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 详细处方信息以本药内容附件PDF文件（2010102719105537.pdf）的“原文Priscribing Information”为准
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部分中文氟马西尼处方资料（仅供参考）

通用名：注射用氟马西尼

英文名：Flumazenil for Injection

化学名：8-氟-5，6-二氢-5-甲基-6-氧代-4H-咪唑并-[1，5-а][1，4]苯并二氮 -3-甲酸乙酯

别名：Flumazepil, Anexate, Lanexat, Mazicon, Ro-15-1788, Romazicon

化学名称：8-Fluoro-5,6-dihydro-5-methyl-6-oxo-4H-Imidazo[1,5-a][1,4]benzodiazepine-3-carboxylic acid, ethyl ester

药理药动：氟马西尼为苯二氮卓类拮抗药。它能通过竞争性地抑制苯二氮卓激动剂到达受体，以阻断其中枢性作用。因而氟马西尼可扭转苯二氮卓的中枢镇静作用，诊断和治疗苯二氮卓过量引起的中毒。其他催眠镇静药如巴比妥类、乙醇、甲丙氨酯、GABA模拟剂等与苯二氮卓受体无亲和性，故不受氟马西尼的影响。

药动学：氟马西尼在胃肠道吸收良好。由于首过效应，其生物利用度约为 20％。大约 50％的氟马西尼可与血浆蛋白结合。氟马西尼静注后经肝脏广泛代谢为无活性的羧酸产物。其消除半减期为 53min。

适应症：
氟马西尼可扭转苯二氮卓中枢镇静作用，用于麻醉和特护中。
麻醉：对住院患者，终止以苯二氮卓诱导和维持的全身麻醉。
特护：提供苯二氮卓中毒或排除其中毒的诊断依据，并可作为苯二氮卓过量时中枢作用的特效逆转剂。

用法用量：
麻醉：在 15s内给予首次剂量 0.2mg静脉内注射，若注射后 60s内未达到所要求的清醒程度，第 2次剂量为 0.1mg，必要时可间隔 60s再重复 1次，直至总量 1mg，通常剂量为 0.3～0.6mg。
特护：首次静注 0.3mg，如果在 60s内仍未达到所要求的清醒程度，可再重复使用直至患者清醒或达总量 2mg。如果再出现嗜睡，可每小时静脉滴注 0.1～0.4mg，滴注速度根据所要求唤醒的程度来调节。 长期大剂量苯二氮卓治疗的患者静注氟马西尼后若发生意外的过度兴奋体征，可静注 5mg地西泮或 5mg咪唑安定。
[剂型与规格]针剂：0.5mg/5ml，1mg/10ml。

不良反应：
常见的不良反应有恶心、呕吐和脸色潮红。快速静注氟马西尼后还会有焦虑、心悸、恐惧等不适感。少数患者出现短暂的血压升高、心率加快。长期接受苯二氮卓的患者可能会出现氟马西尼撤药性反应。

禁忌症
对氟马西尼过敏者禁用；除绝对需要和紧急情况，一般妊娠期和哺乳期妇女不宜使用。对于从事驾驶和精神运动的患者，静注氟马西尼后仍不应参与精神完全集中的危险职业。

药物相互作用
氟马西尼在受体水平经相互竞争以阻断苯二氮卓受体结合的非苯二氮卓类激活剂如佐匹克隆和三唑邻二氮苯。未见与其他中枢神经系统抑制剂的相互作用。

Romazicon
Generic Name: Flumazenil (FLOO-may-ze-nil)
Brand Name: Romazicon

Romazicon may cause seizures, especially in patients who have been on benzodiazepines (eg, diazepam) for a long time or if a patient has taken too much of a benzodiazepine (overdose).

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Romazicon is used for:
Reversing drowsiness, sedation, and other effects caused by benzodiazepines.

Romazicon is a benzodiazepine antagonist. It works by blocking receptors in the brain and central nervous system that benzodiazepines need to reach to be active, which helps reduce drowsiness and sedation.

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Do NOT use Romazicon if:
you are allergic to any ingredient in Romazicon or to benzodiazepines (eg, alprazolam)
you have been given a benzodiazepine for control of a potentially life-threatening condition (eg, increased pressure in the head, seizures)
you are experiencing side effects due to an overdose of a medicine used to treat depression

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Romazicon:
Some medical conditions may interact with Romazicon. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine (especially benzodiazepines), herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a history of seizures, panic disorder, liver problems, alcohol or other substance abuse, or you have had a recent head injury

Some MEDICINES MAY INTERACT with Romazicon. However, no specific interactions with Romazicon are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Romazicon may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

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How to use Romazicon:
Use Romazicon as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Romazicon is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Romazicon at home, carefully follow the injection procedures taught to you by your health care provider.
If Romazicon contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
If Romazicon accidentally spills on your skin, wash it off immediately with soap and water.
Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
If you miss a dose of Romazicon, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Romazicon.

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Important safety information:
Romazicon may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Romazicon. Using Romazicon alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
Avoid drinking alcohol or taking other medicines that cause drowsiness (eg, sedatives, tranquilizers) for at least 24 hours after receiving Romazicon. Romazicon will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
Although Romazicon is given to reverse drowsiness, you may experience a return of drowsiness for up to 24 hours after Romazicon is given. If you notice a return of drowsiness or experience shortness of breath, contact your doctor as soon as possible.
Romazicon is not recommended for use in CHILDREN younger than 1 year of age. Safety and effectiveness in this age group have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Romazicon, discuss with your doctor the benefits and risks of using Romazicon during pregnancy. It is unknown if Romazicon is excreted in breast milk. If you are or will be breast-feeding while you are using Romazicon, check with your doctor or pharmacist to discuss the risks to your baby.

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Possible side effects of Romazicon:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Abnormal or blurred vision; abnormal skin sensations; changes in vision; clumsiness; dizziness; dry mouth; feeling of a whirling motion; flushing; general body discomfort; headache; hot flashes; increased sweating; nausea; nervousness; pain at the injection site; restlessness; sleeplessness; sweating; tiredness; tremors; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; change in behavior, mood, or emotions (eg, anxiety, depression); pounding in the chest; rapid deep breathing; seizures.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. 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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If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; anxiety; emotional or mood changes; increased sensitivity to pain or touch; seizures.

Proper storage of Romazicon:
Romazicon is usually handled and stored by a health care provider. If you are using Romazicon at home, store Romazicon as directed by your pharmacist or health care provider. Keep Romazicon out of the reach of children and away from pets.

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General information:
If you have any questions about Romazicon, please talk with your doctor, pharmacist, or other health care provider.
Romazicon is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Romazicon. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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 详细处方信息以本药内容附件PDF文件（2010102719105537.pdf）的“原文Priscribing Information”为准
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2011-3-2更新