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  药店国别: 美国药房
产地国家: 美国
所属类别: 神经系统药物->头痛药物
处方药:处方药
包装规格: 6bottles/box
计价单位:
  点击放大  
生产厂家中文参考译名:
COLLEGIUM制药公司
生产厂家英文名:
COLLEGIUM PHARMACEUTICAL INC
该药品相关信息网址1:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0bfcba9-0af6-4b45-80e3-c4c94065b777
原产地英文商品名:
ELYXYB (celecoxib) oral solution 120mg/4.8ML/bottle 6bottle/box
原产地英文药品名:
celecoxib oral solution 120mg/4.8ML/bottle 6bottle/box
中文参考商品译名:
ELYXYB塞来昔布口服液120毫克/4.8毫升/瓶 6瓶/盒
中文参考药品译名:
塞来昔布口服液120毫克/4.8毫升/瓶 6瓶/盒
原产地国家批准上市年份:
2020/01/01
英文适应病症1:
migraine
临床试验期:

中文适应病症参考翻译1:
偏头痛
药品信息:

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 详细处方信息以本药内容附件PDF文件(202372618265430.pdf)的“原文Priscribing Information”为准
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部分中文Intuniv处方资料(仅供参考)

ELYXYB ORAL SOL 120mg/4.8ML*6bottles

药品介绍
一种处方非甾体抗炎药 (NSAID),用于急性治疗成人有或没有先兆的偏头痛。ELYXYB不用作偏头痛的预防性治疗目前尚不清楚ELYXYB对儿童是否安全有效。

用法用量
ELYXYB的推荐剂量为口服120毫克,有或没有食物。24小时内的最大剂量为120毫克。24小时内第二剂的安全性和有效性尚未确定。中度肝损伤(Child-Pugh B级)患者的推荐和最大剂量为60mg(2.4mL)。建议使用经过校准的测量设备来准确测量和输送规定的剂量。家用茶匙或汤匙不是适当的测量设备。不建议在严重肝损伤患者中使用 ELYXYB。已知或怀疑为CYP2C9不良代谢者的推荐和最大剂量为60mg(2.4mL)。建议使用经过校准的测量设备来准确测量和输送规定的剂量。家用茶匙或汤匙不是适当的测量设备。

不良反应
由于临床试验是在差异很大的条件下进行的,因此在药物临床试验中观察到的不良反应率不能直接与另一种药物的临床试验中观察到的不良反应率进行比较,并且可能无法反映在实践中观察到的不良反应率。在成年偏头痛患者中,在两项随机,双盲,安慰剂对照试验(研究815和1)中,在2名接受至少一剂ELYXYB的患者中评估了ELYXYB的安全性。在研究2和研究1中,最常见的不良反应(至少2%接受ELYXYB且大于安慰剂)是味觉障碍,3%接受ELYXB的患者发生,而接受安慰剂的患者为1%。有血管炎、深静脉血栓形成,过敏反应,血管性水肿,肝坏死、肝炎、黄疸、肝衰竭等。

For patients who are prescribed the recommended dosage of 120 mg, instruct them to drink the entire amount of ELYXYB directly from the bottle. For patients who are prescribed the reduced dosage (i.e., patients with moderate hepatic impairment or CYP2C9 poor metabolizers), instruct them to use an oral dosing syringe to correctly measure the prescribed amount of medication. Inform these patients that oral dosing syringes may be obtained from their pharmacy and that a household teaspoon is not an accurate measuring device. Instruct these patients to discard the unused portion of ELYXYB. Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately。Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding。 Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, instruct patients to stop ELYXYB and seek immediate medical therapy。 Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur。 Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur。 Advise patients to stop taking ELYXYB immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible。 Inform patients that use of acute migraine drugs for 10 or more days per month, including ELYXYB, may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary). Instruct patients to contact their healthcare provider if the frequency of their migraines increases; withdrawal of ELYXYB may be necessary。 Advise females of reproductive potential who desire pregnancy that NSAIDs, including ELYXYB, may be associated with a reversible delay in ovulation。 Inform pregnant women to avoid use of ELYXYB and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus. If treatment with ELYXYB is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours。 Inform patients that the concomitant use of ELYXYB with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy。 Alert patients that NSAIDs may be present in "over the counter" medications for treatment of colds, fever, or insomnia. Inform patients not to use low-dose aspirin concomitantly with ELYXYB until they talk to their healthcare provider。

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 详细处方信息以本药内容附件PDF文件(202372618265430.pdf)的“原文Priscribing Information”为准
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