HIGHLIGHTS OF PRESCRIBING INFORMATION |
These highlights do not include all the information needed to use AMITIZA safely and effectively. See full prescribing information for AMITIZA. AMITIZA (lubiprostone) capsule, gelatin coated for oral use Initial U.S. Approval: 2006
2012年7月5日,Sucampo制药(SPI)和雅培(Abbott)公司今天宣布,SPI全资子公司Sucampo制药有限公司药物AMITIZA(lubiprostone)已获日本卫生劳动福利部批准,这是种处方药,用于慢性便秘(不包括由气质性病变引发的便秘)。
"能收到日本有史以来首个慢性便秘处方药批准,对此我们非常高兴,这有助于实现我们的目标,即为全球范围内医疗需求未获满足的患者带来全新作用机制的药物,"Sucampo公司董事长兼总裁、医学博士Ryuji Ueno说道。"我们期待着与雅培一起合作,来满足日本患者的需求。"
在2009年,Sucampo与雅培就AMITIZA在日本的商业化及供应签署了协议
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INDICATIONS AND USAGE
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Amitiza is a chloride channel activator indicated for:
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Treatment of chronic idiopathic constipation in adults (1.1)
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Treatment of irritable bowel syndrome with constipation in women ≥ 18 years old (1.2)
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DOSAGE AND ADMINISTRATION
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Chronic idiopathic constipation
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24 mcg taken twice daily orally with food and water (2.1)
Irritable bowel syndrome with constipation
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