药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201061118334739.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文Besivance处方资料(仅供参考)
2009年5月29日,博士伦公司宣布美国食品药品管理局(FDA)批准0.6% Besivance(贝西沙星混悬型滴眼液)用于治疗细菌性结膜炎(俗名“红眼病”)。Besivance是一种局部眼用制剂,加入无菌滴眼剂给药,为针对眼部致病菌(其中包括细菌性结膜炎的最常见致病菌)的广谱抗菌药。据生产商称,Besivance是第一个专用针对眼部研发的氟喹诺酮类药物,也是第一个且惟一一个既往未全身应用的眼用氟喹诺酮类药物。
FDA基于8项临床试验的结果批准Besivance的应用。这些研究旨在检测此局部抗菌药的疗效、安全性、耐药性、药代动力学以及药效动力学。有3项多中心、随机、双盲试验对Besivance的疗效进行了评价,共纳入了近2,400例临床上诊断为细菌性结膜炎的患者。在临床试验中,与接受仅含防腐剂的对照液处置的患者相比,接受Besivance治疗的患者感染消除速率较快。研究表明,Besivance可有效治疗年龄≥1 岁的患者。
Besivance适用于治疗年龄≥1 岁、由下列细菌的致病分离物所致的细菌性结膜炎患者:CDC棒状杆菌G群,假白喉棒杆菌,纹带棒杆菌,流感嗜血杆菌,腔隙莫拉菌,金黄色葡萄球菌,表皮葡萄球菌,人葡萄球菌,路邓葡萄球菌,缓症链球菌群,口腔链球菌,肺炎链球菌以及唾液链球菌。值得一提的是,Besivance针对上述某些细菌的疗效测试是在不足10例的感染患者中进行的。
Besivance的临床研究中患者报告的最常见的不良事件是结膜发红,大约占病例的2%。患者中有1%~2%报告了其他不良事件,其中包括视力模糊、头痛、眼痛、易怒以及瘙痒。
正如其他抗感染药一样,长期应用Besivance可导致真菌等非致病菌过度生长。若发生双重感染,则停用Besivance,选用替代药物治疗。不建议Besivance全身用药,全身应用喹诺酮类药物,即使是单剂治疗,亦可引发超敏反应。应建议患者在首次出现皮疹或过敏反应的征象后,立即停药并与其医生联系。
Besivance Generic Name: besifloxacin ophthalmic (BE si FLOX a sin) Brand Names: Besivance
What is Besivance? Besivance (besifloxacin) is in a group of antibiotics called fluoroquinolones (flor-o-KWIN-o-lones). Besifloxacin fights bacteria in the body.
Besivance ophthalmic (for the eyes) is used to treat bacterial infections of the eyes.
Besivance may also be used for other purposes not listed in this medication guide.
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Important information about Besivance You should not use Besivance if you are allergic to besifloxacin.
Use this medication 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.
Serious side effects of Besivance may include eye drainage or crusting, severe eye irritation, feeling like there is something in your eye, eye redness or swelling, fever, or any signs of new infection.
Keep using Besivance for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.
Do not use this medication 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 Besivance before putting your contact lenses in.
You should not wear contact lenses while you still have active symptoms of the eye infection you are treating.
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Before using Besivance You should not use Besivance if you are allergic to besifloxacin.
FDA pregnancy category C. It is not known whether Besivance is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether besifloxacin passes into breast milk or if it could harm a nursing baby. Do not use Besivance without telling your doctor if you are breast-feeding a baby.
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How should I use Besivance? Use Besivance 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.
Besivance is usually given 3 times per day for 7 days. Follow your doctor's instructions. Space your doses at least 4 hours apart.
To apply the eye drops: Turn the bottle upside down and shake it once before each use. Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the 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. 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.
Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.
Store Besivance at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.
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What happens if I miss a dose? Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed 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 Besivance is not likely to cause life-threatening symptoms.
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What should I avoid while using Besivance? Do not use Besivance while you are wearing contact lenses. Besivance may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using the medication before putting your contact lenses in.
You should not wear contact lenses while you still have active symptoms of the eye infection you are treating.
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Besivance side effects Get emergency medical help if you have any of these signs of an allergic reaction to Besivance: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as: drainage or crusting of your eye; severe eye irritation after using the eye drops; feeling like there is something in your eye; severe eye redness or swelling; or fever, or any signs of a new infection.
Less serious Besivance side effects may include: eye redness or pain; itchy or irritated eyes; headache; or blurred vision.
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 Besivance? It is not likely that other drugs you take orally or inject will have an effect on Besivance used in the eyes. But many drugs can interact with each other. 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 Besivance.
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.
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201061118334739.pdf)的“原文Priscribing Information”为准 ---------------------------------------------------------------
2010年6月12日更新 |