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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->抗癫痫药物
处方药:处方药
包装规格: 100毫克/片 60片/盒
计价单位:
  点击放大  
生产厂家英文名:
Aprecia Pharmaceuticals
该药品相关信息网址1:
http://www.Spritam.com/
该药品相关信息网址2:
https://www.drugs.com/mtm/spritam.html
该药品相关信息网址3:
https://www.rxlist.com/spritam-drug.htm
原产地英文商品名:
SPRITAM TABLET 100mg/Tablet 60Tablets/box
原产地英文药品名:
Levetiracetam
中文参考商品译名:
SPRITAM 100毫克/片 60片/盒
中文参考药品译名:
左乙拉西坦
原产地国家批准上市年份:
2016/02/05
英文适应病症1:
Epilepsy
临床试验期:
完成
中文适应病症参考翻译1:
癫痫
药品信息:

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详细处方信息以本药内容附件PDF文件(2020102800291428.pdf)的“原文Priscribing Information”为准
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部分中文处方资料(仅供参考)

左乙拉西坦
外文名:SPRITAM

2015年7月31日,美国食品药品监督管理局批准了Aprecia制药公司的首款采用3D打印技术制备的 Sprite(左乙拉西坦, levetiracetam)速溶片上市,用于和其它抗癫瘺药物联合治疗成人或儿童患者的局灶性发作、肌阵挛发作、以及原发性全身癫痛发作。 Spritam采用 Aprecia公司自主知识产权的 ZipDose3D打印技术生产,这种以3D打印技术制备的新型制剂内部成多空状因为内表面积高能在短时间内被很少量的水融化。 Spritam是美国FDA批准的首款采用3D打印技术制备的药物。

Spritam是一种可溶于水的易渗性药片,可使患者不必非要吞服药片。  上述功能对癫痫症患者而言至关重要,因为癫痫症患者可能难以吞咽药片。尤其是对儿童癫痫症患者而言,看护人员喂他们吞咽药片颇有难度。药物的生产原理是使用粉末制造,并用液体将粉末固定在一起,这一技术提供了分解得更快的更高用药剂量。据称,与现有的制剂相比,这种药物的优点是水溶性更好,并且口感更佳。

Spritam
Brand Names: Keppra, Keppra XR, Roweepra, Spritam

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What is Spritam?
Spritam is used to treat partial onset seizures in adults and children who are at least 1 month old. The Spritam brand of Spritam is not for use in children younger than 4 years old or children who weigh less than 44 pounds. Spritam is also used to treat tonic-clonic seizures in people who are at least 6 years old, and myoclonic seizures in people who are at least 12 years old. Spritam may also be used for purposes not listed in this medication guide.

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Important Information
Some people have thoughts about suicide when first taking this medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Before taking this medicine:You should not use Spritam if you are allergic to it.Tell your doctor if you have ever had:

kidney disease (or if you are on dialysis);

depression or other mood problems;

mental illness or psychosis; or

suicidal thoughts or actions.

You may have thoughts about suicide while taking Spritam. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Follow your doctor's instructions about taking seizure medication if you are pregnant. Seizure control is very important during pregnancy, and having a seizure could harm both mother and baby. Your dose needs may be different during pregnancy. Do not start or stop taking this medicine without your doctor's advice, and tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of levetiracetam on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Do not give this medicine to a child without medical advice.

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How should I take Spritam?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take the medicine at the same time each day, with or without food.

Spritam doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the form and strength your doctor prescribes.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Swallow the extended-release tablet whole and do not crush, chew, or break it.

To take the Spritam dissolvable tablet:

Remove a tablet from the package only when you are ready to take the medicine.

Use dry hands to remove the tablet and place it on your tongue. Then take a sip of liquid and hold it in your mouth.

Do not swallow the tablet whole. Allow it to dissolve in your mouth with the sip of liquid.

Swallow only after the tablet has completely dissolved, which should take less than 30 seconds.

You should not stop using Spritam suddenly, unless your doctor tells you to stop the medicine because of a serious side effect. Stopping suddenly may cause increased seizures. Follow your doctor's instructions very carefully.

Use all seizure medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice.

In case of emergency, wear or carry medical identification to let others know you use seizure medication.

Your kidney function may need to be tested often.

Store at room temperature away from moisture, heat, and light.

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What should I avoid while taking Spritam?

Drinking alcohol with Spritam can cause side effects and may also increase the risk of seizures.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

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What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

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What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme drowsiness, agitation, aggression, shallow breathing, weakness, or fainting.

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Spritam side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

-Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel agitated, hostile, irritable, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

unusual changes in mood or behavior (unusual risk-taking behavior, being irritable or talkative);

confusion, hallucinations, loss of balance or coordination;

extreme drowsiness, feeling very weak or tired;

problems with walking or movement;

the first sign of any skin rash, no matter how mild;

easy bruising, unusual bleeding; or

fever, chills, weakness, or other signs of infection.Common side

effects may include:

dizziness, drowsiness, tiredness;

weakness;

feeling aggressive or irritable;

loss of appetite;

stuffy nose; or

infection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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What other drugs will affect Spritam?

Other drugs may affect Spritam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

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详细处方信息以本药说明书为准
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更新日期: 2020-10-28
附件:
2020102800293529.pdf    

2020102800291428.pdf    

 
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