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BOTOX Cosmetic injection 100UI(A型肉毒毒素粉末注射剂)
药店国别  
产地国家 美国 
处 方 药: 是 
所属类别 100单位/瓶  
包装规格 100单位/瓶  
计价单位: 瓶 
生产厂家中文参考译名:
爱立根
生产厂家英文名:
Allergan, Inc
该药品相关信息网址1:
http://www.botox.com/
该药品相关信息网址2:
http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=17758
该药品相关信息网址3:
原产地英文商品名:
BOTOX COSMETIC VL 100U DS
原产地英文药品名:
onabotulinumtoxin A
中文参考商品译名:
BOTOX粉末注射剂 100单位/瓶
中文参考药品译名:
A型肉毒毒素
曾用名:
简介:

 

FDA批准BOTOX Cosmetic为第三种适应症,暂时改善外观,成为第一个也是唯一一个用于三个面部治疗区域的神经毒素 - 前额线,鱼尾纹和眉间线,BOTOX Cosmetic也是唯一获得美国眉间线以外美容适应症认可的神经毒素品牌。
批准日期:2016年2月5日 公司: Allergan, Inc.
BOTOX Cosmetic(A型肉毒毒素[onabotulinumtoxinA])注射,用于肌肉注射
最初的美国批准:1989年
警告:毒素效应过大
查看完整的盒装警告的完整处方信息。
BOTOX Cosmetic和所有肉毒杆菌毒素产品的效果从注射区域扩散,产生与肉毒杆菌毒素效应一致的症状。注射后数小时报告了这些症状。吞咽和呼吸困难可能会导致生命危险,并且有死亡报告。在因痉挛而接受治疗的儿童中,症状的风险可能最大,但在成人中也可能出现症状,特别是那些有潜在疾病会使他们易患症状的患者。
最近的重大变化
•适应症和用法:10/2017
•剂量和用法,额头线:10/2017
•警告和注意事项,人体白蛋白和病毒性疾病的传播:10/2017
作用机制
BOTOX化妆品通过与运动神经末梢的受体部位结合,进入神经末梢,抑制乙酰胆碱的释放来阻断神经肌肉传递。 当神经毒素切割SNAP-25时发生这种抑制,SNAP-25是一种突触前蛋白整合体,其成功地从位于神经末梢内的囊泡中对接和释放乙酰胆碱。 当以治疗剂量肌内注射时,BOTOX Cosmetic产生肌肉的部分化学去神经支配,导致肌肉活动的局部减弱。 此外,肌肉可能萎缩,可能发生轴突发芽,并且可能发展出额外的乙酰胆碱受体。 有证据表明可能会发生肌肉的神经再支配,从而缓慢逆转BOTOX Cosmetic产生的肌肉去神经支配。
适应症和用法
BOTOX Cosmetic是一种乙酰胆碱释放抑制剂和神经肌肉阻滞剂,适用于成人患者的暂时性改善:
•与皱眉肌和/或皱纹相关的中度到严重的眉间纹
procerus肌肉活动
•与眼轮匝肌有关的中度至重度侧c线
•与额肌活动相关的中度至重度额头线
剂量和给药
•Botox Cosmetic通过肌内注射给药
•Glabellar Lines Administration:每组5个位点0.1mL(4个单位),总剂量为20个单位。
•横向Canthal线管理:每组3个站点(总共6个注入点)各0.1mL(4个单位),总共24个单位。
•额头线管理:将0.1mL(4个单位)放入5个前额部位(20个单位)的每个中,每个5个眉间线位置(20个单位)中的0.1mL(4个单位),建议总共40个单位。
•遵循剂量和给药建议。在使用BOTOX和BOTOX Cosmetic治疗成人而不是一个批准的适应症时,不要超过在3个月间隔内给予400单位的总剂量。
•有关BOTOXCosmetic重建,储存和注射前准备的说明,请参阅制备和稀释技术。
剂量形式和强度
对于注射:50单位或100单位真空干燥粉末在一次性小瓶中重建。
禁忌症
•对任何肉毒杆菌毒素制剂或制剂中的任何成分过敏。
•注射部位感染。
警告和注意事项_
•BOTOX Cosmetic的效力单位不能与其他肉毒杆菌毒素制剂互换。
•毒素效应的传播;吞咽和呼吸困难会导致死亡。如果呼吸,言语或吞咽,请立即就医困难发生。
•BOTOX用于非危险用途后可能出现严重的不良反应。
•收到涉及心血管系统的不良事件报告,其中一些报告致命。给患有预先存在的心血管疾病的患者施用时要小心。
•伴随的神经肌肉疾病可能会加剧治疗的临床效果。
•对呼吸功能受损或吞咽困难的患者慎用。
不良反应
最常见的不良反应是:
•Glabellar Lines:眼睑下垂(3%)
•侧嵴线:眼睑水肿(1%)
•前额线:头痛(9%)和眉毛下垂(2%)
要报告疑似不良反应,请致电1-800-678-1605联系Allergan或1-800-FDA-1088或www.fda.gov/medwatch联系FDA。
药物相互作用
接收BOTOX化妆品andaminoglycosides或其它试剂与神经肌肉传导的干扰(例如,箭毒样剂),或肌肉松弛剂的伴随治疗的病人,应closelybecause BOTOX Cosmetic的效果可能会强化被观察到。
