the bacteria, blocking RNA-mediated bacterial protein synthesis. Clarithromycin also inhibits the hepatic microsomal CYP3A4 isoenzyme and P-glycoprotein, an energy-dependent drug efflux pump.
|
| Pharmacology |
Clarithromycin¿¡ ´ëÇÑ Pharmacology Á¤º¸ Clarithromycin, a macrolide antibiotic similar to erythromycin and azithromycin, is effective against Mycobacterium avium complex (MAC) and is used for the treatment of Helicobacter pylori-associated peptic ulcer disease, community-acquired pneumonia, sinusitis, and chronic bronchitis. Clarithromycin is also used to treat respiratory tract, sexually transmitted, otitis media, and AIDS-related infections.
|
| Metabolism |
Clarithromycin¿¡ ´ëÇÑ Metabolism Á¤º¸ # Phase_1_Metabolizing_Enzyme:Cytochrome P450 3A4 (CYP3A4)Cytochrome P450 2C19 (CYP2C19)
|
| Protein Binding |
Clarithromycin¿¡ ´ëÇÑ ´Ü¹é°áÇÕ Á¤º¸ Low protein binding
|
| Half-life |
Clarithromycin¿¡ ´ëÇÑ ¹Ý°¨±â Á¤º¸ 3-4 hours
|
| Absorption |
Clarithromycin¿¡ ´ëÇÑ Absorption Á¤º¸ 50%
|
| Pharmacokinetics |
ClarithromycinÀÇ ¾à¹°µ¿·ÂÇÐÀÚ·á
- Èí¼ö : Erythromycin°ú´Â ´Þ¸® À§»ê¿¡¼µµ ¸Å¿ì ¾ÈÁ¤ÇÏ´Ù.
- »ýü³»ÀÌ¿ë·ü : 50%, À½½Ä¹°¿¡ ÀÇÇØ Èí¼ö°¡ Áö¿¬µÉ ¼ö´Â ÀÖÀ¸³ª Èí¼ö·®Àº º¯È°¡ ¾ø´Ù.
- ºÐÆ÷ : ÁßÃ߽Űæ°è¸¦ Á¦¿ÜÇÑ Ã¼³» ¸ðµç Á¶Á÷¿¡ ³Î¸® ºÐÆ÷
- ´ë»ç : ºÎºÐÀûÀ¸·Î Ç×±ÕÈ¿°ú¸¦ °¡Áö´Â ´ë»çüÀÎ clarithromycin 14-OHÀ¸·Î ´ë»çµÈ´Ù.
- ¹Ý°¨±â : 5-7 ½Ã°£
- Ç÷ÁßÃÖ°í³óµµ µµ´Þ½Ã°£ : 2-4 ½Ã°£
- ¼Ò½Ç : ÁÖ·Î ½Å¹è¼³µÇ°í, clearance´Â Á¤»ó »ç±¸Ã¼¿©°úÀ²°ú À¯»çÇÏ´Ù.
|
| Toxicity |
Clarithromycin¿¡ ´ëÇÑ Toxicity Á¤º¸ Symptoms of toxicity include diarrhea, nausea, abnormal taste, dyspepsia, and abdominal discomfort. Pseudomembraneous colitis has been reported with clarithromycin use, allergic reactions ranging from urticaria and mild skin eruptions to rare cases of anaphylaxis and Stevens-Johnson syndrome have occurred. Rare cases of severe hepatic dysfunctions also have been reported. Hepatic failure is usually reversible, but fatalities have been reported.
