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  药店国别: 美国药房
产地国家: 澳大利亚
所属类别: 眼科药物->治疗青光眼药物
处方药:处方药
包装规格: 10毫升/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
ALLERGAN
生产厂家英文名:
ALLERGAN
该药品相关信息网址1:
http://www.allergan.com/
该药品相关信息网址2:
http://www.drugs.com/combigan.html
原产地英文商品名:
COMBIGAN EYE DROPS 10ml/bottle
原产地英文药品名:
BRIMONIDINE TARTRATE+TIMOLOL MALEATE
中文参考商品译名:
COMBIGAN滴眼液10毫升/瓶
中文参考药品译名:
酒石酸臭莫尼定+马来酸噻吗洛尔
原产地国家批准上市年份:
2007/10/30
英文适应病症1:
High intraocular pressure
英文适应病症2:
Chronic open angle glaucoma and chronic angle closure glaucoma
临床试验期:
完成
中文适应病症参考翻译1:
高眼壓
中文适应病症参考翻译2:
慢性隅角開放性青光眼及慢性隅角閉鎖性青光眼
药品信息:


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 详细处方信息以本药内容附件PDF文件(201041205520535.pdf)的“原文Priscribing Information”为准
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部分中文Combigan处方资料(仅供参考)

    英文药名: Combigan (BRIMONIDINE TARTRATE/TIMOLOL MALEATE)
    中文药名: 酒石酸臭莫尼定-马来酸噻吗洛尔滴眼液

    作用:適用於慢性隅角開放性青光眼及慢性隅角閉鎖性青光眼合併已接受為暢通的周邊虹膜切除術或高眼壓病人,當以上病患使用單方降眼壓製劑控制效果不佳時,本品可作為降眼壓之用。

BRIMONIDINE TARTRATE(酒石酸溴莫尼定)
    主要成分化学名:5-溴-6-(2-咪唑啉-2-基)氨基喹喔啉L-酒石酸
         5-Bromo-6-(2-imidazolin-2-ylamino)quinoxaline tartrate
    其它名称:AGN190342-LF,UK14304-18,SK,F190342-LF
    酒石酸溴莫尼定滴眼液的药理学综述
    (1)药理作用
    本品具有双重作用机制,即通过减少房水的产生及增加房水的巩膜色素膜外流而降低眼
压。
