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Æ®·ÎÇdzªÁ¤5mg(Çdzª½ºÅ׸®µå) Tropina Tab. 5mg
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Àü¹®ÀǾàǰ | ±Þ¿©
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µå·°ÀÎÆ÷¿¡¼´Â ÀǾàǰ ÀÎÅÍ³Ý ÆÇ¸Å¸¦ ÇÏÁö ¾Ê½À´Ï´Ù. |
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Àü¹®/ÀÏ¹Ý |
Àü¹®
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µ¿¼ºÁ¦¾à(ÁÖ)
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ÆÇ¸Åȸ»ç |
µ¿¼ºÁ¦¾à(ÁÖ)
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Á¤»ó
(2005.11.14)
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BIT ¾àÈ¿ºÐ·ù |
Àü¸³¼±Áúȯ °ü·Ã ¾à¹°(Drugs for Prostate disorder)
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643201140[A06703911] Àú°¡¾à ´ëü Àμ¾Æ¼ºê Áö±Þ ´ë»ó \516 ¿ø/1Á¤(2017.02.01)(ÇöÀç¾à°¡)\516 ¿ø/1Á¤(2014.02.01) (º¯°æÀü¾à°¡)
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ATCÄÚµå |
Finasteride / G04CB01 |
NDCÄÚµå |
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1µî±Þ: ¿øÄ¢Àû »ç¿ë±Ý±â / 2µî±Þ: ¸íÈ®ÇÑ ÀÓ»óÀû ±Ù°Å ¶Ç´Â »çÀ¯°¡ ÀÖ´Â °æ¿ì ºÎµæÀÌÇÏ°Ô »ç¿ë / Mµî±Þ: ÀÓ»óÀû»óȲ¿¡ µû¶ó 1µî±Þ ¶Ç´Â 2µî±ÞÀ¸·Î ºÐ·ùµÇ´Â ¼ººÐ
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159001ATB |
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20160155 |
20161230 |
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643201140[A06703911]
Àú°¡¾à ´ëü Àμ¾Æ¼ºê Áö±Þ ´ë»ó
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30 Á¤ |
8806432011407 |
8806432011421 |
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10 Á¤ |
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1) ÀÌ ¾àÀº ¼Ò¾Æ ¶Ç´Â ¿©¼º¿¡°Ô Åõ¿©ÇÏÁö ¾Ê´Â´Ù.
2) ÀӺΠ¶Ç´Â ÀÓ½ÅÇϰí ÀÖÀ» °¡´É¼ºÀÌ ÀÖ´Â ¿©¼ºÀº Çdzª½ºÅ׸®µåÀÇ Èí¼ö ¹× ±× ÀÌÈÄ ³²¼º žƿ¡ ´ëÇÑ ÀáÀçÀû À§ÇèÀÇ °¡´É¼ºÀÌ ÀÖÀ¸¹Ç·Î ÀÌ ¾àÀÇ ºÎ¼Áö°Å³ª ±úÁø Á¶°¢À» ¸¸Á®¼´Â ¾È µÈ´Ù. ÀÌ ¾àÀº ÄÚÆÃµÇ¾î Àֱ⠶§¹®¿¡, ±úÁö°Å³ª ºÎ¼ÁöÁö ¾Ê¾Ò´Ù¸é Á¤»óÀûÀÎ Ãë±Þ ½Ã¿¡´Â Ȱ¼º ¼ººÐ°úÀÇ Á¢ÃËÀ» ¹æÁöÇÒ ¼ö ÀÖ´Ù.
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1) ÀÌ ¾à ¶Ç´Â ÀÌ ¾àÀÇ ±¸¼º¼ººÐ¿¡ °ú¹Î¹ÝÀÀ ȯÀÚ
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1) ÀÌ ¾àÀº ³»¾à¼ºÀÌ ¿ì¼öÇϰí ÀÌ»ó¹ÝÀÀÀº ÀϹÝÀûÀ¸·Î °æ¹ÌÇϰí ÀϽÃÀûÀ̾ú´Ù.