|
| Drug Interactions |
Clarithromycin¿¡ ´ëÇÑ Drug_Interactions Á¤º¸ Alprazolam The macrolide increases the effect of the benzodiazepineAminophylline Increases the effect and toxicity of theophyllineAmiodarone Increased risk of cardiotoxicity and arrhythmiasAnisindione The macrolide increases the anticoagulant effectAprepitant This CYP3A4 inhibitor increases the effect and toxicity of aprepitantAstemizole Increased risk of cardiotoxicity and arrhythmiasAtazanavir Atazanavir increases levels of clarithromycinAtorvastatin The macrolide possibly increases the statin toxicityBretylium Increased risk of cardiotoxicity and arrhythmiasBuspirone Increases the effect and toxicity of buspironeCarbamazepine The macrolide increases the effect of carbamazepineCerivastatin The macrolide possibly increases the statin toxicityCisapride Increased risk of cardiotoxicity and arrhythmiasCitalopram Possible serotoninergic syndrome with this combinationColchicine Severe colchicine toxicity can occurCyclosporine The macrolide increases the effect of cyclosporineDarifenacin This potent CYP3A4 inhibitor slows darifenacin/solifenacin metabolismDarunavir Increased levels of clarithromycinDiazepam The macrolide increases the effect of the benzodiazepineDicumarol The macrolide increases anticoagulant effectDigoxin The macrolide increases the effect of digoxin in 10% of patientsDihydroergotamine Risk of ergotism and severe ischemia with this associationDyphylline Increases the effect and toxicity of theophylline Disopyramide Increased risk of cardiotoxicity and arrhythmiasDofetilide Increased risk of cardiotoxicity and arrhythmiasDyphylline Increases the effect and toxicity of theophyllineEfavirenz Efavirenz decreases levels of clarithromycinEletriptan This macrolide increases the effect and toxicity of eletriptanEplerenone This macrolide increases the effect and toxicity of eplerenoneErgotamine Risk of ergotism and severe ischemia with this associationErlotinib This CYP3A4 inhibitor increases levels/toxicity of erlotinibFluoxetine Possible serotoninergic syndrome with this combinationFosphenytoin Increases the effect and toxicity of phenytoinGefitinib This CYP3A4 inhibitor increases levels/toxicity of gefitinibImatinib The macrolide increases levels of imatinibIndinavir Increases the effect and toxicity of indinavirItraconazole The macrolide increases the effect and toxicity of itraconazoleLovastatin The macrolide possibly increases the statin toxicityMethylprednisolone The macrolide increases the effect of corticosteroidMethysergide Risk of ergotism and severe ischemia with this associationMidazolam The macrolide increases the effect of the benzodiazepineAcenocoumarol The macrolide increases anticoagulant effectOxtriphylline Increases the effect and toxicity of theophyllinePhenytoin Increases the effect and toxicity of phenytoinPimozide Increased risk of cardiotoxicity and arrhythmiasQuetiapine This macrolide increases the effect/toxicity of quetiapineQuinidine Increased risk of cardiotoxicity and arrhythmiasQuinidine barbiturate Increased risk of cardiotoxicity and arrhythmiasQuinupristin This combination presents an increased risk of toxicityRanolazine Increased levels of ranolazine- risk of toxicityRepaglinide Increases the effect of repaglinideRifabutin The rifamycin decreases the effect of the macrolideRifampin The rifamycin decreases the effect of the macrolideSertraline Possible