包装提供/存储和处理
注射用BOTOX化妆品(onabotulinumtoxinA)是一次性小瓶中的真空干燥粉末,其尺寸如下:
50个单位:NDC 0023-3919-50
100个单位:NDC 0023-9232-01
BOTOX Cosmetic纸箱的顶部和底部翻盖具有防篡改密封,包含半透明的银色Allergan标志。
BOTOX Cosmetic的小瓶在小瓶标签上有一个全息胶片,在水平线的颜色中包含名称“Allergan”。为了看全息图,在台灯或荧光灯下,在手指之间来回旋转小瓶。 (注意:标签上的全息胶片在日期/批次区域中不存在。)每个BOTOX Cosmetic样品瓶标签和纸箱还包含美国许可证号:1145。
如果出现以下情况,请勿在太平洋时间上午7:00至下午3:00致电1-800-890-4345使用该产品并联系Allergan获取更多信息:
•小瓶标签上不存在彩虹色水平线或“Allergan”名称
•防篡改密封不完整,存在于纸箱的两端
•密封处的半透明银色Allergan标识不清晰可见,或者有一个黑色圆圈,对角线穿过它
(即禁止标志)
•样品瓶标签和cartonStorage上没有美国许可证号1145
未开封的BOTOX Cosmetic样品瓶应存放在2°至8°C(36º至46ºF)的冰箱中。在小瓶上的有效期后不要使用。重组BOTOX化妆品应储存在2°至8°C(36º至46ºF)的冰箱中,并在24小时内给药
完整说明书附件:https://www.allergan.com/assets/pdf/botox_cosmetic_pi.pdf
BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
IMPORTANT SAFETY INFORMATION
BOTOX® and BOTOX® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® or BOTOX® Cosmetic:
Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing.
There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX® has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, strabismus, or when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow’s feet lines, and/or forehead lines.
Indications
BOTOX® is a prescription medicine that is injected into muscles and used:
to treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken
to treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder due to neurologic disease who still have leakage or cannot tolerate the side effects after trying an anticholinergic medication
to prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older
to treat increased muscle stiffness in elbow, wrist, finger, thumb, ankle, and toe muscles in people 18 years and older with upper and lower limb spasticity
to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older
to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older
BOTOX® is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older.
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow’s feet lines, and frown lines between the eyebrows in adults.
It is not known whether BOTOX® and BOTOX® Cosmetic are safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).