2) ¿Ü±¹ÀÇ ÀÓ»ó
4³â°£ÀÇ À§¾à´ëÁ¶ ÀÓ»ó½ÃÇè(PLESS, Proscar Long¡©Term Efficacy and Safety Study)¿¡¼ ÀÌ ¾àÀ¸·Î Ä¡·á¸¦ ¹ÞÀº 1,524¸íÀÇ È¯ÀÚ¿Í À§¾à Ä¡·á¸¦ ¹ÞÀº 1,516¸íÀÇ È¯ÀÚ¿¡ ´ëÇÑ 4³â¿¡ °ÉÄ£ ¾ÈÀü¼º Æò°¡¸¦ ½Ç½ÃÇÏ¿´´Ù. ÀÌ ¾àÀ¸·Î Ä¡·áÇÑ 3.7 %(57¸íÀÇ È¯ÀÚ), À§¾àÀ¸·Î Ä¡·áÇÑ 2.1 % (32¸íÀÇ È¯ÀÚ)°¡ ¼º±â´É°ü·Ã ÀÌ»ó¹ÝÀÀÀ¸·Î Ä¡·á¸¦ Áß´ÜÇÏ¿´À¸¸ç, °¡Àå ºó¹øÇÏ°Ô º¸°íµÈ ÀÌ»ó¹ÝÀÀÀº ¼º±â´É°ü·Ã ÀÌ»ó¹ÝÀÀÀ̾ú´Ù. 4³â°£ÀÇ ÀÓ»ó½ÃÇè¿¡¼ À§¾àº¸´Ù ³ôÀº ºóµµ·Î ¹ßÇöÇÏ¿´°í ÀÌ ¾à¿¡¼ÀÇ ¹ßÇöÀ²ÀÌ 1 % ÀÌ»óÀ̾úÀ¸¸ç ÀÓ»ó½ÃÇ迬±¸ÀÚ¿¡ ÀÇÇØ ¾à¹°°ú °ü·ÃµÇ¾î ÀÖÀ» °¡´É¼ºÀÌ Àְųª, ¾Æ¸¶µµ °ü·ÃµÇ¾î Àְųª, ºÐ¸íÈ÷ °ü·ÃµÇ¾î ÀÖ´Ù°í °£ÁÖµÈ ÀÌ»ó¹ÝÀÀÀº ´ÙÀ½ Ç¥1°ú °°¾Ò´Ù. ÀÓ»ó½ÃÇè 2 ¡ 4³â¿¡¼´Â Åõ¿©±º°£ ¹ß±âºÎÀü, ¼º¿å°¨Åð, »çÁ¤Àå¾Ö ¹ßÇöÀ²¿¡ À¯ÀÇÇÑ Â÷À̰¡ ¾ø¾ú´Ù.
