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西替利嗪在儿童用药的主要风险是什么？
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西替利嗪用于儿童，不同资料说法不一：包括“不推荐用于6岁以下儿童”，“不推荐用于12岁以下儿童”，“2岁以下儿童禁用”，“可用于儿童及妊娠或哺乳的妇女”不一而足。 目前权威的说法是？ 西替利嗪在儿童用药的主要风险是什么？ 希望有最新资料的站友给予解释 |
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qinhy(金币+1): 谢谢回帖交流~ 2011-07-14 17:55:39
qinhy(金币+1): 谢谢回帖交流~ 2011-07-14 17:55:39
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以下是国外网站的资料，显示对6个月以上儿童进行过安全性评价，应该可以使用。 国外上市的有片剂、糖浆剂和咀嚼片。 ZYRTEC (cetirizine) can be taken without regard to food consumption. ZYRTEC (cetirizine) is available as 5 mg and 10 mg tablets, 1 mg/mL syrup, and 5 mg and 10 mg chewable tablets which can be taken with or without water. Adults and Children 12 Years and Older: The recommended initial dose of ZYRTEC (cetirizine) is 5 mg or 10 mg per day in adults and children 12 years and older, depending on symptom severity. Most patients in clinical trials started at 10 mg. ZYRTEC (cetirizine) is given as a single daily dose. The time of administration may be varied to suit individual patient needs. Children 6 to 11 Years: The recommended initial dose of ZYRTEC (cetirizine) in children aged 6 to 11 years is 5 mg or 10 mg once daily depending on symptom severity. The time of administration may be varied to suit individual patient needs. Children 2 to 5 Years: The recommended initial dose of ZYRTEC (cetirizine) in children aged 2 to 5 years is 2.5 mg (? teaspoon) syrup once daily. The dosage in this age group can be increased to a maximum dose of 5 mg per day given as 1 teaspoon syrup once a day or one ? teaspoon syrup given every 12 hours, or one 5 mg chewable tablet once a day. Children 6 months to <2 years: The recommended dose of ZYRTEC (cetirizine) syrup in children 6 months to 23 months of age is 2.5 mg (? teaspoon) once daily. The dose in children 12 to 23 months of age can be increased to a maximum dose of 5 mg per day, given as ? teaspoon (2.5 mg) every 12 hours. Syrup is recommended for children under the age of 2 years. Pediatric Use: The safety of ZYRTEC (cetirizine) has been demonstrated in pediatric patients aged 6 months to 11 years. The safety of ZYRTEC (cetirizine) , at daily doses of 5 or 10 mg, has been demonstrated in 376 pediatric patients aged 6 to 11 years in placebo-controlled trials lasting up to four weeks and in 254 patients in a non-placebo-controlled 12-week trial. The safety of cetirizine has been demonstrated in 168 patients aged 2 to 5 years in placebo-controlled trials of up to 4 weeks duration. On a mg/kg basis, most of the 168 patients received between 0.2 and 0.4 mg/kg of cetirizine HCl. The safety of cetirizine in 399 patients aged 12 to 24 months has been demonstrated in a placebo-controlled 18-month trial, in which the average dose was 0.25 mg/kg bid, corresponding to a range of 4 to 11 mg/day. The safety of ZYRTEC (cetirizine) syrup has been demonstrated in 42 patients aged 6 to 11 months in a placebo-controlled 7-day trial. The prescribed dose was 0.25 mg/kg bid, which corresponded to a mean of 4.5 mg/day, with a range of 3.4 to 6.2 mg/day. The effectiveness of ZYRTEC (cetirizine) for the treatment of allergic rhinitis and chronic idiopathic urticaria in pediatric patients aged 6 months to 11 years is based on an extrapolation of the demonstrated efficacy of ZYRTEC (cetirizine) in adults with these conditions and the likelihood that the disease course, pathophysiology and the drug's effect are substantially similar between these two populations. Efficacy is extrapolated down to 6 months of age for perennial allergic rhinitis and down to 2 years of age for seasonal allergic rhinitis because these diseases are thought to occur down to these ages in children. The recommended doses for the pediatric population are based on cross-study comparisons of the pharmacokinetics and pharmacodynamics of cetirizine in adult and pediatric subjects and on the safety profile of cetirizine in both adult and pediatric patients at doses equal to or higher than the recommended doses. The cetirizine AUC and Cmax in pediatric subjects aged 6 to 23 months who received a mean of 2.3 mg in a single dose, and in subjects aged 2 to 5 years who received a single dose of 5 mg of cetirizine syrup and in pediatric subjects aged 6 to 11 years who received a single dose of 10 mg of cetirizine syrup were estimated to be intermediate between that observed in adults who received a single dose of 10 mg of cetirizine tablets and those who received a single dose of 20 mg of cetirizine tablets. The safety and effectiveness of cetirizine in pediatric patients under the age of 6 months have not been established. Last reviewed on RxList: 5/17/2007 This monograph has been modified to include the generic and brand name in many instances. 别人的回复，贴到这，与同道共享 |
4楼2011-07-14 10:35:31