serotoninergic syndrome with this combinationSildenafil Increases the effect and toxicity of sildenafilSimvastatin The macrolide possibly increases the statin toxicitySirolimus The macrolide increases sirolimus levelsSotalol Increased risk of cardiotoxicity and arrhythmiasSunitinib Possible increase in sunitinib levelsTacrolimus This antibiotic increases the effect and toxicity of tacrolimusTerfenadine Increased risk of cardiotoxicity and arrhythmiasTheophylline Increases the effect and toxicity of theophyllineTriazolam The macrolide increases the effect of the benzodiazepineVardenafil Increases the effect and toxicity of vardenafilWarfarin The macrolide increases anticoagulant effectEverolimus The macrolide increases everolimus levels/toxicitySolifenacin This potent CYP3A4 inhibitor slows darifenacin/solifenacin metabolism
|
CYP450 Drug Interaction |
[CYP450 TableÁ÷Á¢Á¶È¸] Clarithromycin¿¡ ´ëÇÑ P450 table
SUBSTRATES
CYP 3A4/3A5/3A7
Macrolide antibiotics:
**clarithromycin**
erythromycin
NOT azithromycin
telithromycin
Anti-arrhythmics:
quinidine
Benzodiazepines:
alprazolam
diazepam
midazolam
triazolam
Immune Modulators:
cyclosporine
tacrolimus (FK506)
HIV Protease Inhibitors:
indinavir
ritonavir
saquinavir
Prokinetic:
cisapride
Antihistamines:
astemizole
chlorpheniramine
Calcium Channel Blockers:
amlodipine
diltiazem
felodipine
nifedipine
nisoldipine
nitrendipine
verapamil
HMG CoA Reductase Inhibitors:
atorvastatin
cerivastatin
lovastatin
NOT pravastatin
simvastatin
aripiprazole
buspirone
gleevec
haloperidol (in part)
methadone
pimozide
quinine
NOT rosuvastatin
sildenafil
tamoxifen
trazodone
vincristine
INHIBITORS
CYP 3A4/3A5/3A7
HIV Protease Inhibitors:
indinavir
nelfinavir
ritonavir
amiodarone
NOT azithromycin
cimetidine
**clarithromycin**
diltiazem
erythromycin
fluvoxamine
grapefruit juice
itraconazole
ketoconazole
mibefradil
nefazodone
troleandomycin
verapamil
INDUCERS
CYP 3A4/3A5/3A7
carbamazepine
phenobarbital
phenytoin
rifabutin
rifampin
St. John's wort
troglitazone
SUBSTRATES
CYP 3A4/3A5/3A7
Macrolide antibiotics:
**clarithromycin**
erythromycin
NOT azithromycin
telithromycin
Anti-arrhythmics:
quinidine
Benzodiazepines:
alprazolam
diazepam
midazolam
triazolam
Immune Modulators:
cyclosporine
tacrolimus (FK506)
HIV Protease Inhibitors:
indinavir
ritonavir
saquinavir
Prokinetic:
cisapride
Antihistamines:
astemizole
chlorpheniramine
Calcium Channel Blockers:
amlodipine
diltiazem
felodipine
nifedipine
nisoldipine
nitrendipine
verapamil
HMG CoA Reductase Inhibitors:
atorvastatin
cerivastatin
lovastatin
NOT pravastatin
simvastatin
aripiprazole
buspirone
gleevec
haloperidol (in part)
methadone
pimozide
quinine
NOT rosuvastatin
sildenafil
tamoxifen
trazodone
vincristine
INHIBITORS
CYP 3A4/3A5/3A7
HIV Protease Inhibitors:
indinavir
nelfinavir
ritonavir
amiodarone
NOT azithromycin
cimetidine
**clarithromycin**
diltiazem
erythromycin
fluvoxamine
grapefruit juice
itraconazole
ketoconazole
mibefradil
nefazodone
troleandomycin
verapamil
INDUCERS
CYP 3A4/3A5/3A7
carbamazepine
phenobarbital
phenytoin
rifabutin
rifampin
St. John's wort
troglitazone
|
| Food Interaction |
Clarithromycin¿¡ ´ëÇÑ Food Interaction Á¤º¸ Biaxin - take without regard to meals (however absorption appears to be improved when drug is taken with food).Biaxin XL - take with a meal, taking it on an empty stomach is associated with total product exposure 30% inferior to that observed when administered with food.