It is not known whether BOTOX® is safe or effective to treat increased stiffness in upper limb muscles other than those in the elbow, wrist, fingers, and thumb, or in lower limb muscles other than those in the ankle and toes. BOTOX® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. Treatment with BOTOX® is not meant to replace existing physical therapy or other rehabilitation that may have been prescribed.
It is not known whether BOTOX® and BOTOX® Cosmetic are safe or effective for other types of muscle spasms or for severe sweating anywhere other than your armpits.
It is not known if BOTOX® Cosmetic is safe and effective for use more than 1 time every 3 months.
BOTOX® and BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® and BOTOX® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Do not receive BOTOX® or BOTOX® Cosmetic if you: are allergic to any of its ingredients (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
Do not receive BOTOX® for the treatment of urinary incontinence if you: have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing.
Due to the risk of urinary retention (not being able to empty the bladder), only patients who are willing and able to initiate catheterization post-treatment, if required, should be considered for treatment.
Patients treated for overactive bladder
In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment with BOTOX® compared to 2 of the 542 treated with placebo.
Patients with diabetes mellitus treated with BOTOX® were more likely to develop urinary retention than non-diabetics.
Patients treated for overactive bladder due to neurologic disease
In clinical trials, 30.6% of patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection, required catheterization for urinary retention following treatment with BOTOX® 200 Units as compared to 6.7% of patients (7/104) treated with placebo. The median duration of post-injection catheterization for these patients treated with BOTOX® 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days) as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7).
Among patients not using CIC at baseline, those with MS were more likely to require CIC post-injection than those with SCI.
The dose of BOTOX® and BOTOX® Cosmetic is not the same as, or comparable to, any other botulinum toxin product.
Serious and/or immediate allergic reactions have been reported, including itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX® or BOTOX® Cosmetic should be discontinued.
Tell your doctor about all your muscle or nerve conditions such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX® or BOTOX® Cosmetic.
Tell your doctor if you have any breathing-related problems. Your doctor may monitor you for breathing problems during treatment with BOTOX® for spasticity or for detrusor overactivity associated with a neurologic condition. The risk of developing lung disease in patients with reduced lung function is increased in patients receiving BOTOX®.
Cornea problems have been reported. Cornea (surface of the eye) problems have been reported in some people receiving BOTOX® for their blepharospasm, especially in people with certain nerve disorders. BOTOX® may cause the eyelids to blink less, which could lead to the surface of the eye being exposed to air more than is usual. Tell your doctor if you experience any problems with your eyes while receiving BOTOX®. Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch.
Bleeding behind the eye has been reported. Bleeding behind the eyeball has been reported in some people receiving BOTOX® for their strabismus. Tell your doctor if you notice any new visual problems while receiving BOTOX®.
Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in people receiving BOTOX® for upper limb spasticity. Upper respiratory infections were also reported more frequently in people with prior breathing related problems with spasticity.
Autonomic dysreflexia in patients treated for overactive bladder due to neurologic disease. Autonomic dysreflexia associated with intradetrusor injections of BOTOX® could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in patients treated with BOTOX® 200 Units compared with placebo (1.5% versus 0.4%, respectively).
Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles; trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; have symptoms of a urinary tract infection (UTI) and are being treated for urinary incontinence (symptoms of a urinary tract infection may include pain or burning with urination, frequent urination, or fever); have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX® or BOTOX® Cosmetic can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX® or BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® or BOTOX® Cosmetic with certain medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you received BOTOX® or BOTOX® Cosmetic in the past.
Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic injection; take muscle relaxants; take allergy or cold medicines; take sleep medicine; take aspirin-like products or blood thinners.
Other side effects of BOTOX® and BOTOX® Cosmetic include: dry mouth, discomfort or pain at injection site, tiredness, headache, neck pain, eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of eyelids, dry eyes, and drooping eyebrows. In people being treated for urinary incontinence other side effects include: urinary tract infection, painful urination, and/or inability to empty your bladder on your own. If you have difficulty fully emptying your bladder after receiving BOTOX®, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again. 

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