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8.1 |
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5.1 |
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6.4 |
3.4 |
2.6 |
2.6 |
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3.7 |
0.8 |
1.5 |
0.5 |
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0.8 |
0.1 |
0.2 |
0.1 |
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0.5 |
0.1 |
1.8 |
1.1 |
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0.4 |
0.1 |
0.7 |
0.3 |
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0.5 |
0.2 |
0.5 |
0.1 |
3) Àå±â»ç¿ë¿¡ °üÇÑ ÀÚ·á
3,047¸íÀÇ È¯ÀÚ¸¦ ´ë»óÀ¸·Î 4 ¡ 6³â°£ ¼öÇàÇÑ À§¾à ¹× ¾ç¼º´ëÁ¶ ÀÓ»ó½ÃÇè¿¡¼, ÀÌ ¾à 5 mgÀ» Åõ¿©ÇÑ Åõ¿©±º¿¡¼ 4°ÇÀÇ À¯¹æ¾ÏÀÌ ¹ß»ýÇÏ¿´°í, À§¾à±º ¹× ¾ç¼º´ëÁ¶±º¿¡¼´Â ¹ß»ýÇÏÁö ¾Ê¾Ò´Ù. º°µµÀÇ 3,040¸íÀÇ È¯ÀÚ¸¦ ´ë»óÀ¸·Î 4³â°£ ¼öÇàÇÑ À§¾à´ëÁ¶ ÀÓ»ó½ÃÇè¿¡¼ À§¾à±º¿¡¼ 2°ÇÀÇ À¯¹æ¾ÏÀÌ ¹ß»ýÇÏ¿´°í ÀÌ ¾à 5 mg Åõ¿©±º¿¡¼´Â ¹ß»ýÇÏÁö ¾Ê¾Ò´Ù. 18,882¸íÀÇ ³²¼ºÀÌ Âü¿©ÇÑ 7³â°£ÀÇ À§¾à´ëÁ¶ÀÓ»ó½ÃÇè(Prostate Cancer Prevention Trial, PCPT)¿¡¼ ÀÌ ¾à Åõ¿©±º ¹× À§¾à±º¿¡¼ °¢°¢ 1°ÇÀÇ À¯¹æ¾ÏÀÌ ¹ß»ýÇÏ¿´´Ù. ³²¼º À¯¹æ¾Ï¿¡ ´ëÇÑ ½ÃÆÇ ÈÄ º¸°í°¡ ÀÖ´Ù. ÀÌ ¾àÀÇ Àå±â°£ Åõ¿©¿Í ³²¼ºÀ¯¹æ ½Å»ý¹°°£ÀÇ °ü·Ã¼ºÀº ÇöÀç ¾Ë·ÁÁ® ÀÖÁö ¾Ê´Ù.
PCPT ÀÓ»ó½ÃÇèÀº Á÷Àå¼öÁö°Ë»ç¿¡¼ Á¤»óÀ̰í Àü¸³¼± ƯÀÌÇ׿ø(Prostate Specific Antigen, PSA) ¼öÄ¡°¡ ¡Â3.0 ng/mLÀÎ 55¼¼ ÀÌ»ó 18,882¸íÀÇ ³²¼ºÀÌ Âü¿©ÇÑ 7³â°£ÀÇ ¹«ÀÛÀ§, ÀÌÁ߸ͰË, À§¾à´ëÁ¶ ÀÓ»ó½ÃÇèÀ̾ú´Ù. ³²¼ºµéÀº ÀÌ ¾à 5 mg ¶Ç´Â À§¾àÀ» 1ÀÏ 1ȸ Åõ¿©¹Þ¾Ò´Ù. ȯÀÚµéÀº ¸ÅÇØ Á÷Àå¼öÁö°Ë»ç ¹× PSA¸¦ Æò°¡¹Þ¾ÒÀ¸¸ç, »ýüÁ¶Á÷°Ë»ç´Â PSA°¡ »ó½ÂµÇ°Å³ª Á÷Àå¼öÁö°Ë»ç¿¡¼ ºñÁ¤»óÀ¸·Î ³ª¿Â °æ¿ì¿Í ÀÓ»ó½ÃÇè ¸¶Áö¸·¿¡ ½ÃÇàÇÏ¿´´Ù. À§¾àÀ» Åõ¿©¹ÞÀº ³²¼º(1.1 %)¿¡ ºñÇØ ÀÌ ¾àÀ» Åõ¿©¹ÞÀº ³²¼º(1.8 %)¿¡¼ Gleason µî±Þ 8 ¡ 10ÀÇ Àü¸³»ù¾ÏÀÇ ¹ß»ýºóµµ°¡ ´õ ³ô¾Ò´Ù. ´Ù¸¥ 5¥á-ȯ¿øÈ¿¼Ò ¾ïÁ¦Á¦(µÎŸ½ºÅ׸®µå)¿¡ ´ëÇÑ 4³â°£ÀÇ À§¾à´ëÁ¶ ÀÓ»ó½ÃÇè¿¡¼µµ Gleasonµî±Þ 8 ¡ 10ÀÇ Àü¸³»ù¾Ï¿¡ ´ëÇÑ À¯»çÇÑ °á°ú°¡ °üÂûµÇ¾ú´Ù(1 % µÎŸ½ºÅ׸®µå vs. À§¾à 0.5 %). ÀÌ ¾à 5 mgÀ» Åõ¿©¹ÞÀº Àü¸³»ù¾Ï ȯÀÚ¿¡¼ÀÇ ÀÓ»óÀû À¯ÀͼºÀº ÀÔÁõµÇÁö ¾Ê¾Ò´Ù.
