部分中文Nucynta处方资料（仅供参考）                 
J＆J公司向美国FDA提出它的口服镇痛药tapentadol延长释放配方的NDA，用于18岁和以上病人中到重度慢性疼痛的治疗。慢性疼痛被定义为疼痛持续3个月以上。该药的即时释放配方于2008年11月获准用于急性疼痛治疗，商品名为Nucynta。
Nucynta (他喷他多(tapentadol))立即释放片
批准日期：2008年11月20日；公司：Ortho-McNeil-Janssen Pharmaceuticals, Inc.
一般描述：NUCYNTA(他喷他多)片是为口服给药的立即释放膜包裹片。化学名是3-[(1R,2R)-3- (dimethylamino)-1-ethyl-2methylpropyl]phenol monohydrochloride。
适应证： NUCYNTA是一种阿片类镇痛药适用于在18岁或以上患者解除中度至严重急性疼痛。
剂量和用法：
如许多中枢作用镇痛药一样，NUCYNTA?的给药方案应按照正在被治疗疼痛的严重程度个体化，用相似药物既往经验和监查患者的能力。.
起始量NUCYNTA?有或无食物剂量50 mg、75 mg、或100 mg每4至6小时依赖于疼痛强度。在给药第1天，如首次给药未达到适当解除疼痛那末在首次给药后立即可给予第2剂量。随后给药是每4至6小时50 mg，75 mg，或100 mg和应调整维持可接受耐受性适当镇痛。尚未研究在治疗第1天每天剂量大于700 mg和尚未研究随后天600 mg和所以不推荐使用。
剂型和规格：
片：50 mg、75 mg、100 mg。
禁忌证：
受损肺功能(显著呼吸压抑，急性或严重支气管哮喘或在非监查情况下的血碳酸过多症或缺乏复苏设备)。
麻痹性肠梗阻与单胺氧化酶抑制剂(MAOI)同时使用或在14天内使用。
警告和注意事项：
呼吸压抑：在老年人、虚弱患者、患有缺氧、 高碳酸血症、或上呼吸道阻塞伴随情况增加风险。
CNS效应：当与酒精、其它阿片类或非法药物联合使用增加CNS压抑作用。
颅内压升高：可能明显地加重存在的头损伤，其它颅内病变。
可能发生滥用。严密监查患者滥用和成瘾的征象。
受损的精神/身体能力：潜在危害性活动时必须慎用。
癫痫发作：有癫痫发作史患者慎用。
羟色胺综合征：同时给予血清素可能造成潜在危及生命情况。
不良反应：最常见不良事件是恶心、眩晕、呕吐和嗜睡。
药物相互作用：
患者当前使用指定中枢作用药物或酒精时慎用NUCYNTA。
当前使用或14天内使用单胺氧化酶抑制剂(MAOI)患者不要使用NUCYNTA。
特殊人群中的使用：
分泌和生产：分娩和生产期间和前立即不要使用。母亲曾服用NUCYNTA监查新生儿呼吸压抑。
哺乳母亲：不要哺乳。
儿童使用：尚未确定在18岁以下患者的安全性和有效性。
肾或肝功能受损：在严重肾或肝功能受损患者中建议不使用。中度肝功能受损患者中慎用。
老年人：当选择初始剂量应谨慎。

Nucynta
Generic Name: tapentadol (ta PEN ta dol)
Brand Names: Nucynta
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What is Nucynta?
Nucynta (tapentadol) is in a group of drugs called narcotic pain relievers. It is similar to morphine.
Nucynta is used to treat moderate to severe pain.
Nucynta may also be used for other purposes not listed in this medication guide.
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Important information about Nucynta
You should not use Nucynta if you are allergic to tapentadol, or if you have severe liver or kidney disease, if you are having an asthma attack, or if you have a bowel obstruction called paralytic ileus. Do not take Nucynta if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take Nucynta before the MAO inhibitor has cleared from your body.
Nucynta may be habit-forming and should be used only by the person it was prescribed for. This medicine should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Do not drink alcohol while you are taking Nucynta. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol.
