长效组胺阻断剂Karbinal ER获得FDA批准

圣路易斯(MD Consult)——2013年4月3日，Tris制药公司宣布，美国食品药品管理局(FDA)已批准Karbinal ER(马来酸卡比沙明)用于治疗年龄≥2岁患者的季节性和常年性过敏性鼻炎。Karbinal ER是一种可持续释放组胺受体阻断性物质的口服混悬剂(4 mg/5 ml)。该药已获准的其他适应证包括，过敏性结膜炎、轻度过敏性皮肤表现、皮肤划痕症，以及用于过敏反应的辅助治疗。

据Tris制药公司介绍，在2006年之前市场上已有多种卡比沙明产品，但它们中很多是并未获准的。当时，FDA从市场上清除了所有未获准的产品，只留下了2种速释型制剂。

该产品的标签上指出，与使用Karbinal ER相关的最常见不良反应包括镇静作用、嗜睡、头晕、共济失调、上腹痛和支气管分泌物变稠。应当建议患者在服用Karbinal ER期间避免进行需要保持精神警觉的有危险的活动，并且避免同时使用酒精饮料、镇静药物和镇定剂。

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ST LOUIS (MD Consult) - On April 3, 2013, Tris Pharma announced that the US Food and Drug Administration (FDA) has approved Karbinal ER (carbinoxamine maleate) for the treatment of seasonal and perennial allergic rhinitis in persons aged 2 years and older. Karbinal ER is sustained-release histamine-receptor blocking agent formulated as an oral suspension (4 mg/5 mL). Other approved uses include allergic conjunctivitis, mild allergic skin manifestations, dermatographism, and as an adjunct in the treatment of allergic reactions.

According to Tris Pharma, carbinoxamine was widely available until 2006 in numerous products, but many of these were unapproved. At that time, the FDA removed all unapproved products from the market, with the exception of 2 immediate-release formulations.

The product label states that the most common adverse reactions associated with the use of Karbinal ER include sedation, sleepiness, dizziness, disturbed coordination, epigastric distress, and thickening of bronchial secretions. Patients should be advised to avoid participating in hazardous tasks that require mental alertness while taking Karbinal ER, and to avoid concomitant use of alcoholic beverages, sedatives, and tranquilizers.