    降眼压作用:眼压正常的白兔眼,用浓度由0.0001%~0.5%的酒石酸溴莫尼定局部点眼单滴试验,发生系列的降眼压作用,其中0.1%产生最佳的降眼压效果,最大下降值为5.1±0.6mmHg;眼压正常白兔眼,用浓度由0.08%~0.8%的酒石酸溴莫尼定连续6个月、每天2次局部点眼试验,浓度为0.08%,0.2%,0.5%,0.8%眼压的最大下降值分别为3.9±0.4,5.1±0.4,6.9±0.3,7.1±0.4mmHg;在猴眼,用浓度分别为0.3%,0.5%,1.0%的酒石酸溴莫尼定可分别降低眼压4.9±2.0,9.9±1.2,7.3±1.5mmHg;高眼压猴,用氯胺酮麻醉后,滴0.5%的酒石酸溴莫尼定可使平均眼压最大下降22.3±3.2mmHg(发生在点药后4小时);猫眼,0.1%酒石酸溴莫尼定眼压最大下降值为6.9±1.1mmHg。
     对瞳孔的影响:瞳孔开大肌上有α1受体,刺激此受体可使瞳孔放大,酒石酸溴莫尼定对α2受体的选择性高于α1受体的1000倍,因此对瞳孔几乎无影响。
    对血管收缩性的影响:治疗浓度的酒石酸溴莫尼定对血管收缩无影响。
    神经保护作用:对成年大鼠视神经的研究发现,酒石酸溴莫尼定可防止由挤压伤引起的视神经和视网膜节细胞的继发变性。挤压伤后腹膜内注射酒石酸溴莫尼定100μg/kg,可使视神经的应激性增加2.5倍,使视神经细胞的活性增加4倍。
   (2)药动学及毒性
    酒石酸溴莫尼定不仅分布于眼球的前节,而且也能达到后节,大部分经肝脏代谢,经肾脏排泄。
    大量动物试验表明酒石酸溴莫尼定是安全的。在长达一年的眼部(浓度0.08%~0.8%,每日2次)和全身(0.1~2.5mg/kg,口服)用   药证明,酒石酸溴莫尼定对各种器官均无毒性;对生殖也无影响,无致癌和致畸形作用。
   (3)临床评价
    在治疗原发性开角型青光眼和高眼压患者时,0.2%酒石酸溴莫尼定有显著的降眼压作用,并有较好的眼部耐受性,对呼吸系统和心血管系统的影响也较小。降眼压作用:0.5%酒石酸溴莫尼定可有效地防止氩激光小梁成形术(ALT)引起的眼压升高,使眼压下降幅度高于赋形剂10mmHg,对术后3小时发生的眼压升高,用药组的发生率为1%~2%,而对照组为23%;0.2%和0.5%的酒石酸溴莫尼定均有显著的降眼压作用,最大的降眼压值分别为6.7±3.6和7.7±3.5mmHg,降眼压效果大致相同,对于原发性开角型青光眼和高眼压长期使用者,0.2%为最佳浓度,而对于ALT手术者多选用0.5%的酒石酸溴莫尼定;
    耐受性:使用4种不同浓度的酒石酸溴莫尼定(0.08%,0.2%,0.35%,0.5%)和其赋形剂
进行观察,一眼用酒石酸溴莫尼定,另一眼用赋形剂,每日点2次,连续5天,结果表明,酒石酸溴莫尼定有明显的降眼压的作用,且局部和全身能够很好地耐受此药,仅0.5%有不适感;
    安全性:在ALT手术前后使用酒石酸溴莫尼定,0.5%酒石酸溴莫尼定的基础心率与对照组相比无明显变化,手术前后收缩压和舒张压均略有下降,无临床意义;点药后的副作用有视物模糊、刺痛及烧灼感、口干、眼睑退缩、结膜苍白、疲劳等。