Never take more Nucynta than is prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
Nucynta can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Do not stop using Nucynta suddenly, or you could have unpleasant withdrawal symptoms.
Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.
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Before taking Nucynta
You should not use Nucynta if you are allergic to tapentadol, or if you have severe liver or kidney disease, if you are having an asthma attack, or if you have a bowel obstruction called paralytic ileus. Do not take Nucynta if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take Nucynta before the MAO inhibitor has cleared from your body.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:
asthma, COPD, sleep apnea, or other breathing disorders;liver or kidney disease;
curvature of the spine;
a history of head injury or brain tumor;
epilepsy or other seizure disorder;
gallbladder disease or pancreas problems;
mental illness; ora history of drug or alcohol addiction.
FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Nucynta may cause breathing problems and addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy.
Tell your doctor if you are pregnant or plan to become pregnant during treatment.
Tapentadol can pass into breast milk and may harm a nursing baby. Do not breast-feed while taking this medication.
Older adults may be more sensitive to the effects of this medicine.
Do not give Nucynta to a child. Tapentadol may be habit-forming and should be used only by the person it was prescribed for. Nucynta should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.
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How should I take Nucynta?
Take Nucynta exactly as it was prescribed for you. Never take Nucynta in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.
Tell your doctor if the medicine seems to stop working as well in relieving your pain.
Your doctor may occasionally change the timing of your dose to make sure you get the best results from this medication.
Take this medicine with a full glass of water.
You may take Nucynta with or without food.
Nucynta can cause constipation. Talk to your doctor before using a laxative or stool softener to treat or prevent this side effect.
Do not stop using Nucynta suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.
Store this medicine at room temperature away from moisture and heat.
Keep track of how many tablets have been used from each new bottle of this medicine. Nucynta is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription. Ask a pharmacist about how to dispose of any unused pills after you have stopped taking Nucynta.
Never crush a tablet or other pill to mix into a liquid for snorting tapentadol or injecting the drug into your vein.
This practice has resulted in death with the misuse of narcotic pain medicines and similar prescription drugs.
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What happens if I miss a dose?
Since this medicine is sometimes used as needed, you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.
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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. An overdose of tapentadol can be fatal.
Overdose symptoms may include extreme drowsiness, blurred vision, confusion, vomiting, cold and clammy skin, weak pulse, shallow breathing,fainting,orbreathing that stops.
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What should I avoid while taking Nucynta?
Do not drink alcohol while you are using Nucynta. Dangerous side effects or death can occur when alcohol is combined with tapentadol. Check your food and medicine labels to be sure these products do not contain alcohol. Nucynta can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
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Nucynta side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Nucynta: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:weak or shallow breathing, weak pulse, slow heartbeat;seizure (convulsions);severe drowsiness or dizziness;confusion, problems with speech or balance; oragitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.
Less serious Nucynta side effects may include:mild nauseaorvomiting;constipation;
mild dizziness, drowsiness;dry mouth;itching; orincreased sweating.
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 Nucynta?
Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by Nucynta.
Tell your doctor if you regularly use any of these medicines, or any other narcotic pain medicines.
This list is not complete and there may be other drugs that can interact with Nucynta. Tell your doctor about all the prescription and over-the-counter medications you use.
This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
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Where can I get more information?
Your pharmacist can provide more information about Nucynta.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum
provides.
The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
药品信息:
友情提示：Nucynta为药师麻醉药品，2级管制。
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原产地英文商品名:
NUCYNTA
原产地英文药品名:
TAPENTADOL HYDROCHLORIDE
原产地英文化合物名称:
3-[(1R,2R)-3- (dimethylamino)-1-ethyl-2methylpropyl]phenol monohydrochloride
中文参考商品译名:
NUCYNTA
中文参考药品译名:
盐酸他喷他多
生产厂家中文参考译名:
ORTHO MCNEIL JANSSEN
生产厂家英文名:
ORTHO MCNEIL JANSSEN