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  药店国别: 加拿大药房
产地国家: 加拿大
所属类别: 神经系统药物->亨廷顿舞蹈病
处方药:处方药
包装规格: 25毫克/片 100片/瓶
计价单位:
  点击放大  
原产地英文商品名:
Generic Xenazine 25mg/tab 100tabs/bottle
原产地英文药品名:
tetrabenazine
中文参考商品译名:
Xenazine仿制药 25毫克/片 100片/瓶
中文参考药品译名:
丁苯那嗪
原产地国家批准上市年份:
2008/12/01
英文适应病症1:
Huntington's chorea (uncontrolled muscle)movements)
临床试验期:
完成
中文适应病症参考翻译1:
亨廷顿舞蹈病
药品信息:

        FDA近日批准了Prestwick公司用于治疗亨廷顿舞蹈病(Huntington's Disease)的药物Xenazine (tetrabenazine),这是首个在美国获准治疗该症的治疗药。它获准的依据是一项III期临床实验结果显示,这种具有选择性作用功能的多巴胺耗竭治疗药疗效显著,并且安全性和耐受性良好。
  Prestwick表示Xenazine将在一项经FDA批准的风险评估项目下进行销售,这个评估项目主要防止该药有可能导致的抑郁和自杀倾向等不良反应。此前,该药也已被指定为罕见病治疗药,它在美国具有7年的独家销售权。

  该药获准后在美国受到欢迎,当地约有3万名患者深受这种疾病的困扰。美国遗传性疾病基金会表示,舞蹈病不仅给患者带来不便,它还会严重影响患者在步行、说话、工作和看电视等各方面的能力。

  目前,该药已在其他14个国家通过批准,新近获准的国家包括荷兰、瑞典和瑞士。

XENAZINE®: 25 mg, scored tablets
(INN: tetrabenazine)

Xenazine® is indicated for the treatment of Huntington’s chorea.

GENERIC NAME: Tetrabenazine
BRAND NAME: Xenazine
How does it work?

Xenazine (Tetrabenazine) works by depleting the stores of certain chemicals called neurotransmitters within nerve cells in the brain. These neurotransmitters include dopamine, serotonin and noradrenaline and are normally involved with the passage of messages between nerve cells in the brain and the normal functioning of the brain and nervous system.

Depleting the brain of these neurotransmitters can help control movement disorders caused by diseases of the brain and nervous system, although the exact mechanism of action is not fully understood.

Xenazine (Tetrabenazine) is mainly used to control movement disorders associated with diseases of the brain and nervous system, such as Huntington's chorea, but can also be used to control movement disorders caused by antipsychotic medicines.

The older antipsychotic medicines such as chlorpromazine, haloperidol and flupentixol can cause side effects involving involuntary movement of the tongue, face, mouth and jaw, which may sometimes be accompanied by involuntary movements of the arms and legs (tardive dyskinesia). If this is disabling or socially embarrasing, and persists despite stopping or reducing the dose of the antipsychotic, the symptoms can be treated using tetrabenazine. Xenazine (Tetrabenazine) can also be used if it is not possible to stop or change the antipsychotic.

What is it used for?

Movement disorders associated with disease of the brain and spinal cord

Nerve cell breakdown resulting in irregular involuntary movements and brain disease (Huntington's chorea)

Rhythmical involuntary movement of the tongue, face, mouth and jaw, which may sometimes be accompanied by involuntary movements of the arms and legs (tardive dyskinesia)

Warning!

 

Do not drink alcohol whilst taking this medicine.

This medicine may cause drowsiness. If affected do not drive or operate machinery.

Not to be used in: No known conditions
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding: Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

 

There is no information about the safety of this medicine during pregnancy, but it has been widely used for many years without apparent ill consequence.

As there is no safety information available, the manufacturer does not recommend the use of this medicine when breastfeeding. Alternatively, if this medicine must be used, the mother should not breastfeed. Seek medical advice from your doctor.

Label warnings: This medication may cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.

Side effects: Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain

Low blood pressure (hypotension)

High temperature combined with falling levels of consciousness, paleness, sweating and a fast heart beat (neuroleptic malignant syndrome). Requires stopping the medicine and immediate medical treatment.

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

Xenazine (Tetrabenazine) should not be taken at the same time as, or for 14 days following a course of monoamine oxidase inhibitor (MAOI) antidepressants, as this can cause restlessness, disorientation and confusion.
Xenazine (Tetrabenazine) opposes the effects of levodopa.
Xenazine (Tetrabenazine) should not be taken with alcohol as this may increase the drowsiness experienced.

更新于2011年2月28日

更新日期: 2011-2-28
附件:
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