|
| Drug Target |
[Drug Target]
|
| Description |
Clarithromycin¿¡ ´ëÇÑ Description Á¤º¸ A semisynthetic macrolide antibiotic derived from erythromycin that is active against a variety of microorganisms. It can inhibit protein synthesis in bacteria by reversibly binding to the 50S ribosomal subunits. This inhibits the translocation of aminoacyl transfer-RNA and prevents peptide chain elongation. [PubChem]
|
| Dosage Form |
Clarithromycin¿¡ ´ëÇÑ Dosage_Form Á¤º¸ Tablet OralTablet, extended release Oral
|
| Drug Category |
Clarithromycin¿¡ ´ëÇÑ Drug_Category Á¤º¸ Anti-Bacterial AgentsOther MacrolidesProtein Synthesis Inhibitors
|
| Smiles String Canonical |
Clarithromycin¿¡ ´ëÇÑ Smiles_String_canonical Á¤º¸ CCC1OC(=O)C(C)C(OC2CC(C)(OC)C(O)C(C)O2)C(C)C(OC2OC(C)CC(C2O)N(C)C)C(C)(CC(C)C(=O)C(C)C(O)C1(C)O)OC
|
| Smiles String Isomeric |
Clarithromycin¿¡ ´ëÇÑ Smiles_String_isomeric Á¤º¸ CC[C@@H]1OC(=O)[C@H](C)[C@@H](O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@@H]2O[C@H](C)C[C@@H]([C@H]2O)N(C)C)[C@@](C)(C[C@@H](C)C(=O)[C@@H](C)[C@@H](O)[C@]1(C)O)OC
|
| InChI Identifier |
Clarithromycin¿¡ ´ëÇÑ InChI_Identifier Á¤º¸ InChI=1/C38H69NO13/c1-15-26-38(10,45)31(42)21(4)28(40)19(2)17-37(9,47-14)33(52-35-29(41)25(39(11)12)16-20(3)48-35)22(5)30(23(6)34(44)50-26)51-27-18-36(8,46-13)32(43)24(7)49-27/h19-27,29-33,35,41-43,45H,15-18H2,1-14H3/t19-,20-,21-,22+,23-,24+,25+,26+,27+,29-,30+,31-,32+,33-,35+,36-,37-,38-/m1/s1
|
| Chemical IUPAC Name |
Clarithromycin¿¡ ´ëÇÑ Chemical_IUPAC_Name Á¤º¸ (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-6-[(2S,3R,4S,6R)-4-dimethylamino-3-hydroxy-6-methyloxan-2-yl]oxy-14-ethyl-12,13-dihydroxy-4-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-7-methoxy-3,5,7,9,11,13-hexamethyl-1-oxacyclotetradecane-2,10-dione
|
| Drug-Induced Toxicity Related Proteins |
CLARITHROMYCIN ÀÇ Drug-Induced Toxicity Related ProteinÁ¤º¸ Replated Protein:HERG Drug:clarithromycin Toxicity:torsade de pointes. [¹Ù·Î°¡±â] Replated Protein:Potassium voltage-gated channel subfamily KQT member 1 (KvLQT1) Drug:clarithromycin Toxicity:torsade de pointes. [¹Ù·Î°¡±â] Replated Protein:Misshapen-like kinase(Mink) Drug:clarithromycin Toxicity:torsade de pointes. [¹Ù·Î°¡±â]
|
|
|
 | »ç¿ëÀÚÄÁÅÙÃ÷ |
|
|
|
|
|
-
ÃÖ±ÙÁ¤º¸¼öÁ¤ÀÏ 2025-07-08
-
º» ¼öÁ¤ÀÏ Á¤º¸´Â Çã°¡Á¤º¸ ÀÌ¿ÜÀÇ ±âŸÁ¤º¸ ¼öÁ¤ÀÏÀ» ÀǹÌÇϹǷÎ, Çã°¡Á¤º¸¼öÁ¤ÀÏÀº º»¹®¿¡ Ç¥±âµÈ ³¯Â¥¸¦ ÂüÁ¶ÇϽñ⠹ٶø´Ï´Ù.
|
|
¾Ë¸² |
»ó¼¼Á¤º¸´Â ½ÄǰÀǾàǰ¾ÈÀüóÀÇ Á¦Ç°Çã°¡»çÇ×À» Åä´ë·Î ÀÛ¼ºµÇ¾úÀ¸¸ç ¿ä¾àÁ¤º¸´Â »ó¼¼Á¤º¸ ¹× ±âŸ¹®ÇåÀ» ±â¹ÝÀ¸·Î µå·°ÀÎÆ÷¿¡¼ ÆíÁýÇÑ ³»¿ëÀÔ´Ï´Ù. Á¦Ç°Çã°¡»çÇ×ÀÇ ¸ñÂ÷¿Í ´Ù¼Ò »óÀÌÇÒ ¼ö ÀÖ½À´Ï´Ù. |
|
°æ°í |
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
¿©±â·Î À̵¿ÇϽñ⠹ٶø´Ï´Ù.
º´¿ë±Ý±â ¹× ƯÁ¤¿¬·É´ë ±Ý±â ¼ººÐ
|