英文药名: Alphagan P(Brimonidine Eye Solution)

中文参考药名: 阿法P(溴莫尼定滴眼液)

生产厂家: Allergan

药物名称

【通用名】酒石酸溴莫尼定滴眼液
【商品名】阿法根滴眼液
【英文名】Alphagan
【成分】酒石酸溴莫尼定
【性状】本品为淡黄绿色澄明液体。 
药理毒理

药理研究作用机制：酒石酸溴莫尼定为一种α?肾上腺素受体激动剂。用药后两小时降眼压效果达到峰值。在动物及人体中用荧光光度测定法进行的研究表明，酒石酸溴莫尼定具有双重的作用机制；既减少房水的生成，又增加葡萄膜巩膜的外流。临床药理研究，眼内压升高是造成青光眼性视野缺损的主要危险因素，眼内压越高，视神经受损和视野缺损的可能性也就越大。酒石酸溴莫尼定有降低眼内的作用，而对心血管和肺功能的影响很小。在多项长达一年与0.5%噻吗心安对比的临床研究中，酒石酸溴莫尼定滴眼液降低眼内压约4～6mmHg，噻吗心安约6mmHg。因未能适当地控制眼内压而退出研究的受试者占80%，其中30%发生在治疗的第一个月，因各种不良反应而未继续用药者占20%。
毒理研究：为期一年猴眼部安全性研究中滴用约4倍推荐剂量的酒石酸溴莫尼定也未见显著眼部毒性。致癌作用、致突变作用及对生殖能力的损害，在给小鼠和大鼠每日分别口服2.5mg/kg和1.0mg/kg剂量（按推荐的滴眼剂量计，分别约在人血浆中本品的77和118倍），为期21个月和2年的研究观察中，均未见任何与药物有关的致癌作用。在一系列体内及体外的研究，包括Ames试验，宿主一介导分析，中国仓鼠卵巢（CHO）细胞染色体畸变试验，小鼠促细胞发生的研究以及显性致死分析中，酒石酸溴莫尼定均无任何致突变或促细胞发生作用。妊娠（致畸作用）：大鼠口服溴莫尼定0.55mg/kg的生殖研究表明，溴莫尼定不影响动物的生殖能力，对胎鼠亦无任何损害，此剂量相当于给人多次滴眼后人血浆中药物浓度的100倍。 
药代动力学

眼部给予溶液后，血浆浓度于1～4小时内达到峰值，然后下降，全身的半衰期约为3小时，在人体中，溴莫尼定的全身代谢是广泛的，主要代谢部位为肝脏。原形药物及其代谢物主要经尿排泄。口服放射性标记的溴莫尼定后，约87%的药物在120小时内被消除，尿中约占74%。 
适应症

本品适用于降低开角型青光眼及高眼压症患者的眼内压，部分患者长期使用本品时，其降低眼内压的作用逐渐减弱。作用减弱出现的时间因人而异，因此应予以密切监视。 
用法用量

滴入眼睑内：常规剂量滴患眼每日2次，每次1滴，眼内压在下午达高峰的患者或眼内压需额外控制的患者，下午可增加一滴。
任何疑问，请遵医嘱！ 
不良反应

约有10-30%的受试者曾出现以下不良反应，按降序排列，包括口干，眼部充血，烧灼感及刺痛感、头痛、视物模糊、疲劳/倦怠、结膜滤泡、眼部过敏反应以及眼部瘙痒，约有3-9%的受试者曾出现以下不良反应，按降序排列，包括角膜染色/糜烂、畏光、眼睑红斑、眼部酸痛/疼痛、眼部干燥、流泪、上呼吸道症状、眼睑水肿、结膜水肿、头晕、睑炎、眼部刺激、胃肠道症状、虚弱无力、结膜变白、视物异常以及肌肉痛，有不足3%的患者曾出现以下不良反应，包括眼睑痂、结膜出血、味觉异常、失眠、结膜分泌物增多、精神抑郁、高血压、焦虑、心悸、鼻干以及晕厥。 
禁忌

本品禁用于对酒石酸溴尼定或本品中任何成份过敏者，亦禁用于使用单胺氯化抑制剂治疗的患者。 
注意事项

一般注意事项：尽管临床研究中本品对患者的血压影响甚小，但有严重心血管疾患的患者使用的仍应谨慎，由于未进行肝或肾功能受损患者使用本品的研究，故在治疗此类患者时，应谨慎，精神抑郁，大脑或冠状动脉机动不，雷诺氏现象，直立性低血压，血栓闭塞性脉管炎的患者，使用本品均谨慎，研究期间某些患者使用本品的作用减弱，使用酒石酸莫尼定滴眼液治疗时，在第一个月观察到降眼压未必都能反映长期降眼压的水平，对每日2次用药尚不能很好控制眼内压的患者不午应再增加1滴，对使用降眼压药的患者，应按常规期监测眼内压。
患者须知；本品中使用的保存剂为苯扎氯铵，而苯扎氯铵有可能被软性接触镜，困此应向配戴软性接触镜的患者说明，在滴用本品后至少等待15分钟再配戴，与各种α?肾上腺素能受体激动剂一样，本品亦可使某些患者产生疲劳和/或倦怠，因此应提醒从事危险作业的患者使用本品有出现精神集中下降的可能性。 
孕妇及哺乳期妇女用药

孕妇用药：未进行孕妇使用本品的研究，但在动物研究中有极少量的溴莫尼定可通过胎盘，进入胎鼠的循环系统，因此只有判定本品可能给母亲带来的利益大于给胎儿带来的潜在危险时，方可使用。
哺乳期妇女用药：虽然在动物试验中已发现酒酸溴尼定出现心博徐缓、血压过低，降低体温，张力减弱以及呼吸暂停的症状。 
老年患者用药