TIMOLOL MALEATE(马来酸噻吗洛尔)
    药物相互作用:
  1.与肾上腺素合用可引起瞳孔扩大。2.不主张两种局部p受体阻断剂同时应用。3.本品与钙通道拮抗剂合用应慎重,囚可引起房室传导阻滞,左心室衰竭及低血压。肘心功能受损的患者,应避免两种药合并使用4.正在服用儿茶酚胺耗竭药(如利血平)者,使用本品时应严密观察,因可引起低血压和明显的心动过缓。5.本品与洋地黄类和钙通道拮抗剂合用可进一步延长房室传导时间。 6,本品与奎宁丁合用能引起心率减慢等全身p受休阻断的副作用。可能的原因是奎宁丁可抑制P450酶和CYPZD6对噻吗洛尔的代谢作用。
  药理作用:
  药理作用:马来酸噻吗洛尔是一种非选择性p—肾上腺能受体阻滞剂,没有明显的内源性拟交感活性和局麻作用,对心肌无直接抑制作用。本品为马来酸噻吗洛尔滴眼液.对高眼压患者和正常人均有降低眼内压作用、其降低眼内压的确切机理尚不清楚,眼压描记和房水荧光光度研究提示本品的降眼压作用与减少房水生成有关非临床毒理研究:致癌性:动物实验显示长期大量口服马来酸噻吗洛尔可使雄性大鼠肾卜腺嗜铬细胞瘤,雌性小鼠良性及恶性肺部肿瘤,良性子宫息肉及乳腺痛的发生率明显增高。生殖毒性:动物实验显示大剂量门服马来酸噻吗洛尔,对雄、雌性小鼠的生殖功能均无影响。
    孕妇及哺乳期妇女用药:本品对于孕妇的安全性尚未确定。滴眼后可在哺乳期妇女乳汁中测到本品,因对授乳婴儿具有多种潜在不良反应,需根据滴用本品对母亲的重要性决定终止哺乳或终止用药。
  儿童用药:本品对于儿童的安全性和疗效尚未确定。
  药物相互作用:1.与肾上腺素合用可引起瞳孔扩大。2.不主张两种局部β受体阻断剂同时应用。3.本品与钙通道拮抗剂合用应慎重,因可引起房室传导阻滞,左心室衰竭及低血压。对心功能受损的患者,应避免两种药合并使用。4.正在服用儿茶酚胺耗竭药(如利血平)者,使用本品时应严密观察,因可引起低血压和明显的心动过缓。5.本品与洋地黄类和钙通道拮抗剂合用可进一步延长房室传导时间。6.本品与奎宁丁合用能引起心率减慢等全身β受体阻断的副作用。可能的原因是奎宁丁可抑制P450酶和CYPZD6对噻吗洛尔的代谢作用。
   药物过量:过量应用本品可引起类似全身应用β受体阻断剂的副作用,如头晕,头痛,气短,心动过缓,支气管痉挛及心搏停止。
    适应症:
  对原发性开角型青光眼具有良好的降低眼内压疗效。对于某些继发性青光眼,高眼压症,部分原发性闭角型青光眼以及其他药物及手术无效的青光眼,加用本品滴眼可进一—步增强降眼压效果。
    禁忌:
  1.支气管哮喘者或有支气管哮喘史者,严重慢性阻塞性肺部疾病。2.窦性心动过缓,II或III度房室传导阻滞,明显心衰,心源性休克。3.对本品过敏者。
  注意事项:
  1.当出现呼吸急促、脉搏明显减慢、过敏等症状时,请立即停止使用本品。2.使用中若出现脑供血不足症状时应立即停药,3.心功能损害者,使用本品时应避免服用钙离子拮抗剂.4.对无心衰史的患者,如出现心衰症状应立即停药。5.正在服用儿茶酚胺耗竭药(如利血平)者,使用本品时应严密观察。6.冠状动脉疾患、糖尿病、甲状腺功能亢进和重症肌无力患者,用本品滴眼时需遵医嘱。7.本品慎用于自发性低血糖患者及接受胰岛素或口服降糖药治疗的患者,因p受体阻滞剂可掩盖低血糖症状。8.本品不宜单独用于治疗闭角型青光眼。9.与其他滴眼液联合使用时,请间隔lO分钟以上。10.定期复查眼压,根据眼压变化调整用药方案11.用前应摇匀,避免容器尖端接触眼睛,防止滴眼液污染。