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ÀÌ ¾à ±×¸®°í/¶Ç´Â ÀÌ ¾à Àú¿ë·®¿¡¼ ´ÙÀ½°ú °°Àº ÀÌ»ó¹ÝÀÀÀÌ Ãß°¡·Î º¸°íµÇ¾ú´Ù. ÀÌ ÀÌ»ó¹ÝÀÀÀº ºÒƯÁ¤ Àα¸Áý´Ü¿¡¼ ÀÚ¹ßÀûÀ¸·Î º¸°íµÈ °ÍÀ̱⠶§¹®¿¡, ¹ß»ýºóµµ¸¦ ½Å·Ú¼º ÀÖ°Ô ¿¹ÃøÇϰųª ¾à¹°³ëÃâ°úÀÇ Àΰú°ü°è¸¦ È®¸³ÇÏ´Â °ÍÀº ÀϹÝÀûÀ¸·Î °¡´ÉÇÏÁö ¾Ê´Ù.
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| DUR (ÀǾàǰ»ç¿ëÆò°¡) |
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Finasteride¿¡ ´ëÇÑ µ¶¼ºÁ¤º¸ : Á¤º¸º¸±â
Ãâó: ±¹¸³µ¶¼º°úÇпø µ¶¼º¹°ÁúÁ¤º¸DB : http://www.nitr.go.kr/nitr/contents/m134200/view.do |
| Mechanism of Action |
Finasteride¿¡ ´ëÇÑ Mechanism_Of_Action Á¤º¸ The mechanism of action of Finasteride is based on its preferential inhibition of Type II 5a-reductase, an intracellular enzyme that converts the androgen testosterone into DHT. Inhibition of Type II 5a-reductase blocks the peripheral conversion of testosterone to DHT, resulting in significant decreases in serum and tissue DHT concentrations.
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| Pharmacology |
Finasteride¿¡ ´ëÇÑ Pharmacology Á¤º¸ Finasteride is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in men only. Finasteride is a competitive and specific inhibitor of Type II 5a-reductase, an intracellular enzyme that converts the androgen testosterone into DHT. Two distinct isozymes are found in mice, rats, monkeys, and humans: Type I and II. Each of these isozymes is differentially expressed in tissues and developmental stages. In humans, Type I 5a-reductase is predominant in the sebaceous glands of most regions of skin, including scalp, and liver. Type I 5a-reductase is responsible for approximately one-third of circulating DHT. The Type II 5a-reductase isozyme is primarily found in prostate, seminal vesicles, epididymides, and hair follicles as well as liver, and is responsible for two-thirds of circulating DHT.