年龄较大患者（65岁以上患者）单剂量使用溴莫尼定后的Cmax、AUC以及半衰期与年轻人相同，表明溴莫尼定的全身吸收和消除不受年龄影响。包括年龄较大患者参加的为期3个月临床研究的数据显示，溴莫尼定对全身的影响非常小。 
药物相互作用

虽然尚未对本品的药物间相互作用做过专门的研究，但与中枢神经系统抑制药（酒精、巴比妥类、鸦片制剂、镇静剂或麻醉剂）产生叠加作用或使之强化的可能性应予以考虑，临床研究中并未发现本品对脉搏或血压有明显影响，但由于α-受体激动剂也有使脉搏减慢或使血压药和/或强心药物时，亦应予以注意，文献中报道三环类抗抑郁药要使全身用戴压定（clonidine）的降压作用减弱，同时使用这类药物是否会干扰本品的降眼压作用，尚不明确。滴用本品后是否影响循环中的儿茶酚胺水平高亦无资料可寻。然而，当患者服用能影响循环中胺类的代谢或摄取的三环类抗抑郁药时，应慎用本品。 
药物过量

未见过药物过量的报道，口服本品过量时可采用支持疗法或对症治疗，应保持呼吸道通畅。

包装规格：

0.15% 2支 x 5ml  
0.15% 3支 x 5ml 

Alphagan P 0.1 % Eye Drops
 
Medication name
Generic name: Brimonidine Solution - Ophthalmic
Pronunciation: (bri-MOE-ni-deen)
Brand name(s): Alphagan P
Uses
This medication is used to treat open-angle glaucoma or high fluid pressure in the eye. Lowering high fluid pressure in the eye reduces the risk of vision loss, nerve damage, or blindness. This medication lowers pressure by allowing better fluid drainage from within the eye and also by reducing the amount of fluid formed in the eye. It is known as an alpha agonist.This drug is not recommended for use in children less than 2 years of age due to an increased risk of serious side effects such as very slowed breathing. Ask the doctor or pharmacist for details.
How to use
To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.If you are wearing contact lenses, remove them before using this medication. After applying this medication, wait at least 15 minutes before putting in your contact lens.Tilt your head back, look upward and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and insert one drop, usually three times daily, or as directed by your doctor. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. Try not to blink and do not rub your eye. This will prevent the medication from draining out. Repeat these steps for your other eye if so directed by your doctor.Do not rinse the dropper. Replace the dropper cap after each use.If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 minutes before applying the other medications. Use eye drops before eye ointments to allow the eye drops to enter the eye.It is important to continue this medication even if you do not have any symptoms. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day. Do not stop using this medication without consulting your doctor.Inform your doctor if your condition worsens.
Precautions
Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to apraclonidine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood vessel diseases (thromboangiitis obliterans), blood circulation disorders (cerebral or coronary insufficiency), depression, severe heart disease, kidney disease, liver disease, Raynaud's disease, low blood pressure upon standing (orthostatic hypotension).This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.Caution is advised when using this medication in children because they may be more sensitive to its side effects, especially drowsiness. See also Uses section.This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Drug interactions
Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.This drug should not be used with the following medications because very serious interactions may occur: MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine).If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: beta-blockers (e.g., atenolol, metoprolol, timolol eye drops), digoxin, high blood pressure medications (e.g., clonidine, terazosin), tricyclic antidepressants (e.g., amitriptyline).Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: antihistamines that cause drowsiness (e.g., diphenhydramine), anti-anxiety drugs (e.g., diazepam), anti-seizure drugs (e.g., carbamazepine), barbiturates (e.g., phenobarbital), medicine for sleep (e.g., zolpidem), muscle relaxants (e.g., cyclobenzaprine), narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine), tranquilizers.Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
Side effects
Eye discomfort/itching/redness, blurred vision, dizziness, dry mouth, drowsiness, or tiredness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/pounding heartbeats, persistent headache, eye pain/burning/swelling, extreme sensitivity to light, vision changes.Tell your doctor immediately if any of these rare but very serious side effects occur: fainting, slow/irregular heartbeats.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Missed dose
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Overdose
If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. This medication may be harmful if swallowed.
Notes
Do not share this medication with others.Laboratory and/or medical tests (e.g., measuring intraocular pressure) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
Storage
Store at room temperature between 59 and 77 degrees F (15-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Photos by medication strength
Click the "Photos" link to see sample photographs for a specific medication strength.
Common strengths  
Alphagan P 0.1 % Eye Drops *Photos   
Alphagan P 0.1 % Eye Drops
PrintThe photos shown are samples only. Not all photos of the drug may be displayed. Your medication may look different. If you have questions, ask your pharmacist. 
 
Alphagan P 0.15 % Eye Drops *Photos   
Alphagan P 0.15 % Eye Drops
PrintThe photos shown are samples only. Not all photos of the drug may be displayed. Your medication may look different. If you have questions, ask your pharmacist. 
 
*The photos shown are samples only. Not all photos of the drug may be displayed. Your medication may look different. If you have questions, ask your pharmacist. 
Important note
HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised October 2011 Copyright(c) 2011 First DataBank, Inc.

Ophthalmic
Drops
1
1
brimonidine tartrate|
Increased Intraocular Pressure|Increased IOP|Raised Intraocular Pressure|Glaucoma Simplex|Compensated Glaucoma|Open-Angle Glaucoma|Simple Glaucoma|Chronic Glaucoma|
Increased Pressure in the Eye|Wide-Angle Glaucoma|
OHT|
Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First DataBank, Inc., 2012. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.