Combigan
Generic Name: brimonidine and timolol ophthalmic (bri MOE ni deen and TIM oh lol)
Brand Names: Combigan

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What is Combigan?
Combigan contains brimonidine and timolol.

Brimonidine is an alpha-agonist that reduces the amount of fluid in the eye, which decreases pressure inside the eye.

Timolol is a beta-blocker that also reduces pressure inside the eye.

Combigan is used to treat glaucoma or ocular hypertension (high pressure inside the eye).

Combigan may also be used for other purposes not listed in this guide.

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Important information about Combigan
Do not use Combigan 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.

You should not use Combigan if you are allergic to brimonidine (Alphagan) or timolol (Timoptic, Cosopt), or if you have certain conditions. Be sure your doctor knows if you have asthma, or severe chronic obstructive pulmonary disease (COPD), heart disease or heart failure, slow heartbeats, or a heart condition called "AV block."

Before using Combigan, tell your doctor if you have diabetes, overactive thyroid, circulation problems, allergies, low blood pressure, myasthenia gravis, or a history of depression

Do not use Combigan while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using Combigan before putting your contact lenses in.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

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Before using Combigan
Do not use Combigan 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.

You should not use Combigan if you are allergic to brimonidine (Alphagan) or timolol (Timoptic, Cosopt), or if you have certain conditions. Be sure your doctor knows if you have:
asthma, or severe chronic obstructive pulmonary disease (COPD);
heart disease or heart failure;
slow heartbeats; or
a heart condition called "AV block."

If you have any other conditions, you may need a dose adjustment or special tests to safely use Combigan:
depression;
diabetes;
overactive thyroid;
circulation problems, such as Raynaud's syndrome or Buerger's disease;
a history of fainting or low blood pressure;
allergies; or
a muscle disorder such as myasthenia gravis.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use Combigan.

FDA pregnancy category C. Combigan may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Brimonidine and timolol can pass into breast milk and may harm a nursing baby. Do not use Combigan without telling your doctor if you are breast-feeding a baby.

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How should I use Combigan?
Use Combigan exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before using the eye drops. Do not use Combigan while you are wearing contact lenses. Combigan may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using the eye drops before putting your contact lenses in.

To apply the eye drops:
Tilt your head back slightly and pull down your lower eyelid. Hold the Combigan dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.
Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.
If you use any other eye medications, wait about 5 minutes after using Combigan eye drops before using the other medication.
Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use Combigan if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

Tell your doctor right away if you have any eye injury or infection. If you have any type of surgery, including eye surgery, tell the surgeon ahead of time that you are using Combigan. You may need to stop using the medicine for a short time.

Store Combigan at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

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What happens if I miss a dose?
Use the medication 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, or if anyone has accidentally swallowed it.

Overdose symptoms may include dizziness, headache, slow heart rate, and feeling short of breath or like you might pass out.

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What should I avoid while using Combigan?
Combigan 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. Avoid using any eye medications your doctor has not prescribed. Cold or allergy medicine, narcotic pain medicine, sleeping pills, sedatives, and medicine for seizures can add to sleepiness caused by Combigan. Tell your doctor if you regularly use any of these medicines.

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Combigan side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Combigan: 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:
severe swelling, itching, burning, redness, pain, or discomfort in or around your eye;
bronchospasm (wheezing, chest tightness, trouble breathing);
pounding heartbeats or fluttering in your chest;
slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
feeling like you might pass out;
numbness, tingling, or cold feeling in your hands or feet;
muscle weakness; or
confusion, hallucinations, unusual thoughts or behavior.

Less serious Combigan side effects may include:
mild burning, stinging, or itching of your eyes;
dry eyes, blurred vision;
mildly swollen or puffy eyes;
feeling like something is in your eye;
weakness, tired feeling;
cough, sore throat;
nausea, upset stomach;
headache;
drowsiness;
unusual or unpleasant taste in your mouth;
sensitivity to light;
dry nose;

Side effects other than those listed here may also occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Combigan side effects in more detail

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What other drugs will affect Combigan?
Before using Combigan, tell your doctor if you are using any of the following medications:
an antidepressant;
blood pressure medications;
cimetidine (Tagamet);
digoxin (digitalis, Lanoxin);
HIV /AIDS medicine such as ritonavir (Norvir);
an antihistamine such as diphenhydramine (Benadryl);
an antifungal antibiotic such as terbinafine (Lamisil);
anti-malaria medication such as hydroxychloroquine (Plaquenil);
medicine to treat psychiatric disorders, such as thioridazine (Mellaril);
a heart rhythm medication such as propafenone (Rythmol) or quinidine (Quinidex, Quin-Release Quin-G);
a calcium channel blocker such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), nifedipine (Procardia, Adalat), verapamil (Calan, Covera, Isoptin, Verelan), and others; or
another beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta, Ziac), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), timolol (Betimol, Blocadren, Cosopt, Timoptic, Istalol), and others.

This list is not complete and there may be other drugs that can interact with Combigan. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

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Where can I get more information?
Your pharmacist can provide more information about Combigan.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Combigan only for the indication prescribed.

Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive.

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. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.


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 详细处方信息以本药内容附件PDF文件(201041205520535.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

于2010年4月12日更新

更新日期: 2010-4-12
附件:
 
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