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| Metabolism |
Finasteride¿¡ ´ëÇÑ Metabolism Á¤º¸ # Phase_1_Metabolizing_Enzyme:Cytochrome P450 3A4 (CYP3A4)Cytochrome P450 2C19 (CYP2C19)
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| Protein Binding |
Finasteride¿¡ ´ëÇÑ ´Ü¹é°áÇÕ Á¤º¸ Not Available
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| Half-life |
Finasteride¿¡ ´ëÇÑ ¹Ý°¨±â Á¤º¸ 4.5 hours (range 3.3-13.4 hours)
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| Absorption |
Finasteride¿¡ ´ëÇÑ Absorption Á¤º¸ Not Available
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| Biotransformation |
Finasteride¿¡ ´ëÇÑ Biotransformation Á¤º¸ Not Available
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| Toxicity |
Finasteride¿¡ ´ëÇÑ Toxicity Á¤º¸ Not Available
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| Drug Interactions |
Finasteride¿¡ ´ëÇÑ Drug_Interactions Á¤º¸ Cimetidine Cimetidine increases the effect of the benzodiazepineClozapine Increased risk of toxicityEthotoin Possible increased levels of the hydantoin, decrease of benzodiazepineFluconazole Fluconazole increases the effect of the benzodiazepineFosphenytoin Possible increased levels of the hydantoin, decrease of benzodiazepineIndinavir The protease inhibitor increases the effect of the benzodiazepineNelfinavir The protease inhibitor increases the effect of the benzodiazepineRitonavir The protease inhibitor increases the effect of the benzodiazepineSaquinavir The protease inhibitor increases the effect of the benzodiazepineMephenytoin Possible increased levels of the hydantoin, decrease of benzodiazepinePhenytoin Possible increased levels of the hydantoin, decrease of benzodiazepineItraconazole The imidazole increases the effect of the benzodiazepineKetoconazole The imidazole increases the effect of the benzodiazepineVoriconazole The imidazole increases the effect of the benzodiazepineKava Kava increases the effect of the benzodiazepineOmeprazole Omeprazole increases the effect of benzodiazepine
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CYP450 Drug Interaction |
[CYP450 TableÁ÷Á¢Á¶È¸]
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| Food Interaction |
Finasteride¿¡ ´ëÇÑ Food Interaction Á¤º¸ Take without regard to meals.
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| Drug Target |
[Drug Target]
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| Description |
Finasteride¿¡ ´ëÇÑ Description Á¤º¸ An orally active testosterone 5-alpha-reductase inhibitor. It is used as a surgical alternative for treatment of benign prostatic hyperplasia. [PubChem]
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| Drug Category |
Finasteride¿¡ ´ëÇÑ Drug_Category Á¤º¸ Anti-baldness AgentsAntihyperplasia AgentsEnzyme InhibitorsSkin and Mucous Membrane Agents
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| Smiles String Canonical |
Finasteride¿¡ ´ëÇÑ Smiles_String_canonical Á¤º¸ CC(C)(C)NC(=O)C1CCC2C3CCC4NC(=O)C=CC4(C)C3CCC12C
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| Smiles String Isomeric |
Finasteride¿¡ ´ëÇÑ Smiles_String_isomeric Á¤º¸ CC(C)(C)NC(=O)[C@H]1CC[C@H]2[C@@H]3CC[C@H]4NC(=O)C=C[C@]4(C)[C@H]3CC[C@]12C
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| InChI Identifier |
Finasteride¿¡ ´ëÇÑ InChI_Identifier Á¤º¸ InChI=1/C23H36N2O2/c1-21(2,3)25-20(27)17-8-7-15-14-6-9-18-23(5,13-11-19(26)24-18)16(14)10-12-22(15,17)4/h11,13-18H,6-10,12H2,1-5H3,(H,24,26)(H,25,27)/t14-,15-,16-,17+,18+,22-,23+/m0/s1/f/h24-25H
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| Chemical IUPAC Name |
Finasteride¿¡ ´ëÇÑ Chemical_IUPAC_Name Á¤º¸ (1S,3aS,3bS,5aR,9aR,9bS,11aS)-N-tert-butyl-9a,11a-dimethyl-7-oxo-1,2,3,3a,3b,4,5,5a,6,9b,10,11-dodecahydroindeno[5,4-f]quinoline-1-carboxamide
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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
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ÀüÈ: 02-3486-1061 ¤Ó À̸ÞÀÏ: webmaster@druginfo.co.kr
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